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
Condition: Health Status Unknown, Elevated PSA
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03234556
Sponsor: University of Southern California
Eligibility:
- Age: minimum 40 Years maximum N/A
- Gender: Male
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
View trial on ClinicalTrials.gov