Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Sponsor: Edwin Posadas, MD + Enviro Therapeutics, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab
Time frame: From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.
Secondary Endpoints
Incidence of Adverse events (grade 3 or higher) related to carotuximab and apalutamide
Overall radiographic response rate (ORR) of the combination of apalutamide + carotuximab
Proportion of patients resistant to apalutamide benefit from the addition of carotuximab
Eligibility Criteria
Inclusion Criteria: * History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor: abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide will not be considered as contemporary ARSIs * Patient must have had 1 and can have up to 2 prior AR targeted therapy with the exception of apalutamide. * Patients must decline or be ineligible for taxane therapy in the opinion of the treating physician. * All patients must agree to use an adequate method of contraception, in the opinion of the treating investigator, while on protocol treatment and for 3 months after the last dose of protocol treatment (apalutamide and/or carotuximab) Exclusion Criteria: * Non-PSA producing prostate cancers such as small cell prostate cancers or those prostate cancers which exhibit radiographic progression without PSA rise * Prior use of apalutamide * Other prior malignancy requiring active…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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