Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach

Study Overview
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Brief Summary
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The primary objective of this prospective multi-centre study is to prove the diagnostic accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other prostate tissue. The gold standard for distinguishing the tissue types is the analysis of whole-mount sections of the resected prostate by a genitourinary histopathologist.

Detailed Description
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Goal Proving that multi-parametric MR imaging in a multi-centre setting allows for localizing clinically significant (volume > 0.5cc; Gleason > 6) prostate carcinoma in the prostate. Objective 1 To determine the diagnostic accuracy (area under the receiver-operating characteristic curve) of 3-Tesla multi-modality non-endorectal coil (ERC) MR imaging in localizing prostate cancer, by correlating: focal areas of low signal intensity on T2-weighted images; the extent and degree of deviating metabolite ratios derived from MRSI. This can be the choline+creatine/citrate ratio or if possible, the choline / citrate ratio; the extent and degree of apparent diffusion coefficient reduction on DWI; the extent and degree of perfusion abnormality on DCE-MRI; with the presence or absence of cancer at (reconstructed) whole mount section histopathology. Objective 2 Proving that multi-modality MR data allows for predicting tumor grade. The parameters from the different MR methods for a tumor focus can be correlated to the local Gleason grade of the corresponding lesion in the histopathological specimens.

Official Title
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Prostate Cancer Localization With a Multiparametric MR Approach

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: MRI examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-proven diagnosis of adenocarcinoma of the prostate Subject will sign a consent form prior to study entry Radical prostatectomy and histopathological exam planned The time interval between last biopsy and the MR exam must be at least 4 weeks The time interval between MR exam and radical prostatectomy should not exceed 12 weeks Exclusion Criteria: Subjects who are unable to give valid informed consent Subjects who are unwilling or unable to undergo an MR exam, including subjects with contra-indications to MR exams Therapy or surgical procedure applied to the prostate or to other organs in vicinity to the prostate: among the therapies preventing inclusion are any form of radiation therapy, cryo-therapy, thermal-therapy, therapy based on any other medication (including hormonal therapy). Patients under hormone deprivation therapy.
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biopsy-proven prostate cancer<br>Patients with biopsy-proven prostate cancer, planned for radical prostatectomy | Other: MRI examination<br>* 45-minute MRI examination of the prostate and surrounding tissues with T2-weighted MRI, diffusion-weighted MRI, Spectroscopic Imaging and dynamic contrast enhanced imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate |  | December 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer |  | december 2015 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multi-parametric MRI approach