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?

In the United States, doctors perform about 1 million biopsies each year to check for prostate cancer. During a biopsy, doctors use a needle to remove a small piece of tissue from the prostate for testing. Biopsies confirm whether a tissue sample is cancer or not. Doctors can use one of two types of prostate biopsy:

  • Transrectal biopsies pass a needle through the wall of the rectum into the prostate.
  • Transperineal biopsies pass a needle through the skin of the perineum into the prostate. The perineum is the skin between the anus and the scrotum.

In this study, the research team is comparing these two types of biopsies for two reasons. First, about five percent of patients who have a transrectal biopsy get an infection. Because transperineal biopsies avoid the rectum, this type may help avoid infections. Second, transperineal biopsies may work better to find cancer in the anterior, or front, of the prostate. Finding anterior prostate cancer earlier could help reduce the number of deaths from this disease. African-American men are more likely to get anterior prostate cancer and are more than twice as likely to die from prostate cancer compared with White men.

Who can this research help?

Results may help doctors and patients when considering ways to detect prostate cancer.

What is the research team doing?

The research team is recruiting 1,302 patients who are having a prostate biopsy at one of 12 clinics and outpatient health centers across the United States. The team is assigning patients by chance to have either a transrectal or transperineal biopsy. Patients who are having a transrectal biopsy take an antibiotic before the biopsy to reduce their risk for infection.

Before the biopsy, right after, and a week later, the research team is surveying patients. Surveys ask about infections, pain, anxiety, and other adverse events. The team is looking at biopsy results to see if they detect cancer.

Prostate cancer survivors and staff from a national prostate cancer education organization are giving feedback on the study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 1,302 patients ages 18 and older receiving a prostate biopsy
  • Transperineal prostate biopsy
  • Transrectal prostate biopsy

Primary: infection rates for transperineal and transrectal biopsies

Secondary: pain, anxiety, cancer detection, non-infection-related complications

Timeframe 1-week follow-up for primary outcome

Project Information

Jim C. Hu, MD, MPH
Edward Schaeffer, MD, PhD
Weill Cornell Medicine
Randomized Trial Comparing Transperineal vs. Transrectal MRI-targeted Prostate Biopsy

Key Dates

March 2020
April 2025

Study Registration Information


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
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. 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: May 8, 2024