Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods

Not Applicable

Terminated

• Conditions: Prostate Cancer
• Interventions: Other: MRI with gadofosveset and MR elastography

• Registration Number: NCT01761812
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

The purpose of this study is to determine the ability of several new MRI techniques (MR elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo MRI will also be conducted on the prostate specimen to obtain high resolution imaging correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators hypothesize that the addition of these three techniques will increase the accuracy, sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-01-01
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-07
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 5

Inclusion Criteria

• male patients diagnosed with T1C or T2 prostate cancer, awaiting prostatectomy

Exclusion Criteria

• unable to give informed consent
• contraindication to MRI or MRI contrast agent
• claustrophobia
• renal impairment
• prior hormonal or radiation therapy for prostate cancer
• active prostatitis
• moderate to severe rectal inflammation
• previous rectal surgery
• prostate biopsy within 4 weeks of planned MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	MRI with gadofosveset and MR elastography	-

Primary Outcome Measures

Name	Time	Method
Correlation coefficient	This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).	Correlation coefficient between the expected location and grade of prostate cancer as determined by each new MRI method compared with whole mount histological specimen using a 5 mm grid for spatial reference.
Receiver operator characteristic curve for the prediction of prostate cancer for each new MRI method	This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).

Trial Locations

Locations (1)

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