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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 : May 9, 2022
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
Women's College Hospital
Information provided by (Responsible Party):
Danny Vesprini, MD, MSc, FRCPC, Toronto Sunnybrook Regional Cancer Centre

Study Description
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Brief Summary:

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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).

Other Names:
  • Multispectral 3T MRI
  • Transrectal Ultrasound


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Danny J Vesprini, MD, MSc, FRCPC 416-480-4806 danny.vesprini@sunnybrook.ca
Contact: Justin A Lorentz, MSc, CGC 416-480-500 ext 83683 justin.lorentz@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Danny J Vesprini, MD, MSc, FRCPC    416-480-4806    danny.vesprini@sunnybrook.ca   
Contact: Justin A Lorentz, MSc, CGC    416-480-5000 ext 83683    justin.lorentz@sunnybrook.ca   
Sub-Investigator: Justin A Lorentz, MSc, CGC         
Principal Investigator: Danny J Vesprini, MD, MSc, FRCPC         
Sponsors and Collaborators
Toronto Sunnybrook Regional Cancer Centre
Sunnybrook Health Sciences Centre
Women's College Hospital
Investigators
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Principal Investigator: Danny J Vesprini, MD, MSc, FRCPC Sunnybrook Health Sciences Centre
More Information
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Responsible Party: Danny Vesprini, MD, MSc, FRCPC, Radiation Oncologist, Toronto Sunnybrook Regional Cancer Centre
ClinicalTrials.gov Identifier: NCT01990521    
Other Study ID Numbers: 500-2013
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases