Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Prostate cancer is the second most common cause of cancer death among men in the United States. Black men are twice as likely to die from prostate cancer as White men. Patients with prostate cancer have many treatment options, including several newer approaches. But studies haven’t directly compared the benefits and harms of newer and older approaches. Also, research studies of prostate cancer treatment have tended to include few Black men.

In this study, the research team is comparing five prostate cancer treatment approaches:

  • Radical prostatectomy, or surgery to remove the prostate gland
  • Partial gland ablation, which uses heat or cold to kill cancer cells in the prostate
  • Intensity-modulated radiation therapy, which uses beams of radiation to kill cancer cells in the prostate
  • Stereotactic body radiation therapy, which uses strong, focused doses of radiation to kill cancer cells in the prostate and limits damage to healthy tissue
  • Active surveillance, where the doctor checks the patient every few months to make sure the cancer isn’t getting worse

The research team is comparing quality of life and other health outcomes across the five treatment approaches.

Who can this research help?

Results may help patients with prostate cancer and their doctors when considering treatment options.

What is the research team doing?

The research team is enrolling 2,378 men who are receiving prostate cancer treatment at hospitals in Los Angeles County and New York State. The hospitals treat a racially diverse group of men. Patients and their doctors are choosing one of the five treatment approaches.

Patients are answering surveys when they start the study and again 8 and 12 months later. Surveys ask about quality of life, physical function, anxiety, regrets about treatment choice, and adverse events such as pain or bleeding.

Prostate cancer survivors, prostate cancer specialists, representatives from the US Food and Drug Administration, companies that make medical devices, and health insurance companies are giving input on the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 2,378 men over age 18 with low- and intermediate-risk prostate cancer 
Interventions/
Comparators
  • Radical prostatectomy
  • Partial gland ablation
  • Intensity-modulated radiation therapy
  • Stereotactic body radiation therapy
  • Active surveillance
Outcomes

Primary: health-related quality of life; prostate-cancer specific quality of life; urinary, sexual, and bowel function; cancer anxiety; treatment regret

Secondary: adverse events

Timeframe 12-month follow-up for primary outcomes

Project Information

Jim C. Hu, MD, MPH, and Ronald C. Chen, MD, MPH
Joan & Sanford I. Weill Medical College of Cornell University
$3,123,033
Prostate Cancer Comparative Outcomes of New Conceptual Paradigms for Treatment (PC CONCEPT)

Key Dates

November 2019
November 2024
2019

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022