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Treatments for Localized Prostate Cancer

Systematic Review to Update the 2002 U.S. Preventive Services Task Force Recommendation

Evidence Syntheses, No. 91

Investigators: , MD, , MLS, , BS, , PhD, , MPH, , MD, and , MD, MPH.

Author Information and Affiliations
Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 12-05161-EF-1

Structured Abstract


Screening with prostate-specific antigen testing can detect prostate cancer in earlier, asymptomatic stages, when treatments might be more effective. However, treatments for prostate cancer are also associated with potential harms.


To systematically review benefits and harms associated with treatments for screen-detected or localized prostate cancer.

Data Sources:

We searched the Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews (through the second quarter of 2011), and Ovid MEDLINE (2002 to July 2011) for relevant studies and systematic reviews published in English. Electronic database searches were supplemented by reviews of reference lists of relevant articles.

Study Selection:

We selected randomized trials and cohort studies that reported all-cause mortality, prostate cancer-specific mortality, or harms associated with prostatectomy, radiation therapy, hormonal therapy, cryotherapy, and high-intensity focused ultrasonography versus watchful waiting or active surveillance in men with localized prostate cancer. We also included large (n>1,000) uncontrolled observational studies that reported perioperative harms. If no randomized trials, cohort studies, or large uncontrolled studies were available, we included smaller uncontrolled studies.

Data Extraction:

One investigator abstracted data and a second investigator checked data abstraction for accuracy. Two investigators independently assessed study quality using methods developed by the U.S. Preventive Services Task Force.

Data Synthesis (Results):

Two randomized trials and nine cohort studies on benefits of prostate cancer treatments and two randomized trials, 14 cohort studies, and 11 intervention series of harms were included in the review. One good-quality randomized trial found that prostatectomy for localized (primarily stage T2) prostate cancer was associated with decreased risk of prostate cancer-specific mortality compared with watchful waiting through 13 years of followup (relative risk, 0.62 [95% CI, 0.44–0.87]; absolute risk reduction, 6.1 percentage points); subgroup analyses suggested that benefits were limited to men younger than age 65 years. Cohort studies consistently found that prostatectomy and radiation therapy were associated with decreased risk of all-cause mortality and prostate cancer-specific mortality compared with watchful waiting, but estimates were susceptible to residual confounding. Based primarily on cohort studies, treating approximately three men with prostatectomy, seven men with radiation therapy, or two to three men with androgen deprivation therapy instead of watchful waiting would each result in one additional case of erectile dysfunction, and treating approximately five men with prostatectomy would result in one additional case of urinary incontinence. Prostatectomy was associated with perioperative (30-day) mortality (about 0.5%) and cardiovascular events (0.6% to 3%), radiation therapy with bowel dysfunction, and androgen deprivation therapy with gynecomastia and hot flashes. Evidence did not suggest adverse effects related to general health-related quality of life with either prostatectomy or radiation therapy compared with watchful waiting. Evidence on cryotherapy and high-intensity focused ultrasonography was too limited to reliably estimate benefits or harms.


Only English-language articles were included, few randomized trials met inclusion criteria, the lone randomized trial of treatment did not specifically enroll men with screen-detected prostate cancer, and few studies evaluated newer therapies and techniques.


Additional research is needed to understand benefits of treatments for screen-detected, localized prostate cancer. Commonly selected therapies for localized prostate cancer are associated with an increased risk of important harms. More research is needed to understand whether newer therapies and techniques for treating localized prostate cancer are associated with fewer harms.


Acknowledgements: The authors thank AHRQ Medical Officer Jennifer Croswell, MD, MPH, and U.S. Preventive Services Task Force Leads Ned Calonge, MD, MPH, Michael LeFevre, MD, MSPH, Rosanne Leipzig, MD, PhD, and Timothy Wilt, MD, MPH, for their contributions to this report. The authors also thank Kenneth Lin, MD, and Mary Barton, MD, MPP, for their contributions.

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. HHSA-290-2007-10057-I-EPC3, Task Order No. 3, Prepared by: Oregon Evidence-based Practice Center, Oregon Health & Science University2,

Suggested citation:

Chou R, Dana T, Bougatsos C, Fu R, Blazina I, Gleitsmann K, Rugge JB. Treatments for Localized Prostate Cancer: Systematic Review to Update the 2002 U.S. Preventive Services Task Force Recommendation. Evidence Synthesis No. 91. AHRQ Publication No. 12-05161-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; October 2011.

This report is based on research conducted by the Oregon Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0024). The investigators involved have declared no conflicts of interest with objectively conducting this research. The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. 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.

The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment.

This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.


540 Gaither Road, Rockville, MD 20850; www​.ahrq.gov


3181 SW Sam Jackson Park Road, Portland, OR 97239; www​.ohsu.edu/epc

Bookshelf ID: NBK82315PMID: 22171386


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