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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03234556). StuddyBuddy aggregates publicly available trial information.