This trial is active, not recruiting.

Condition prostate cancer
Treatment mri assisted trus guided biopsy
Phase phase 3
Sponsor Canadian Urology Research Consortium
Collaborator OICR
Start date November 2011
End date September 2016
Trial size 250 participants
Trial identifier NCT01354171, CURC-003


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
(No Intervention)
mri assisted trus guided biopsy
All subjects to have a confirmatory biopsy at one year. Those assigned ARM 1 to have a TRUS guided biopsy and those assigned to ARM 2to have a MRI assisted TRUS guided biopsy

Primary Outcomes

To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher
time frame: one year

Secondary Outcomes

To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher
time frame: one year

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Active Surveillance Magnetic Resonance Imaging Study
Principal investigator Laurence Klotz, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Canadian Urology Research Consortium.