Status:
COMPLETED
Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Siemens AG
Mount Vernon Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
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...
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 T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01138527
Start Date
June 1 2010
End Date
July 1 2019
Last Update
May 13 2021
Active Locations (9)
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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