Prostate Screening Study Using MRI in BRCA Carriers
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|ClinicalTrials.gov Identifier: NCT01990521|
Recruitment Status : Recruiting
First Posted : November 21, 2013
Last Update Posted : September 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: MS3TMRI / TRUS Guided Biopsy Device: MS3TMRI / TRUS Guided Biopsy||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Screening Male BRCA Mutation Carriers: Effectiveness of Multispectral 3T Magnetic Resonance Imaging|
|Actual Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2021|
|Experimental: MS3TMRI / TRUS Guided Biopsy||
Procedure: 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).
Device: MS3TMRI / TRUS Guided Biopsy
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).
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990521
|Contact: Danny J Vesprini, MD, MSc, FRCPCfirstname.lastname@example.org|
|Contact: Justin A Lorentz, MSc, CGC||416-480-500 ext email@example.com|
|Sunnybrook Odette Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Danny J Vesprini, MD, MSc, FRCPC 416-480-4806 firstname.lastname@example.org|
|Contact: Justin A Lorentz, MSc, CGC 416-480-5000 ext 83683 email@example.com|
|Sub-Investigator: Justin A Lorentz, MSc, CGC|
|Principal Investigator: Danny J Vesprini, MD, MSc, FRCPC|
|Principal Investigator:||Danny J Vesprini, MD, MSc, FRCPC||Sunnybrook Health Sciences Centre|