MRI in Diagnosing Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Men at risk of prostate cancer who have been advised to have a prostate biopsy Suspected stage ≤ T2 on rectal examination (organ confined) Serum PSA ≤ 15 ng/mL within the past 3 months PATIENT CHARACTERISTICS: Fit for general/spinal anesthesia Fit to undergo all protocol procedures including a transrectal ultrasound No evidence of a urinary tract infection or history of acute prostatitis within the past 3 months No contraindication to MRI (e.g., claustrophobia, pacemaker, or estimated GFR ≤ 50) No other medical condition precluding procedures described in the protocol PRIOR CONCURRENT THERAPY: No prior prostate biopsy, prostate surgery, or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction are acceptable) No prior hip replacement surgery
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: biologic sample preservation procedure|nan|
|Other: laboratory biomarker analysis|nan|
|Other: study of socioeconomic and demographic variables|nan|
|Procedure: diffusion-weighted magnetic resonance imaging|nan|
|Procedure: dynamic contrast-enhanced magnetic resonance imaging|nan|
|Procedure: multiparametric magnetic resonance imaging|nan|
|Procedure: quality-of-life assessment|nan|
|Procedure: transperineal prostate biopsy|nan|
|Procedure: transrectal prostate biopsy|nan|
|Procedure: ultrasound-guided prostate biopsy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer