NCT01292291

MRI in Diagnosing Prostate Cancer

PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 714 (estimated)
• Sponsor: University College London Hospitals · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	biologic sample preservation procedure
OTHER	laboratory biomarker analysis
OTHER	study of socioeconomic and demographic variables
PROCEDURE	diffusion-weighted magnetic resonance imaging
PROCEDURE	dynamic contrast-enhanced magnetic resonance imaging
PROCEDURE	multiparametric magnetic resonance imaging
PROCEDURE	quality-of-life assessment
PROCEDURE	transperineal prostate biopsy
PROCEDURE	transrectal prostate biopsy
PROCEDURE	ultrasound-guided prostate biopsy

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-04-01
• First posted: 2011-02-09
• Last updated: 2013-08-07