This trial is active, not recruiting.

Condition prostate cancer
Treatment mri examination
Sponsor Radboud University
Collaborator Siemens AG
Start date June 2010
End date August 2015
Trial size 150 participants
Trial identifier NCT01138527, RU PCa-MAP


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients with biopsy-proven prostate cancer, planned for radical prostatectomy
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

Primary Outcomes

Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate
time frame: December 2015

Secondary Outcomes

Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer
time frame: december 2015

Eligibility Criteria

Male participants of any age.

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.

Additional Information

Official title Prostate Cancer Localization With a Multiparametric MR Approach
Principal investigator Tom W Scheenen, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Radboud University.