Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach

Status:	Active, not recruiting
Conditions:	Prostate Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	4/21/2016
Start Date:	June 2010
End Date:	December 2016

Prostate Cancer Localization With a Multiparametric MR Approach

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:

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.

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.

We found this trial at

sites

Johns Hopkins Medical Institutions

Baltimore, Maryland 21287

from

Baltimore, MD