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

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ClinicalTrials.gov Identifier: NCT01896713
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : July 11, 2013
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
Masoom Haider, Sunnybrook Health Sciences Centre

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
Prostate Cancer Other: MS3TMRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
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 : April 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Diagnostic: Single Arm
Imaging (MS3TMRI)
Other: MS3TMRI
Multispectral 3 Tesla MRI imaging with contrast followed by biopsy
Other Name: Multispectral 3 Tesla MRI imaging




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. [ 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 ]
    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 [ 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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): NCT01896713


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Philips Healthcare
Investigators
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Principal Investigator: Masoom Haider, MD Sunnybrook Health Sciences Centre, University of Toronto

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Responsible Party: Masoom Haider, Chief, Department of Medical Imaging, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01896713     History of Changes
Other Study ID Numbers: 154-2009
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Masoom Haider, Sunnybrook Health Sciences Centre:
Prostate Cancer
MRI
TRUSBx

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases