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Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00924313
First Posted: June 18, 2009
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter Choyke, M.D., National Institutes of Health Clinical Center (CC)
  Purpose

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 National Institutes of Health (NIH) Clinical Center.

Design:

  • 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: None (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:
  • Count 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.

  • Diagnostic Accuracy of the Standardized Uptake Value of [11C]AC Obtained Using Positron Emission Tomography (PET)/Computed Tomography (CT) for Detecting Region (Sextant)-Specific Malignancy Using Receiver Operating Curves (ROC) for a Lesion >0.9cm [ Time Frame: 2 years ]
    The diagnostic accuracy of 11C-Acetate PET/CT imaging in prostate cancer was compared with multi-parametric magnetic resonance imaging (MP-MRI) using sector based analysis, generating receiver-operating-characteristic (ROC) curves (plots of 1-specificity versus sensitivity) for both modalities.

  • Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging [ Time Frame: 2 years ]
    Pelvic biodistribution was obtained for the prostate tumor, normal prostate and benign prostatic hyperplasia (BPH). Uptake is expressed in standardized uptake value (SUV).

  • Count of Participants With Physiological Effects of [11C]AC [ Time Frame: 2 years ]
    Buildup of positron emission tomography (PET) radiopharmaceuticals excreted by the urinary system can accumulate in the bladder and limit pelvic imaging. This effect contributes to low physiologic distribution in the pelvis.

  • Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection [ Time Frame: 2 years ]
    Suspicious lesions noted on biopsy were compared with standard care imaging diagnostic modalities, additional biopsies, and/or clinical follow up performed at the discretion of the referring physician.

  • Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score [ Time Frame: 2 years ]
    Intensity [11C]AC uptake with histopathologic Gleason grade were done with a Spearman rank correlation following prostatectomy. Two biopsies were performed and graded according to tumor pattern. The two grades were added together for a final Gleason score. Gleason score equal to or less than 3+4 is considered low risk. Gleason score equal to or greater than 4+3 is considered high-risk.

  • Lesion Based Sensitivity Analysis Using Positron Emission Tomography (PET)/Computed Tomography (CT), Multi-parametric Magnetic Resonance Imaging (MP-MRI), Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI), and DCE-MRI. [ Time Frame: 2 years ]
    PET/CT, MP-MRI, DW-MRI, and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) were used to detect lesion sensitivity.

  • 11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation [ Time Frame: 2 years ]
    Tumor foci was histopathologically identified and tested to determine SUVmax relative to PSA levels. PSA normal range is 0-4ng/mL.


Enrollment: 40
Actual Study Start Date: September 10, 2008
Study Completion Date: April 19, 2011
Primary Completion Date: April 19, 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:  
  • 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.
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • 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.

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 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924313


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

Publications:
Responsible Party: Peter Choyke, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00924313     History of Changes
Obsolete Identifiers: NCT00771550
Other Study ID Numbers: 080226
08-C-0226
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: July 12, 2012
Results First Posted: August 17, 2012
Last Update Posted: July 11, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases