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Biopsy Methods for Prostate Cancer (PREVENT Trial)

N/A
Recruiting
Led By Jim C Hu, MD MPH
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male sex
Men without previous prostate biopsy (first time prostate biopsy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days post-biopsy
Awards & highlights
No Placebo-Only Group

PREVENT Trial Summary

This trial will compare the rates of infection, pain, and detection of prostate cancer between the two biopsy methods.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Possible side effects include discomfort or pain during biopsy and potential infection risks. However, the new transperineal approach aims to significantly lower these infection risks compared to the traditional transrectal method.

PREVENT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am male.
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I have never had a prostate biopsy before.
Select...
I am 18 years old or older.

PREVENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days post-biopsy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days post-biopsy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biopsy
Secondary outcome measures
Change in adverse events, as measured on Transrectal Ultrasound Guided prostate Biopsy Questionnaire (TRUS-BxQ)
Change in patient-reported anxiety, as measured on a 0-10 Likert scale
Change in patient-reported pain and discomfort, as measured on a 0-10 Likert scale
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

PREVENT Trial Design

2Treatment groups
Active Control
Group I: TransrectalActive Control2 Interventions
Patients will receive a transrectal MRI-guided prostate biopsy.
Group II: TransperinealActive Control1 Intervention
Patients will receive a transperineal MRI-guided prostate biopsy.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,050 Previous Clinical Trials
1,328,940 Total Patients Enrolled
7 Trials studying Infections
9,370 Patients Enrolled for Infections
National Cancer Institute (NCI)NIH
13,587 Previous Clinical Trials
41,242,102 Total Patients Enrolled
90 Trials studying Infections
63,096 Patients Enrolled for Infections
Jim C Hu, MD MPHPrincipal InvestigatorWeill Cornell Medicine, NewYork-Presbyterian
3 Previous Clinical Trials
1,905 Total Patients Enrolled
1 Trials studying Infections
1,302 Patients Enrolled for Infections

Media Library

Transperineal MRI-guided prostate biopsy Clinical Trial Eligibility Overview. Trial Name: NCT04843566 — N/A
Infections Research Study Groups: Transrectal, Transperineal
Infections Clinical Trial 2023: Transperineal MRI-guided prostate biopsy Highlights & Side Effects. Trial Name: NCT04843566 — N/A
Transperineal MRI-guided prostate biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04843566 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment for this experiment begun yet?

"Affirmative. Information available on clinicaltrials.gov reveals that this medical research, which was originally listed on March 22nd 2021, is actively seeking participants. 400 subjects must be recruited from 4 distinct locales."

Answered by AI

How many participants are actively taking part in this research?

"Affirmative. Current information on clinicaltrials.gov states that this medical research is currently enrolling volunteers - the trial was publicized on March 22nd 2021 and most recently updated on November 1st 2022. The study plans to recruit 400 patients from 4 distinct sites."

Answered by AI
~120 spots leftby Jun 2025