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Comprehensive Prostate MRI for the Evaluation of Prostate Cancer at 3.0T: A Pilot Study

18 Years
Not Enrolling
Prostatic Neoplasms

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Trial Information

Comprehensive Prostate MRI for the Evaluation of Prostate Cancer at 3.0T: A Pilot Study

Progress in effective local therapy of prostate cancer has been stymied by the lack of an
imaging technique capable of reliably identifying the location of cancer within the
prostate. Magnetic Resonance Imaging is a promising candidate for imaging the prostate
because of its high soft tissue contrast, multiplanar capabilities, and the potential for
providing unique biologic information not available with other modalities. In addition to
conventional T2-weighted imaging MRI techniques that provide unique biologic information
include MR spectroscopy, diffusion weighted MRI, dynamic enhanced MRI and hypoxia imaging.
All have shown promise in imaging tumors at a magnetic field strength of 1.5 Tesla but all
have been limited by sensitivity. Since MR signal is proportional to magnetic field
strength, 3.0 Tesla clinical systems potentially could improve overall diagnostic accuracy.
A comprehensive imaging package which incorporates all these techniques to study prostate
cancer on a state-of-the-art 3.0 Tesla magnet has not yet been developed.

In this pilot study we seek to develop and evaluate a comprehensive prostate MR exam at 3.0
Tesla. Patients with biopsy proven prostate cancer will undergo an MRI with endorectal and
surface phased array coils which will include conventional sequences, MR spectroscopy,
Diffusion weighted MRI, Dynamic enhanced MR and Hypoxia imaging. In the development phase
of this trial (30 patients), the robustness of the techniques and test-retest
reproducibility will be evaluated. In the second phase, the comprehensive prostate MRI exam
will be validated against the results of prostate biopsy (50 patients). The expected
accrual period is two years. We hope that this method will offer prostate cancer patients a
more accurate method of localizing their prostate cancer than is now possible which should
improve outcomes and minimize complications of treatment.

Inclusion Criteria


Recent transrectal biopsy of the prostate gland in which at least sextant biopsies were
obtained. Knowledge of the location of each specimen is required for inclusion.

Age greater than or equal to18 years.

ECOG performance status of 0 or 1.

Informed consent: All patients must sign a document of informed consent indicating their
understanding of the investigational nature and risks of the study before any protocol
related studies are performed.


Patients with contraindication to endorectal coil placement.

- Bleeding disorder documented by history.

- Severe immunocompromise documented by history.

- PT/PTT greater than 1.5 times the upper limit of normal.

- Platelets less than 50K.

- Artificial heart valve.

- Severe hemorrhoids.

- Surgically absent rectum.

Patients with contraindications to MRI.

- Patients weighing greater than 136 kg (weight limit for scanner table).

- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or other
implanted electronic devices not compatible with MRI.

Patients with contraindications to prostate biopsy.

- See above contraindications for endorectal coil placement.

- Previous severe adverse event with prostatic biopsies.

Patients with distant metastatic disease.

Patients with a prior history of pelvic or prostate radiotherapy.

Patient with a prior history of androgen ablative hormonal therapy (orchiectomy, LHRH
analogues, anti-androgens).

Cognitively impaired patients who cannot give informed consent.

Other medical conditions deemed by the PI or associates to make the patient ineligible for
protocol procedures.

Type of Study:


Study Design:



United States: Federal Government

Study ID:




Start Date:

February 2004

Completion Date:

September 2007

Related Keywords:

  • Prostatic Neoplasms
  • Prostate Cancer
  • Magnetic Resonance Imaging
  • Spectroscopy
  • Neoplasms
  • Prostatic Neoplasms



National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892