Protocol Number: 08-C-0226

Title:

A Pilot Study of 11C-Acetate Positron Emission Tomography (PET) and 3 Telsa Magnetic Resonance Imaging (MRI) in Men with Prostate Cancer Undergoing Prostatectomy

Number:

08-C-0226

Summary:

Background:

- Prostate cancers are difficult to see on most imaging studies such as X-rays, computed tomography (CT) scans, conventional magnetic resonance imaging (MRI) scans and conventional positron emission tomography (PET) scans.

- An experimental radioactive tracer called 11C-acetate accumulates in prostate tumor cells and may help find prostate cancers more accurately than other imaging methods.

Objectives:

- To determine the accuracy of prostate tumor imaging using the tracer 11C-acetate.

Eligibility:

- Patients 18 years of age and older who are undergoing surgery for localized prostate cancer at the NIH Clinical Center.

Design:

- Patients have a PET scan. For this test, an intravenous (IV) line is placed in the patient's arm and the patient lies on a table inside the donut shaped scanner. (11)C-acetate is injected into the vein through the catheter and images of the lower pelvis and abdomen are obtained over 30 minutes.

- Patients have an endorectal coil MRI scan. For this test, a tube is placed in the rectum, just behind the prostate, to increase the amount of signal received by the MR unit. Other coils may be wrapped around the pelvis to further improve the quality of the scan. The patient lies on the scanning table for about 75 to 90 minutes while images are obtained. During the scan, a contrast agent called gadolinium is injected through an IV line to brighten the images.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male

Referral Letter Required: No

Population Exclusion(s): Female

Children

Eligibility Criteria:

INCLUSION CRITERIA:

- Participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center.

- Recent (within 12 months of study entry) trans-rectal biopsy indicating the presence of adenocarcinoma of the prostate gland in which at least sextant biopsies were obtained. Knowledge of the location of each specimen is required for inclusion.

- Participant must be 18 years or older.

- Serum creatinine within 1 week prior to MR imaging less than or equal to 1.8mg/dl AND eGFR must be greater than 30 ml/min/1.73(m2)

- ECOG Performance score of 0 or 1.

- Ability to provide 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:

- Known allergy to gadolinium or acetate.

- Participants for whom participating would significantly delay the scheduled standard of care therapy.

- Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded.

- Participants with severe claustrophobia.

- 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 or metal not compatible with MRI.

- Patients with contraindication to endorectal coil placement

- Severe hemorrhoids.

- Surgically absent rectum.

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

- Patients who have previously received radiation therapy to the pelvis.

- Patients who have received androgen deprivation therapy.

Special Instructions:

Currently Not Provided

Keywords:

Prostate Cancer

MRI

C-11 Acetate

PET

Recruitment Keyword(s):

Prostate Cancer

Condition(s):

Prostate Cancer

Investigational Drug(s):

(C-11 Acetate)

Investigational Device(s):

None

Intervention(s):

Drug: (C-11 Acetate)

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Oyama N, Miller TR, Dehdashti F, Siegel BA, Fischer KC, Michalski JM, Kibel AS, Andriole GL, Picus J, Welch MJ. 11C-acetate PET imaging of prostate cancer: detection of recurrent disease at PSA relapse.J Nucl Med. 2003 Apr;44(4):549-55.

Qayyum A, Coakley FV, Lu Y, Olpin JD, Wu L, Yeh BM, Carroll PR, Kurhanewicz J. Organ-confined prostate cancer: effect of prior transrectal biopsy on endorectal MRI and MR spectroscopic imaging.AJR Am J Roentgenol. 2004 Oct;183(4):1079-83.

Jung JA, Coakley FV, Vigneron DB, Swanson MG, Qayyum A, Weinberg V, Jones KD, Carroll PR, Kurhanewicz J. Prostate depiction at endorectal MR spectroscopic imaging: investigation of a standardized evaluation system. Radiology. 2004 Dec;233(3):701-8.

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