Active Surveillance Magnetic Resonance Imaging Study

Canadian Urology Research Consortium3 sites in 1 country250 target enrollmentNovember 2011

ConditionsProstate Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Canadian Urology Research Consortium
Enrollment: 250
Locations: 3
Primary Endpoint: To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-centre, prospective, randomized phase III trial to determine if multi-parametric Magnetic Resonance Imaging (MRI) can improve selection of patients eligible for active surveillance through better detection of clinically significant cancer.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

December 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Canadian Urology Research Consortium

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•histological confirmation of adenocarcinoma of the prostate
•candidate for active surveillance (favourable risk prostate cancer) as defined by the following:
•Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis
•Clinical (diagnostic biopsy) Gleason sum \< 6
•PSA \< 10.0 ng/ml (ug/L)

Exclusion Criteria

•Previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy, hormonal therapy (e.g. megestrol, medroxyprogesterone, cyproterone, DES), glucocorticoids (except inhaled or topical), LHRH analogues (e.g. Leuprolide, goserelin), ketoconazole, non-steroidal antiandrogens (e.g. bicalutamide, flutamide) and/or any 5α-reductase inhibitors within 3 months of randomization
•Planned anti-androgen therapy
•Inability to undergo TRUS biopsy
•Inability to undergo multi-parametric MRI