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

Radboud University Medical Center

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: MRI examination

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01138527

RU PCa-MAP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

148 participants in 1 patient group

Biopsy-proven prostate cancer

Description:

Patients with biopsy-proven prostate cancer, planned for radical prostatectomy

Treatment:

Other: MRI examination