Recruiting

MRI vs. Standard Evaluation

Sponsor:

Canadian Urology Research Consortium

Code:

NCT02936258

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care

MRI

MRI Targeted Biopsy

Study Details

Brief 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

Prostate Cancer

Study ID

NCT02936258

Start date

Nov, 2016

Status verified date

Jan, 2018

Completion date

Nov, 2019

Anticipated

Primary completion date

Nov, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

In order to be eligible, all inclusion criteria must be met:

1. Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy;
2. ≥5% chance of high-grade prostate cancer as calculated using individualized risk assessment of prostate cancer calculator, PCPTRC 2.0, found at http://deb.uthscsa.edu/URORiskCalc/Pages/calcs.jsp;
3. Serum PSA ≤ 20ng/ml within 3 months of randomization
4. Fit to undergo all procedures listed in protocol;
5. Able to provide written informed consent.

Exclusion Criteria:

1. Prior prostate biopsy
2. Prior treatment for prostate cancer
3. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR ≤ 50mls/min)
4. Contraindication to prostate biopsy
5. Men in whom artifact would reduce the quality of the MRI, i.e. previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
6. Unfit to undergo any procedures listed in protocol.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: MRI

Men in Arm A 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. The unbiopsied men will have a repeat MRI at 2 years.

active comparator: 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).

Interventions

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).

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.

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.

Primary outcome measure

  • MRI-The proportion of men with clinically significant cancer (Gleason > 7) [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

London Health Sciences Centre-Victoria Hospital

Recruiting

London, Ontario, Canada, N6A5W9

Contacts

Principal Investigator:

Joseph Chin, MD

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Laurence Klotz, MD

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G1X6

Contacts

Principal Investigator:

Antonio Finelli, MD

CIUSSS du Centre-Ouest-de-I'ile-de-Montreal-Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T1E2

Contacts

Principal Investigator:

Franck Bladou, MD

More Information

Sponsor

Canadian Urology Research Consortium

Last update posted

Feb 22, 2018

Last verified

Jan, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Urology Research Consortium on 2018-02-22.