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Active Not Recruiting
NCT03234556
Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
Conditions: Health Status Unknown, Elevated PSA
Sex: Male
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 288
Sponsor: University of Southern California
Location: USC / Norris Comprehensive Cancer Center Los Angeles California
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.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT03234556). StuddyBuddy aggregates publicly available trial information.