Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach
This trial is active, not recruiting.
|Start date||June 2010|
|End date||August 2015|
|Trial size||150 participants|
|Trial identifier||NCT01138527, RU PCa-MAP|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Los Angeles, CA||David Geffen School of Medicine at UCLA||no longer recruiting|
|Baltimore, MD||Johns Hopkins Medical Institutions||no longer recruiting|
|Vienna, Austria||Medical University Vienna||no longer recruiting|
|Ghent, Belgium||Ghent University Hospita||no longer recruiting|
|Toronto, Canada||University Health Network, Princess Margaret Hospital||no longer recruiting|
|Mannheim, Germany||University Medical Center Mannheim, Heidelberg University||no longer recruiting|
|Nijmegen, Netherlands||Radboud University Nijmegen Medical Centre||no longer recruiting|
|Trondheim, Norway||Norwegian University of Science and Technology||no longer recruiting|
|London, United Kingdom||Mount Vernon Hospital, Paul Strickland Scanner Centre||no longer recruiting|
Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate
time frame: December 2015
Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer
time frame: december 2015
Male participants of any age.
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.
|Official title||Prostate Cancer Localization With a Multiparametric MR Approach|
|Principal investigator||Tom W Scheenen, PhD|
|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: 1. focal areas of low signal intensity on T2-weighted images; 2. 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; 3. the extent and degree of apparent diffusion coefficient reduction on DWI; 4. 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.|
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