Overview

Evaluation of Transperineal Biopsy Under Local Anesthesia

Status:
Recruiting
Trial end date:
2025-06-01
Target enrollment:
0
Participant gender:
Male
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. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer. This randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy. The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Anti-Bacterial Agents
Criteria
Inclusion Criteria:

- Clinical indications for prostate biopsy to be performed under local anesthesia based
on an elevated prostate-specific antigen (PSA) level (≤30 ng/mL) or abnormal digital
rectal exam

- Willingness to sign informed consent and adhere to the study protocol

Exclusion Criteria:

- Prior prostate biopsy performed in the last 5 years; OR prior diagnosis of prostate
cancer

- 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)