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.

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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.

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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.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

148

Study ID:

NCT01138527

Recruitment Status:

Completed

Sponsor:

Radboud University Medical Center

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There are 3 Locations for this study

See Locations Near You

David Geffen School of Medicine at UCLA
Los Angeles California, 90095, United States
Johns Hopkins Medical Institutions
Baltimore Maryland, 21287, United States
Medical University Vienna
Vienna , , Austria
Ghent University Hospita
Ghent , , Belgium
University Health Network, Princess Margaret Hospital
Toronto , , Canada
University Medical Center Mannheim, Heidelberg University
Mannheim , , Germany
Radboud University Nijmegen Medical Centre
Nijmegen , 6525G, Netherlands
Norwegian University of Science and Technology
Trondheim , , Norway
Mount Vernon Hospital, Paul Strickland Scanner Centre
London , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

148

Study ID:

NCT01138527

Recruitment Status:

Completed

Sponsor:


Radboud University Medical Center

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