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PRostate Evaluation for Clinically Important Disease: MRI vs Standard Evaluation Procedures

NCT02936258 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2018-02-22

No results posted yet for this study

Summary

The aim of this study is to assess the efficacy of MRI-targeted biopsy compared to standard of care systematic TRUS guided biopsy in the detection of clinically significant and clinically insignificant prostate cancer in men without prior biopsy. The implication of this trial is that MRI-targeted biopsy could replace systematic TRUS guided biopsy as the standard of care in the diagnosis of prostate cancer.

Conditions

Interventions

PROCEDURE

Standard of Care

Men in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first).

PROCEDURE

MRI

Men will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI.

PROCEDURE

MRI Targeted Biopsy

Men will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI.

Sponsors & Collaborators

  • Ontario Institute for Cancer Research

    collaborator OTHER

  • Prostate Cancer Canada

    collaborator OTHER

  • Canadian Urology Research Consortium

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02936258 on ClinicalTrials.gov