Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach
- Conditions
- Prostate Cancer
- Interventions
- Other: MRI examination
- Registration Number
- NCT01138527
- Lead Sponsor
- Radboud University Medical Center
- 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.
- 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:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 148
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Biopsy-proven prostate cancer MRI examination Patients with biopsy-proven prostate cancer, planned for radical prostatectomy
- Primary Outcome Measures
Name Time Method Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate December 2015
- Secondary Outcome Measures
Name Time Method Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer december 2015
Trial Locations
- Locations (9)
Johns Hopkins Medical Institutions
🇺🇸Baltimore, Maryland, United States
Norwegian University of Science and Technology
🇳🇴Trondheim, Norway
Medical University Vienna
🇦🇹Vienna, Austria
Ghent University Hospita
🇧🇪Ghent, Belgium
University Health Network, Princess Margaret Hospital
🇨🇦Toronto, Canada
Mount Vernon Hospital, Paul Strickland Scanner Centre
🇬🇧London, United Kingdom
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
University Medical Center Mannheim, Heidelberg University
🇩🇪Mannheim, Germany
Radboud University Nijmegen Medical Centre
🇳🇱Nijmegen, Netherlands