Clinical Management Decisions for Recurrent Prostate Cancer Patients Based on [11C]Acetate PET Scan
Primary Purpose
Prostate Cancer
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
[11C]Acetate
Sponsored by
About this trial
This is an expanded access trial for Prostate Cancer focused on measuring Prostate Cancer, Recurrent Prostate Cancer, PET Scan, FDG-PET, [11C]Acetate, C11-Acetate
Eligibility 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)
Sites / Locations
- University of Kansas Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01777061
First Posted
January 17, 2013
Last Updated
May 10, 2018
Sponsor
Wendell Yap, MD
Collaborators
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01777061
Brief Title
Clinical Management Decisions for Recurrent Prostate Cancer Patients Based on [11C]Acetate PET Scan
Official Title
Clinical Management Decisions Based on [11C]Acetate Positron Emission Tomography Performed on Prostate Cancer Patients With Biochemical Recurrence
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wendell Yap, MD
Collaborators
University of Kansas Medical Center
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Recurrent Prostate Cancer, PET Scan, FDG-PET, [11C]Acetate, C11-Acetate
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
[11C]Acetate
Other Intervention Name(s)
carbon-11 acetate [[11C]acetate], sodium acetate [11C]Acetate injection
Intervention Description
intravenous injection of an average of 40 mCi of [11C]Acetate
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendell Yap, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Management Decisions for Recurrent Prostate Cancer Patients Based on [11C]Acetate PET Scan
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