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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.
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 developing CSPCa within three years of initial biopsy at the start of the study.
I. To determine complications and patient morbidity associated with either systematic random prostate biopsy (SR-Bx) versus (vs) magnetic resonance imaging-ultrasound image fusion biopsy (MRUS-Bx) + SR-Bx.
I. To compare Gleason score between MRUS-Bx and radical prostatectomy (RP) specimen among men who elect RP (~110 in the randomized controlled trial [RCT]).
II. To assess within Arm 1 the detection of CSPCa three months after SR-Bx among men initially diagnosed with clinically insignificant prostate cancer (CinsPCa) or no cancer.
III. To identify among men invited to participate and those actually enrolled in the RCT: determinants of study participation.
IV. To identify among men invited to participate and those actually enrolled in the RCT: determinants of treatment decision (active surveillance [AS] vs radiation vs RP) including the diagnostic method.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients undergo SR-Bx.
ARM II: Patients undergo MRI scans at least one day before prostate biopsy, three months after SR-Bx, and 12 months after initial MRI. Patients with no lesion present only undergo SR-Bx. Patients with a lesion present undergo MRUS-Bx followed by SR-Bx.
After completion of study, patients are followed up at 2-4 weeks, 3, 6, 9, and 12 months, and then periodically for up to 5 years.
Health Status Unknown
Biopsy of Prostate, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, MRI Ultrasound Fusion Guided Biopsy
USC / Norris Comprehensive Cancer Center
Not yet recruiting
University of Southern California
Published on BioPortfolio: 2017-08-01T13:38:21-0400
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