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Biopsy Methods for Prostate Cancer (PREVENT Trial)

N/A
Waitlist Available
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
Age ≥18 years
Men without previous prostate biopsy (first time prostate biopsy)
Must not have
Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease) in men who have previously undergone prostate biopsy
Unfit to undergo prostate biopsy under local anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days post-biopsy
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have a prostate MRI due to claustrophobia, a pacemaker, or kidney disease.
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I cannot have a prostate biopsy with local anesthesia due to health reasons.
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I have had treatments like radiation or partial gland removal for prostate cancer.
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My PSA level is above 20 ng/mL after a prostate biopsy.
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I am currently being treated with antibiotics for a bacterial infection not related to the urinary system.

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

Trial Design

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.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,064 Previous Clinical Trials
1,318,448 Total Patients Enrolled
7 Trials studying Infections
9,370 Patients Enrolled for Infections
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,958,663 Total Patients Enrolled
90 Trials studying Infections
62,670 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: Transperineal, Transrectal
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
~170 spots leftby Jul 2025
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