The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer
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
1 other identifier
interventional
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 7, 2013
CompletedFirst Posted
Study publicly available on registry
July 11, 2013
CompletedJuly 11, 2013
July 1, 2013
2.7 years
January 7, 2013
July 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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 Outcomes (1)
The number of cores required for diagnosis of prostate cancer for MS3TMRI-TRUSBx versus TRUSBx alone
The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy
Study Arms (1)
Diagnostic: Single Arm
OTHERImaging (MS3TMRI)
Interventions
Multispectral 3 Tesla MRI imaging with contrast followed by biopsy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- Philips Healthcarecollaborator
Study Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Masoom Haider, MD
Sunnybrook Health Sciences Centre, University of Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Department of Medical Imaging
Study Record Dates
First Submitted
January 7, 2013
First Posted
July 11, 2013
Study Start
April 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 11, 2013
Record last verified: 2013-07