MRI Screening for Prostate Cancer

Overseen By Danny Vesprini, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Toronto Sunnybrook Regional Cancer Centre

Disqualifiers: Claustrophobia, MRI contraindication, Prostate cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Danny J Vesprini, MD, MSc, FRCPC

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

This trial is for men over 50 who are part of the Male Hereditary Cancer Research Program, have a BRCA1 or BRCA2 mutation, and can undergo an ultrasound biopsy. It's not for those with claustrophobia, MRI contraindications, contrast agent issues, or previous prostate cancer diagnosis.

Inclusion Criteria

I am 50 years old or older.

Enrolled in the Male Hereditary Cancer Research Program at Sunnybrook Health Sciences Center

I am willing and able to have an ultrasound biopsy within 4 weeks after my MRI.

Exclusion Criteria

Claustrophobia

I cannot have MRI contrast due to a medical reason.

I have been diagnosed with prostate cancer before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Screening

Participants undergo Multispectral 3T MRI to assess its value as a screening tool for prostate cancer

2 years

Regular MRI visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after MRI screening

4 weeks

Treatment Details

Interventions

• MS3TMRI
• TRUS Guided Biopsy

Trial Overview The study tests if using MRI as a screening tool helps detect prostate cancer earlier in men at high risk due to BRCA mutations. This is compared to standard PSA testing and digital rectal examination.

Participant Groups

Group I: MS3TMRI / TRUS Guided Biopsy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Toronto Sunnybrook Regional Cancer Centre

Lead Sponsor

Trials

10

Recruited

950+

Women's College Hospital

Collaborator

Trials

108

Recruited

43,700+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+