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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days post-biopsy
Awards & highlights
PREVENT2 Trial 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.Check my eligibility
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.See study design
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.
PREVENT2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days post-biopsy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days post-biopsy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in infection adverse events, as measured on TRUS-BxQ
Secondary outcome measures
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 morePREVENT2 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
1,054 Previous Clinical Trials
1,315,007 Total Patients Enrolled
7 Trials studying Infections
8,806 Patients Enrolled for Infections
Patient-Centered Outcomes Research InstituteOTHER
550 Previous Clinical Trials
29,995,646 Total Patients Enrolled
4 Trials studying Infections
93,534 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have a prostate MRI due to claustrophobia, having a pacemaker, or kidney issues.I cannot have a prostate biopsy with local anesthesia.I have had treatment aimed at curing my prostate cancer.I was diagnosed with low-grade prostate cancer within the last 2 years and had an MRI before my biopsy.I am currently being treated with antibiotics for a bacterial infection not related to the urinary system.I have had acute prostatitis in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Transrectal
- Group 2: Transperineal
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many facilities are conducting this clinical research?
"Presently, 12 clinical sites are participating in this trial. These locations span from Elkins Park to Chicago with 10 other cities included as well. If you choose to join the study, it is beneficial to pick a clinic that is geographically close by so that travel time can be minimized."
Answered by AI
How many participants have been enrolled to partake in this experiment?
"In order to execute this trial, precisely 1302 participants that meet the required qualifications must volunteer. There are many medical centres across America where individuals can take part in this study; two such examples include Einstein Healthcare Network located in Elkins Park, Pennsylvania and University Hospitals Cleveland Medical Center situated in Cleveland, Ohio."
Answered by AI
Are there vacancies for this research opportunity still available?
"According to findings on clinicaltrials.gov, this experiment is still seeking volunteers; it was initially launched on June 24th 2021 and most recently modified on August 30th 2022."
Answered by AI
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