Download Victorian Prostate Cancer Clinical Registry

FIVE YEAR REPORT Victorian Prostate Cancer
Clinical Registry
VIC PCR 5-YEAR REPORT
This publication was produced on behalf of the Victorian Prostate Cancer Clinical Registry (Vic PCR)
and was approved by the Vic PCR Steering Committee.
Suggested citation. Sampurno F and Evans SM (eds) for the Victorian Prostate Cancer Clinical
Registry Steering Committee. Victorian Prostate Cancer Clinical Registry - Five Year Report
[Internet] Melbourne, Victoria. Monash University (2015) Available at http://pcr.registry.org.au
Victorian Prostate Cancer Clinical Registry (Vic PCR)
Editors: Fanny Sampurno
A/Professor Sue Evans
Cover design by Jessica Callaghan
Level 6, The Alfred Centre
99 Commercial Road, Prahran, VIC 3004
Tel: +61 3 9903 0245
Fax: +61 3 9903 0556
Email: [email protected]
Website: http://pcr.registry.org.au
© Victorian Prostate Cancer Clinical Registry (2015)
The Vic PCR acknowledges the support of these organisations
Contents
List of Figures ................................................................................................................................................ 3 List of Tables ................................................................................................................................................. 4 List of Abbreviations ..................................................................................................................................... 5 Foreword ....................................................................................................................................................... 6 About the Vic PCR ......................................................................................................................................... 8 Vic PCR Governance ...................................................................................................................................... 9 ISO 27001 Certified Web‐Based Registry .................................................................................................... 11 International Collaborators ......................................................................................................................... 12 Significant Milestones ................................................................................................................................. 13 Methodology ............................................................................................................................................... 14 Recruitment and Data Collection Process .............................................................................................. 14 Data Quality and Data Access ................................................................................................................. 15 Ethical Review ......................................................................................................................................... 16 Findings from the Vic PCR ........................................................................................................................... 17 Data Completeness ................................................................................................................................. 17 Documentation of Clinical T Stage .......................................................................................................... 18 Number of Notifications ......................................................................................................................... 19 Benchmarking Reports ................................................................................................................................ 23 Gippsland Project ........................................................................................................................................ 27 Validation Study .......................................................................................................................................... 28 Patterns of Care .......................................................................................................................................... 30 Patient Characteristics ............................................................................................................................ 30 Risk of Disease ......................................................................................................................................... 32 Method of Diagnosis ............................................................................................................................... 33 Treatment ............................................................................................................................................... 34 Low Risk Disease ................................................................................................................................. 34 Intermediate Risk Disease ................................................................................................................... 35 High Risk Disease ................................................................................................................................ 36 Very High Risk or Metastatic Disease ................................................................................................. 37 Type of Surgical Approach .................................................................................................................. 38 VIC PCR | 5‐YEAR REPORT 1 Diagnosis to Initial Treatment over Time ................................................................................................ 39 Diagnosis to Initial Treatment by Location of Hospital where Diagnosed .............................................. 40 Reported Urinary Bother at 12 and 24 Months Post Diagnosis .............................................................. 41 Reported Bowel Bother at 12 and 24 Months Post Diagnosis ................................................................ 42 Reported Sexual Bother at 12 and 24 Months Post Diagnosis ............................................................... 43 Concluding Remarks .................................................................................................................................... 44 Getting to Know Our Registry Team… ........................................................................................................ 45 Publications ................................................................................................................................................. 48 2014 ........................................................................................................................................................ 48 2013 ........................................................................................................................................................ 48 2012 ........................................................................................................................................................ 48 Presentations .............................................................................................................................................. 49 2013 ........................................................................................................................................................ 49 2012 ........................................................................................................................................................ 49 2011 ........................................................................................................................................................ 50 2010 ........................................................................................................................................................ 50 Funding ....................................................................................................................................................... 51 Acknowledgements ..................................................................................................................................... 52 Appendices .................................................................................................................................................. 54 Appendix A. NCCN Risk Category ............................................................................................................ 54 Appendix B. PRIAS Protocol .................................................................................................................... 55 Appendix C. Interpreting the Funnel Plot ............................................................................................... 56 References .................................................................................................................................................. 58 . VIC PCR | 5‐YEAR REPORT 2 List of Figures 8 Figure 1. The building blocks of the Vic PCR 9 Figure 2. Governance structure of the Vic PCR stage data in the Vic PCR 18 Figure 3. Percentage of completeness of clinical T stage 19 Figure 4. Contributions to the Vic PCR 19 Figure 5. Notifications from the VCR 19 Figure 6. Map of integrated cancer service regions in Victoria 21 Figure 7. Percent number of participants completed follow up at 12 and 24 months post diagnosis 23 Figure 8. Percent of diagnoses where a clinical T stage has been recorded in the patient’s medical history by diagnosing clinicians 24 Figure 9. Percent of men with positive margin post prostatectomy: low risk of disease progression 25 Figure 10. Percent of men with positive margin post prostatectomy: intermediate risk of disease progression 25 Figure 11. Percent of men with positive margin post prostatectomy: high risk of disease progression 30 Figure 12. Box plots for age at diagnosis by diagnosing ICS 30 Figure 13. Age at diagnosis by diagnosing ICS over the past five years 31 Figure 14. PSA level at diagnosis by diagnosing ICS 31 Figure 15. Gleason score at diagnosis by diagnosing ICS 32 Figure 16. Risk disease at prostate cancer diagnosis by diagnosing ICS 33 Figure 17. Method of diagnosis over the past five years 33 Figure 18. Method of diagnosis at metropolitan hospitals 38 Figure 19. Type of prostatectomy procedures over the past five years 39 Figure 20. Box plots of number of days taken from diagnosis to initial treatment from 2008 to 2013 40 Figure 21. Box plots of number of days taken from diagnosis to initial treatment by diagnosing ICS 51 Figure 22. Expenditure of the Vic PCR 56 Figure 23. Registry reporting ‐ example of a funnel plot VIC PCR | 5‐YEAR REPORT 3 List of Tables 17 Table 1. Percentage of completeness of data items from the Vic PCR 20 Table 2. Number of participants notified to the Vic PCR and overall rate of opt off 22 Table 3. Reason for lost to follow up at 12 and 24 months post diagnosis 34 Table 4. Treatment modalities for men in LOW RISK disease progression at diagnosis 35 Table 5. Treatment modalities for men in INTERMEDIATE RISK disease progression at diagnosis 36 Table 6. Treatment modalities for men in HIGH RISK disease progression at diagnosis 37 Table 7. Treatment modalities for men in VERY HIGH/ METASTATIC RISK disease progression at diagnosis 41 Table 8. Reported urinary bother at 12 months post diagnosis by treatment group 41 Table 9. Reported urinary bother at 24 months post diagnosis by treatment group 42 Table 10. Reported bowel bother at 12 months post diagnosis by treatment group 42 Table 11. Reported bowel bother at 24 months post diagnosis by treatment group 43 Table 12. Reported sexual bother at 12 months post diagnosis by treatment group 43 Table 13. Reported sexual bother at 24 months post diagnosis by treatment group 51 Table 14. Funding history of the Vic PCR 54 Table 15. Guidelines of NCCN risk category 55 Table 16. Guidelines of PRIAS protocol VIC PCR | 5‐YEAR REPORT 4 List of Abbreviations ANZUP Australian and New Zealand Urogenital and Prostate AS/WW Active surveillance / watchful waiting BSWRICS
Barwon South Western Regional Integrated Cancer Service EBRT External beam radiation therapy EPIC Expanded Prostate Cancer Index Composite GRICS Gippsland Regional Integrated Cancer Service HIFU High Intensity Focal Ultrasound HREC Human Research Ethics Committee ICS
Integrated Cancer Service LDR / HDR
Low‐dose‐rate / High‐dose‐rate brachytherapy LMICS Loddon Mallee Integrated Cancer Service NCCN National Comprehensive Cancer Network NEMICS North Eastern Melbourne Integrated Cancer Service PCOR‐ANZ
Prostate Cancer Outcomes Registry – Australia and New Zealand PCR Prostate Cancer Clinical Registry PoCoG Psycho‐Oncology Co‐operative Research Group PRIAS Prostate Cancer Research International Active Surveillance PSA Prostate Specific Antigen SMICS TRUS biopsy Southern Melbourne Integrated Cancer Service Trans‐rectal ultrasound guided biopsy TURBT Transurethral Resection of Bladder Tumour TURP Transurethral resection of the prostate Unk Brachy
Unknown type of brachytherapy VCR Victorian Cancer Registry Vic PCR Victorian Prostate Cancer Clinical Registry WCMICS
Western & Central Melbourne Integrated Cancer Service
VIC PCR | 5‐YEAR REPORT 5 Foreword The hard work of a diverse multidisciplinary team underpin our prostate cancer registry. The “Pilot of a population‐based prostate cancer clinical registry”, funded by Cancer Australia in the 2009 round of their Priority‐
driven Collaborative Cancer Research Scheme has by most measures been a smashing success. This report reviews the progress and growth of this concept from an idea for six hospitals, as a pilot in 2009, to a clinical quality registry covering an estimated 75–80% of the Victorian population through 33 different health services or clinics, enrolling now nearly 10,000 men. Our “pilot” worked: we have largely achieved what we set out to do in the initial 2009 proposal. We demonstrated the feasibility of an opt‐off population based registry; achieved timely notification of cases from the Cancer Council of Victoria’s cancer registry in a productive partnership; and have had overwhelming support and co‐operation across the State. And provided data to inform clinicians, patients, funders, and policy‐makers… Our reports back to Victorian clinicians have clearly improved documentation. The registry has provided feedback to doctors regarding specific patients who appeared to have unusual features of management and outcomes, to alert clinicians to these men who may not have otherwise come to their attention. The reports to health services on patterns and quality of care has led to reviews of treatment processes in local hospitals and discussion about or changes to the treatment programmes. On a larger scale our data has provided insights as to the combination of reasons that help explain the worse prostate cancer outcomes in Gippsland, compared with other regions in Victoria. The Registry has inspired others here and overseas… The Victorian Prostate Cancer Clinical Registry (Vic PCR) has provided a springboard for activity within Australia and internationally. Our team has assisted in the development of registries overseas and in the development of an internationally compatible dataset to truly foster international benchmarking of care. Here in Australia, our first reports of patterns of presentation and of care for men with prostate cancer provoked the interest of Movember Foundation. The Movember Foundation leadership were committed to efforts to improve “outcomes that matter to men with prostate cancer” but were aware that they (like many funders of health services) had no mechanism for evaluating whether their efforts might be “moving the dial”. Movember Foundation’s interest and belief in the merits of the prostate cancer clinical registry (PCR) have resulted in funding being provided for a federated national prostate cancer clinical quality registry. Monash University has been funded to oversee and administer this national effort. VIC PCR | 5‐YEAR REPORT 6 Challenges came up and challenges remain. The rapid growth of the registry places pressure on registry personnel to keep up with the pace of enrolling doctors and health services, preparing ethics applications, keeping up‐to‐date with patient notifications and patient follow up 12 and 24 months after diagnosis. Ongoing funding for data collection is challenging; we are working with hospitals to promote data collection as a part of their normal hospital business and to develop ways to automate collection as much as possible. The future is bright. The importance of these efforts is becoming more widely recognised. In 2015 we plan to enlarge the scope of the registry to capture 10–15% more of the state by extending our current enrolments within southern Melbourne as well as within the large metropolitan centres. I hope that this report will fire the imagination, and persuade more to join the effort in whatever way they can best do this, since it is only through quality registries such as the PCR that we can ever hope to know and understand whether or not care provided to men with prostate cancer is safe, timely, effective, appropriate, and equitable. If we do not measure it, we will never really know. A/Professor Jeremy Millar Principal Investigator Victorian Prostate Cancer Clinical Registry The primary purpose of a CLINICAL REGISTRY is to monitor outcomes and report on quality of care VIC PCR | 5‐YEAR REPORT 7 About the Vic PCR The Vic PCR has been developed as Australia’s first prostate cancer clinical quality registry. The Vic PCR is established and operated with the aim of improving knowledge of patterns of care and outcomes of men diagnosed with prostate cancer in Victorian hospitals. The Vic PCR provides a valuable resource to monitor treatments and outcomes following diagnosis of prostate cancer. It captures data about patterns of presentation, management of prostate cancer, treatments, procedures, interventions, and patient‐reported outcomes related to quality of life, complications and impact of prostate cancer treatment on daily living. The data collected will help to guide best clinical practices and processes, and improve quality of patient care. Figure 1. The building blocks of the Vic PCR VIC PCR | 5‐YEAR REPORT 8 Vic PCR Governance The governance structure of the Vic PCR is outlined in Figure 2. It has been developed to meet the standards outlined in the Operating Principles and Technical Standards for Australian Clinical Quality Registries. STEERING COMMITTEE
STEERING COMMITTEE Responsibilities: o Develop and ensure registry meets
overall objectives; o Facilitate policy support for issues
identified by the Management
Committee; o Establish an outlier policy and ensure
that it is enacted;
o Ensure that Management
Committee meets its reporting
obligations to hospitals, clinicians
and working groups; o Review and advise on registry
output;
o Establish data access policy and
ensure that it is enacted;
o Monitor data quality management
processes;
o Review and provide advice on
communication strategy.
MANAGEMENT COMMITTEE
Comprises  Senior clinicians in a
leadership role;  Representation from:
o Clinician stakeholders
o Epidemiology
o Bench scientist
o Victorian Cancer Registry
o Funding body;  Professional society/ies;
 Consumer.
Responsibilities: MANAGEMENT COMMITTEE
Comprises  At least 2 clinical specialists;
 At least 2 members of the Data
Management Unit;
 Data custodian.
SCIENTIFIC WORKING GROUPS
o Management of staff, work duties
and budget; o Ensure that data collection and
quality processes function
effectively; o Ensure data issues are managed
in a timely and effective manner;
o Arrange for timely and
appropriate statistical analyses;
o Ensure compliance with
requirements of ethics
committees and legislation;
o Provide reports to Steering
Committee; o Liaise with funding bodies and
stakeholders; o Provide support for the function
of the various scientific working
groups. DATA MANAGEMENT UNIT
Comprises clinicians with interest in area and ≥ 1 member of the data management unit. Comprises registry data custodian, data collectors and follow up interviewers. Responsibilities: Responsibilities: o Report to the Management Committee;
o Submit report/s to Steering Committee as agreed.
o Ensure data is collected in a timely and accurate fashion,
in accordance with the Vic PCR protocol; o Report to the Management Committee at least monthly.
Figure 2. Governance structure of the Vic PCR VIC PCR | 5‐YEAR REPORT 9 The Vic PCR Steering Committee meeting is held once every six months. Members of the Vic PCR Steering Committee are outlined on page 53 of this report. Management Committee meetings are held annually in February and August and fortnightly Operations Committee meetings are held with the central registry team at Monash University to review data accuracy, follow up rates, requests for data, reports to hospitals and clinicians, and to discuss database development issues. The Vic PCR Management Committee is responsible for developing and supporting the function of the registry; reviewing data quality; developing ideas for research using the registry data and ensuring that the registry is adequately supported. A/Professor Sue Evans Database Custodian of the Vic PCR VIC PCR | 5‐YEAR REPORT 10 ISO 27001 Certified Web‐Based Registry Significant achievement has been made in 2014 where we finally have our state‐of‐the art, web‐
enabled clinical registry. The Vic PCR web‐based system facilitates data collection at participating Victorian hospitals as well as aiding data accuracy. It has taken the registry project management team and Monash’s Clinical Informatics and Data Management Unit development staff nearly two years to ensure that all of the registry functional requirements are met. Some key features include: 
Compliance with security standards ISO 27001 ensuring secure access controls and secure collection, storage, and transmission of clinical registry data; 
Various levels of authorised access to the database, including clinicians, hospitals, super users, registry researchers, data collectors and follow up staff; 
Capacity for many concurrent users to log into the registry at any one time; 
Online data entry forms with data range and validation checks in place; 
A traffic‐light colouring system to assist data collectors to quickly identify forms which have/have not been completed; 
Various work lists which enable our administrative, data collector and follow up staff to monitor their work progress; 
Capacity to import data from various data sources; 
Capacity for reports to be generated in real time; 
Data back up so no information will be lost if the system is corrupted. VIC PCR | 5‐YEAR REPORT 11 International Collaborators The Vic PCR is part of an international effort to improve quality of care for men with prostate cancer. The protocol developed for the Vic PCR has been made available to collaborators in Ireland, Hong Kong, New Zealand, Malaysia and Canada. Team members from the Vic PCR contribute to the governance, advisory or working committees for a number of Movember Foundation‐funded initiatives, including: 
Irish Prostate Cancer Outcomes Research (IPCOR)
IPCOR is collecting a comparable dataset to the Vic PCR on men diagnosed in the Republic of
Ireland.

Life After Prostate Cancer Diagnosis
This project, supported by the Movember Foundation and Prostate Cancer UK, is collecting
patient‐reported outcome measures on approximately 115,000 men diagnosed with prostate
cancer in the four United Kingdom countries of England, Scotland, Wales and Northern Ireland.

Pilot of New Zealand Prostate Cancer Clinical Registry
This registry will contribute to the national registry, PCOR‐ANZ to which the Vic PCR is
contributing data.

International Consortium for Health Outcomes Measurement (ICHOM)
ICHOM is a non‐profit organisation founded by Harvard University in the US, the Karolinska
Institutet in Stockholm and the Boston Consulting Group with the purpose of transforming
health care systems worldwide by measuring and reporting patient outcomes in a standardised
way.
VIC PCR | 5‐YEAR REPORT 12 Significant Milestones The Vic PCR was established following successful funding by a Cancer Australia Priority‐driven Collaborative Cancer Research Scheme to monitor patterns and quality of care for Victorian men diagnosed with prostate cancer. The registry commenced in 2009 with three metropolitan hospitals initially contributing data. Within two years, and with additional funding support provided by Cancer Australia and the Victorian Department of Health, the registry has expanded into the Barwon South Western, Loddon Mallee and Gippsland regions. By the end of 2014, a total of 33 hospitals were actively contributing to the Vic PCR. Jun ‘09 Austin Health Cabrini Institute Oct ‘09 Grants from Cancer Australia Nov ‘09 Mar ‘09 Alfred Health Nov ‘08 First Steering Committee Meeting Masada Private Hospital Jan ‘10 Peter MacCallum Cancer Centre May ‘10 

Melbourne Health Latrobe Regional Hospital
Jun ‘11 Epworth HealthCare Additional Grants from May ‘11 Cancer Australia; the Victorian Department of Health 

Feb ‘10 

Aug ‘11 Barwon Health  Colac Area Health
 St John of God, Geelong
 Geelong Private Hospital
South West Healthcare Oct ‘11 Bendigo Health Care Group
Nov ‘11  Portland District Health o Swan Hill District Health
 Echuca Regional Health
o Kerang District Health
Western District Health Jan ‘12
Kyabram District Health
Rochester & Elmore District Health Mar ‘12 Bass Coast Health Jun ‘12
Dec ‘11 

Feb ‘12 

May ‘12 

St John of God, Bendigo West Gippsland Healthcare
Mildura Private Hospital Maryvale Private Hospital
Mildura Base Hospital Gippsland Southern Health
Jul ‘12 Kyneton District Health South Gippsland Hospital Aug ‘12 Sep ‘12 Clinical Quality Indicators 1st Reported to Hospitals Dec ‘12 Clinical Quality Indicators 1st Reported to Clinicians Sep ‘13 Movember Foundation‐Funded PCOR‐ANZ
Mar ‘14 Web‐Based Platform for Data Collection VIC PCR | 5‐YEAR REPORT 13 Methodology Recruitment and Data Collection Process All patients diagnosed with prostate cancer are mandatorily reported to the Cancer Council of Victoria for inclusion on the Victorian Cancer Registry (VCR). Upon ethics approval at a site, hospitals authorise the release of mandatorily reported prostate cancer notifications sent to the VCR. The hospital information management system is reviewed to ensure that men listed on the notification have not since died and to determine the method used for diagnosing prostate cancer. The latter review is to ensure we only contact men who are aware of their diagnosis. An explanatory statement and accompanying letter is sent to men who are eligible to participate in the study. A waiver of consent is provided to enable collection of diagnostic and treatment details on all men with prostate cancer, who (1) died before consent could be sought; and (2) were diagnosed via a transurethral resection of the prostate (TURP) and in whom their treating clinician has requested not to contact the patient. Men are able to opt out of the registry at any time. Histopathological data are captured through hospital information systems and pathology reports. Clinical information is collected from medical records by trained data collectors. Twelve months and twenty four months after the positive diagnosis is made, men will be telephoned by a Monash University researcher to reconfirm consent and assess their progress. A general health Quality of Life (SF12) questionnaire is administered and six disease‐specific complications questions are asked relating to urinary, erectile and bowel dysfunction. Men will also ask to confirm that treatment details are accurate and up‐to‐date and to provide the most recent PSA result. VIC PCR | 5‐YEAR REPORT 14 Data Quality and Data Access The Vic PCR is web‐enabled and can be accessed via a secure password protected login by registry personnel for data collection, audit purposes and central data management. The Vic PCR undergoes rigorous quality control to ensure the accuracy of the data being entered into the registry. As data are imported into the registry potential duplicate records are identified and reviewed. On receipt of notification data into the Vic PCR, data collectors check the contact details, the diagnosis date and health status with the notifying clinician. The in‐built validation tool is in place as data are entered into the registry web system and thus the risk of data entry error is minimised. At the point of analysis, data quality checks are performed and unusual or inconsistent data points are queried. Trend analysis is performed to ensure consistency in case notifications. When patients are telephoned, follow up staff review the details they have in the registry with the patient to check information accuracy and completeness. Where possible, the patient’s GP is contacted to collect missing prostate specific antigen (PSA) and treatment data (typically androgen deprivation therapy information). Clinician and hospital reports are automatically generated by the registry at set time points. A report is distributed to participating clinicians and hospitals, providing details of their outcomes. At this stage, if the treating clinician has any concern of uncertainty about the data they are encouraged to contact the registry so that an investigation can be undertaken. Researchers can apply to the registry to have access to de‐identified data provided that the project has been approved by the relevant ethics committee(s). Access to information collected and collated by the Vic PCR is guided by strict protocols and procedures to ensure that privacy and other ethical principles are maintained at all times. In particular, specific measures have been put in place to maintain the confidentiality of personal identifying information. All requests for data are authorised by the Steering Committee. Data access forms can be downloaded from the Internet (http://pcr.registry.org.au). There are approximately 1650 patient cases being collected each year which takes on average, FIVE MINUTES to complete each case VIC PCR | 5‐YEAR REPORT 15 Ethical Review The Vic PCR is reviewed by each hospital’s Human Research Ethics Committee (HREC) or Medical Advisory Committee prior to hospitals contributing data to the registry. Each hospital’s ethics committee requires that an annual progress report be submitted outlining progress on recruitment and any issues which have arisen during the 12 month period. Of course, any serious adverse events are required to be notified to the ethics committee at the time of the event. To date, no serious adverse events have been reported. In addition to hospital ethics committee review, the registry is reviewed on an annual basis by the VCR and the Monash University Human Research Ethics Committees. In accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct of Research, all paper and electronic data are stored securely within the Department of Epidemiology and Preventive Medicine at Monash University, with access restricted to authorised registry personnel. VIC PCR | 5‐YEAR REPORT 16 Findings from the Vic PCR Data Completeness The value of any registry is in the quality of data it collects. Registries typically collect a relatively small amount of data but attention is paid to ensuring that it is both accurate and complete. A challenge for the Vic PCR is obtaining data which is not captured in a consistent manner in the medical record. Table 1 contains details on the completeness of the data items collected by the Vic PCR. Table 1. Percentage of completeness of data items from the Vic PCR Data Items Date of Diagnosis Diagnosing Institution Diagnosing Clinician PSA Prior to Diagnosis Diagnosis Method of Diagnosis Gleason Score Clinical T Stage Clinical N Stage Clinical M Stage Date of Prostatectomy Type of Prostatectomy Urologist Treatment Institution Prostatectomy Pathological T Stage Pathological N Stage Gleason Score Pathological Margins Date of Radiotherapy Type of Radiotherapy Radiotherapy Radiation Oncologist Treatment Institution Date of ADT Type of ADT ADT Clinician Treatment Institution Date of Brachytherapy Type of Brachytherapy Brachytherapy Radiation Oncologist Treatment Institution Date of Chemotherapy Chemotherapy Medical Oncologist Treatment Institution PSA at 12 Month Post Diagnosis VIC PCR | 5‐YEAR REPORT % of Completeness 100.0% 92.4% 91.5% 98.1% 97.2% 97.7% 79.7% 93.5% 93.5% 97.2% 95.4% 97.2% 98.8% 93.9% 96.5% 97.1% 96.7% 90.2% 90.9% 93.7% 98.1% 93.6% 98.5% 94.3% 96.9% 90.8% 96.2% 93.3% 98.5% 66.7% 68.9% 88.9% 91.6% 17 Documentation of Clinical T Stage The clinical stage is a vital data element to assist in accurately grading prostate cancer and in determining treatment. Risk models are developed using the clinical T stage (cT) as one of the predictor variables for disease progression. When the Vic PCR initially began collecting clinical stage in the medical record, documentation was very poor. In an effort to reduce the number of missing clinical T stage data, a number of strategies have been implemented. Firstly, data collectors are advised to record the text details of the physical examination result (digital rectal examination ‐ DRE notes) in the registry and a report is sent to clinicians with these notes. They are asked to assign a clinical T stage to patients for whom it has not been clearly documented in the medical record. This is then collected by the data collectors and entered into the registry. Secondly, a quality indicator has been developed which provides clinicians with an indication of the completeness of their clinical T stage documentation relative to peers. Lastly, a report of DRE notes recorded by the data collector is provided to the Vic PCR coordinator and the clinical lead. Where the clinical T stage is unambiguous to both the Vic PCR coordinator and the clinical lead, it is recorded in the registry. Over time, the completeness of the documentation of the clinical T stage has increased from 38% to 65% (Figure 3). We will continue to work towards improving documentation in the medical record. cT subsequently assigned based on DRE notes Figure 3. Percentage of completeness of clinical T stage data in the Vic PCR Delay in providing quality indicators reports to clinicians due to the development of the Vic PCR web‐based system. Improvement in the documentation of the cT stage VIC PCR | 5‐YEAR REPORT 18 Number of Notifications Between August 2008 when the first patient was enrolled in the registry and December 2013 a total of 9925 patients were participating in the registry. The PCR commenced as a pilot project in six Victorian hospitals in 2009. Through further funding in 2011 it expanded to include regional health services. Between August 2012 and December 2014 no additional sites were invited to join the registry. During this time the registry database was redeveloped. With funding provided by Movember Foundation and the new web‐based registry platform completed in March 2014, our goal is to attain complete coverage of Victorian hospitals by 2018. Figure 4 provides a display of the growth in the number of notifications and sites contributing to the registry. Figure 4. Contributions to the Vic PCR The majority of cases notified to the registry up to and including 2014 were made from hospitals in the Melbourne metropolitan area (Figure 5). In total the registry captures patients diagnosed in three regional Integrated Cancer Service (ICS regions of Victoria) and within three metropolitan ICS (NEMICS, WCMICS and SMICS). The regions highlighted in yellow in Figure 6 below denote the regional ICS from where patients are recruited. Figure 5. Notifications from the VCR Figure 6. Map of integrated cancer service regions in Victoria (LMICS)
(GRICS)
(BSWRICS)
VIC PCR | 5‐YEAR REPORT 19 Number of Participants
Table 2 provides an overview of the recruitment rates across the five year period from 2008 to 2013. More than 2,000 notifications of prostate cancer diagnoses are reported to Vic PCR annually. Patients are given the opportunity to opt off the registry either at the point of recruitment or when they are followed up 12 and 24 months post diagnosis. The overall opt off rate over the five‐year period is 2.7% (Table 2). Table 2. Number of participants notified to the Vic PCR and overall rate of opt off Year of Diagnosis 2008 2009 2010 2011 2012 2013 Number of Participants 162 1181 1342 2503 2539 2198 Cumulative Number of Participants 162 1343 2685 5188 7727 9925 Cumulative Number of Opt Off 2 29 52 101 187 271 Overall % Opt Off 1.2 2.2 1.9 1.9 2.4 2.7 On average 50 letters were mailed to
registry participants each week VIC PCR | 5‐YEAR REPORT 20 Number of Follow Up Completed Currently, the Vic PCR attempts to collect patient‐reported outcomes on all men diagnosed with prostate cancer. Trained follow up staff based within the Department of Epidemiology and Preventive Medicine at Monash University are employed to telephone men to collect quality of life data and confirm treatment details. A window of four weeks (two weeks either side of the date of diagnosis) is provided to collect follow up details from men. A message will be left on the answering machine or mobile phone if a man is not answering calls after a number of attempts. Due to the sensitive nature of the call, follow up staff have to always keep in mind that the words “Prostate Cancer Registry” should be avoided at all times (when answering the phone, contacting next of kin and leaving messages) until they have established that they have reached the right man. Figure 7. Percent number of participants completed follow up at 12 and 24 months post diagnosis Our overall success rate is 75% across both 12 and 24 month time points. Reasons for the missed phone call are documented and they are outlined in Table 3. VIC PCR | 5‐YEAR REPORT 21 Table 3: Reason for lost to follow up at 12 and 24 months post diagnosis Reason for lost to follow up Patient deceased Patient unwell Non English speaking Unable to contact Waiver for TURP Waiver for Death Declined participation in follow up interview Clinician not recruited at time of follow up Hearing impairment Late notification of TURP awareness Wrong/disconnected number Delay due to web system development Resource issue Other (e.g. patient has dementia, patient moved overseas, reported no cancer ) % Lost to follow up % Lost to follow up at 12 month at 24 month 2.9 8.6 4.0 3.7 17.8 17.9 43.2 44.4 0.1 0.1 0.4 0.1 12.6 13.3 2.1 0.5 2.4 3.3 0.4 0.1 1.1 2.2 3.4 0.1 4.3 0.7 5.4 5.1 A follow up interview takes approximately 10 MINUTES to complete VIC PCR | 5‐YEAR REPORT 22 Benchmarking Reports The Vic PCR has been providing clinicians and hospitals with feedback on their performance to allow them to compare their results with those of other providers. These benchmarking reports have facilitated a cycle of continuous improvement in various aspects of prostate cancer care. Units whose performance has deviated below par have requested a review by outside consultants to identify areas for improvement. The following clinical quality indicators have been approved by the Vic PCR steering committee and are reported to participating hospitals and urologists every six months. o
INDICATOR 1: Mortality
Rationale for choosing the indicator: To identify men who have died in the previous six months.
o
INDICATOR 2: PSA level recorded post prostatectomy
Rationale for choosing the indicator: PSA levels for all men with prostate cancer who are having
radical treatment should be checked at the earliest 6 weeks following treatment, at least every 6
months for the first 2 years, and at least once a year thereafter.1
Men who have not had a PSA test taken post prostatectomy are presented here.
o
INDICATOR 3: Documentation of clinical T stage (cT) in medical record
Rationale for choosing the indicator: Documentation of clinical TNM provides evidence that a physical assessment has been undertaken in the assessment of patient risk and disease progression.2 Figure 8. Percent of diagnoses where a clinical T stage has been recorded in the patient’s medical history by diagnosing clinicians The rate of completeness in the documentation of cT in medical records for each hospital and clinician is presented in a funnel plot (refer to Appendix C for an interpretation of a funnel plot). Diagnosing clinician VIC PCR | 5‐YEAR REPORT 23 o
INDICATOR 4: Men with high‐risk disease who were managed with active surveillance
Rationale for choosing the indicator: Active surveillance is NOT recommended for men with
advanced prostate disease.1 o
INDICATOR 5: Radical prostatectomy performed when patient met PRIAS criteria
Rationale for choosing the indicator: The PRIAS protocol is designed to help preserve quality of life
during the management of a patient’s condition after cancer has been detected following screening.
Refer to Appendix B for PRIAS protocol guidelines. Men who met PRIAS criteria and underwent
prostatectomy are presented here.
o
INDICATOR 6: Positive margins were reported on the histopathology report stratified by NCCN
risk category Rationale for choosing the indicator: The presence of a positive surgical margin in the radical prostatectomy specimen has been positively and independently associated with disease progression, even after accounting for stage of disease. Surgical experience and technique has been shown to impact on margin rates.3
Positive surgical margins refer to those cases where the pathology report unequivocally states that the tumour has extended beyond the resected tissue. Margin status is assessed according to risk categories outlined in Appendix A. The positive margin rates from each urologist and hospital are presented in a funnel plot (refer to Appendix C for an interpretation of a funnel plot). Figure 9. Percent of men with positive margin post prostatectomy: low risk of disease progression Urologists performing the prostatectomy procedures VIC PCR | 5‐YEAR REPORT Hospitals where the prostatectomy procedures were undertaken 24 Figure 10. Percent of men with positive margin post prostatectomy: intermediate risk of disease progression Urologists performing the prostatectomy procedures Hospitals where the prostatectomy procedures were undertaken Figure 11. Percent of men with positive margin post prostatectomy: high risk of disease progression Urologists performing the prostatectomy procedures
o
Hospitals where the prostatectomy procedures were undertaken INDICATOR 7, 8 and 9: Disease‐specific quality of life – urinary, sexual and bowel bother
Rationale for choosing the indicator: Patient assessment of complications may assess underlying
quality of care issues at clinician or institution level.2
Men are telephoned at 12 and 24 months post diagnosis and are asked a series of questions about
their general health and more specific questions relating to their urinary, bowel and sexual bother.
VIC PCR | 5‐YEAR REPORT 25 Specifically, men are asked: How big a problem has your (urinary/bowel/sexual) function been for you during the last 4 weeks? 
No problem

A very small problem

A small problem

A moderate problem

A big problem
Men who reported that their urinary/bowel/sexual function is causing them a big problem are presented here. o
INDICATOR 10 and 11: General health quality of life ‐ poor physical and mental health
Rationale for choosing the indicator: To identify men who are demonstrating clinical signs of
disability so that interventions may be considered to improve quality of life.
Men are administered a general health quality of life tool (the SF12v2) 12 and 24 months post
diagnosis. Physical and mental health scores are measured for each participating man. Men with
physical and/or mental scores in the bottom 5% of the population are presented here.
1. National Collaborating Centre for Cancer. Prostate Cancer: diagnosis and treatment. Full guideline. London: National Institute for Clinical
Excellence (NICE), 2008; NICE clinical guideline 58. 2. Spencer B, Steinberg M, Malin J, et al. Quality‐of‐care indicators for early‐stage prostate cancer. J Clin Oncol. 2003; 21:1928‐36.
3. Eastham JA, Kattan MW, Riedel E et al. Variations among individual surgeons in the rate of positive surgical margins in radical
prostatectomy specimens. Journal of Urology 2003; 170(6 Pt 1):2292‐5.
VIC PCR | 5‐YEAR REPORT 26 Gippsland Project This project was made possible through a funding grant provided by the Prostate Cancer Foundation of Australia (PCFA). Funds were provided to the PCFA through a fund‐raising activity in the Gippsland region, Latrobe’s Biggest Ever Blokes BBQ. The aim of this project was to determine the profile, treatment and outcomes of men diagnosed with prostate cancer in Gippsland compared with other regions of Victoria and other ICS. There were some existing data that men diagnosed in Gippsland had a poorer five‐year survival rate compared with metropolitan Victoria. The findings from this research demonstrate that, compared with men living in other Victorian regions, men diagnosed with prostate cancer in Gippsland Regional ICS are more likely to: 



Source: Latrobe Valley Express Be diagnosed at an older age;
Be diagnosed with more advanced disease at diagnosis;
Be diagnosed through an operation to relieve urinary symptoms (TURP) than through
purposeful screening for prostate cancer (TRUS);
Have a longer time interval between diagnosis and active treatment for low,
intermediate and high risk disease.
These findings go some way towards explaining the higher mortality rate post‐prostate cancer diagnosis in Gippsland compared to the rest of Victoria. The second phase of the Gippsland project is currently underway and its aims are to better understand: 

From GPs, how they determine treatment paths for men in the region;
From men, whether they receive and act on advice on prostate cancer management.
VIC PCR | 5‐YEAR REPORT 27 Validation Study Patient reported outcome measures (PROMs) are standardised, validated questionnaires used in a clinical setting to measure patients’ perceptions of their own physical and mental status and wellbeing. Health related quality‐of‐life (HRQOL) tools can be delivered by paper and pencil questionnaires, face‐to‐face or telephone interviews, or by electronic means (e.g., via a computer or a handheld electronic device). The mode of questionnaire administration can have significant effects on data quality. As part of the clinical and research data collected by the Vic PCR, patient‐reported HRQOL and complications data were routinely collected from participating men by trained registry staff via a structured telephone interview. At 12 and 24 months post‐diagnosis, participants were contacted by telephone to verify management details and to measure general health and disease specific quality of life. For the disease‐specific QOL men were asked the following three questions extracted from the EPIC‐26 relating to bowel‐, urinary‐ and sexual‐bother: (1) “How big a problem has your urinary function been for you during the last 4 weeks?” (2) “How big a problem have your bowel habits been for you during the last 4 weeks?” (3) “How big a problem has your sexual function or lack of sexual function been for you during the last 4 weeks?” These questions were scored as discrete items within the EPIC‐26 tool. For each of the questions above, men were given an option from a five‐point ordinal response scale: ‘no problem’, ‘very small problem’, ‘small problem’, ‘moderate problem’ and ‘big problem’. This validation study was undertaken to assess the level of variation in HRQOL when the tool was administered using a different mode of administration. The “gold standard” HRQOL tool is the self‐
administered EPIC‐26 as this has been widely validated. When results obtained using the gold standard were compared with those collected via telephone or via a web survey we found a moderate level of agreement for all three domains of urinary, bowel and sexual bother. This study also demonstrated that responses obtained via interactive voice method of survey for urinary and sexual function were lower (less bother was reported) when compared to the responses obtained via paper questionnaire. In other words, men were less likely to report problems on the telephone. A possible explanation for this finding is men responding to sensitive questions, such as their sexual function after prostate cancer diagnosis and/or treatment, might be more likely to indicate that they are feeling better when interviewed on the telephone or in person compared to answering a written survey. This may be because men feel more embarrassed to verbalise the true state of their sexual function to another person. VIC PCR | 5‐YEAR REPORT 28 Results of this study have wider consequences for prostate cancer research. As the Vic PCR uses telephone‐administered surveys, QOL outcomes from this registry will likely under‐estimate the true bother experienced by men. VIC PCR | 5‐YEAR REPORT 29 Patterns of Care In this section, we provided information using data collected from registered patients who were diagnosed from 1st January 2008 until 31st December 2013. Patient Characteristics Figure 12. Average age at diagnosis by location of hospital where men were diagnosed (diagnosing ICS) The average age of men with prostate cancer in the Vic PCR was 66 years old. Outliers not shown. Figure 13. Average age at diagnosis over the past five years by location of hospital where men were diagnosed (diagnosing ICS) Men from regional areas were more likely to be diagnosed at an older age. VIC PCR | 5‐YEAR REPORT 30 Figure 14. PSA level at diagnosis by location of hospital where men were diagnosed (diagnosing ICS) 
Approximately 73% of men were diagnosed with a PSA level less than 10ng/mL;

Higher PSA levels at diagnosis (>20ng/mL) were seen in GRICS, BSWRICS, LMICS (20%, 17%,
14% respectively), compared to only 10% in men diagnosed in metropolitan hospitals.
Figure 15. Gleason score at diagnosis by location of hospital where men were diagnosed (diagnosing ICS) 
Approximately 45% of men were diagnosed with a Gleason score = 7;

Higher Gleason Scores at diagnosis (8‐10) was seen especially in GRICS, 28% compared to only
20% in the overall population.
VIC PCR | 5‐YEAR REPORT 31 Risk of Disease Figure 16. Risk of disease progression* at prostate cancer diagnosis by location of hospital where men were diagnosed (diagnosing ICS) Most men were in the intermediate risk group when first diagnosed with prostate cancer. A slightly higher proportion of men in Gippsland were diagnosed with metastatic disease (12%) compared to only 5%, 6% and 9% in Metro, LMICS and BSWRICS respectively. *Refer to Appendix A for classification of NCCN risk group VIC PCR | 5‐YEAR REPORT 32 Method of Diagnosis The vast majority of men were diagnosed following transrectal ultrasound (TRUS) procedures and approximately 10% of newly prostate cancer diagnoses were found due to incidental findings in tissue removed during a TURP procedure since 2008 (Figure 17). Figure 17. Method of diagnosis over the past five years Whilst TRUS biopsy is currently the standard approach for an initial prostate biopsy, a growing number of hospitals in the metropolitan area are now adopting a newer approach to obtaining prostate biopsy specimens using transperineal procedures (Figure 18). The proportion of TRUS procedures has decreased from 90% in 2012 to 84% in 2013, whereas a sharp increase of the use of transperineal biopsy can be seen from 0.8% in 2012 to 7% in 2013. Figure 18. Method of diagnosis at metropolitan hospitals VIC PCR | 5‐YEAR REPORT 33 Treatment The following tables outline treatment modalities of men with prostate cancer adjusted by risk group. It is important to note that the risk group is determined on the biopsy specimen taken immediately prior to the active treatment, or the diagnosing biopsy for those on active surveillance or watchful waiting. LOW RISK DISEASE Table 4 below demonstrates that overall most men (43%) with low risk disease were conservatively managed with either active surveillance or watchful waiting. A further 39% of men underwent a radical prostatectomy. Men diagnosed in metropolitan areas and BSWRICS were most likely to undergo radical prostatectomy procedures than those in LMICS and GRICS. Table 4. Modes of treatment for men in LOW RISK disease progression at diagnosis* Diagnosing ICS Metro BSWRICS LMICS GRICS Prostatectomy 41.4% 48.7% 29.8% 15.3% EBRT 4.9% 2.6% 14.9% 5.1% EBRT+Prostatectomy 2.5% 2.6% 2.2% 1.0% LDR 5.2% 0.9% 16.6% 8.2% HDR 0.1% 0.0% 0.0% 0.0% Unknown Type of Brachytherapy 1.4% 0.0% 1.1% 1.0% EBRT+HDR 0.1% 0.0% 0.0% 0.0% ADT 0.5% 0.9% 0.6% 2.0% HIFU 0.7% 0.0% 0.6% 0.0% AS/WW 42.2% 44.4% 33.1% 66.3% No Treatment (No Rx) 1.0% 0.0% 1.1% 1.0% Overall 39.2% 5.8% 2.4% 6.3% 0.1% 1.2% 0.1% 0.6% 0.6% 42.8% 0.9% Most common treatment within the study ICS 2nd most common treatment within the study ICS 3rd most common treatment within the study ICS *Refer to Appendix A for NCCN risk calculation Most men with low risk disease were treated conservatively with either active surveillance or watchful waiting VIC PCR | 5‐YEAR REPORT 34 INTERMEDIATE RISK DISEASE Table 5 describes treatment provided to men with intermediate risk disease. Prostatectomy procedures were the most common treatment received by men in this risk group. More than half of all treatment provided to men in hospitals contributing to the registry involved surgery. However this was not reflected in men diagnosed in LMICS of whom approximately 38% received radiation therapy. A higher proportion of men diagnosed in BSWRICS and GRICS had no treatment when compared to men diagnosed in metropolitan areas and LMICS. Table 5. Treatment modalities for men in INTERMEDIATE RISK disease progression at diagnosis* Diagnosing ICS Metro BSWRICS LMICS GRICS Overall Prostatectomy 59.0% 58.9% 33.3% 32.9% 56.2% EBRT 14.6% 14.4% 37.5% 20.5% 16.4% EBRT+Prostatectomy 6.7% 3.0% 5.8% 2.7% 6.3% LDR 4.1% 2.0% 8.3% 5.5% 4.4% HDR 0.3% 0.0% 0.4% 0.7% 0.3% Unknown Type of Brachytherapy 0.8% 0.5% 0.8% 0.7% 0.8% EBRT+HDR 0.7% 0.5% 0.4% 0.0% 0.7% ADT 1.2% 1.0% 2.5% 4.8% 1.4% Chemotherapy 0.1% 0.0% 0.0% 0.0% 0.1% HIFU 0.3% 0.0% 0.0% 0.0% 0.3% AS/WW 11.6% 19.8% 9.6% 26.0% 12.5% No Treatment (No Rx) 0.5% 0.0% 1.3% 6.2% 0.7% Most common treatment within the study ICS 2nd most common treatment within the study ICS 3rd most common treatment within the study ICS *Refer to Appendix A for risk calculation Most men with intermediate risk disease underwent prostatectomy procedures VIC PCR | 5‐YEAR REPORT 35 HIGH RISK DISEASE Table 6 describes treatment provided to men with high risk disease. The majority of men in the high risk group received either radiation therapy or radical prostatectomy (32.6% and 32.0% respectively). As with the intermediate risk group, a higher proportion of men presented with high risk disease progression from BSWRICS and GRICS were not receiving any treatment compared to men from metropolitan areas and LMICS. Table 6. Treatment modalities for men in HIGH RISK disease progression at diagnosis* Diagnosing ICS Metro BSWRICS LMICS GRICS Overall Prostatectomy 35.1% 31.8% 12.5% 15.9% 32.0% EBRT 31.3% 22.7% 57.8% 31.0% 32.6% EBRT+Prostatectomy 11..9% 7.6% 5.5% 7.1% 10.8% LDR 0.1% 0.0% 0.0% 0.0% 0.1% HDR 0.3% 0.0% 0.0% 0.0% 0.2% Unknown Type of Brachytherapy 0.1% 0.0% 1.6% 0.0% 0.2% EBRT+HDR 3.2% 0.0% 3.9% 3.5% 3.1% ADT 11.4% 22.0% 11.7% 31.9% 13.5% Chemotherapy 0.1% 0.0% 0.8% 0.9% 0.2% AS/WW 6.2% 15.2% 6.3% 9.7% 7.1% No Treatment (No Rx) 0.2% 0.8% 0.0% 0.0% 0.2% Most common treatment 2nd most common treatment 3rd most common treatment within the study ICS within the study ICS within the study ICS *Refer to Appendix A for NCCN risk calculation Surgery and radiotherapy were the most common treatments for men with high risk disease VIC PCR | 5‐YEAR REPORT 36 VERY HIGH RISK OR METASTATIC DISEASE Radiotherapy and Androgen Deprivation Therapy were most commonly administered to men with very high risk or metastatic disease (Table 7). Table 7. Treatment modalities for men in VERY HIGH/ METASTATIC RISK disease progression at diagnosis* Prostatectomy EBRT EBRT+Prostatectomy LDR HDR EBRT+HDR ADT Chemotherapy HIFU AS/WW No Treatment (No Rx) Metro 10.8% 42.7% 4.1% 0.0% 0.3% 0.9% 33.9% 5.3% 0.3% 1.5% 0.3% BSWRICS 8.2% 38.8% 4.1% 0.0% 0.0% 0.0% 44.9% 4.1% 0.0% 0.0% 0.0% Diagnosing ICS LMICS 3.8% 61.5% 3.8% 0.0% 0.0% 0.0% 25.0% 5.8% 0.0% 0.0% 0.0% GRICS 3.8% 34.0% 0.0% 1.9% 1.9% 0.0% 49.1% 5.7% 0.0% 1.9% 1.9% Overall 9.1% 43.3% 3.6% 0.2% 0.4% 0.6% 35.7% 5.2% 0.2% 1.2% 0.4% Most common treatment within the study ICS 2nd most common treatment within the study ICS 3rd most common treatment within the study ICS *Refer to Appendix A for NCCN risk calculation VIC PCR | 5‐YEAR REPORT 37 TYPE OF SURGICAL APPROACH The traditional approach to prostate gland removal, known as open prostatectomy was widely used prior to 2011. Progressively the registry has recruited a number of hospitals which provide men with the option of having their surgery performed by urologists using a robot‐assisted technique. This is reflected in Figure 19 which demonstrates an increase in the percentage of men having surgery performed using the robot from 15% in 2010 to 60% in 2013. Figure 19. Type of prostatectomy procedures performed over the past five years VIC PCR | 5‐YEAR REPORT 38 Diagnosis to Initial Treatment over Time Figure 20 outlines by year of diagnosis the average time delay between diagnosis and initial treatment, according to the different risk groups for disease progression. Registry data (Table 4) showed almost half of men with low‐risk disease were not receiving immediate treatment, consistent with increasing use of "Active Surveillance" approaches. Thus, in this group of men, a measure of "time‐to‐first‐
treatment" is not an indicator of quality of care and we have not included the time for this group of men in the box plots below (Figure 20 and 21). Figure 20. Box plots of number of days taken from diagnosis to initial treatment for patients diagnosed from 2008 to 2013 Outliers not shown. INTERMEDIATE RISK of disease progression*
HIGH RISK of disease progression*
VERY HIGH & METASTATIC risk of disease progression*
*Refer to Appendix A for classification of NCCN risk group VIC PCR | 5‐YEAR REPORT 39 Diagnosis to Initial Treatment by Location of Hospital where Diagnosed A shorter duration between diagnoses and initial treatment was shown as men were presenting with more advanced prostate cancer disease. The median number of days [lower‐upper quartile] between diagnosis and initial treatment according to risk group were: 



102 days [55‐209] for men with low risk disease; 65 days [41‐111] for men with intermediate risk disease; 46 days [28‐73] for men with high risk disease; and 23 days [9‐54] for men with very high/metastatic risk group respectively. Figure 21 outlines the time interval between diagnosis and initial treatment according to the ICS where the hospital is located. Of some concern was the significant time delay between diagnosis and treatment in men in the intermediate risk disease diagnosed in GRICS and LMICS compared to men from metropolitan areas and BSWRICS. Figure 21. Box plots of number of days taken from diagnosis to initial treatment by diagnosing ICS Outliers not shown. INTERMEDIATE RISK of disease progression*
HIGH RISK of disease progression*
VERY HIGH & METASTATIC risk of disease progression*
*Refer to Appendix A for classification of NCCN risk group VIC PCR | 5‐YEAR REPORT 40 Reported Urinary Bother at 12 and 24 Months Post Diagnosis Tables 8 and 9 below describe, by initial treatment, the response men gave when asked about their urinary bother 12 and 24 months after diagnosis. Table 8. Reported urinary bother at 12 months post diagnosis by treatment group Treatment(s) received prior to 12 month follow up Prostatectomy EBRT EBRT+ Prostatectomy AS/WW “How big a problem has your urinary function been for you during the last 4 weeks?” Declined No Very small A small Moderate A big to answer problem problem problem problem problem 3.9% 45.8% 23.3% 15.5% 8.7% 2.9% 6.6% 41.8% 15.5% 16.7% 14.0% 5.3% 2.8% 36.7% 19.8% 18.5% 16.9% 5.2% 8.8% 51.4% 15.1% 13.1% 9.4% 2.3% Table 9. Reported urinary bother at 24 months post diagnosis by treatment group Treatment(s) received prior to 24 month follow up Prostatectomy EBRT EBRT+ Prostatectomy AS/WW “How big a problem has your urinary function been for you during the last 4 weeks?” Declined No Very small A small Moderate A big to answer problem problem problem problem problem 2.5%
46.9%
20.3%
10.4%
6.4% 2.5%
4.7%
40.5%
11.5%
15.3%
12.2% 5.4%
2.4%
46.4%
25.8%
25.4%
12.9% 8.9%
5.8%
42.6%
9.5%
9.8%
8.5% 2.5%
Most common reported urinary bother status 2nd most common reported urinary bother status 3rd most common reported urinary bother status Nearly half of the participating men reported that their urinary function had caused them no bother at either 12 or 24 months post diagnosis VIC PCR | 5‐YEAR REPORT 41 Reported Bowel Bother at 12 and 24 Months Post Diagnosis Tables 10 and 11 below describe, by initial treatment, the response men gave when asked about their bowel bother 12 and 24 months after diagnosis. Table 10. Reported bowel bother at 12 months post diagnosis by treatment group “How big a problem have your bowel habits been for you during the last 4 weeks?” Declined No Very small A small Moderate A big to answer problem problem problem problem problem 3.8% 80.7% 5.4% 5.7% 3.4% 1.0% 6.6% 55.2% 10.8% 12.7% 11.0% 3.8% 2.8% 51.2% 13.3% 16.5% 12.5% 3.6% 8.7% 72.2% 6.3% 7.1% 4.6% 1.0% Treatment(s) received prior to 12 month follow up Prostatectomy EBRT EBRT+ Prostatectomy AS/WW Table 11. Reported bowel bother at 24 months post diagnosis by treatment group “How big a problem have your bowel habits been for you during the last 4 weeks?” Declined No Very small A small Moderate A big to answer problem problem problem problem problem 2.6% 73.0% 4.9% 4.8% 3.0% 0.8% 4.8% 51.9% 8.2% 11.4% 8.4% 4.8% 2.4% 75.8% 12.9% 17.3% 9.3% 4.0% 5.9% 57.0% 5.3% 4.6% 4.2% 1.6% Treatment(s) received prior to 24 month follow up Prostatectomy EBRT EBRT+ Prostatectomy AS/WW Most common reported bowel bother status 2nd most common reported bowel bother status 3rd most common reported bowel bother status More than half of the participating men reported that their bowel function had caused them no problem at either 12 or 24 months post diagnosis VIC PCR | 5‐YEAR REPORT 42 Reported Sexual Bother at 12 and 24 Months Post Diagnosis Tables 12 and 13 below describe, by initial treatment, the response men gave when asked about their sexual bother 12 and 24 months after diagnosis. Table 12. Reported sexual bother at 12 months post diagnosis by treatment group “How big a problem has your sexual function or lack of sexual function been for you during the last 4 weeks?” Declined No Very small A small Moderate A big to answer problem problem problem problem problem 4.2%
19.3%
5.4%
12.7%
20.1% 38.2%
8.3%
46.5%
4.9%
8.6%
9.4% 22.2%
3.7%
22.4%
4.5%
11.4%
19.1% 39.0%
10.1%
56.4%
4.9%
8.5%
10.1% 10.1%
Treatment(s) received prior to 12 month follow up Prostatectomy EBRT EBRT+ Prostatectomy AS/WW Table 13. Reported sexual bother at 24 months post diagnosis by treatment group “How big a problem has your sexual function or lack of sexual function been for you during the last 4 weeks?” Declined No Very small A small Moderate A big to answer problem problem problem problem problem 3.1% 20.6% 6.0% 12.7% 17.0% 29.7% 5.9% 38.9% 4.0% 8.1% 9.9% 22.6% 3.7% 27.6% 7.7% 15.0% 22.8% 45.1% 6.9% 46.1% 4.1% 7.0% 6.1% 8.2% Treatment(s) received prior to 24 month follow up Prostatectomy EBRT EBRT+ Prostatectomy AS/WW Most common reported sexual bother status 2nd most common reported sexual bother status 3rd most common reported sexual bother status Sexual function remained a big bother for many men even two years after diagnosis, particularly for those underwent prostatectomy and radiotherapy VIC PCR | 5‐YEAR REPORT 43 Concluding Remarks The Vic PCR has been developed as Australia’s first prostate cancer clinical quality registry. Since its inception in 2009, the Vic PCR has been successful in accruing recruiting sites and now collects data from 33 Victorian hospitals, accounting for 85% of all newly diagnosed cases. The Vic PCR will continue to drive quality improvement by providing clinicians and hospitals with feedback on performance data regarding their adherence to quality of care indicators and thus ensuring that prostate cancer patients receive the highest quality of care. The information provided by the Vic PCR is becoming increasingly valuable for researchers to undertake meaningful research projects within prostate cancer. With rapid growth of the registry comes a number of challenges for the registry personnel to keep up with the enrolment of new patients, clinicians and health services, HREC applications, data collection activities, ongoing maintenance of the registry web system and the most important of all is to identify ways to find an adequate and reliable funding base to facilitate continuous development and improvement of the Vic PCR. This report has highlighted the registry’s achievements over its first five years of operation. It is hoped that the information presented in this five‐year report is useful to clinicians, health service providers, patients and their carers, funding bodies, stakeholders and policy makers. VIC PCR | 5‐YEAR REPORT 44 Getting to Know Our Registry Team… Max Shub Consumer Representative How long have you been a member of the Vic PCR steering committee? I have been a member since 2010. Tell us about your background, including what motivated you to become involved in this registry? I am a prostate cancer patient with my cancer being managed so far successfully. I decided some years ago that I would do whatever I could to support those affected by prostate cancer. As a result I am facilitating a support group. I have been involved in the support group network at a state and national level. I am also a PCFA Ambassador and sit on the following committees: ANZUP Consumer Advisory Group, NEMICS Consumer Reference Group, NEMICS Clinical Reference Group, Joint Consumer Advisory Group of PC4 & PoCoG, PoCoG Scientific Advisory Group, Cancer Trials Consumer Network and Cancer Action Victoria. Can you please tell us more about your role as a ‘consumer representative’? As a consumer on a committee, my role is to always consider the impact on the consumer that committee actions will have. What do you see as the biggest issue affecting men with prostate cancer? Relying on only one source of information about their disease and treatment options. What do you hope will be achieved by the registry? I am excited about the research potential of the registry and see it as an opportunity to significantly improve diagnosis, treatment and the management of side effects of prostate cancer. Do you have any advice to men living with prostate cancer and to their carers or family members? Learn as much as possible about the disease both before and after treatment. VIC PCR | 5‐YEAR REPORT 45 Cassandra Jayde De Lacy‐Vawdon Follow Up Interviewer Supervisor How long have you worked for Vic PCR? I started working for Vic PCR in January 2014 after completing a placement under Sue Evans in November/December 2013. Whilst my placement was in Clinical Registries more generally, I spent most of my time working on the Prostate Cancer Registry. I also got to know some of the PCR staff as we shared offices. At the end of my placement, Sue asked me if I'd like to take on some follow‐up work and now here I am. What do you like best about your role? The thing that I probably like best about my role is that I really enjoy speaking to patients. Sometimes when you're on the phone to a patient and they're essentially telling you about how it is to be them and to live their life, you realise that you may be the only person that they have spoken to all day. It's times like this that I think that the most important thing that you can do for that patient is be human; listen to their stories and try to appreciate where they are coming from. Completing the survey is important, but it needs to be done in a very caring way. I really like the feeling you get when a patient seems to have really enjoyed talking to you. You can't help but enjoy that! What is the biggest challenge you have faced on this role? The biggest challenge that I think you face in the role is having to deal with difficult patients. Sometimes you seem to catch patients at the perfectly wrong time and they can be really unpleasant towards you. It can be really hard not to take personally, but ultimately you have to realise that there are other things in their lives that are making them so unhappy and that if it wasn't you it would have been someone else. What is probably harder than this, though, is to hear just how poorly some people are and just how hard they are finding it. This can be so heart‐wrenching. Ultimately, though, this is why we are doing the research that we are doing; to try and improve patient experiences and outcomes. VIC PCR | 5‐YEAR REPORT 46 Can you please tell us about the most memorable conversation that you experienced with registry participants? My most memorable conversation with a patient was also probably one of my longest calls ever. I was talking to a gentleman who had lost his wife and found out that he had prostate cancer all in a matter of a few weeks. I could only imagine how hard that must be for someone but he had the most positive outlook on life. He told me about how he loved singing and music, and how he used them every day to bring joy to himself and those around him. He told me about how he'd performed in musical theatre all over the world and even sang to me over the phone! It was a really lovely call and one I'll probably always remember. What’s something your colleagues don’t know about you? I became an aunty when I was 8 years old and now have 3 beautiful nieces who are some of my favourite people to hang out with! All staff members are asked to sign a Declaration of Confidentiality when they first join the registry. This is highlighted as part of the compulsory Research Governance Induction. VIC PCR | 5‐YEAR REPORT 47 Publications 2014 Evans SM, Millar JL, Frydenberg M, Murphy DG, Davis ID, Spelman T, Bolton DM, Giles GG, Dean J, Costello AJ, Frauman AG, Kearns PA, Day L, Daniels C, McNeill JJ. Positive surgical margins: rate, contributing factors and impact on further treatment: findings from the Prostate Cancer Registry. BJU Int. 2014 Nov;114(5):680‐90. doi: 10.1111/bju.12509. Weerakoon M, Evans SM, Millar J, Lawrenthschuk N, Frydenberg M, Bolton D, Murphy DG. The current use of Active Surveillance in an Australian cohort of men: a pattern of care analysis from the Victorian Prostate Cancer Registry. BJU Int 2014 (1): 113‐125. Weerakoon M, Evans SM, Millar J, Murphy DG, Frydenberg M, Bolton D. Do active surveillance patients in Victoria, Australia, meet the criteria for PRIAS? BJU Int 2014;113 (Supp4):45. Roth H, Millar J, Cheng A, Byrne A, Evans SM, Grummet J. The state of TRUS biopsy sepsis. Re‐
admissions to all Victorian hospitals with TRUS biopsy infection over 5 years. BJU Int 2014;113 (Supp 4):42. 2013 Evans SM, Millar JL, Davis ID, Murphy DG, Bolton DM, Giles GG, Frydenberg M, Andrianopoulos N, Wood JM, Frauman AG, Costello AJ, McNeil JJ. Patterns of care for men diagnosed with prostate cancer in Victoria from 2008 to 2011. Med J Aust. 2013 Jun 3;198(10):540‐5. 2012 Evans SM, Millar JL, Wood JM, Davis ID, Bolton D, Giles GG, Frydenberg M, Frauman A, Costello A, McNeil JJ. The Prostate Cancer Registry: monitoring patterns and quality of care for men diagnosed with prostate cancer. BJU Int. 2012 Jul; 111(4 Pt B):E158‐66. doi: 10.1111/j.1464‐410X.2012.11530.x. D Ilic, S Evans, D Murphy, M Frydenberg. Laparoscopic versus open prostatectomy for the treatment of localised prostate cancer. The Cochrane Collaboration 2012, Issue 2. VIC PCR | 5‐YEAR REPORT 48 Presentations 2013 Declan G Murphy, Sue M Evans, Jeremy L Millar, Ian D Davis, Damien Bolton, Graham G Giles, Mark Frydenberg, Nick Andrianopoulos, Julie M Wood, Albert G Frauman, Anthony Costello, John J McNeil. Importance of a prostate cancer registry for describing changing patterns of care. USANZ Conference 68 Scientific Meeting. 13th‐16th April 2013. Melbourne. Millar J on behalf of the PCR Steering Committee. Quality‐of‐life outcomes for prostate cancer treatment in Australia. 2013 Genitourinary Cancers Symposium (ASCO, ASTRO and SUO). 14th‐16th February 2013. Orlando, Florida. Murphy DG, Evans SM, Millar J, Davis I, Bolton D, Giles GG, Frydenberg M, Andrianopoulos N, Wood J, Frauman A, Costello A, McNeil JJ. Importance of prostate cancer registry for describing patterns of care. 27th Annual European Association of Urology Congress. 15th–19th March 2013. Milan. 2012 Evans SM on behalf of the PCR Steering Committee. The Prostate Cancer Registry: an update on progress and achievements. Southern Metropolitan Integrated Cancer Services (SMICS) Genito‐
Urinary Tumour Group Meeting. 6th August 2012. Melbourne. Murphy D on behalf of the PCR Steering Committee. Enormous change in patterns of care in Victoria: data from the prostate cancer clinical registry. 13th Australasian Prostate Cancer Conference. 1st August 2012. Melbourne. Kiven L, Evans SM, Frydenberg M, Murphy D, Millar J on behalf of the PCR Steering Committee. Contemporary outcomes of radical prostatectomy in a population based registry. 13th Australasian Prostate Cancer Conference. 1st August 2012. Melbourne. Frydenberg M on behalf of the PCR Steering Committee. Contemporary patterns of disease, patients and management characteristics from the Victorian PCR. ANZUP Annual Scientific Meeting. 15th‐17th July 2012. Sydney. VIC PCR | 5‐YEAR REPORT 49 2011 Wood J, Evans SM, Millar J et al. Development of a clinical registry to monitor quality of care for men diagnosed with prostate cancer. Cabrini Research. 15th August 2011. Melbourne. Millar J on behalf of the PCR Steering Committee. Contemporary Patterns of Prostate Cancer Presentation, Management and Outcomes in Victoria. 12th Australasian Prostate Cancer Conference 2011. 3rd‐5th August, 2011. Melbourne. Millar J and Evans S on behalf of the Prostate Cancer Clinical Registry Steering Committee. Introducing the Prostate Cancer Clinical Quality Registry. Barwon South Western Regional Integrated Cancer Service Urology Multidisciplinary Meeting. 5th April 2011. Geelong. Evans SM, Millar J, Wood J, McNeil JJ. The importance of aligning registries monitoring quality and safety with nationally endorsed Operating Principles for Clinical Quality Registries. International Society for Quality (ISQua) 28th International Conference. 15th–17th September 2011. Hong Kong. 2010 Millar J Evans SM on behalf of the Prostate Cancer Clinical Registry Steering Committee. Pilot of a Prostate Cancer Clinical Registry. Victorian Cooperative Oncology Group. 21st October 2010. Melbourne. Millar J on behalf of the Prostate Cancer Clinical Registry Steering Committee. The prostate cancer registry – developing useful data sources to guide quality improvement and practice change. Integrated Cancer Centres Symposium. 8th‐9th September 2010. Melbourne. Evans SM on behalf of the Prostate Cancer Clinical Registry Steering Committee. Pilot of a prostate cancer registry. 11th National Prostate Cancer Symposium. 11th‐13th August 2010. Melbourne. Millar J and Evans SM on behalf of the Prostate Cancer Clinical Registry Steering Committee. Introducing the prostate cancer clinical registry. Cancer Clinical Outcomes Group (CCOG) Department of Human Services. 15th April 2010. Melbourne. Evans SM, Millar on behalf of the Prostate Cancer Clinical Registry Steering Committee. Updating clinicians on the prostate cancer registry. Monash Comprehensive Cancer Consortium Research Seminar. 14th April 2010. Melbourne. VIC PCR | 5‐YEAR REPORT 50 Funding The Vic PCR has received funds through competitive research grants and key stakeholder groups over the past five years. Table 14 acknowledges these funding groups. Table 14. Funding history of the Vic PCR Organisation 2009
Cancer Australia, Federal 197,625
Department of Health and Ageing Prostate Cancer Foundation of Australia ANZ Trustees Victorian Department of Health Australian Prostate Cancer Research Victorian Cancer Agency ‐ CAPTIV Movember Foundation TOTAL 197,625
2010
197,625
32,000
Funding
2011
2012 64,000
5,625 23,680 31,250 13,230
361,875 200,140
213,370
117,000
210,500 181,000
2014
64,000 12,500
242,125
2013 298,180 Figure 22. Expenditure of the Vic PCR Registry personnel are the primary resource required to operate the registry. Central staffing costs include project oversight, data maintenance, statistical analyses, clinician engagement and communication, consultants’ fees, ethics application and report dissemination. VIC PCR | 5‐YEAR REPORT 51 Acknowledgements The Vic PCR would like to acknowledge and extend their appreciation to the investigators, committee members, data collectors, follow up interviewers, the doctors, practice managers and hospital staff for their active contribution and support to the registry. A/Professor Jeremy Millar (Principal Investigator) A/Professor Sue Evans (Data Custodian) Fanny Sampurno (Research Co‐ordinator) Administrative Assistant Follow Up Interviewers Masuma Hoque Cassandra Jayde De Lacy‐Vawdon Erica Flint Data Collectors Natasha Rooney Joanie McPhee Stephanie Dearaugo Lisa Selbie Kate Richards Masuma Hoque Cherubina Ratnam Laura Edmonds Renee Conroy Erica Flint Christine Sherwell Former Staff Colin Anderson Joanne Dean Julie Wood Programmers Jacki Dunning Ramya Jaganathan Adele Maria Storch Yunus Nio Diana Abu‐Ssaydeh Waranon Buranasiri Suvarna Joshi VIC PCR | 5‐YEAR REPORT 52 Vic PCR Steering Committee Members A/Professor Jeremy Millar (William Buckland Radiation Centre / Monash University) Professor John McNeil (Monash University) A/Professor Damien Bolton (Austin Health) Professor Ian Davis (Eastern Health Clinical School) Ms Helen Farrugia (Victorian Cancer Registry) Professor Graham Giles (Cancer Council of Victoria) Ms Kathryn Whitfield (Department of Health) A/Professor Declan Murphy (Peter MacCallum Cancer Centre/Epworth Health) Professor Anthony Costello (Melbourne Health/Epworth Health) A/Professor Mark Frydenberg (Cabrini Health) Professor Albert Frauman (Austin Health) Dr Paul Kearns (Barwon Health) A/Professor Sue Evans (Monash University) Mr Max Shub (Consumer representative) Mr Colin O’Brien (Consumer representative) VIC PCR | 5‐YEAR REPORT 53 Appendices Appendix A. NCCN Risk Category Table 15 provides an outline of the variables used to derive the National Comprehensive Cancer Network (NCCN) risk categories.1,2 These measures have been validated and extensively used when evaluating prostate cancer outcomes.1,3 Table 15. Guidelines of NCCN risk category NCCN Risk Category Low Intermediate High Locally advanced: very high Metastatic disease Clinical T, N and M T1‐T2a T2b‐T2c OR T3a OR T3b‐T4 Any T, N1 Any T, Any N, M1 Gleason Score 2‐6 7 OR 8‐10 OR PSA ≤ 10 ng/mL 10‐20 ng/mL >20 ng/mL 1. Mohler JL, Armstrong AJ, Bahnson RR, et al. Prostate cancer, Version 3.2012: featured updates to the NCCN guidelines. Journal of the National Comprehensive Cancer Network;10:1081‐7. 2. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf; 2012. 3. Zhao KH, Hernandez DJ, Han M, Humphreys EB, Mangold LA, Partin AW. External validation of University of California, San Francisco, Cancer of the Prostate Risk Assessment score. Urology 2008;72:396‐400. VIC PCR | 5‐YEAR REPORT 54 Appendix B. PRIAS Protocol Table 16 below provides an outline of the variables used to assess if a patient meets the Prostate Cancer Research International Active Surveillance (PRIAS) protocol. Table 16. Guidelines of PRIAS protocol PRIAS Protocol Clinical T Primary Gleason Secondary Gleason T1 or T2 1‐3 1‐3 PSA ≤ 10 ng/mL Number of Cores Positive < 3 Source: https://www.prias‐project.org/ VIC PCR | 5‐YEAR REPORT 55 Appendix C. Interpreting the Funnel Plot Benchmarking results are commonly presented in the form of funnel plots where results of an individual unit are compared with the risk adjusted results from other similar units. Figure 23. Registry reporting ‐ example of a funnel plot Interpreting the funnel plot:
The horizontal axis (x‐axis) measures the number of cases being examined. In the clinical quality indicators report these refer to: • documentation of the clinical stage in the medical records (INDICATOR 3); • positive surgical margin rate by risk category (INDICATOR 6). VIC PCR | 5‐YEAR REPORT 56 The vertical axis (y‐axis) measures the percentage of cases which meet the reported clinical quality indicators – namely: • the % of notes where documentation of clinical stage was recorded by the clinician/hospital (INDICATOR 3); • the % of radical prostatectomy patients with positive surgical margins (INDICATOR 6). A point estimate (black dot) which represents the percentage of observed cases is then plotted for each clinician/hospital contributing to the registry. The larger number of cases (volume) notified to the Vic PCR, the further to the right will be its figure; the smaller the volume, the further to the left its black dot will be. Clinician/hospital own data is represented as a red dot. The red line represents the pooled average % observed cases for all clinicians/hospitals combined. As samples/patient numbers get larger, the closer to the pooled estimate they become, as represented by the convergence of dashed contour lines (themselves representing 5% and 1% or 0.2% significance respectively). Visit the following website for more information on the Vic PCR http://pcr.registry.org.au VIC PCR | 5‐YEAR REPORT 57 References 1. Registry Science Handbook. Monash University. November 2013. 2. Australian Bureau of Statistics, 3218.0‐ Regional Population growth, Australia 2011‐12. 3. Mohler JL, Armstrong AJ, Bahnson RR, et al. Prostate cancer, Version 3.2012: featured updates to the NCCN guidelines. Journal of the National Comprehensive Cancer Network;10:1081‐7. 4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf; 2012. 5. Zhao KH, Hernandez DJ, Han M, Humphreys EB, Mangold LA, Partin AW. External validation of University of California, San Francisco, Cancer of the Prostate Risk Assessment score. Urology 2008;72:396‐400. 6. Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the Expanded Prostate Cancer Index Composite (EPIC) for comprehensive assessment of health‐related quality of life in men with prostate cancer. Urology. 2000 Dec 20; 56(6):899‐905. 7. National Collaborating Centre for Cancer. Prostate Cancer: diagnosis and treatment. Full guideline. London: National Institute for Clinical Excellence (NICE), 2008; NICE clinical guideline 58. 8. Spencer B, Steinberg M, Malin J, et al. Quality‐of‐care indicators for early‐stage prostate cancer. J Clin Oncol. 2003; 21:1928‐36. 9. Kumar P, Clarke M. Malignant disease. Kumar P, Clarke M. Clinical Medicine. 7th edition. Elsevier Limited, 2009. 10. Eastham JA, Kattan MW, Riedel E et al. Variations among individual surgeons in the rate of positive surgical margins in radical prostatectomy specimens. Journal of Urology 2003; 170(6 Pt 1):2292‐5. VIC PCR | 5‐YEAR REPORT 58