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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: MS3TMRI

• Registration Number: NCT01896713
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-01-07
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-08
• Last Update Submitted: 2013-07-08
• Study First Posted: 2013-07-11
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic: Single Arm	MS3TMRI	Imaging (MS3TMRI)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada