Status:
COMPLETED
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Cancer Institute (NCI)
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
- Inclusion Criteria
- Male sex
- Age ≥18 years
- Men without previous prostate biopsy (first time prostate biopsy)
- Willingness to sign informed consent and adhere to the study protocol
- Exclusion Criteria
- Acute prostatitis within the last 6 months
- PSA \> 20 ng/mL in men who have previously undergone prostate biopsy
- 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
- Men who have previously undergone prostate biopsy in whom artifact would reduce quality of prostate MRI (extensive orthopedic pelvic metal)
- Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease) in men who have previously undergone prostate biopsy
Exclusion
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2024
Estimated Enrollment :
687 Patients enrolled
Trial Details
Trial ID
NCT04843566
Start Date
March 22 2021
End Date
April 19 2024
Last Update
April 15 2025
Active Locations (10)
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1
University of Connecticut
Farmington, Connecticut, United States, 06030
2
Georgetown University
Washington D.C., District of Columbia, United States, 20007
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Johns Hopkins University
Baltimore, Maryland, United States, 21287