Status:
RECRUITING
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Infection
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. P...
Detailed Description
Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office b...
Eligibility Criteria
Inclusion
- 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
- 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
- Willingness to sign informed consent and adhere to the study protocol
Exclusion
- Acute prostatitis within the last 6 months
- Current non-urologic bacterial infection requiring active treatment with antibiotics
- Unfit to undergo prostate biopsy under local anesthesia
- Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
- Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)
Key Trial Info
Start Date :
June 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
1302 Patients enrolled
Trial Details
Trial ID
NCT04815876
Start Date
June 24 2021
End Date
February 1 2026
Last Update
August 3 2025
Active Locations (16)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
University of Connecticut
Farmington, Connecticut, United States, 06030
3
Georgetown University
Washington D.C., District of Columbia, United States, 20007
4
Northwestern University
Chicago, Illinois, United States, 60611