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NCT03234556Active, not recruiting

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

Diagnosing Clinically Significant Prostate Cancer in African American and White Men Phase II, Randomized Clinical Trial, Multi-center, MR-Guided vs. 12-core Systematic Random Biopsy, Localized Prostate Cancer

Source: ClinicalTrials.gov · Last updated 5 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
288 (actual)
First submitted
26 Jul 2017
Start date
25 Sept 2017
Primary completion date
31 Dec 2026
Lead sponsor
University of Southern California
NCT number
NCT03234556

What you commit to

  • Study type: Interventional
  • Participants enrolled: 288
  • From 25 Sept 2017 to the primary completion date, 31 Dec 2026
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients receiving any other investigational agents
  • Patients who had any surgery of the prostate including TURP (transurethral resection of the prostate)
  • Patients who had \> 1 prior prostate biopsy

Other illness

  • Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer
  • 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

Other

  • Patients who are unable to undergo MRI

Who the study is looking for

  • 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

Age in the registry: 40 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Maryland
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Henry Ford Hospital Vattikuti Urology Institute
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.