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Brief Title: MRI in Diagnosing Prostate Cancer
Official Title: PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer
Study ID: NCT01292291
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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Name: Mark Emberton, MD, FRCS, MBBS
Affiliation: University College London Hospitals
Role: PRINCIPAL_INVESTIGATOR