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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: MS3TMRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diagnostic: Single Arm<br>Imaging (MS3TMRI) | Other: MS3TMRI<br>* Multispectral 3 Tesla MRI imaging with contrast followed by biopsy<br>* Other names: Multispectral 3 Tesla MRI imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, MRI, TRUSBx