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Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease planning to undergo Ra-223 therapy may be eligible for this study. Positron emission tomography (PET/CT) imaging will use the investigational radiotracer [11C]acetate. Imaging will occur prior to Ra-223 therapy and after 2 cycles, in addition to standard of care 99mTcMDP bone scan at baseline and a research 99mTc-MDP bone scan post-therapy
Our proposed study aims to use 11C-acetate PET/CT for evaluation of treatment response to Ra-223 dichrolide therapy. 11C-acetate has been shown to have superior detection of osseous and non-osseous metastatic lesions as compared to 18F-FDG PET/CT and 99Tc-MDP imaging. 11C-acetate is generally >80% sensitive for detection of metastatic lesions as compared to less than 70% for 18F-FDG PET/CT with higher tumor than tumor to background ratio14-19. The majority of interest in 11C-acetate PET/CT imaging is focused on the detection of distant metastatic disease in patients with biochemical relapse status post definitive local therapy18,20,21. In patients with 99Tc-MDP detected prostate bone metastases, Yu et al. have found that 11C-acetate PET/CT was superior to 18F-FDG PET/CT for evaluation of bone metastases treatment response regardless of hormonal or taxol based chemotherapy. In the Yu et al. pilot study, 11C-acetate PET/CT findings correlated with composite clinical designation of treatment response in 100% of patients22.
Our study will evaluate baseline standard uptake value (SUVmax) and change in SUVmax of 11C-acetate PET/CT at approximately 10 weeks weeks (+/- 3 weeks) , generally after two cycles of Ra-223 dichloride therapy. SUVmax will be recorded for a selected index lesion and an average of the 5 most 11C-acetate avid lesions, from the baseline scan. Evaluation of 11C-acetate uptake changes to therapy in this pilot study will allow sample size calculation for future trials correlating 11C-acetate changes to therapy to TTP, OS and symptomatic relief end points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease. | Experimental | Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease planning to undergo Ra-223 therapy may be eligible for this study. Patients may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania. Positron emission tomography (PET/CT) imaging will use the investigational radiotracer [11C]acetate. Imaging will occur prior to Ra-223 therapy and after 2 cycles, in addition to standard of care 99mTcMDP bone scan at baseline and a research 99mTc-MDP bone scan post-therapy Patients will also undergo serial lab tests (PSA, and alkaline phosphatase levels). If these tests are done as part of clinical standard of care they will not need to be repeated for this study. Patients will be asked to complete a quality of life metric (short form of the McGill pain questionnaire) on the day of each PET/CT scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-Acetate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the fold change in SUVmax () | • Estimate the fold change in SUVmax () of selected index lesions and the sum of SUVmax over the most 11C-acetate avid lesions, up to five, measured at pre and post Ra-223 dichrolide therapy. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Pryma, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19004 | United States |
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| ID | Term |
|---|---|
| C438206 | carbon-11 acetate |
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