Clinical trial · Interventional
Prostate Screening Study Using MRI in BRCA Carriers
Screening Male BRCA Mutation Carriers: Effectiveness of Multispectral 3T Magnetic Resonance Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MS3TMRI / TRUS Guided Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MS3TMRI / TRUS Guided Biopsy
- interventionNames
- Procedure: MS3TMRI / TRUS Guided Biopsy
- Device: MS3TMRI / TRUS Guided Biopsy
Primary outcomes (1)
- measure
- Prostate MRI in BRCA carriers
- timeFrame
- 2 years (January 2016)
- description
- Measure of prostate MRI to determine the PPV of MRI for detection of actionable prostate cancer
Secondary outcomes (1)
- measure
- Prostate cancer in BRCA carriers
- timeFrame
- 2 years January 2016
- description
- Prevalence of any prostate cancer compared to actionable cancer in men with a BRCA1 or BRCA2 mutation independent of serum PSA value.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available