Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
4 other identifiers
interventional
288
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2017
CompletedFirst Posted
Study publicly available on registry
July 31, 2017
CompletedStudy Start
First participant enrolled
September 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 23, 2028
December 22, 2025
December 1, 2025
8.8 years
July 26, 2017
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Biopsy detection rate of clinically significant prostate cancer
Will code patients as having clinically significant prostate cancer if they are diagnosed with Gleason score \>= 7 or any Gleason score with core length \>= 5 mm or any Gleason score that includes Gleason pattern \>= 4 at initial systematic random biopsy.
Up to 5 years
Secondary Outcomes (1)
Presence of any of the complications
Up to 5 years
Other Outcomes (1)
Highest Gleason score
Up to 5 years
Study Arms (2)
Arm I (SR-Bx)
ACTIVE COMPARATORPatients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI.
Arm II (MRI, MRUS-Bx, SR-Bx)
EXPERIMENTALPatients undergo MRI. Must be scheduled at least one day before MRUS biopsy. * If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only. * If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx.
Interventions
Undergo MRUS-Bx
Undergo SR-Bx
Undergo MRI
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (4)
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Henry Ford Hospital Vattikuti Urology Institute
Detroit, Michigan, 48202, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inderbir Gill
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2017
First Posted
July 31, 2017
Study Start
September 25, 2017
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
May 23, 2028
Last Updated
December 22, 2025
Record last verified: 2025-12