Prostate Screening Study Using MRI in BRCA Carriers

Screening Male BRCA Mutation Carriers: Effectiveness of Multispectral 3T Magnetic Resonance Imaging

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01990521

Enrollment

Registered

2013-11-21

Start date

2014-01-31

Completion date

2026-09-30

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief 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.

Detailed 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.

Interventions

PROCEDUREMS3TMRI / TRUS Guided Biopsy

Patients would undergo MS3TMRI and then have a transrectal ultrasound (TRUS) biopsy performed within one month after the MRI. The initial cores would be obtained using TRUS without MRI information (TRUSBx). During the same biopsy session, the MS3TMRI information would be given to the physician performing the biopsy and additional cores specifically targeted to suspicious areas would be performed (MS3TMRI-TRUSBx).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Prostate MRI in BRCA carriers	2 years (January 2016)	Measure of prostate MRI to determine the PPV of MRI for detection of actionable prostate cancer

Secondary

Measure	Time frame	Description
Prostate cancer in BRCA carriers	2 years January 2016	Prevalence of any prostate cancer compared to actionable cancer in men with a BRCA1 or BRCA2 mutation independent of serum PSA value.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026