PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University College London Hospitals
- Enrollment
- 714
- Primary Endpoint
- Safety of multiparametric magnetic resonance imaging (MP-MRI)
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- 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