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

Sunnybrook Health Sciences Centre

Status

Completed

Conditions

Prostate Cancer

Treatments

Other: MS3TMRI

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01896713

154-2009

Details and patient eligibility

About

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.

Full 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.

Enrollment

81 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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