Active Surveillance Magnetic Resonance Imaging Study
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
Active Surveillance Magnetic Resonance Imaging Study
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher
Outcome Time Frame:
one year
Safety Issue:
No
Principal Investigator
Laurence Klotz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Canadian Urology Research Consortium
Authority:
Canada: Health Canada
Study ID:
CURC-003
NCT ID:
NCT01354171
Start Date:
November 2011
Completion Date:
December 2014
Related Keywords:
- Prostate Cancer
- active surveillance
- low risk prostate cancer
- Prostatic Neoplasms
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