PCa-MAP: Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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:
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focal areas of low signal intensity on T2-weighted images;
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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;
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the extent and degree of apparent diffusion coefficient reduction on DWI;
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Biopsy-proven prostate cancer Patients with biopsy-proven prostate cancer, planned for radical prostatectomy |
Other: MRI examination
45-minute MRI examination of the prostate and surrounding tissues with T2-weighted MRI, diffusion-weighted MRI, Spectroscopic Imaging and dynamic contrast enhanced imaging
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Outcome Measures
Primary Outcome Measures
- Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate [December 2015]
Secondary Outcome Measures
- Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer [december 2015]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Biopsy-proven diagnosis of adenocarcinoma of the prostate
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Subject will sign a consent form prior to study entry
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Radical prostatectomy and histopathological exam planned
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The time interval between last biopsy and the MR exam must be at least 4 weeks
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The time interval between MR exam and radical prostatectomy should not exceed 12 weeks
Exclusion Criteria:
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Subjects who are unable to give valid informed consent
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Subjects who are unwilling or unable to undergo an MR exam, including subjects with contra-indications to MR exams
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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).
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Patients under hormone deprivation therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | David Geffen School of Medicine at UCLA | Los Angeles | California | United States | 90095 |
| 2 | Johns Hopkins Medical Institutions | Baltimore | Maryland | United States | 21287 |
| 3 | Medical University Vienna | Vienna | Austria | ||
| 4 | Ghent University Hospita | Ghent | Belgium | ||
| 5 | University Health Network, Princess Margaret Hospital | Toronto | Canada | ||
| 6 | University Medical Center Mannheim, Heidelberg University | Mannheim | Germany | ||
| 7 | Radboud University Nijmegen Medical Centre | Nijmegen | Netherlands | 6525GA | |
| 8 | Norwegian University of Science and Technology | Trondheim | Norway | ||
| 9 | Mount Vernon Hospital, Paul Strickland Scanner Centre | London | United Kingdom |
Sponsors and Collaborators
- Radboud University Medical Center
- Siemens AG
- Mount Vernon Hospital
- Multi-Imagem and CDPI, Rio de Janeiro, Brasil
- Norwegian University of Science and Technology
- University of California, Los Angeles
- University Hospital, Ghent
- Johns Hopkins University
- Medical University of Vienna
- University Health Network, Toronto
- Heidelberg University
Investigators
- Principal Investigator: Tom W Scheenen, PhD, Radiology, Radboud University Nijmegen Medical Centre
- Principal Investigator: Jurgen J Fütterer, MD PhD, Radiology, Radboud University Nijmegen Medical Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RU PCa-MAP