Results Summary

What was the research about?

Prostate cancer occurs most often in men age 50 years and older. Usually, the cancer doesn’t spread beyond the prostate gland. Doctors call this localized prostate cancer. Many men live for a long time after being diagnosed with localized prostate cancer.

The research team looked at three common treatments for localized prostate cancer:

  • Surgery, called radical prostatectomy, which removes the prostate gland completely
  • External beam radiation therapy, which focuses tissue-destroying beams of radiation onto the prostate gland
  • Active surveillance, which includes regular checkups to see if the cancer progresses; checkups usually include blood tests or biopsies, where a small amount of prostate tissue is removed and sent to a lab

The research team wanted to know if there was a difference in the effects for the three treatment choices. Over three years, the team asked the men about their sexual function and urine or bowel problems.

What were the results?

Sexual function. After three years, men who had surgery reported lower sexual function than the men who had radiation or active surveillance. Men who had radiation and those who had active surveillance reported similar sexual function.

Leaking of urine. Men who had surgery reported more leaking of urine than the men who had radiation or active surveillance. Men who had radiation and those who had active surveillance reported similar leaking of urine.

Other urine or bowel problems. The research team asked about pain or reduced stream when passing urine, blood in the urine, and passing urine often. The team also asked about bowel function and hormone function. The only difference was that men who had surgery reported fewer of the urinary problems than men who had active surveillance.

Who was in the study?

The study included 2,550 men from across the United States with localized prostate cancer. All the men started the study within six months of being diagnosed. Of these, 74 percent were white, and 26 percent were other races. The average patient age was 64, and all were younger than 80. Of the surgeries, 76 percent used a laparoscope, a small robotic instrument with a video camera that works through small cuts to the body. Among the men who chose radiation, 45 percent also took medicines to reduce male hormones.

What did the research team do?

The research team used health records to find out which treatment each man received. The men completed a survey when the study began and three years later. The survey asked about sexual function and urine or bowel problems.

A group of 15 prostate cancer survivors helped the research team plan the study; 2 survivors helped conduct the study.

What were the limits of the study?

The study didn’t measure other results that may be important to men with localized prostate cancer, such as overall quality of life, anxiety, satisfaction, and the effect of the cancer on their finances. Also, some results may occur beyond three years.

Future research could follow men for more than three years and might look at other results from treatment such as quality of life or anxiety about cancer.

How can people use the results?

The results could help men with localized prostate cancer and their doctors make treatment choices based on what is most important to the patient.

Final Research Report

View this project's final research report.


Journal Citations

Article Highlight: This study compared three common treatments—surveillance, radiation, and surgery—for prostate cancer that hasn’t spread beyond the prostate gland. After three years, men who had surgery reported lower sexual function and more leaking of urine than men who had radiation or surveillance. However, men who had surgery reported fewer other urine problems, such as painful urination or passing urine often. Now, funding from the Agency for Healthcare Research and Quality has advanced this research to study five-year outcomes, which the research team has published in JAMA.

Related Journal Citations

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers, noting that the exclusion of 7 percent of the sample, or 200 patients, from analyses because researchers had no post-baseline data, asked whether these patients differed in any way from the included patients. The investigators replied that the two groups differed on race and on one quality-of-life outcome at baseline. While the researchers added this limitation to the report, they said that they did not believe this difference changed their conclusions.
  • The reviewers expressed concern that the analyses did not include a correction for multiple comparisons and that some apparently statistically significant differences might be due to chance. The researchers responded that they identified all of their hypotheses a priori and an adjustment for multiple comparisons was not appropriate when testing a pre-specified hypothesis.
  • The reviewers requested additional information on how the researchers accounted for potential clustering by site in the analyses. Clustering by site can lead to unmeasured between-patient correlations that could bias the aggregate results. The researchers explained that they had accounted for site as a covariate in their statistical models but said that they did not test for a site by treatment interaction. The researchers added as a study limitation a comment about the potential for bias due to clustering by site.

Conflict of Interest Disclosures

Project Information

David Penson, MD, MPH
Vanderbilt University
Generating Critical Patient-Centered Information for Decision Making in Localized Prostate Cancer

Key Dates

May 2013
September 2018

Study Registration Information


Has Results
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Last updated: March 14, 2024