Transperineal MRI-targeted prostate biopsy to reduce infection risk
Randomized Trial Comparing Transperineal vs. Transrectal MRI-targeted Prostate Biopsy; Randomized Controlled Trial Assessing Transperineal Prostate Biopsy to Reduce Infection Complications
This study is testing a new way to do prostate biopsies that uses a different approach to see if it can lower the risk of infections while still finding cancer effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1302 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Drugs / interventions | radiation |
| Locations | 16 sites (Los Angeles, California and 15 other locations) |
| Trial ID | NCT04815876 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a transperineal MRI-targeted prostate biopsy approach compared to the standard transrectal method. The study aims to determine if the transperineal method, performed under local anesthesia, can significantly lower the risk of post-biopsy infections while maintaining similar levels of pain and improving cancer detection rates. Participants will be randomly assigned to receive either biopsy method, and the outcomes will be assessed to establish the safety and efficacy of the new approach. This is the first prospective study to investigate this method in an office setting.
Who should consider this trial
Good fit: Ideal candidates include men with a history of Grade Group 1 prostate cancer or those with clinical concerns for prostate cancer and prior negative biopsy results.
Not a fit: Patients with acute prostatitis, current bacterial infections, or those unfit for biopsy under local anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of infections associated with prostate biopsies, improving patient safety and outcomes.
How similar studies have performed: While transperineal biopsy has been explored, this specific approach under local anesthesia in an office setting is novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Los Angeles, California and 15 other locations
- University of Southern California — Los Angeles, California, United States (Not_yet_recruiting)
- University of Connecticut — Farmington, Connecticut, United States (Recruiting)
- Georgetown University — Washington, District of Columbia, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Not_yet_recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States (Completed)
- NewYork-Presbyterian Queens — Flushing, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Not_yet_recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Einstein Healthcare Network — Elkins Park, Pennsylvania, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jim C Hu, MD MPH — Weill Cornell Medicine, NewYork-Presbyterian
- Study coordinator: Dianis Rivera, BS
- Email: dir4010@med.cornell.edu
- Phone: 212.746.1496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.