Status:
ACTIVE_NOT_RECRUITING
Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Health Status Unknown
Elevated PSA
Eligibility:
MALE
40+ years
Phase:
NA
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 ele...
Detailed Description
PRIMARY OBJECTIVES: I. To compare the detection of clinically significant prostate cancer (CSPCa) in Arm 1 versus Arm 2. II. To compare between African American (AA) and white men the probability of...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2028
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT03234556
Start Date
September 25 2017
End Date
May 23 2028
Last Update
December 22 2025
Active Locations (4)
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1
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
University of Maryland
Baltimore, Maryland, United States, 21201
3
Henry Ford Hospital Vattikuti Urology Institute
Detroit, Michigan, United States, 48202
4
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065