Prostate Cancer Clinical Trial
Official title:
FASN Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer Salvaging Taxane Failure
The purpose of this research study is to find out what effects (good and bad) omeprazole and cabazitaxel, or omeprazole and docetaxel, has on participants and their condition. Investigators believe omeprazole may help the other medications work.
Primary Objective(s): Obtain Overall Response Rate (ORR) to taxane therapy by adding the fatty acid synthase inhibitor, omeprazole to the current "failing" taxane regimen in 15% of subjects using Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria, defined by partial response (PR) or complete response (CR) Secondary Objectives (only at patients treated at Wake Forest Baptist Comprehensive Cancer Center main campus): - Pharmacodynamics-demonstrate omeprazole in vivo fatty acid synthase inhibition by 11C-Acetate PET/CT (3-6) Non-invasive approach to demonstrate the fatty acid synthase inhibitor (omeprazole) is hitting its target - Obtain a prostate specific antigen response rate by adding the fatty acid synthase inhibitor omeprazole to the current "failing" taxane regimen. (16) - Measure pain using the Patient-Reported Outcomes Measurement Information System (PROMIS) at Baseline, Cycle 5, Cycle 12, and every cycle thereafter. ;
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