Comparing two methods of prostate biopsy for cancer detection
Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)
This study tests which of two prostate biopsy methods—transrectal or transperineal—is better at finding cancer and causing fewer complications for men who need a biopsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Sex | Male |
| Sponsor | Albany Medical College Academic / other |
| Locations | 1 site (Albany, New York) |
| Trial ID | NCT04081636 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and complications of two prostate biopsy methods: transrectal and transperineal. Men needing a prostate biopsy due to suspected cancer will be randomly assigned to one of the two approaches. The research aims to determine which method is more effective in reducing complications and improving cancer detection rates. Both methods will utilize MRI/ultrasound fusion guidance to enhance accuracy and minimize risks. The study will also assess differences in infection rates and the detection of high-grade cancers.
Who should consider this trial
Good fit: Ideal candidates are men scheduled for a prostate biopsy due to clinical suspicions of prostate cancer.
Not a fit: Patients who have had previous rectal surgery or have perineal skin abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more effective method for prostate cancer detection, reducing complications for patients.
How similar studies have performed: While transrectal biopsy is common, the transperineal approach is less tested in the U.S., making this study's comparative analysis novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care * Either with or without an MRI Exclusion Criteria: * Patients with no access to rectum (due to previous rectal surgery) * Any abnormalities of the perineal skin (e.g. infection) * Patients whose procedure requires sedation or general anesthesia
Where this trial is running
Albany, New York
- Albany Medical College — Albany, New York, United States (Recruiting)
Study contacts
- Principal investigator: Badar M Mian, MD — Albany Medical College
- Study coordinator: Brenda Romeo, CCRC
- Email: amcurologyresearch@amc.edu
- Phone: 518-262-8579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.