Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA

Running, not enrolling · Not applicable

Conditions studied: Health Status Unknown, Elevated PSA

In brief

This randomized phase II trial studies how well systematic random biopsy or magnetic resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate cancer in patients with elevated prostate specific antigen. Systematic random biopsy and MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.

Key facts

Study ID

NCT03234556

Run by

University of Southern California

People needed

288

Starts

2017-09-25

Expected to finish

2028-05-23

Last updated by the study team

2026-06-05

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
• Note: HIPAA authorization may be included in the informed consent or obtained separately
• Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 3 months (93 days) prior to being registered for protocol
• African-American or white men (Hispanic or non-Hispanic)
• Prostate biopsy-naive or a single negative biopsy
• Having elevated prostate specific antigen (PSA) (> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE)
• Ability to understand the willingness to sign a written informed consent
• Patients must be willing to undergo a radiologic imaging before and after biopsy of the prostate
• Patients must be willing to undergo a biopsy of the prostate

You may not qualify if…

• Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer
• Patients receiving any other investigational agents
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with active inflammatory bowel disease
• Patients who are unable to undergo MRI
• Patients who had any surgery of the prostate including TURP (transurethral resection of the prostate)
• Patients who had > 1 prior prostate biopsy

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of Maryland — Baltimore, Maryland, United States
• Henry Ford Hospital Vattikuti Urology Institute — Detroit, Michigan, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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