Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer

This is an open-label, multi-site study of apalutamide with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin with a safety assessment in the first 10 subjects (part 1: Safety Lead-in). If the combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this study is to compare progression free survival (PFS) between patients receiving apalutamide and apalutamide + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3. The secondary obje

Trial Details

NCT ID
NCT05534646
Phase
PHASE2
Sponsor
Edwin Posadas, MD
Status
RECRUITING
Cancer Type
Castration-Resistant (CRPC) Prostate Cancer
Interventions
  • Apalutamide
  • Carotuximab
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • Salt Lake City, Utah, United States|40.76078,-111.89105

Key Eligibility Criteria

  • History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signalin…
  • 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 fo…

For full eligibility, visit ClinicalTrials.gov.

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