Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body
Categories (click each to see list of all clinical trials associated with that category): GU (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Teply, Benjamin
Contact Information:
Amanda Redmond
aredmond@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06470243?term=NCT06470243&rank=1#participation-criteria
Summary
1.1 Primary Objectives
a. To compare radiographic progression free survival (rPFS) between the two treatment arms in the subset of Aggressive Variant Prostate Cancer - Molecular Pathologic Signature (AVPC-MS)-positive participants.
b. If the AVPC-MS positive test is statistically significant, test in AVPC-MS negative participants whether the combination of carboplatin and cabazitaxel improves rPFS.
1.2 Secondary Objectives
a. To compare overall survival (OS) between the two treatment arms, stratified by AVPC-MS positive vs. negative.
b. To compare response rates for PSA, Total Alkaline Phosphatase, and RECIST 1.1 between the two treatment arms, stratified by AVPC-MS positive vs. negative.
c. To compare rPFS between the two treatment arms for the full trial.
d. To compare rPFS between the two treatment arms for the AVPC-MS negative group in the absence of a positive treatment effect in the AVPC-MS positive group.
e. To compare progression free survival (PFS) between the two treatment arms, stratified by AVPC-MS positive vs. negative.
f. To compare toxicities between the two arms in participants who receive any treatment on study.
1.3 Banking Objectives
a. To bank specimens for future correlative studies.