Prostate Cancer Clinical Trial
Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach
Summary
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.
Full Description
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.
Eligibility Criteria
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.
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There are 3 Locations for this study
Los Angeles California, 90095, United States
Baltimore Maryland, 21287, United States
Vienna , , Austria
Ghent , , Belgium
Toronto , , Canada
Mannheim , , Germany
Nijmegen , 6525G, Netherlands
Trondheim , , Norway
London , , United Kingdom
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