Prostate Screening Study Using MRI in BRCA Carriers

Toronto Sunnybrook Regional Cancer Centre

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Device: MS3TMRI / TRUS Guided Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01990521

500-2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

MS3TMRI / TRUS Guided Biopsy

Experimental group

Treatment:

Device: MS3TMRI / TRUS Guided Biopsy

Device: MS3TMRI / TRUS Guided Biopsy