Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
- Conditions
- Castration-resistant Prostate Cancer
- Registration Number
- NCT05534646
- Lead Sponsor
- Edwin Posadas, MD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria:<br><br> - History of castration-resistant prostate cancer with rising PSA (prostate-specific<br> antigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor:<br> abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide<br> will not be considered as contemporary ARSIs<br><br> - Patient must have had 1 and can have up to 2 prior AR targeted therapy with the<br> exception of apalutamide.<br><br> - Patients must decline or be ineligible for taxane therapy in the opinion of the<br> treating physician.<br><br> - All patients must agree to use an adequate method of contraception, in the opinion<br> of the treating investigator, while on protocol treatment and for 3 months after the<br> last dose of protocol treatment (apalutamide and/or carotuximab)<br><br>Exclusion Criteria:<br><br> - Non-PSA producing prostate cancers such as small cell prostate cancers or those<br> prostate cancers which exhibit radiographic progression without PSA rise<br><br> - Prior use of apalutamide<br><br> - Other prior malignancy requiring active anticancer therapy<br><br> - Prior exposure to carotuximab or any CD105 targeted antibody<br><br> - Active bleeding or pathologic medical conditions that carries a high bleeding risk<br><br> - A known diagnosis of Osler-Weber-Rendu syndrome
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiographic progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab
- Secondary Outcome Measures
Name Time Method 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;Overall radiographic response rate (ORR) in the overall population;To determine the radiographic progression free survival (rPFS) in the overall population;To determine the biochemical PFS (by PCWG3) in the overall population