Active Surveillance Magnetic Resonance Imaging Study

Phase 3

• Conditions: Prostate Cancer
• Interventions: Device: MRI assisted TRUS guided biopsy

• Registration Number: NCT01354171
• Lead Sponsor: Canadian Urology Research Consortium

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Study Start: 2011-11
• Status Verified: 2012-03
• Primary Completion: 2016-09
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI Assisted TRUS guided biopsy	MRI assisted TRUS guided biopsy	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada