Results Summary and Professional Abstract

Results Summary

Results Summary

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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.

Professional Abstract

Professional Abstract

Objective

To compare the effects of prostate cancer treatments on quality of life, anxiety related to prostate cancer, decisional regret, prostate cancer recurrence, and healthcare utilization

Study Design

Design Element	Description
Design	Observational: cohort study
Population	1,413 patients with newly diagnosed prostate cancer in North Carolina from 2011–2013
Interventions/ Comparators	Active surveillance Radical prostatectomy EBRT SBRT Brachytherapy
Outcomes	Patient-reported quality of life (including sexual, urinary, and bowel function), anxiety related to prostate cancer, and decisional regret; prostate cancer recurrence; healthcare utilization
Timeframe	5-year follow-up for study outcomes

This prospective observational cohort study compared the effects of five treatments for prostate cancer on patient-reported outcomes, prostate cancer recurrence, and healthcare utilization. The treatments were active surveillance, radical prostatectomy, external beam radiation therapy (EBRT), stereotactic body radiation therapy (SBRT), and brachytherapy.

The research team used the North Carolina Central Cancer Registry to recruit patients. To identify patients’ treatments, the team reviewed medical records and cancer registry data. Patients completed phone surveys about quality of life, anxiety related to prostate cancer, and decisional regret before treatment initiation and 3, 12, 24, 36, and 48 months later. The team described clinically meaningful differences between treatments specific to each patient-reported outcome. Five years after treatment, the team reviewed medical records and claims data to determine prostate cancer recurrence and healthcare utilization.

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

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

Results

Compared with patients who chose active surveillance,

• Patients who chose radical prostatectomy had greater increases in sexual dysfunction and urinary incontinence at 3, 12, 24, 36, and 48 months.
• Patients who chose EBRT or brachytherapy had greater increases in sexual dysfunction, urinary obstruction, and bowel problems at three months but not at other times.
• Patients who chose SBRT had lower anxiety about prostate cancer at 24 months but not at other times.

Patients did not differ in decisional regret across treatment groups.

Patients who chose SBRT or EBRT had a 51% decreased risk of prostate cancer recurrence within five years (hazard ratio=0.49) relative to patients who had radical prostatectomy.

Compared with patients who chose other treatments, patients who chose active surveillance had, on average per year, more physician visits related to prostate cancer (6.1 versus 4.6), total physician visits (7.6 versus 6.1), and urology or oncology specialist visits (5.1 versus 4.1).

Limitations

Patients chose their treatment, which may have influenced how they answered surveys. Most patients who chose active surveillance went on to choose another treatment later, which limited data available for patients who used active surveillance for five years.

Conclusions and Relevance

In this study, different treatment strategies were associated with distinct effects on patient quality of life, healthcare utilization, and prostate cancer recurrence. Patients and physicians can use these findings in combination with patients’ expressed preferences to choose a prostate cancer treatment that works best for them.

Future Research Needs

Future research can examine outcomes for patients who continue with active surveillance long term.

More on this Project  

Evidence for Decisions

Early-Stage and Localized Prostate Cancer
Early-stage prostate cancer can be treated in different ways. Two recent PCORI-funded research studies provide new information on the effects of treatments and can help patients navigate their treatment decisions.

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.

Conflict of Interest Disclosures

The Conflict of Interest Disclosures for this project will be posted here soon. 

Project Details

Principal Investigator

Ronald C. Chen, MD, MPH

Project Status

Completed; PCORI Public and Professional Abstracts Posted

Project Title

North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS): A Stakeholder-Driven, Population-Based Prospective Cohort Study

Board Approval Date

September 2014

Project End Date

May 2020

Organization

University of North Carolina at Chapel Hill

Year Awarded

2014

State

North Carolina

Year Completed

2019

Project Type

Research Project

Health Conditions  

Cancer

Prostate Cancer

Intervention Strategies

Screening Interventions
Other Clinical Interventions

Populations

Low Income
Older Adults
Racial/Ethnic Minorities

Funding Announcement

Assessment of Prevention, Diagnosis, and Treatment Options

Project Budget

$1,645,374

Study Registration Information

HSRP20153204

NCT02564120