MRI in Diagnosing Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01292291|
Recruitment Status : Unknown
Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was: Not yet recruiting
First Posted : February 9, 2011
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||714 participants|
|Official Title:||PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||April 2013|
- Safety of multiparametric magnetic resonance imaging (MP-MRI)
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292291
|Principal Investigator:||Mark Emberton, MD, FRCS, MBBS||University College London Hospitals|