The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MS3TMRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, MRI, TRUSBx
Eligibility Criteria
Inclusion Criteria:
- Enrolled in active surveillance at Sunnybrook Health Sciences Centre, requiring biopsy as part of surveillance protocol.
- Clinically eligible for radical prostatectomy and willing to undergo surgery
- Clinically eligible for and willing to undergo ultrasound biopsy within 8 weeks of MRI
Exclusion Criteria:
- Claustrophobia
- Contraindication to MRI
- Contraindication to receiving low molecular weight MRI contrast agent
- Prior hormone therapy except 5-alpha reductase inhibitors such as Avodart. FloMax etc
- Clinically suspected or known compromised renal function or calculated estimated Glomerular Filtration Rate (eGFR) <30ml/min
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Diagnostic: Single Arm
Arm Description
Imaging (MS3TMRI)
Outcomes
Primary Outcome Measures
The Positive Predictive Value (PPV) of MS3TMRI-TRUSBx for detection of a patient with a cancer burden requiring consideration of immediate therapy.
Compare the targeted biopsy to the random biopsies
Secondary Outcome Measures
The number of cores required for diagnosis of prostate cancer for MS3TMRI-TRUSBx versus TRUSBx alone
Full Information
NCT ID
NCT01896713
First Posted
January 7, 2013
Last Updated
July 8, 2013
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Philips Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT01896713
Brief Title
The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer
Official Title
To Determine if MultiSpectral 3 Tesla MRI Can Provide Added Value in the Detection of Significant Cancers in Patients o n Active Surveillance for Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Philips Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy (TRUSBx) to improve identification of patients on active surveillance requiring treatment.
Detailed Description
This is a prospective single arm study. 120 patients at risk for significant occult prostate cancer on an active surveillance program will undergo MS3TMRI followed by a standard TRUSBx and additional biopsies guided by the MS3TMRI results. The positive predictive value (PPV) of MS3TMRI-TRUSBx for cancer requiring consideration of therapy will be compared to the PPV of TRUSBx alone. MS3TMRI consists of T2, diffusion-weighted imaging (DWI), dynamic contrast enhanced MRI (DCEMRI), proton MR spectroscopy (MRS) interpreted by a radiologist and by CAD methods validated on whole mount prostate specimens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, MRI, TRUSBx
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic: Single Arm
Arm Type
Other
Arm Description
Imaging (MS3TMRI)
Intervention Type
Other
Intervention Name(s)
MS3TMRI
Other Intervention Name(s)
Multispectral 3 Tesla MRI imaging
Intervention Description
Multispectral 3 Tesla MRI imaging with contrast followed by biopsy
Primary Outcome Measure Information:
Title
The Positive Predictive Value (PPV) of MS3TMRI-TRUSBx for detection of a patient with a cancer burden requiring consideration of immediate therapy.
Description
Compare the targeted biopsy to the random biopsies
Time Frame
The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy
Secondary Outcome Measure Information:
Title
The number of cores required for diagnosis of prostate cancer for MS3TMRI-TRUSBx versus TRUSBx alone
Time Frame
The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrolled in active surveillance at Sunnybrook Health Sciences Centre, requiring biopsy as part of surveillance protocol.
Clinically eligible for radical prostatectomy and willing to undergo surgery
Clinically eligible for and willing to undergo ultrasound biopsy within 8 weeks of MRI
Exclusion Criteria:
Claustrophobia
Contraindication to MRI
Contraindication to receiving low molecular weight MRI contrast agent
Prior hormone therapy except 5-alpha reductase inhibitors such as Avodart. FloMax etc
Clinically suspected or known compromised renal function or calculated estimated Glomerular Filtration Rate (eGFR) <30ml/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoom Haider, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer
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