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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
Age ≥18 years
Men without previous prostate biopsy (first time prostate biopsy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days post-biopsy
Awards & highlights
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 belowSelect...
I am 18 years old or older.
Select...
I have never had a prostate biopsy before.
Select...
I am male.
PREVENT 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
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 morePREVENT 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
1,054 Previous Clinical Trials
1,315,878 Total Patients Enrolled
7 Trials studying Infections
9,370 Patients Enrolled for Infections
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,931,723 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have a prostate MRI due to claustrophobia, a pacemaker, or kidney disease.I am 18 years old or older.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.I have never had a prostate biopsy before.My PSA level is above 20 ng/mL after a prostate biopsy.I have had acute prostatitis in the last 6 months.I am male.I have metal implants in my pelvis that could interfere with a prostate MRI.I am currently being treated with antibiotics for a bacterial infection not related to the urinary system.
Research Study Groups:
This trial has the following groups:- Group 1: Transperineal
- Group 2: Transrectal
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.
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
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