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CLINICAL PRACTICE GUIDELINE GU-012 Version 1 Local Prostate Cancer Effective Date: January, 2017 The recommendations contained in this guideline are a consensus of the Alberta Provincial GU Tumour Team and are a synthesis of currently accepted approaches to management, derived from a review of relevant scientific literature. Clinicians applying these guidelines should, in consultation with the patient, use independent medical judgment in the context of individual clinical circumstances to direct care. CLINICAL PRACTICE GUIDELINE GU-012 Version 1 BACKGROUND Prostate cancer is the most common cancer among Canadian men, and is the 3rd leading cause of cancer related death in men in Canada. In 2016, it is estimated that 21,600 (age-standardized incidence rate of prostate cancer is 115 per 100,000) men will be diagnosed with prostate cancer in Canada, representing 21% of all new cancers in men. Approximately 1 in 8 Canadian men is expected to develop prostate cancer during their lifetime, and 1 in 27 will die from prostate cancer. In Alberta, 2600 new prostate cancer diagnoses are anticipated in 20161. GUIDELINE QUESTIONS How should patients with localized prostate cancer be risk stratified? How should patients with localized prostate cancer be managed? How should patients with localized prostate cancer be followed after they have completed treatment? DEVELOPMENT AND REVISION HISTORY This guideline was reviewed and endorsed by the Alberta Provincial GU Tumour Team. Members of the Alberta Provincial GU Tumour Team include (medical oncologists, radiation oncologists, surgical oncologists, nurses, pathologists, and pharmacists). Evidence was selected and reviewed by a working group comprised of members from the Alberta Provincial GU Tumour Team and a Knowledge Management Specialist from the Guideline Resource Unit. A detailed description of the methodology followed during the guideline development process can be found in the Guideline Resource Unit Handbook. This guideline was originally developed in (January, 2017). TARGET POPULATION Adult men (18 years of age or older) with a suspicion or recent diagnosis of localized prostate cancer. RECOMMENDATIONS For a complete list of early diagnosis and screening recommendations please see the Early Diagnosis and Screening for Prostate Cancer guideline located (http://www.albertahealthservices.ca/info/cancerguidelines.aspx) and the Canadian Task Force on Preventive Health Care guidelines (http://canadiantaskforce.ca/guidelines/published-guidelines/prostatecancer/) 1. Staging A. Assessment for patients who are being considered for active surveillance or treatment with curative intent should consist of: i. History and physical examination. ii. PSA (which should be done prior to biopsy. iii. Radionuclide bone scan and CT scan abdomen/pelvis is indicated only in patients with high-risk disease* or if clinical suspicion, and may be considered in select patients with high-tier intermediate risk disease*. Page 2 of 11 CLINICAL PRACTICE GUIDELINE GU-012 Version 1 2. Definition of risk categories for clinical staging: A. Low-risk: Must have all of the following: T1-T2a/b, Gleason score ≤6, PSA <10 ng/mL*. B. Intermediate-risk: This group can be further divided into low-tier intermediate (one intermediate risk feature) or high-tier intermediate (more than one intermediate risk feature) for those patients who do not clearly segregate into low or high risk groups. Intermediate-risk features include: T2c, Gleason score 7, and PSA 10-20 ng/mL* 2. C. High-risk: Any one of the following: T3a or higher, Gleason score ≥8, or PSA >20ng/mL*. *In patients taking 5-alpha reductase inhibitors, measured PSA should be doubled for the purposes of risk stratification. 3. Any patient being considered for curative-intent treatment for prostate cancer should be strongly encouraged to explore treatment options with a urologist and a radiation oncologist. Treatment options (e.g. prostatectomy, brachytherapy, and/or external beam radiotherapy (EBRT)) have equivalent cancer-specific outcomes, with different toxicity profiles. 4. Patients should be offered clinical trials wherever available. 5. Management of low-risk disease A. Active surveillance3,4: i. This is the preferred management option in low-risk patients with the understanding that curative treatment will be offered if follow-up demonstrates either worrisome PSA elevation or worsening biopsy characteristics (e.g. Gleason grade and or/volume changes) ii. The patient may choose to proceed with curative therapy due to personal preference at any time. iii. Curative intervention may be required later and patients may be candidates for clinical trials. iv. Patients with localized, low-risk prostate cancer can consider an active surveillance protocol to monitor their disease for signs of disease progression. A reasonable surveillance protocol would include: a. PSA assessment every 3-6 months, DRE annually (at the physician's discretion). b. Consider repeat biopsies 1-2 years after initial diagnosis, then consider further biopsies every 2-3 years or as clinically indicated. v. Disease progression: a. Pathological progression defined as presence of Gleason pattern ≥4 or an increase in the number of positive cores. b. Additional factors to consider repeat biopsy include: -Clinical progression: increase in clinical stage from baseline status. -Biochemical progression: PSA doubling time <3 years. c. If there are signs of disease progression, intervention is recommended with curative therapy (radical prostatectomy, EBRT, or brachytherapy). vi. For patients that will not benefit from curative therapy, watchful waiting or other therapies (e.g. hormonal therapy or palliative radiotherapy) can be considered, see the Advanced/ Metastatic Prostate Cancer guideline for a complete list of recommendations (http://www.albertahealthservices.ca/info/cancerguidelines.aspx). B. Treatment options 5: Page 3 of 11 CLINICAL PRACTICE GUIDELINE GU-012 Version 1 Radical treatment is not appropriate for patients with a life expectancy of <10 years. i. Radical prostatectomy6-8 options include: a. Open retropubic prostatectomy. b. Robotic assisted laparoscopic surgery. c. Both treatments have similar oncological outcomes; furthermore, a wait time of up to 3 months for treatment in low-risk prostate cancer is not associated with worse outcomes. d. Pelvic lymph node dissection in this group is optional, but yield is very low in lowrisk patients. ii. Low dose rate (LDR) Brachytherapy9-11 a. Patients with pubic arch interference may not be eligible for brachytherapy. b. Patients with borderline pubic arch interference may be considered for a short course of hormones to reduce gland size c. Patients with a prior transurethral resection (TURP) should be assessed on an individual basis. d. Patients with significant baseline obstructive symptoms may not be eligible for brachytherapy (i.e. American Urological Association symptom score >20). iii. External beam radiotherapy12 a. 3d-conformal radiotherapy or intensity modulated radiation therapy (IMRT) should be utilized to deliver an International Commission on Radiation Units (ICRU) dose of 74-78 Gy in 1.8-2.0 Gy fractions 13. b. Hypofractionated radiation (e.g. 60 Gy in 3 Gy fractions) may be considered14. c. Daily image guidance is standard of care d. The clinical target volume (CTV) is defined as the prostate alone. C. Alternative therapeutic options for patients who are not eligible or declining standard therapies: i. Cryosugery 15. ii. High intensity focused ultrasound (HIFU)16. D. Follow-up i. PSA every 6 to 12 months for 5 years, then yearly. ii. Digital rectal examination yearly, but may be omitted if PSA undetectable. iii. Evaluation of treatment morbidity and/or complications. 6. Management of intermediate-risk disease A. Treatment options5: i. Radical prostatectomy plus bilateral pelvic lymph node dissection17. ii. External beam radiotherapy13,18,19 a. Based on current evidence, the recommended prescribed dose to the target is 74-78 Gy in standard fractionation. b. Hypofractionated radiation (e.g. 60 Gy in 3 Gy fractions) may be considered14. c. Short term (neoadjuvant + concurrent) androgen deprivation therapy (ADT) may be considered for select patients undergoing radiotherapy (REF 33, 34). iii. Brachytherapy a. Brachytherapy alone is a treatment option for low-tier intermediate risk patients (REF 31-33). b. EBRT with a brachytherapy boost (+/- ADT) is an option for patients with high-tier intermediate risk disease20-22. Page 4 of 11 CLINICAL PRACTICE GUIDELINE GU-012 Version 1 c. Brachytherapy may be delivered as either low dose rate (LDR) or high dose rate (HDR)20-22. d. Short term (neoadjuvant + concurrent) androgen deprivation therapy (ADT) may be considered for select patients undergoing radiotherapy (REF 33, 34). B. Alternative therapeutic options for patients who are not eligible or declining standard therapies: i. Cryosurgery23. C. Follow-up i. PSA every 6 to 12 months for the first 5 years, then yearly. ii. Digital rectal examination yearly. iii. Evaluation of treatment morbidity and/or complications. 7. Management of high-risk disease A. Treatment options5: i. EBRT + ADT 24-26 a. Radiotherapy should treat the prostate planning target volume with 74-78 Gy in standard fractions +/- regional lymph nodes b. EBRT with a brachytherapy boost (+/- ADT) is an option for patients with high risk disease20-22.c. Hypofractionated radiation (e.g. 60 Gy in 3 Gy fractions) may be considered14. d. ADT should be administered for at 18 – 36 months duration and may be initiated prior to radiotherapy or concurrently with EBRT 27. e. An anti-androgen could be co-administered with a LHRH agonist and be continued for at least 7 days for possible flare in testosterone with initial LHRH agonist alone. f. Refer to the Bone Health for Prostate cancer guideline for recommendations regarding bone health for patients on ADT (http://www.albertahealthservices.ca/info/cancerguidelines.aspx) ii. Radical prostatectomy and pelvic lymphadenectomy28 a. Patients should be counselled that they there is a significant likelihood of requiring post-operative radiotherapy +/- ADT. iii. Post-prostatectomy radical RT29 a. Patients with any of the following pathological risk factors for local recurrence should be offered referral to a radiation oncologist for a discussion regarding adjuvant therapy within 6 months of surgery: -Positive surgical margins -Seminal vesicle involvement (pT3b) -Capsular perforation (pT3a) b. Early salvage radiotherapy should be considered at the time of biochemical failure (PSA ≥0.2 ng/mL on at least 2 readings) c. ADT can be considered in post-operative radiation therapy; the optimal type and duration of ADT has not been established. B. Alternative therapeutic options of those patients not eligible for, or declining curative local treatment: i. ADT alone24-26 a. Refer to the Bone Health for Prostate cancer guideline for recommendations regarding bone health for patients on ADT (http://www.albertahealthservices.ca/info/cancerguidelines.aspx) Page 5 of 11 CLINICAL PRACTICE GUIDELINE GU-012 Version 1 C. Follow-up i. First post-operative PSA should be done 4-12 weeks after surgery. ii. Routine PSA should be done every 6 months, unless otherwise specified. iii. Low-risk patients (pT2, Gleason ≤ 3+4, margins negative) may have PSA done yearly. Page 6 of 11 CLINICAL PRACTICE GUIDELINE GU-012 Version 1 SEARCH STRATEGY For the 2017 update, guidelines were updated according to a consensus meeting without a formal literature search. For the 2015 update, no formal literature review was conducted. For the 2014 update of this guideline, the Pubmed database was searched using the search terms Locally Advanced Prostate Cancer and Metastatic Prostate Cancer from 2010 to 2014. Only phase III trials were evaluated for inclusion. For the 2012 update of this guideline, Ovid Medline was searched using the term Prostatic neoplasms (MeSH term, subheadings drug therapy, surgery, therapy and radiotherapy), limited to clinical trials involving humans published in English, between August 2011 and August 2012. Articles were excluded if they were not phase II-IV trials, did not include survival or recurrence outcomes, was retrospective. Cochrane Database of Systematic Reviews was searched using the term “prostate cancer”, published 2011-2012. Medline & Embase were further searched using the term prostate cancer (keyword), limited to clinical trials related to “therapy (best balance of sensitivity and specificity) involving male humans published in English between August 2011-2012. Page 7 of 11 CLINICAL PRACTICE GUIDELINE GU-012 Version 1 GLOSSARY OF ABBREVIATIONS Acronym ADT CTV EBRT HDR HIFU ICRU IMRT LDR PSA RT TURP Description Androgen deprivation therapy Clinical target volume External beam radiotherapy High dose rate High intensity focused ultrasound International commission on radiation units Intensity modulated radiotherapy Low dose rate Prostate specific antigen Radiotherapy Transurethral resection DISSEMINATION Present the guideline at the local and provincial tumour team meetings and weekly rounds. Post the guideline on the Alberta Health Services website. Send an electronic notification of the new guideline to all members of CancerControl Alberta. MAINTENANCE A formal review of the guideline will be conducted at the Annual Provincial Meeting in 2017. If critical new evidence is brought forward before that time, however, the guideline working group members will revise and update the document accordingly. CONFLICT OF INTEREST Participation of members of the Alberta Provincial GU Tumour Team in the development of this guideline has been voluntary and the authors have not been remunerated for their contributions. There was no direct industry involvement in the development or dissemination of this guideline. CancerControl Alberta recognizes that although industry support of research, education and other areas is necessary in order to advance patient care, such support may lead to potential conflicts of interest. Some members of the Alberta Provincial GU Tumour Team are involved in research funded by industry or have other such potential conflicts of interest. However the developers of this guideline are satisfied it was developed in an unbiased manner. COPYRIGHT DISCLOSURE Copyright © (2017) Alberta Health Services. This material is protected by Canadian and other international copyright laws. All rights reserved. This material may not be copied, published, distributed or reproduced in any way in whole or in part without the express written permission of Alberta Health Services (please contact the Guideline Resource Unit Manager at CancerControl Alberta at [email protected]). Page 8 of 11 CLINICAL PRACTICE GUIDELINE GU-012 Version 1 This material is intended for general information only and is provided on an "as is", "where is" basis. Although reasonable efforts were made to confirm the accuracy of the information, Alberta Health Services does not make any representation or warranty, express, implied or statutory, as to the accuracy, reliability, completeness, applicability or fitness for a particular purpose of such information. This material is not a substitute for the advice of a qualified health professional. Alberta Health Services expressly disclaims all liability for the use of these materials, and for any claims, actions, demands or suits arising from such use. REFERENCES 1. Canadian Cancer Statistics 2016. Toronto, ON: Canadian Cancer Society. Canadian Cancer Society's Advisory Committee on Cancer Statistics. 2016. 2. Rodrigues G, Lukka H, Warde P, Brundage M, Souhami L, Crook J, et al. The prostate cancer risk stratification (ProCaRS) project: recursive partitioning risk stratification analysis. Radiother Oncol 2013 Nov;109(2):204-210. 3. Dahabreh IJ, Chung M, Balk EM, Yu WW, Mathew P, Lau J, et al. Active surveillance in men with localized prostate cancer: a systematic review. Ann Intern Med 2012 Apr 17;156(8):582-590. 4. Simpkin AJ, Tilling K, Martin RM, Lane JA, Hamdy FC, Holmberg L, et al. Systematic Review and Metaanalysis of Factors Determining Change to Radical Treatment in Active Surveillance for Localized Prostate Cancer. Eur Urol 2015 Jun;67(6):993-1005. 5. Grimm P, Billiet I, Bostwick D, Dicker AP, Frank S, Immerzeel J, et al. 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Equivalent biochemical control and improved prostate-specific antigen nadir after permanent prostate seed implant brachytherapy versus high-dose three-dimensional conformal radiotherapy and high-dose conformal proton beam radiotherapy boost. Int J Radiat Oncol Biol Phys 2010 Jan 1;76(1):36-42. Page 9 of 11 CLINICAL PRACTICE GUIDELINE GU-012 Version 1 10. Zelefsky MJ, Yamada Y, Pei X, Hunt M, Cohen G, Zhang Z, et al. Comparison of tumor control and toxicity outcomes of high-dose intensity-modulated radiotherapy and brachytherapy for patients with favorable risk prostate cancer. Urology 2011 Apr;77(4):986-990. 11. Merrick GS, Butler WM, Wallner KE, Galbreath RW, Adamovich E. Permanent interstitial brachytherapy in younger patients with clinically organ-confined prostate cancer. Urology 2004 Oct;64(4):754-759. 12. Morris DE, Emami B, Mauch PM, Konski AA, Tao ML, Ng AK, et al. 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Crouzet S, Chapelon JY, Rouviere O, Mege-Lechevallier F, Colombel M, Tonoli-Catez H, et al. Wholegland ablation of localized prostate cancer with high-intensity focused ultrasound: oncologic outcomes and morbidity in 1002 patients. Eur Urol 2014 May;65(5):907-914. 17. Boorjian SA, Karnes RJ, Rangel LJ, Bergstralh EJ, Blute ML. Mayo Clinic validation of the D'amico risk group classification for predicting survival following radical prostatectomy. J Urol 2008 Apr;179(4):1. 18. Zietman AL, DeSilvio ML, Slater JD, Rossi CJ, Miller DW, Adams JA, et al. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA 2005 Sep 14,;294(10):1233-1239. 19. Peeters STH, Heemsbergen WD, Koper PCM, van Putten, Wim L J, Slot A, Dielwart MFH, et al. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol 2006 May 01,;24(13):1990-1996. 20. Morris WJ, Tyldesley S, Pai HH, et al. A multicenter, randomized trial of dose-escalated external beam radiation therapy (EBRT-B) versus low-dose-rate brachytherapy (LDR-B) for men with unfavorablerisk localized prostate cancer (abstract). J Clin Oncol 2015(Suppl 7):3. Page 10 of 11 CLINICAL PRACTICE GUIDELINE GU-012 Version 1 21. Prestidge BR, Winter K, Sanda MG, et al. Initial report of NRG Oncology/RTOG 0232: a phase 3 study comparing combined external beam radiation and transperineal interstitial permanent brachytherapy with brachytherapy alone for selected patients with intermediate-risk prostatic carcinoma (abstract). 2016. 22. Hoskin PJ, Rojas AM, Bownes PJ, Lowe GJ, Ostler PJ, Bryant L. Randomised trial of external beam radiotherapy alone or combined with high-dose-rate brachytherapy boost for localised prostate cancer. Radiother Oncol 2012 May;103(2):217-222. 23. Cohen JK, Miller RJ,Jr, Ahmed S, Lotz MJ, Baust J. Ten-year biochemical disease control for patients with prostate cancer treated with cryosurgery as primary therapy. Urology 2008 Mar;71(3):515-518. 24. Warde P, Mason M, Ding K, Kirkbride P, Brundage M, Cowan R, et al. Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial. Lancet 2011 Dec 17;378(9809):2104-2111. 25. Mason MD, Parulekar WR, Sydes MR, Brundage M, Kirkbride P, Gospodarowicz M, et al. Final Report of the Intergroup Randomized Study of Combined Androgen-Deprivation Therapy Plus Radiotherapy Versus Androgen-Deprivation Therapy Alone in Locally Advanced Prostate Cancer. J Clin Oncol 2015 Jul 1;33(19):2143-2150. 26. Brundage M, Sydes MR, Parulekar WR, Warde P, Cowan R, Bezjak A, et al. Impact of Radiotherapy When Added to Androgen-Deprivation Therapy for Locally Advanced Prostate Cancer: Long-Term Quality-of-Life Outcomes From the NCIC CTG PR3/MRC PR07 Randomized Trial. J Clin Oncol 2015 Jul 1;33(19):2151-2157. 27. Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh, A C, Oddens J, Poortmans PM, et al. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med 2009 Jun 11;360(24):2516-2527. 28. Briganti A, Spahn M, Joniau S, Gontero P, Bianchi M, Kneitz B, et al. Impact of age and comorbidities on long-term survival of patients with high-risk prostate cancer treated with radical prostatectomy: a multi-institutional competing-risks analysis. Eur Urol 2013 Apr;63(4):693-701. 29. Rusthoven CG, Carlson JA, Waxweiler TV, Raben D, Dewitt PE, Crawford ED, et al. The impact of definitive local therapy for lymph node-positive prostate cancer: a population-based study. Int J Radiat Oncol Biol Phys 2014 Apr 1;88(5):1064-1073. Page 11 of 11