Prostate Cancer Clinical Trial
Official title:
A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial
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.
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