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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 October 2017 by Wendell Yap, MD, University of Kansas Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777061
First Posted: January 28, 2013
Last Update Posted: October 18, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Kansas Medical Center
Information provided by (Responsible Party):
Wendell Yap, MD, University of Kansas Medical Center
  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
Prostate Cancer Drug: [11C]Acetate

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:


Further study details as provided by Wendell Yap, MD, University of Kansas Medical Center:

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

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes 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
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): NCT01777061


Contacts
Contact: Angela Barton, MS 913-588-6815 radiologyresearch@kumc.edu
Contact: Rosanne Hoover 913-588-6815 radiologyresearch@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Contact: Angela Barton, MS    913-588-6815    radiologyresearch@kumc.edu   
Contact: Rosanne Hoover    913-588-6815    radiologyresearch@kumc.edu   
Principal Investigator: Wendell Yap, MD         
Sponsors and Collaborators
Wendell Yap, MD
University of Kansas Medical Center
Investigators
Principal Investigator: Wendell Yap, MD University of Kansas Medical Center
  More Information

Responsible Party: Wendell Yap, MD, Assistant Professor, Department of Radiology, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01777061     History of Changes
Other Study ID Numbers: 13429
First Submitted: January 17, 2013
First Posted: January 28, 2013
Last Update Posted: October 18, 2017
Last Verified: October 2017

Keywords provided by Wendell Yap, MD, University of Kansas Medical Center:
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