An interventional study of MS3TMRI / TRUS Guided Biopsy and MS3TMRI / TRUS Guided Biopsy in Prostate Cancer, sponsored by Toronto Sunnybrook Regional Cancer Centre. Active, not recruiting at 1 site in Canada. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Toronto Sunnybrook Regional Cancer Centre · Not applicable, Interventional, and Treatment
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 60 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Toronto Sunnybrook Regional Cancer Centre is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: MS3TMRI / TRUS Guided Biopsy · Device: 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).
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).
Also known as: Multispectral 3T MRI, Transrectal Ultrasound
Prostate MRI in BRCA carriers
Measure of prostate MRI to determine the PPV of MRI for detection of actionable prostate cancer
Time frame: 2 years (January 2016)
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.
Time frame: 2 years January 2016
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Toronto Sunnybrook Regional Cancer Centre