Active Surveillance Magnetic Resonance Imaging Study

NCT01354171 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2016-10-14

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Ontario Institute for Cancer Research

    collaborator OTHER
  • Eigen

    collaborator OTHER
  • Canadian Urology Research Consortium

    lead OTHER

Principal Investigators

  • Laurence Klotz, MD · Canadian Urology Research Consortium

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-09-30
Completion
2017-12-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01354171 on ClinicalTrials.gov