Active Surveillance Magnetic Resonance Imaging Study
This trial is active, not recruiting.
|Treatment||mri assisted trus guided biopsy|
|Sponsor||Canadian Urology Research Consortium|
|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|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher
time frame: one year
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher
time frame: one year
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
|Official title||Active Surveillance Magnetic Resonance Imaging Study|
|Principal investigator||Laurence Klotz, MD|
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