- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01990521
Prostate Screening Study Using MRI in BRCA Carriers
Screening Male BRCA Mutation Carriers: Effectiveness of Multispectral 3T Magnetic Resonance Imaging
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Danny J Vesprini, MD, MSc, FRCPC
- Phone Number: 416-480-4806
- Email: danny.vesprini@sunnybrook.ca
Study Contact Backup
- Name: Justin A Lorentz, MSc, CGC
- Phone Number: 83683 416-480-500
- Email: justin.lorentz@sunnybrook.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Odette Cancer Centre
-
Contact:
- Danny J Vesprini, MD, MSc, FRCPC
- Phone Number: 416-480-4806
- Email: danny.vesprini@sunnybrook.ca
-
Contact:
- Justin A Lorentz, MSc, CGC
- Phone Number: 83683 416-480-5000
- Email: justin.lorentz@sunnybrook.ca
-
Sub-Investigator:
- Justin A Lorentz, MSc, CGC
-
Principal Investigator:
- Danny J Vesprini, MD, MSc, FRCPC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prostate MRI in BRCA carriers
Time Frame: 2 years (January 2016)
|
Measure of prostate MRI to determine the PPV of MRI for detection of actionable prostate cancer
|
2 years (January 2016)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prostate cancer in BRCA carriers
Time Frame: 2 years January 2016
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Danny J Vesprini, MD, MSc, FRCPC, Sunnybrook Health Sciences Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 500-2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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