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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896713
• Other study ID #: 154-2009
• Status: Completed
• Phase: N/A
• First received: January 7, 2013
• Last updated: July 8, 2013
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Philips Healthcare

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No