Prostate Screening Study Using MRI in BRCA Carriers

  • STATUS
    Recruiting
  • days left to enroll
    48
  • participants needed
    60
  • sponsor
    Toronto Sunnybrook Regional Cancer Centre
Updated on 25 May 2022
transrectal ultrasound
BRCA1
BRCA2
digital rectal examination

Summary

Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset, aggressive prostate cancer compared to men in the general population.

Standard of care screening for men with a BRCA mutation includes PSA testing and digital rectal examination (DRE), the same as with men in the general population.

This study is being done to assess whether there is value in using MRI as a screening tool to detect prostate cancer at an earlier stage than may otherwise be detected using standard of care screening (PSA, DRE). It is unclear whether MRI has utility as a screening tool in this specific population at high risk for aggressive disease.

Description

To determine the value of using Multispectral 3T MRI (MS3TMRI) for prostate cancer screening in men with a high risk of developing early onset aggressive prostate cancer given known BRCA1 or BRCA2 mutation carrier status, with no prior prostate cancer diagnosis, independent of baseline PSA levels.

  • Determine the prevalence of prostate cancer in BRCA1 and BRCA2 mutation carriers independent of baseline PSA levels.
  • To evaluate the accuracy of tumor targeting based on MRI and ultrasound (US) tumor co-localization. To evaluate the sensitivity, specificity, PPV, NPV, and accuracy of an automated computer aided diagnosis method (CAD) applied to MS3TMRI in the prediction of zonal biopsy results for the presence or absence of a significant cancer.

Details
Condition Prostate Cancer
Treatment MS3TMRI / TRUS Guided Biopsy
Clinical Study IdentifierNCT01990521
SponsorToronto Sunnybrook Regional Cancer Centre
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Enrolled in the Male Hereditary Cancer Research Program at Sunnybrook Health Sciences Center
Have positive genetic testing for a pathogenic BRCA1 or BRCA2 mutation
Clinically eligible for and willing to undergo ultrasound biopsy within 4 weeks after the MRI
Be 50 years of age or older

Exclusion Criteria

Claustrophobia
Contraindication to MRI
Contraindication to receiving low molecular weight MRI contrast agent
Previously diagnosed with prostate cancer
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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