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Transperineal vs Transrectal Biopsy for Infections(PREVENT2 Trial)

NewYork-Presbyterian Brooklyn Methodist Hospital, Brooklyn, NY

Transperineal MRI-guided prostate biopsy +2 moreN/ARecruitingLed by Jim C Hu, MD MPHResearch 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

Prior negative cohort: Clinical concern for the presence of prostate cancer as determined by the treating urologist and prior negative prostate biopsy performed ≤36 months prior to date of planned biopsy

Active surveillance cohort: History of Grade Group 1 prostate cancer, first diagnosed ≤24 months prior to date of planned confirmatory biopsy and diagnostic biopsy was preceded by a multiparametric MRI of the prostate

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up7 days post-biopsy

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Infection

PREVENT2 Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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

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

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

PREVENT2 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,039 Previous Clinical Trials

1,325,866 Total Patients Enrolled

7 Trials studying Infections

8,468 Patients Enrolled for Infections

Patient-Centered Outcomes Research InstituteOTHER

535 Previous Clinical Trials

29,956,928 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

1,003 Total Patients Enrolled

1 Trials studying Infections

400 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

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

Recent research and studies

clinicaltrials.govStudy

PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2

2021. "PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04815876.

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