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Prostate Cancer Localization With a Multiparametric MR Approach


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Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Prostate Cancer Localization With a Multiparametric MR Approach


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Tom W Scheenen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiology, Radboud University Nijmegen Medical Centre

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

RU PCa-MAP

NCT ID:

NCT01138527

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • multi-parametric MRI approach
  • Prostatic Neoplasms

Name

Location

David Geffen School of Medicine at UCLALos Angeles, California  90095
Johns Hopkins Medical InstitutionsBaltimore, Maryland  21205