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The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Completed
CT.gov ID
NCT01896713
Collaborator
Philips Healthcare (Industry)
81
Enrollment
1
Location
1
Arm
32
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: MS3TMRI
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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 Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Other: Diagnostic: Single Arm

Imaging (MS3TMRI)

Other: MS3TMRI
Multispectral 3 Tesla MRI imaging with contrast followed by biopsy
Other Names:
  • Multispectral 3 Tesla MRI imaging

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The Positive Predictive Value (PPV) of MS3TMRI-TRUSBx for detection of a patient with a cancer burden requiring consideration of immediate therapy. [The outcome measure will be evaluated at the time of the results of the TRUSbx which will be approximately 2 weeks after the biopsy]

      Compare the targeted biopsy to the random biopsies

    Secondary Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

    Sponsors and Collaborators

    • Sunnybrook Health Sciences Centre
    • Philips Healthcare

    Investigators

    • Principal Investigator: Masoom Haider, MD, Sunnybrook Health Sciences Centre, University of Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Masoom Haider, Chief, Department of Medical Imaging, Sunnybrook Health Sciences Centre
    ClinicalTrials.gov Identifier:
    NCT01896713
    Other Study ID Numbers:
    • 154-2009
    First Posted:
    Jul 11, 2013
    Last Update Posted:
    Jul 11, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Masoom Haider, Chief, Department of Medical Imaging, Sunnybrook Health Sciences Centre
    Prostate Cancer
    MRI
    TRUSBx
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jul 11, 2013