Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer

This study has been completed.
Information provided by (Responsible Party):
Peter Choyke, M.D., National Institutes of Health Clinical Center (CC) Identifier:
First received: June 17, 2009
Last updated: October 13, 2015
Last verified: October 2015


  • 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.


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


  • Patients 18 years of age and older who are undergoing surgery for localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.


  • Patients have a positron emission tomography (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 magnetic resonance (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 intravenous (IV) line to brighten the images.

Condition Intervention Phase
Prostate Cancer
Drug: (C-11 Acetate)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official 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

Resource links provided by NLM:

Further study details as provided by Peter Choyke, M.D., National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate [ Time Frame: 2 years ]
    Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test.

Secondary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 2 years ]
    Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

Enrollment: 40
Study Start Date: September 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 11C-acetate for Prostate Cancer Patients
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Drug: (C-11 Acetate)
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
  • Participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the National Institutes of Health (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 magnetic resonance (MR) imaging less than or equal to 1.8mg/dl AND epidermal growth factor receptor (eGFR) must be greater than 30 ml/min/1.73 m^2
  • Eastern Cooperative Oncology Group (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.


  • 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 magnetic resonance imaging (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 principal investigator (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00924313

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Peter L Choyke, M.D. National Cancer Institute, National Institutes of Health
  More Information

Responsible Party: Peter Choyke, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC) Identifier: NCT00924313     History of Changes
Obsolete Identifiers: NCT00771550
Other Study ID Numbers: 080226
Study First Received: June 17, 2009
Results First Received: July 12, 2012
Last Updated: October 13, 2015

Keywords provided by Peter Choyke, M.D., National Institutes of Health Clinical Center (CC):
Prostate Cancer
C-11 Acetate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on May 25, 2017