Active Surveillance Magnetic Resonance Imaging Study

Canadian Urology Research Consortium250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

250

Conditions

Prostate Cancer

Interventions

MRI assisted TRUS guided biopsyDEVICE

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

London Health Sciences Centre

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Outcomes

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

Data from ClinicalTrials.gov

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