1. Using multiparametric MRI Ultrasound-guided or MRI-guided biopsies will allow more accurate sampling of the tumors and therefore will increase the rate of "progression" on early (first and second) surveillance biopsies and decrease the rate of "progression" on late (third and further) surveillance biopsies compared to Transrectal Ultrasound-guided biopsies. 2. Quality of life (QoL) will be similar in patients undergoing MRI Ultrasound or MRI-guided and Transrectal Ultrasound-guided biopsies. 3. Biomarker expression levels will correlate with biopsy progression.
Favorable risk patients will be randomized to one of two active surveillance arms. Stratification will be based on Prostate-specific antigen density (PSAD) (=\< 0.15 vs \> 0.15 ng/mL per mL), and number of positive cores in the diagnostic biopsy (1 vs 2): * Arm I: Active Surveillance Alone (AS). TRUS guided biopsies at start (within 6 months of enrollment) and at yearly intervals thereafter up to 36 months after the initial biopsy (maximum four biopsies). * Arm II: MRI-Managed Active Surveillance (MRI-AS). MRIus or MRI-guided biopsies at start (within 6 months of enrollment) and at yearly intervals thereafter up to 36 months after the initial biopsy (maximum four biopsies). Patients will also complete Quality of Life (QoL) assessments to provide unique data on the effects of MRI monitoring for patients undergoing active surveillance on QOL. The investigators have selected a group of measures that have been used extensively in prostate cancer populations.
Study Type
OBSERVATIONAL
Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
MRI-Managed Active Surveillance (MRI-AS). MRI Ultrasound or MRI-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies)
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
University of Miami
Miami, Florida, United States
Rate of Progression in Subjects undergoing MRIus Biopsy vs Standard Ultrasound biopsy
To determine of multiparametric MRIus-guided biopsies increase the rate of progression on early (first two) biopsies in men undergoing active surveillance as compared with early detection using standard ultrasound biopsy.
Time frame: 42 months
Expression Levels of Biomarkers from biopsies collected with MRI-us Biopsy vs Standard Ultrasound Biopsy
Time frame: 42 months
Effect of MRI Monitoring on Health-Related Quality of Life
To determine the effect of MRI monitoring on health-related quality of life (HRQOL), prostate cancer-specific anxiety QOL (ie general, PSA-testing \& recurrence anxiety, PC-Anxiety) and prostate cancer-specific QOL (ie sexual, urinary \& bowel function, PC-QOL), particularly as they relate to ethnically and socioeconomically diverse and disparate populations.
Time frame: 42 months
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Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Plasma/Serum Sample for biomarkers obtained at Baseline, and at 12, 24 and 36 months after initial biopsy for correlative studies (CTC, fcDNA, SNPs)
Urine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA)
Blood Tests for Blood Urea Nitrogen (BUN) and Creatinine obtained at 0 - 6 months, and at 12, 24, and 36 months from initial biopsy. This is optional, subject may refuse
Blood test for Serum PSA obtained at Baseline, at every 6 months up to 36 months from initial biopsy.