Prostate Cancer Clinical Trial
Official title:
Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)
To find the best dose of ADI-PEG20 that can be given in combination with carboplatin and cabazitaxel to patients with AVPC.
Primary Objective: To select an optimal dose of ADI-PEG 20 to combine with carboplatin+cabazitaxel Secondary Objectives: To determine the effects of ADI-PEG 20+carboplatin+cabazitaxel on 1. Serum levels of arginine, citrulline and circulating anti-ADI-PEG 20 antibodies 2. Intratumoral levels of arginine by ion chromatography/mass spectrometry 3. Expression of ASS1 by immunohistochemistry 4. Expression of genes involved in arginine metabolism and downstream pathways 5. Immune checkpoint expression and immune-cell populations in the AVPC tumor microenvironment 6. Safety and tolerability 7. Overall response 8. Progression-free survival 9. Overall survival ;
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