MRI in Diagnosing Prostate Cancer
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.
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
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer|
- Safety of multiparametric magnetic resonance imaging (MP-MRI) [ Designated as safety issue: Yes ]
- Recruitment [ Designated as safety issue: No ]
- Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values [ Designated as safety issue: Yes ]
- Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values [ Designated as safety issue: No ]
- Proportion of men who could safely avoid biopsy [ Designated as safety issue: Yes ]
- Proportion of men testing positive on MP-MRI [ Designated as safety issue: No ]
- Performance characteristics of TRUS versus template prostate mapping (TPM) [ Designated as safety issue: No ]
- Evaluation of the optimal combination of MP-MRI functional parameters [ Designated as safety issue: No ]
- Intra-observer variability in the reporting of MP-MRI [ Designated as safety issue: No ]
- Evaluation of socio-demographic, clinical, imaging and radiological variables in relation to the detection of clinically significant prostate cancer [ Designated as safety issue: No ]
- Health-related quality of life using the EQ-5D questionnaire [ Designated as safety issue: No ]
- Resource use and costs for further economic evaluation [ Designated as safety issue: No ]
- Translational research [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
- 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.