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Prostate Biopsy Techniques for Reducing Infection Risk (PREVENT2 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
Be older than 18 years old
Must not have
Unfit to undergo prostate biopsy under local anesthesia
Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days post-biopsy
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the rate of infection and other complications after in-office transperineal MRI targeted prostate biopsy to the standard transrectal MRI targeted prostate biopsy.

Who is the study for?
Men with concerns of prostate cancer, having had a negative biopsy within the last 3 years or history of low-grade prostate cancer diagnosed in the past 2 years are eligible. They must be able to undergo local anesthesia and MRI unless they have acute prostatitis, prior cancer treatments like radiation, contraindications to MRI, or active infections treated with antibiotics.
What is being tested?
This study compares two types of prostate biopsies: transperineal (through the skin) and transrectal (through the rectum), both guided by MRI. The goal is to see if the transperineal approach reduces infection risk while still being comfortable and effective at detecting cancer.
What are the potential side effects?
Potential side effects include discomfort or pain from the biopsy procedure itself and risks associated with local anesthesia. There's also a chance of infection post-biopsy which this trial aims to minimize.

Eligibility Criteria

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 biopsy with local anesthesia.
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I have had treatment aimed at curing my prostate cancer.
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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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in infection adverse events, as measured on TRUS-BxQ
Secondary study objectives
Change in adverse events, as measured on 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.

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
1,086 Previous Clinical Trials
1,146,045 Total Patients Enrolled
8 Trials studying Infections
9,414 Patients Enrolled for Infections
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,077,657 Total Patients Enrolled
4 Trials studying Infections
93,650 Patients Enrolled for Infections
Jim C Hu, MD MPHPrincipal InvestigatorWeill Cornell Medicine, NewYork-Presbyterian
3 Previous Clinical Trials
1,341 Total Patients Enrolled
1 Trials studying Infections
738 Patients Enrolled for Infections

Media Library

Transperineal MRI-guided prostate biopsy Clinical Trial Eligibility Overview. Trial Name: NCT04815876 — N/A
Infections Research Study Groups: Transrectal, Transperineal
Infections Clinical Trial 2023: Transperineal MRI-guided prostate biopsy Highlights & Side Effects. Trial Name: NCT04815876 — N/A
Transperineal MRI-guided prostate biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04815876 — N/A
~166 spots leftby Jun 2025
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