Biopsy Methods for Prostate Cancer
(PREVENT Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byJim C Hu, MD MPH

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Trial Summary

What is the purpose of this trial?

Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer. This randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy. The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.

Research Team

Jim C Hu, MD MPH

Principal Investigator

Weill Cornell Medicine, NewYork-Presbyterian

Eligibility Criteria

This trial is for men over 18 who have never had a prostate biopsy and are willing to follow the study rules. It's not for those with certain metal implants, claustrophobia, pacemakers, severe kidney issues, very high PSA levels if previously biopsied, past prostate cancer treatments, current serious infections or recent prostatitis.

Inclusion Criteria

I am 18 years old or older.

I have never had a prostate biopsy before.

Willingness to sign informed consent and adhere to the study protocol

See 1 more

Exclusion Criteria

I cannot have a prostate MRI due to claustrophobia, a pacemaker, or kidney disease.

I cannot have a prostate biopsy with local anesthesia due to health reasons.

I have had treatments like radiation or partial gland removal for prostate cancer.

See 4 more

Treatment Details

Interventions

Antibiotic (prophylaxis) (Antibiotic)
Transperineal MRI-guided prostate biopsy (Procedure)
Transrectal MRI-guided prostate biopsy (Procedure)

Trial OverviewThe study compares two types of MRI-guided prostate biopsies: transperineal (through the skin) versus transrectal (through the rectum), without using antibiotics beforehand. The goal is to see if the new method reduces infection risk while still detecting cancer effectively.

Participant Groups

2Treatment groups

Active Control

Group I: TransperinealActive Control1 Intervention

Patients will receive a transperineal MRI-guided prostate biopsy.

Group II: TransrectalActive Control2 Interventions

Patients will receive a transrectal MRI-guided prostate biopsy.