MRI in Diagnosing Prostate Cancer

Not Applicable

• Conditions: Prostate Cancer

• Registration Number: NCT01292291
• Lead Sponsor: University College London Hospitals

Brief Summary

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find prostate cancer and learn the extent of disease.

PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in diagnosing prostate cancer.

Detailed Description

OBJECTIVES:

* To determine the ability of multiparametric magnetic resonance imaging (MP-MRI) to identify men who can safely avoid unnecessary biopsy.

* To assess the ability of the MP-MRI-based diagnostic pathway to improve the rate of detection of clinically significant cancer as compared to transrectal ultrasound (TRUS) biopsy.

* To estimate the cost-effectiveness of an MP-MRI based diagnostic pathway.

OUTLINE: This is a multicenter study.

Patients undergo multiparametric magnetic resonance imaging (MRI) (T2-weighted imaging, diffusion-weighted MRI, and dynamic contrast-enhanced MRI) followed by template prostate mapping and transrectal ultrasound biopsy.

Some patients may undergo blood, urine, and tissue sample collection periodically for biomarker studies. Samples are banked for future research analysis.

Patients complete a quality-of-life questionnaire (EQ-5D) at baseline, during, and after completion of study. An economic analysis will be performed for cost-effectiveness.

After completion of study intervention, patients are followed up periodically.

Study Timeline

• Study First Submitted: 2011-02-08
• Study First Submitted QC: 2011-02-08
• Study First Posted: 2011-02-09
• Study Start: 2011-04
• Status Verified: 2011-09
• Primary Completion: 2013-04
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 714

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of multiparametric magnetic resonance imaging (MP-MRI)
Recruitment
Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values
Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values

Secondary Outcome Measures

Name	Time	Method
Proportion of men who could safely avoid biopsy
Proportion of men testing positive on MP-MRI
Performance characteristics of TRUS versus template prostate mapping (TPM)
Evaluation of the optimal combination of MP-MRI functional parameters
Intra-observer variability in the reporting of MP-MRI
Evaluation of socio-demographic, clinical, imaging and radiological variables in relation to the detection of clinically significant prostate cancer
Health-related quality of life using the EQ-5D questionnaire
Resource use and costs for further economic evaluation
Translational research