Prostate Screening Study Using MRI in BRCA Carriers

NCT01990521 | Active Not Recruiting

• 1 other identifier: 500-2013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Prostate cancer in BRCA carriers

  2 years January 2016

Study Arms (1)

MS3TMRI / TRUS Guided Biopsy

EXPERIMENTAL

Procedure: MS3TMRI / TRUS Guided Biopsy; Device: MS3TMRI / TRUS Guided Biopsy

Interventions

MS3TMRI / TRUS Guided Biopsy PROCEDURE

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).

MS3TMRI / TRUS Guided Biopsy

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Claustrophobia
• Contraindication to MRI
• Contraindication to receiving low molecular weight MRI contrast agent
• Previously diagnosed with prostate cancer

Sponsors & Collaborators

• Toronto Sunnybrook Regional Cancer Centre: lead
• Sunnybrook Health Sciences Centre: collaborator
• Women's College Hospital: collaborator

Study Sites (1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ultrasound, High-Intensity Focused, Transrectal

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

High-Intensity Focused Ultrasound Ablation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Danny J Vesprini, MD, MSc, FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

CA (1)