Prostate Screening Study Using MRI in BRCA Carriers

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01990521
• Other study ID #: 500-2013
• Status: Recruiting
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2025

Study information

• Verified date: April 2023
• Source: Toronto Sunnybrook Regional Cancer Centre
• Contact: Danny J Vesprini, MD, MSc, FRCPC
• Phone: 416-480-4806
• Email: danny.vesprini[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• MS3TMRI / 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).

Device:
• MS3TMRI / TRUS Guided Biopsy
Multispectral 3T MRI (MS3TMRI) is a device that uses a 3T MRI system without an endorectal receiver coil and with a surface phased array coil. 3T MRI in addition to established computer aided diagnosis (CAD) has been used to perform guided biopsies in an active surveillance population and demonstrated a positive predictive value and negative predictive value of 83% and 81%. A recently completed a study looking at repeat prostate biopsies in men followed on an active surveillance population at Sunnybrook has shown that the PPV of MS3TMRI guided biopsy to be 85%, while the negative predictive value was 100% (Haider, Vesprini and Milot, unpublished).

Locations

Country	Name	City	State
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Toronto Sunnybrook Regional Cancer Centre	Sunnybrook Health Sciences Centre, Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate MRI in BRCA carriers	Measure of prostate MRI to determine the PPV of MRI for detection of actionable prostate cancer	2 years (January 2016)
Secondary	Prostate cancer in BRCA carriers	Prevalence of any prostate cancer compared to actionable cancer in men with a BRCA1 or BRCA2 mutation independent of serum PSA value.	2 years January 2016