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| Name | Class |
|---|---|
| Siemens AG | INDUSTRY |
| Mount Vernon Hospital | OTHER |
| Multi-Imagem and CDPI, Rio de Janeiro, Brasil | UNKNOWN |
| Norwegian University of Science and Technology |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy-proven prostate cancer | Patients with biopsy-proven prostate cancer, planned for radical prostatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI examination | Other | 45-minute MRI examination of the prostate and surrounding tissues with T2-weighted MRI, diffusion-weighted MRI, Spectroscopic Imaging and dynamic contrast enhanced imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate | December 2015 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer | december 2015 |
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Inclusion Criteria:
Exclusion Criteria:
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Biopsy-proven patients with prostate cancer, planned for radical prostatectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Tom W Scheenen, PhD | Radiology, Radboud University Nijmegen Medical Centre | Principal Investigator |
| Jurgen J Fütterer, MD PhD | Radiology, Radboud University Nijmegen Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | United States | ||
| Johns Hopkins Medical Institutions |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| OTHER |
| University of California, Los Angeles | OTHER |
| University Hospital, Ghent | OTHER |
| Johns Hopkins University | OTHER |
| Medical University of Vienna | OTHER |
| University Health Network, Toronto | OTHER |
| Heidelberg University | OTHER |
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fixed histopathology slides of resected prostates at local institutions: Not different from clinical routine
| 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 | 6525GA | Netherlands |
| Norwegian University of Science and Technology | Trondheim | Norway |
| Mount Vernon Hospital, Paul Strickland Scanner Centre | London | United Kingdom |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |