Protocol Number: 04-CC-0109

Title:

Comprehensive Prostate MRI for the Evaluation of Prostate Cancer at 3:OT: A Pilot Study

Number:

04-CC-0109

Summary:

This study will determine whether scanning the prostate using special magnetic resonance imaging (MRI) techniques can detect prostate cancers with greater accuracy than other methods. MRI uses a strong magnet and radio waves to produce images of body tissues. Unlike many cancers, prostate cancer is difficult to see on most imaging studies like x-rays, computed tomography (CT) scans, and conventional MRI scans. This study will use a magnet twice as strong as the magnets commonly used in MRI tests.

Patients 18 years of age and older with prostate cancer confirmed by prostate biopsy may be eligible for this study. Candidates are screened with a medical history, physical examination, and review of pathology reports.

Participants undergo MRI of the prostate and possibly a biopsy of the prostate gland, as follows:

Prostate MRI

Before coming to the NIH Clinical Center for the biopsy, patients take a Fleets enema to empty the rectum of fecal matter. For the MRI, an endorectal coil (a tube containing a specially designed antenna) is placed in the rectum, which is just behind the prostate. The coil increases the amount of signal received by the MRI unit. Additional coils may be wrapped around the pelvis to further improve the quality of the scan. The patient lies on a stretcher that moves into the scanner. A catheter (plastic tube) is placed in an arm vein for injection of a contrast agent called gadolinium, which brightens the images. Patients may also be asked to breathe an oxygen-rich gas through a mask during the scan to test the use of oxygen as a contrast agent in MRI. Patients may be asked to repeat the MRI to test the reproducibility of the procedure. The repeat test is optional.

Prostate Biopsy

Depending on the MRI findings, patients may be asked to undergo a prostate biopsy to obtain a sample of tumor tissue. The tissue is obtained with a needle placed through the rectum. Medicines may be used to reduce pain during the biopsy and to reduce the chance of infection.

Sponsoring Institute:

Warren G. Magnuson Clinical Center (CC)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male

Referral Letter Required: No

Population Exclusion(s): Female

Eligibility Criteria:

INCLUSION CRITERIA:

Pathologically confirmed adenocarcinoma of the prostate gland based on a prostate biopsy 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.

EXCLUSION CRITERIA:

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.

Special Instructions: Currently Not Provided

Keywords:

Prostate Cancer

Magnetic Resonance Imaging

Spectroscopy

Recruitment Keywords:

Prostate Cancer

Conditions:

Prostatic Neoplasms

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Barentsz JO, Engelbrecht M, Jager GJ, Witjes JA, de LaRosette J, van Der Sanden BP, Huisman HJ, Heerschap A. Fast dynamic gadolinium-enhanced MR imaging of urinary bladder and prostate cancer. J Magn Reson Imaging. 1999 Sep;10(3):295-304. Review. PMID: 10508289

el-Gabry EA, Halpern EJ, Strup SE, Gomella LG. Imaging prostate cancer: current and future applications. Oncology (Huntingt). 2001 Mar;15(3):325-36; discussion 339-42. Review. PMID: 11301831

Gibbs P, Tozer DJ, Liney GP, Turnbull LW. Comparison of quantitative T2 mapping and diffusion-weighted imaging in the normal and pathologic prostate. Magn Reson Med. 2001 Dec;46(6):1054-8. PMID: 11746568

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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