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Clinical Management Decisions for Recurrent Prostate Cancer Patients Based on [11C]Acetate PET Scan

Expanded access is currently available for this treatment.
Verified January 2013 by University of Kansas
Sponsor:
Collaborator:
University of Kansas
Information provided by (Responsible Party):
Reginald Dusing, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01777061
First received: January 17, 2013
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

When evaluating prostate cancer patients for recurrent disease, computed tomography (CT), and magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph nodes, but are not specific as to whether the lymph nodes are malignant or benign.

While positron emission tomography (PET) utilizing radioactive glucose (FDG) has revolutionized staging, restaging, and monitoring response to therapy in many prevalent cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma, findings with prostate cancer have proven less sensitive because prostate cancer has a lower avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in detecting prostate cancer.

This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in identifying recurrent prostate cancer.


Condition Intervention Phase
Prostate Cancer
 Drug: [11C]Acetate
 Phase 3

Study Type: Expanded Access     What is Expanded Access?
Official Title: Clinical Management Decisions Based on [11C]Acetate Positron Emission Tomography Performed on Prostate Cancer Patients With Biochemical Recurrence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: [11C]Acetate
    intravenous injection of an average of 40 mCi of [11C]Acetate
    Other Names:
    • carbon-11 acetate [[11C]acetate]
    • sodium acetate [11C]Acetate injection
Detailed Description:

FDG-PET imaging uses a form of radioactive glucose (18-fluoro-deoxyglucose or FDG), which allows the measurement of glucose metabolic rate of any tissue in the body. The most prevalent tumors have a glucose avidity that is typically greater than 2.5 times the avidity of benign tissue. Therefore, FDG-PET is able to discriminate between benign lymph nodes and those containing metastases, and similarly between scar tissue and recurrence of tumor.

Unfortunately, prostate cancer is only minimally glucose avid, and therefore, FDG-PET is much less effective in staging prostate cancer. The current FDA-approved imaging agent for prostate cancer is a monoclonal antibody specific for prostate cancer cells, capromab pendetide, labeled with a long-lived radionuclide [111]Indium that is used to image the patient over a six day period. However, recent data show that another PET radiopharmaceutical, [11C]Acetate (which has been FDA approved for years for cardiac imaging), is avidly taken up by prostate metastasis and is more sensitive than either [111]Indium capromab pendetide or FDG-PET.

This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in identifying recurrent prostate cancer and aim to find at what PSA levels it is most effective.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive for recurrent prostate cancer by PSA criteria
  • Recurrence definition:
  • Status post-operative radical prostatectomy, recurrence is defined by a PSA of greater than or equal to 0.2 ng/ml
  • Patients who have failed external beam radiation, or status post-brachytherapy, have recurrence as defined as PSA above 2.0 ng/ml the nadir PSA after treatment
  • Subject is able to comprehend the study objectives and provide written informed consent before the initiation of any study-related procedures.

Exclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) status of ≥ 2
  • Any other concurrent malignancy
  • Patients without remission of disease (no PSA decrease)
  • Patients without recurrence of disease (PSA remains low)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777061

Contacts
Contact: Chris McMillin 913-588-6815 cmcmilli@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Contact: Chris McMillin     913-588-6815     cmcmilli@kumc.edu    
Principal Investigator: Reginald Dusing, MD            
Sponsors and Collaborators
Reginald Dusing, MD
University of Kansas
Investigators
Principal Investigator: Reginald Dusing, MD University of Kansas
  More Information

No publications provided

Responsible Party: Reginald Dusing, MD, Director, Division of Nuclear Medicine, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01777061     History of Changes
Other Study ID Numbers: 13429
Study First Received: January 17, 2013
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Kansas:
Prostate Cancer
Recurrent Prostate Cancer
PET Scan
 FDG-PET
[11C]Acetate
C11-Acetate

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

ClinicalTrials.gov processed this record on May 16, 2013