Therapies for Clinically Localized Prostate Cancer: Final Report
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Comparative Effectiveness Review Number 230 R Therapies for Clinically Localized Prostate Cancer Comparative Effectiveness Review Number 230 Therapies for Clinically Localized Prostate Cancer Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. 290-2015-0000-81 Prepared by: Minnesota Evidence-based Practice Center Minneapolis, MN Investigators: Philipp Dahm, M.D., M.H.S.C. Michelle Brasure, Ph.D., M.S.P.H., M.L.I.S. Elizabeth Ester, M.D. Eric J. Linskens, B.S. Roderick MacDonald, M.S. Victoria A. Nelson, M.Sc. Charles Ryan, M.D. Jayati Saha, Ph.D. Shahnaz Sultan, M.D., M.H.S.C. Kristen E. Ullman, M.P.H. Timothy J. Wilt, M.D., M.P.H. AHRQ Publication No. 20-EHC022 September 2020 This report is based on research conducted by the Minnesota Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2015-0000-81). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report. The information in this report is intended to help healthcare decision makers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of healthcare services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders. AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies may not be stated or implied. This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report. AHRQ appreciates appropriate acknowledgment and citation of its work. Suggested language for acknowledgment: This work was based on an evidence report, Therapies for Clinically Localized Prostate Cancer, by the Evidence-based Practice Center Program at the Agency for Healthcare Research and Quality (AHRQ). Suggested citation: Dahm P, Brasure M, Ester E, Linskens EJ, MacDonald R, Nelson VA, Ryan C, Saha J, Sultan S, Ullman KE, Wilt TJ. Therapies for Clinically Localized Prostate Cancer. Comparative Effectiveness Review No. 230. (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 290-2015-0000-81) AHRQ Publication No. 20-EHC022. Rockville, MD: Agency for Healthcare Research and Quality; September 2020. DOI: https://doi.org/10.23970/AHRQEPCCER230. Posted final reports are located on the Effective Health Care Program search page. ii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- and private-sector organizations in their efforts to improve the quality of healthcare in the United States. These reviews provide comprehensive, science-based information on common, costly medical conditions, and new healthcare technologies and strategies. Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. In the context of developing recommendations for practice, systematic reviews can help clarify whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about AHRQ EPC systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm AHRQ expects that these systematic reviews will be helpful to health plans, providers, purchasers, government programs, and the healthcare system as a whole. Transparency and stakeholder input are essential to the Effective Health Care Program. Please visit the website (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an e- mail list to learn about new program products and opportunities for input. If you have comments on this systematic review, they may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, or by email to [email protected]. Gopal Khanna, M.B.A. Arlene Bierman, M.D., M.S. Director Director Agency for Healthcare Research and Quality Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Lionel Bañez, M.D. Director Task Order Officer Evidence-based Practice Center Program Center for Evidence and Practice Center for Evidence and Practice Improvement Improvement Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality iii Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project: Jeannine Ouellette for editorial help bringing the report to completion. Technical Expert Panel Peter Carroll, M.D., M.P.H.* Paul L. Nguyen, M.D. University of California, San Francisco Dana-Farber Cancer Institute San Francisco, CA Boston, MA Daniel Lin, M.D.* Howard M. Sandler, M.D.* University of Washington Cedars-Sinai, ASTRO Society of Urologic Oncology Los Angeles, CA Fred Hutchinson Cancer Research Center Seattle, WA Janice Tufte* PCORI Sponsored Public Ambassador Nicolas Mottet, M.D., Ph.D. Clinique Mutualiste in Saint Etienne, France *This TEP member also served as a peer reviewer Peer Reviewers Mitchell S. Anscher, M.D. Alvin Cabrera, M.D. Virginia Commonwealth University Kaiser Permanente Department of Radiation Oncology Seattle, WA Richmond, VA Richard M. Hoffman, M.D., M.P.H. Michael J. Barry, M.D. University of Iowa Carver College of Massachusetts General Hospital Medicine Harvard Medical School Iowa City, IA Boston, MA Terrence Kungel Chairman, Emeritus of the Maine Coalition to Fight Prostate Cancer Woolwich, ME iv Therapies for Clinically Localized Prostate Cancer Structured Abstract Objective. To update findings from previous Agency for Healthcare Research and Quality (AHRQ)- and American Urological Association (AUA)-funded reviews evaluating therapies for clinically localized prostate cancer (CLPC). Sources. Bibliographic databases (2013–January 2020); ClinicalTrials.gov; systematic reviews Methods. Controlled studies of CLPC treatments with duration ≥5 years for mortality and metastases and ≥1 year for quality of life and harms. One investigator rated risk of bias (RoB), extracted data, and assessed certainty of evidence; a second checked accuracy. We analyzed English-language studies with low or medium RoB. We incorporated findings from randomized controlled trials (RCTs) identified in the prior reviews if new RCTs provided information on the same intervention comparison. Results. We identified 67 eligible references; 17 were unique RCTs. Among clinically rather than prostate-specific antigen (PSA) detected CLPC, Watchful Waiting (WW) may increase mortality and metastases versus Radical Prostatectomy (RP) at 20+ years. Urinary and erectile dysfunction were lower with WW versus RP. WW’s effect on mortality may vary by tumor risk and age but not by race, health status, comorbidities, or PSA. Active Monitoring (AM) probably results in little to no difference in mortality in PSA-detected CLPC versus RP or external beam radiation (EBR) plus Androgen Deprivation (AD) regardless of tumor risk. Metastases were slightly higher with AM. Harms were greater with RP than AM and mixed between EBR plus AD versus AM. 3D-conformal EBR and AD plus low-dose-rate brachytherapy (BT) provided a small reduction in all-cause mortality versus three-dimensional conformal EBR and AD but little to no difference on metastases. EBR plus AD versus EBR alone may result in a small reduction in mortality and metastases in higher risk disease but may increase sexual harms. EBR plus neoadjuvant AD versus EBR plus concurrent AD may result in little to no difference in mortality and genitourinary toxicity. Conventionally fractionated EBR versus ultrahypofractionated EBR may result in little to no difference in mortality and metastases and urinary and bowel toxicity. Active Surveillance may result in fewer harms than photodynamic therapy and