Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
Health Status Unknown, Elevated PSA
About this trial
This is an interventional diagnostic trial for Health Status Unknown
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
Sites / Locations
- USC / Norris Comprehensive Cancer CenterRecruiting
- University of MarylandRecruiting
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Chesapeake Urology Associates
- Henry Ford Hospital Vattikuti Urology InstituteRecruiting
- Memorial Sloan-Kettering Cancer CenterRecruiting
- UT Southwestern/Simmons Cancer Center-Dallas
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (SR-Bx)
Arm II (MRI, MRUS-Bx, SR-Bx)
Patients 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.
Patients 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.