search
Back to results

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
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, MRI, TRUSBx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
January 7, 2013
Last Updated
July 8, 2013
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Philips Healthcare
search

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

We'll reach out to this number within 24 hrs