Results Summary

What was the research about?

Prostate cancer is the most common type of cancer in men. More than 174,000 men in the United States are diagnosed with it each year. Men with prostate cancer have many treatment options. But the options have different benefits, risks, and side effects. In this study, the research team wanted to learn more about the effects of five treatments:

  • Surgery to remove the prostate
  • External beam radiation therapy, or EBRT, which kills cancer cells with beams of radiation
  • Stereotactic body radiation therapy, or SBRT, which kills cancer cells with strong, focused doses of radiation, limiting damage to healthy tissue
  • Brachytherapy, which places radiation pellets in and near the prostate to kill cancer cells
  • Active surveillance, where the doctor and patient check every few months to make sure the cancer isn’t getting worse

What were the results?

Compared with patients who chose active surveillance, patients who chose

  • Surgery had greater increases in sexual problems and leaking urine at 3, 12, 24, 36, and 48 months.
  • EBRT or brachytherapy had greater increases in sexual problems, trouble urinating, and bowel problems at three months but not at other times.
  • SBRT had less anxiety about prostate cancer at 24 months but not at other times.

Across treatment groups, patients didn’t differ in regret about their treatment decision.

Compared with patients who had surgery, patients who chose SBRT or EBRT had a 51 percent lower chance of prostate cancer coming back.

Compared with patients who chose other treatments, patients who chose active surveillance had, on average per year, more

  • Doctor visits to check on their prostate cancer
  • Total doctor visits
  • Specialist visits

Who was in the study?

The study included 1,413 patients with newly diagnosed prostate cancer in North Carolina between 2011 and 2013. Of these, 71 percent were white, 25 percent were black, and 3 percent were another race. The average age was 64. More than 95 percent of patients had early stage prostate cancer.

What did the research team do?

The research team enrolled patients from the North Carolina Central Cancer Registry. Registries store data about people with a specific health problem. The team surveyed patients by phone before treatment began and again 3, 12, 24, 36, and 48 months later. The surveys asked about patient quality of life, regret about their treatment decision, and anxiety about cancer. Five years after treatment, the team looked at patients’ health records to see if the cancer had come back. They also looked at numbers of doctor visits.

Staff from patient and clinician organizations helped design the study and create study materials.

What were the limits of the study?

Patients chose their treatment, which may have affected their survey responses. The research team didn’t have much information on long-term use of active surveillance, as most patients went on to choose another treatment.

Future research could look at which patients are most likely to benefit from long-term active surveillance.

How can people use the results?

Patients and their doctors can use these results when considering treatment for prostate cancer.

Final Research Report

View this project's final research report.

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 asked about the influence of direct-to-consumer advertising on treatment choice for prostate cancer, noting that this could be an important avenue of investigation. The researchers stated that information on the influence of direct-to-consumer advertising is largely anecdotal, but there has been concern that advertisements for some newer therapies may be misleading regarding the advantages of these treatments. The researchers stated that they did not take such advertising into account in this study because understanding the factors associated with treatment selection was not a goal of this study.
  • The reviewers asked about inclusion of hormone therapy, specifically, androgen deprivation therapy (ADT) as a covariate for analyses rather than as one of the compared treatments. The researchers explained that ADT-alone treatment is not guideline recommended, although ADT is acceptable as an adjunct treatment. Therefore, it would not be helpful to measure ADT as an individual treatment.
  • The reviewers asked why the researchers included a small cohort of patients receiving stereotactic body radiation therapy (SBRT) because it is not clear that these patients are comparable to the rest of the North Carolina study participants. The researchers explained that at the time the study started, SBRT was not a common treatment option in North Carolina; however, there was interest in understanding how SBRT compared to other treatment options.  The researchers agreed that the patients receiving SBRT were different from the North Carolina sample, but they collected the same data at the same time points for both groups.
  • The reviewers suggested that aggregating the patient-centered outcomes into a single composite measure might be more meaningful to and useful to patients and their clinicians. The researchers disagreed, saying that it was not clear how a patient would interpret a composite outcome, particularly because two treatments could have similar composite outcomes but vary on individual outcomes. Different patients are likely to put different weights on those individual outcomes and make treatment decisions based on what outcomes are most important to them.

Project Information

Ronald C. Chen, MD, MPH
University of North Carolina at Chapel Hill
North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS): A Stakeholder-Driven, Population-Based Prospective Cohort Study

Key Dates

September 2014
May 2020

Study Registration Information


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Last updated: March 14, 2024