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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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Start Date
March 1, 2016
Primary Completion Date
September 25, 2020
Completion Date
September 25, 2020
Last Updated
May 18, 2022
6
ACTUAL participants
11C-Acetate
DRUG
Lead Sponsor
Abramson Cancer Center at Penn Medicine
NCT07103018
NCT07325721
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