Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Anglia Cancer Network Guidelines for the Management of Prostate Cancer GUIDELINES FOR THE MANAGEMENT OF UROLOGICAL CANCER Prostate Cancer Date of Endorsement: January 2014 Authors: Mr. Vivekanandan Kumar and Mr. Robert Brierly REF: AngCN-U-ProstateGuidelines 2014 v1 II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer Title: Guidelines for the Management of Prostate Cancer Authors: Vivekanandan Kumar and Rob Briely Document management Document ratification and history Date placed on electronic library: Approved by: Urology NSSG Chair and Network CEO Review period: 2 years (or earlier in the light of new evidence) Amended items Prostate Biopsy update (Feb 2014) Management of erectile function post radical prostatectomy and radiotherapy (Feb 2014) Authors: Mr. Vivekanandan Kumar and Rob Brierly Version number as approved and published: 2014 v1 Aug 2014 Document Owner: Anglia Cancer Network Tel: 01638 608208 www.angliacancernetwork.nhs.uk Unique identifier no.: AngCN-U-ProstateGuidelines 2014 v1 For comments / amendments to these guidelines, please contact: Name Vivekanandan Kumar Robert Brierly Hospital Tel. No Email NNUH 01603 286286 [email protected] Ipswich [email protected] For copies of guidelines, please refer to the Anglia Cancer Network website: www.angliacancernetwork.nhs.uk Monitoring the effectiveness of the Process a) Process for Monitoring compliance and Effectiveness - Review of compliance as determined by audit. Any non compliance to be presented by PQ Manager to the AngCN Business Meeting on an annual basis – the minutes of this meeting are retained for a minimum of five years. b) Standards/Key Performance Indicators – This process forms part of a quality system working to, but not accredited to, International Standard BS EN ISO 9001:2008. The effectiveness of the process will be monitored in accordance with the methods given in the quality manual, AngCN-QM Equality and Diversity Statement This document complies with the Suffolk PCT Equality and Diversity statement – an EqIA assessment is available on request to Anglia Cancer Network PQ Manager, Gibson Centre, Exning Road, Newmarket, CB8 7JG. Disclaimer It is your responsibility to check against the electronic library that this printed out copy is the most recent issue of this document. II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer CONTENTS Page No INTRODUCTION .................................................................................................................. 4 REFERRALS ........................................................................................................................ 4 PROSTATE BIOPSY ............................................................................................................ 4 LMDT REVIEW ..................................................................................................................... 5 STAGING ............................................................................................................................. 5 DEFINING TUMOUR STAGE AND GRADE ......................................................................... 5 MANAGEMENT OPTIONS FOR EARLY PROSTATE CANCER ......................................... 5 1. Active Surveillance alone ...................................................................................................... 6 2. Radical Prostatectomy .......................................................................................................... 6 3. External beam radiotherapy - EBRT ..................................................................................... 7 4. Radioactive seed implantation – Brachytherapy ................................................................... 9 5. Radiotherapy after radical prostatectomy ............................................................................. 9 6. Long term androgen deprivation therapy alone .................................................................... 9 MANAGEMENT OPTIONS BASED ON D’AMICO CLASSIFICATION............................... 10 MANAGEMENT OPTIONS FOR LOCALLY ADVANCED PROSTATE CANCER (WITHOUT METASTASES) .................................................................................................................. 10 MANAGEMENT OPTIONS FOR METASTATIC DISEASE ................................................ 10 SMALL CELL CARCINOMA .............................................................................................. 11 PROSTATIC DUCTAL CARCINOMA. ................................................................................ 12 FOLLOW UP ...................................................................................................................... 12 APPENDICES..................................................................................................................... 13 Appendix 1 – Prostate histology, grading ................................................................................ 14 Appendix 2 - Staging ................................................................................................................ 15 Appendix 3 – Osteoporosis Guidelines .................................................................................... 16 Appendix 4 - Clinical Trials ...................................................................................................... 18 Appendix 5 – Prostate Cancer Pathway .................................................................................. 19 II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer Introduction The purpose of this manual is to collate the numerous guidelines that exist, into a working manual for the management of prostate cancer within the Anglia Cancer Network. It should act as a summary guide for the management of patients with prostate cancer based on the available published evidence. Its scope is to aid all health practitioners involved with the patient from primary care and referral through treatment to follow up. However, as constant modifications are being made, these guidelines should only be used to give an indication of current management. They should not be used to treat patients without checking that changes have not been made. These guidelines have been developed by discussion between clinicians within the Anglia Cancer Network Urology Site Specific Group but without the establishment of a formal guideline development group. These guidelines have been endorsed by the Anglia Cancer Network Urology Site Specific Group. They will be reviewed and updated on an annual basis or more frequently as required. The guidelines are intended as a working document for daily practice. For more detailed sources, and for educational material, please refer to guidelines produced by e.g. NICE, BAUS, EAU, AUA. Referrals For referrals from Primary and Secondary Care, see AngCN prostate cancer pathway Appendix 5 – Prostate Cancer Pathway and DH suspected cancer guidance. Prostate biopsy The following can be considered as indications for biopsy: Any patient with PSA > age adjusted upper limit (ULN) Other men with who wish to have a biopsy based on their PSA and general level of risk Any patient with palpably abnormal prostate. A minimum of ten samples should be taken to reduce the risk of underestimating tumour grade. In patients with continued suspicion of prostate cancer, after first negative biopsy, either in the form of rising PSA, change in DRE findings or MRI changes, a TRUS + Trans perineal template, biopsies should be considered for subsequent biopsy to reduce false negative results, especially from the anterior part of the prostate gland and reduce underestimating the cancer grade of the cancer if found. An MRI before repeat biopsies should be considered after discussions with the local MDT. See AngCN Pathology guidelines for details of pathology assessment of biopsy material. II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer LMDT review All positive prostate biopsies should be discussed in the LMDT. The need for staging investigations can be based on the prostate cancer risk categories devised by D’Amico. Low Risk -T1c or T2a, Gleason <6 and PSA <10 ug/l Intermediate Risk - T2b or Gleason 7 or PSA >10 and < 20 ug/l High Risk - > T2c or Gleason > 8 or PSA > 20 ug/l Staging Bone scintigram in all patients in medium and high risk categories, or if bone pain. MR pelvis should be considered in all patients being considered for radical therapy and in all patients considered for active surveillance. MRI should be performed at least three weeks after biopsy to allow changes due to bleeding from biopsy to subside. Defining Tumour Stage and Grade Pathology and tumour grade The recommended histological grading system for adenocarcinoma is described by Gleason (see Appendix 1). Tumour stage In the UK the TNM is used (see Appendix 2) Management options for early prostate cancer Patients will have been assigned a D’Amico Risk Category – low, intermediate or high. For most patients with early stage prostate cancer there are will be a number of options available. These should be discussed with the patient. All patients with prostate cancer being considered for surgery or brachytherapy should be discussed with the Specialist Multi-disciplinary Team at Addenbrooke’s or the Norfolk and Norwich University Hospital, and counselled initially by the local urological and oncological core members of their LMDT. The main management options include: 1. 2. 3. 4. Active surveillance Radical prostatectomy 3-D conformal external beam radiotherapy - EBRT Radioactive seed implantation - brachytherapy II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer 5. Watchful wait 6. Hormone therapy alone 1. Active Surveillance alone Type of patient who may be considered: >10 years life expectancy Gleason sum 6 or 7(3+4) (well/moderately well differentiated) tumours T1/T2a and T2b PSA<10 Asymptomatic Patient preference Baseline MRI should be considered for all patients contemplating active surveillance. The risk of progression is related to grade and stage. These risks should be explained to the patient. If the patient opts for active surveillance and he is suitable for radical treatment should his disease progresses, he should be followed up initially at three monthly intervals with a PSA and also rectal examination at least every 12 months. At a later stage once stability of the PSA reading has been established, the appointment interval may be increased to 6 monthly. Monitoring should include a measure of PSA doubling time (PDAdt). Active surveillance should involve repeat prostate biopsies every 12 to 18 months. The patients managed may be informed by the PSAdt, some suggestions are put below but patient choice remains paramount. PSAdt <10 months – intervention PSAdt >4 years – no intervention / continued active monitoring PDAdt between 10 months and 4 years – consider treatment according to patient parameters (i.e. Radical or palliative treatment). Progression in repeat biopsies (eg. grade shift, increased tumor volume) should trigger intervention Patients with less than 10 years of life expectancy, older or serious medical conditions should be offered watchful wait. 2. Radical Prostatectomy Usually men undergoing radical prostatectomy would have the following criteria. Patients with a predicted life expectancy in excess of 10-15 years; usually these men will be aged under 73 years. T1/T2N0M0 and PSA < 20 ug/l Some men with operable cT3 disease may wish for surgery Patient understands and accepts the risk of impotence and/or incontinence. Patient preference. Prostatectomy may be advantageous if there is a history of marked LUTS. Patients should be offered open, laparoscopic and robotic radical prostatectomy, depending on patient preference, after appropriate counseling, supplemented by information sheets. II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer Management of erectile function post radical prostatectomy and radiotherapy Penile rehabilitation is defined as the use of any drug or device at or after radical prostatectomy to maximize the recovery of erectile function. The purpose of penile rehabilitation is the prevention of corpus cavernosum smooth muscle structural alterations, to limit venous leak development during the period of recovery from neuropraxia, and therefore to maximize the chances of a man returning to his preoperative level of erectile function. Recent studies(1-4) suggest a benefit from early pharmacological rehabilitation after radical prostatectomy. Proposed guideline : a) Pre-op good Erectile function,( IIEF >16/25), Good unilateral / bilateral nerve spare: Cialis (tadalfil) 5mg Once Daily (preferred treatment) Review in 3 months if no early response, consider change to MUSE/ Intracavernosal Injection alprostadil / Vacuum tumescence device. Consider continuing any PDE5 after 3 months as return of normal erections can be delayed up to 24 months Consider use of Vacuum device in combination with PDE5 If at 3 months review there is early response to PDE5 – Cialis or Sildenafil then change over to PRN dose b) Pre-op ED or IIEF <16/25 or poor nerve spare: Direct MUSE/ Intracavernosal Injection alprostadil / Vacuum tumescence device. There is less evidence for management of ED post radiotherapy. However the above should still be considered to offer potential benefit and has been recommended by NICE guidance (2014). Men should be provided with early and ongoing access to specialist erectile dysfunction services including psychosexual counselling. Androgen deprivation therapy and erectile dysfunction NICE guidance (2014) recommends that men should be offered access to specialist erectile dysfunction services including psychosexual counselling as well as treatment with PDE5 inhibitors for loss of erectile function on hormone treatments. Department of Health Guidance DoH guidance(5) (HSC1999/148) on treatment of erectile dysfunction states: “the Department advises doctors that one treatment a week will be appropriate for most patients treated for erectile dysfunction. If the GP in exercising his clinical judgement considers that more than one treatment a week is appropriate he should prescribe that amount on the NHS.” 3. External beam radiotherapy - EBRT Patients should be staged as outlined above. II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer T1-3 N0 M0 Any Gleason grade Life expectancy > 10 years No history of radio sensitivity or previous pelvic radiotherapy. Contraindications to brachytherapy or radical prostatectomy. Patient preference. Radiotherapy and hormone therapy recommendations: a) Radical radiotherapy without associated hormone therapy pT1a/pT1c (10% sample volume) and Gleason <7 and PSA in normal range Normal potency Patient preference b) Hormone cyto-reduction 3-6 months before and concurrent with radical radiotherapy pT1b/c-clinical T2a/b/c Gleason < 8 PSA < = 20 ug/l c) Continuing hormones after radical radiotherapy (3 years) Patients at a higher risk of systemic disease may be considered for adjuvant hormone therapy for 3 years. Gleason 8 or above Clinical T3/4a Initial PSA > 20 ug/l (not in acute retention or with UTI) In this setting three monthly LHRHa depot injections are preferred. d) Indefinite Hormone Therapy Followed By Palliative Radiotherapy N+ and/or M+ disease T4b In this setting three monthly LHRHa depot injections are preferred. Patients intending to pursue long term ADT should be considered for bone densitometry at the start of their treatment and then at two yearly intervals. If bone density is < -2 or worse SD below the mean expected value, the patient should receive oral bisphosphonates and calcium supplements as per the advice of the bone densitometry report. See Appendix 3. Salvage therapy for recurrent prostate cancer post-radiotherapy In the event of biochemical recurrence after EBRT, salvage therapy needs to be considered. Hormones or salvage radical prostatectomy or salvage cryotherapy needs to be considered. There is no clear evidence to prefer one treatment over the II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer other. In depth counseling of the patient is essential to inform the risks and benefits of each. Refer to the Norfolk and Norwich University Hospital SMDT for consideration of salvage therapy. 4. Radioactive seed implantation – Brachytherapy Patients may be considered with the following factors: Well or moderately differentiated tumours (Gleason < 7). No greater than 2 positive cores and <20% of biopsy material in positive cores No prior TURP PSA <15 ug/l if Gleason 6 (3+3) and 10 ug/l if Gleason 7(3+4) Prostate volume 20-50 mls-, no pubic arch interference Minimal lower urinary tract symptoms (LUTS) - IPSS < 8/35 T1N0M0 or small volume T2N0M0 Patient preference Patients should be referred to the Oncology Department at Addenbrooke’s Hospital 5. Radiotherapy after radical prostatectomy Indications include a rising PSA post-operatively, or a PSA which fails to become unrecordable, in men with pT3a disease, bladder neck or seminal vesicle involvement, and with broadly positive margins. Positive margins alone are not an indication for immediate post-operative radiotherapy unless the PSA begins to rise. The use of androgen deprivation in this setting is decided on an individual patient basis. Patients should be warned that there is a risk of worsening urinary incontinence following radiotherapy in this setting. 6. Long term androgen deprivation therapy alone Patients who may reasonably be considered include: Life expectancy less than 10 years. Significant urinary symptoms may increase the advantages of offering androgen deprivation. No other significant risk factor for osteoporosis Patient preference. The options for androgen deprivation are: LHRH agonists – goserelin, leuprorelin, triptorelin (intermittent therapy may be considered, particularly for low volume minimal metastatic disease with a low PSA after 6 to 9 months of treatment). LHRH antagonists - degaralix Orchidectomy Anti-androgen monotherapy therapy e.g. Bicalutamide, may be considered for selected patients in whom active therapy is indicated but potency or the sideeffects of LHRH analogues are important issues. See Appendix 3 for bone densitometry indications. II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer Management options based on D’Amico classification Low risk The following options are possible, assuming a life expectancy of at least 10 years and fitness for radical surgery, and all should be discussed with the patient: active surveillance radical surgery radical EBRT brachytherapy If co-morbidity suggest that the patient’s life expectancy is less than 10 years, active treatments may not be appropriate. Intermediate risk Active treatment will be preferred to active surveillance, although the latter option can be considered. Active treatment will usually be either radical surgery or EBRT, but some intermediate risk men may meet the indications for brachytherapy. Active treatment in some men, who are not candidates for radical treatment on grounds of age or frailty, may be with androgen deprivation therapy High risk Active treatment is required. Radical treatment may be considered for men who otherwise have a life expectancy of at least 10 years: EBRT may be an option, and for those fit enough, radical surgery may be considered. Brachytherapy is not an option. Palliative treatment with androgen deprivation therapy, and possibly also with palliative radiotherapy, will be appropriate for men not treated radically. Management options for locally advanced prostate cancer (without metastases) Patients with T3b or T4 could be considered for radical or palliative radiotherapy plus hormone therapy (see radiotherapy section). Other options include hormone therapy alone or active monitoring in patients with other serious medical conditions or patient preference. Radical prostatectomy or brachytherapy are seldom appropriate for patients with stage cT3b disease or more advanced disease. See Appendix 3 for bone densitometry indications. Management Options for Metastatic Disease Local therapies for the prostate depend on the symptoms, extent of disease (locally and metastatic) and the performance status of the patient. Assessing the symptomatic response to hormone therapy is the usual course but palliative TURP or radiotherapy may well be appropriate (Radical prostatectomy or brachytherapy are not considered). Treatment of systemic disease depends on the existing therapies at the time of metastatic development and the individual circumstances of the patient. II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer An example of a possible pathway, purely for illustrative purposes, is: First line LHRH agonist or orchidectomy Next Second line Third line Fourth line Add Antiandrogen (e.g. Bicalutamide 50mg od) Following antiandrogen withdrawal Diethystilboestrol 13 mg po od and Aspirin 75mg od2,3 Also consider clinical trials Docetaxel chemotherapy 75mg/m2 with prednisolone 10mg daily. Also consider clinical trials Other Considerations Consider breast bud irradiation if long term bicalutamide or diethystilboestrol is planned. Cyproterone acetate 50–100 mg od is useful to treat the hot flushes associated with LHRH analogue. As monotherapy there is a risk of liver damage and it is less effective than LHRH analogue. See Appendix 3 for bone densitometry indications. Therapy for painful bone metastases Local radiotherapy to the painful area is the treatment of choice. Usually an 8 Gy single fraction is recommended, although five fractions may be need when retreated. Other therapies include: Strontium 89 Surgical decompression Internal fixation Bisphosphonates Small cell carcinoma Exclude a small cell tumour of the bladder with prostatic infiltration. For patients with apparently localized disease is initial chemotherapy, for up to six cycles, with CAV (cyclophosphamide, doxorubicin, vincristine), ACE (doxorubicin, cyclophosphamide, etoposide) or EP (etoposide, cisplatin), followed by radiotherapy to a dose of 55Gy/20 fractions over four weeks. For patients with metastatic disease at presentation chemotherapy alone is more appropriate unless there is concern regarding the risk of uncontrolled local progression when a palliative radiotherapy treatment schedule to the prostate can be offered. II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer Prostatic ductal carcinoma. This is an aggressive tumour which should be managed along the lines of a transitional cell carcinoma. Fit patients with apparently localized disease should be offered radical radiotherapy (55Gy/20 fractions). For advanced disease consider chemotherapy with cisplatin/gemcitabine or M-VAC. In elderly and unfit patients a trial of androgen deprivation therapy is appropriate. Follow up Following treatment patients should be given an appointment for review in the appropriate clinic. Thereafter follow up will be three to six monthly for first year, six monthly year two – four and thereafter, if conditions stable, annual follow up. If the condition is stable, consider referral back to Primary Care. II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer Appendices Appendix 1 Prostate Histology, grading Appendix 2 Staging Appendix 3 Osteoporosis Guidelines Appendix 4 Clinical Trials supported by the network Appendix 5 Prostate Cancer Pathway II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer Appendix 1 – Prostate histology, grading Gleason Score Grading systems have been shown to correlate with tumour stage, incidence of seminal vesicle and lymph node involvement, occurrence of distant metastases and survival. However, the reproducibility of such systems is not perfect and there is considerable intra- and inter-pathologist variability (Gallee et al, 1990) The histological grading system most commonly used is that described by Gleason (Gleason et al, 1974) and is given on adenocarcinoma and its variants. Unlike other grading systems, emphasis is placed on the assessment of the architectural growth pattern and degree of glandular differentiation, rather than cytological features, thus enabling grading to be performed at low or medium power magnification. Five tumour grades 1-5 are recognised (with sub-divisions to form 9 originally described patterns), forming a continuous spectrum of appearances from grade 1 being the well differentiated to grade 5, the most poorly differentiated. A simplified description of the histological appearances is given here: Gleason Grading of Prostate Cancer – summary of histological appearances: Grade 1 Uniform closely packed separate glands forming a circumscribed nodule Grade 2 Slightly less uniform, separate glands, more loosely packed, with a partially circumscribed margin Grade 3 Single separate infiltrating often angulated glands (3A), very small infiltrating glands (3B) or circumscribed cribriform or papillary masses (3C) Grade 4 Fused raggedly infiltrating glands (4A), which may also consist of large pale cells ‘hypernephroid’ cells (4B) Grade 5 Solid rounded masses with necrosis (5A) or ragged infiltrating tumour (5B) The majority of tumours do not have a uniform appearance, therefore the primary grade is assigned to the pattern which is predominant, and the secondary grade to the next most frequent. The Gleason score is the sum of the primary and secondary grades, unless only one tumour grade is represented, when the score is then simply the grade doubled. This gives a Gleason score range of 2-10. If a third less frequent grade is present, this is the tertiary grade and should be clearly reported if this is of higher grade than the primary and secondary grades. Modifications to the scoring system to incorporate higher grades into the Gleason score have been proposed for needle biopsy reports (e.g. Pan et al, 2000) because of the worse prognosis conferred by the presence of poorly differentiated elements. If a ‘modified’ method of Gleason score is used (i.e. including the tertiary higher grade element in the score), this should be clear from the text of the report. ‘Modified’ scores are not used in reporting radical prostatectomy specimens. A Gleason grade should be assigned, even for small tumour foci. However, Gleason grading of tumours showing therapy related changes is not possible, unless sufficient areas can be identified within the tumour which do not show these artefacts. Gleason scores of less than 5 are not usually made in assessing needle core biopsies, since entire tumour nodules are not represented in the fine cores. For biopsies from different sites, the Gleason scores at those sites should be stated. II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer Appendix 2 - Staging TNM Classification of Prostate Cancer (TNM 2002 edition) TO TX No evidence of primary tumour Primary tumour cannot be assessed T1 Clinically unapparent tumour, impalpable and not visible by imaging T1a Tumour an incidental finding in <5% of resected tissue T1b Tumour an incidental finding in > 5% of resected tissue T1c Tumour identified by needle biopsy (e.g. because of raised PSA) T2 Tumour confined within prostate T2a Tumour involves < half one lobe T2b Tumour involves > half a lobe but not both lobes T2c Tumour involves both lobes T3 Tumour extends through the prostate capsule T3a Unilateral or bilateral extracapsular extension T3b Tumour invades seminal vesicle(s) T4 Tumour is fixed or invades adjacent structures – i.e. bladder neck, external sphincter or rectum, levator muscles or fixed to pelvic side wall Regional Lymph Nodes NX Nodes cannot be assessed N0 No regional lymph node metastases N1 Regional lymph node metastasis Distant Metastases MX Distant metastasis cannot be assessed M0 No distant metastasis M1 Metastasis II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer Appendix 3 – Osteoporosis Guidelines GUIDELINES FOR THE PREVENTION AND MANAGEMENT OF OSTEOPOROSIS IN PATIENTS WITH PROSTATE CANCER EXPECTED TO RECEIVE PROLONGED ANDROGEN DEPRIVATION. Dr Helen Patterson, Professor Juliet Compston. This recommendation relates to patients on: 1. Indefinite LHRH analogue therapy or 2. Three years of adjuvant androgen deprivation following radical radiotherapy. Bone densitometry (hip and lumbar spine) should be requested at the time the decision to initiate LHRH analogue therapy is made and at 2 yearly intervals if androgen deprivation therapy is continued if initial densitometry satisfactory. If the T score is -2 or worse at initiation of LHRH analogues then patients should commence treatment with oral bisphosphonates e.g. Alendronate 70mg po once weekly or Risedronate 35mg po once weekly with calcium and vitamin D supplementation eg Adcal-D3 one tablet b.d., Calcichew D3 forte one b.d. or Calcit D3 one b.d. A repeat DEXA scan should be repeated at 5 years to reassess the need for continued bisphosphonate and supplement treatment. If the T score is -2 or worse perform lateral thoracic and lateral lumbar spine films to exclude a pre-existing crush vertebral fracture as 2/3 do not come to medical attention, and patients who experience a vertebral fracture have a 20% incidence of a further fracture over the ensuing 12 months. If a fracture is identified, commence treatment as above with oral bisphosphonates, calcium and vitamin D. If the T score is between -1 and -2 patients should have repeat densitometry at 2 years and thereafter every 2 years and if higher than -1 repeat at 3 years to monitor progress. In addition, any patient considered to be at increased risk (see below) of osteoporosis, prior to the commencement of LHRH analogue therapy, should also be considered for bisphosphonate therapy. Past history of fragility fracture. Concurrent corticosteroid therapy. Low body mass index <19kg/m2. Heavy smoking. High alcohol intake. There are national guidelines which state that anyone over the age of 65 years started on any dose of oral corticosteroid expected to be continued for more than 3 months should be offered oral prophylaxis against osteoporosis with a bisphosphonate, either Alendronate 70mg once weekly or Risedronate 35mg once weekly together with calcium and vitamin D supplementation as above. II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer Patients expected to undergo short-term LHRH analogue therapy (neo-adjuvant and concurrent with radical radiotherapy alone) do not need to undergo routine bone densitometry. For patients who are on treatment for known osteoporosis, LHRH analogue therapy should still be considered the treatment of choice to accompany their radical radiotherapy treatment unless other issues indicate the use of bicalutamide. II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer Appendix 4 - Clinical Trials The Manual for Cancer Services 2004 states that one of the responsibilities of the MDT Lead Clinician is ‘To ensure mechanisms are in place to support entry of eligible patients into clinical trials…’. The infrastructure to support clinical trials activity is the responsibility of the West Anglia, Norfolk & Waveney and Ipswich locality of the Mid-Anglia Cancer Research Networks (WACRN, NWCRN and MACRN) which provide facilities enabling patient entry into clinical trials in all of its units. The Anglia Cancer Network Urology SSG committed to participation in high quality research studies and clinical trials. Whenever possible, patients should be considered for inclusion in local and national research studies and clinical trials. There is an NSSG agreed single list of clinical trials and research studies supported by the individual MDTs. This is updated at least annually. Further details and protocols are available as follow: Trust Addenbrooke’s Bedford Hinchingbrooke Ipswich James Paget King’s Lynn Norfolk & Norwich Papworth Peterborough West Suffolk Contact West Anglia Cancer Research Network West Anglia Cancer Research Network West Anglia Cancer Research Network Anglia East Cancer Research Network Anglia East Cancer Research Network West Anglia Cancer Research Network Anglia East Cancer Research Network West Anglia Cancer Research Network West Anglia Cancer Research Network West Anglia Cancer Research Network II:\CPC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 \NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 Telephone 01223 256193 Email [email protected] 01223 256193 [email protected] 01223 256193 [email protected] 01603 289860 [email protected] 01603 289860 [email protected] 01223 256193 [email protected] 01603 289860 [email protected] 01223 256193 [email protected] 01223 256193 [email protected] 01223 256193 [email protected] Updated, Approved and Published: Feb 2014 Anglia Cancer Network Guidelines for the Management of Prostate Cancer Appendix 5 – Prostate Cancer Pathway PROSTATE CANCER PATHWAY (E&W) Final Other Referrals i.e. non urgent 18ww referral Tertiary Referrals Active Monitoring SPECIALIST MULTIDISCIPLINARY (SMDT) MEETING OPA Decision to treat (DTT) Recurrence detected Brachytherapy Cryotherapy Urgent GP suspected cancer referral (2WW) Prostate Clinic with biopsy LOCAL MULTIDISCIPLINARY TEAM (LMDT) MEETING Histology discussed. Staging investigations requested, if appropriate. RRP Patient informed of diagnosis (OPA / telephone) - Decision to treat (DTT) - Patient referred to SMDT if appropriate (i.e. if patient chooses brachytherapy/ surgery) L/SMDT / OPA to assess fitness for subsequent treatment Radiotherapy +/- Androgen Deprivation Therapy (ADT) Staging MRI / Bone/CT LMDT MEETING Earliest clinically appropriate date, decision to treat (DTT) ADT Adjuvant Radiotherapy Palliative Care Androgen Deprivation Therapy (ADT) Active Monitoring Consultant upgrade points e.g. referral meets NICE criteria; at first seen, during or after diagnostic tests; on or before MDT date & decision to treat date +62 days from these upgrade point dates Palliative Care Consider Clinical Trial and Follow Up Referral to extended MDT services at any point in pathway e.g. Palliative care specialists, Specialist Nurses and AHPs, education about adverse effects of treatment; access to help and advice from all specialists; staff alert to psychosocial needs; therapists/local healthcare teams, Community Matron, Pharmacists (medicines usage review), Social Services, Mental Health Services, Housing benefits (Social Care and other agencies), GPs, Expert Patient Programme, Smoking Cessation, Alcohol Service (NORCAS), Voluntary organisations, information on prescription, Homeshield (over 60s) Day 0 (Referral) Key: By Day 14 (1st seen) Unit / Centre Centre Access to specialist services By Day 28 (LMDT meeting) GFOCW PC1\MEDICAL DIRECTORATE\SCN Team\4. Cancer 13 NCGs\Urology\AngCN Key documents\ AngCN-U-ProstateGuidelines 2014 v1 By Day 42 (DTT) Day 0 (DTT) By Day 62 (treatment) Elapsed time for follow up or presentation of recurrence, mets or predetermined gap between treatments Updated, Approved and Published: Feb 2014 By Day 31 (2nd treatment)