Active Surveillance Magnetic Resonance Imaging Study

Prostate Cancer Clinical Trial

— ASIST  

Official title:

Active Surveillance Magnetic Resonance Imaging Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01354171
• Other study ID #: CURC-003
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 13, 2011
• Last updated: October 13, 2016
• Start date: November 2011
• Est. completion date: December 2017

Study information

• Verified date: March 2012
• Source: Canadian Urology Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 5a-reductase inhibitors within 3 months of randomization

• Planned anti-androgen therapy

• Inability to undergo TRUS biopsy

• Inability to undergo multi-parametric MRI

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• 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

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Canadian Urology Research Consortium	Eigen, OICR

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher		one year	No
Secondary	To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher		one year	No