eligibility_summary
Eligible: CRPC with rising PSA on a contemporary ARSI (abiraterone, enzalutamide, darolutamide, not bicalutamide/nilutamide/flutamide), 1–2 prior AR‑targeted therapies (not apalutamide), declines or ineligible for taxanes, uses contraception during treatment and 3 months after. Exclude: non‑PSA–producing disease or PSA‑negative progression, prior apalutamide, active other malignancy, prior carotuximab/CD105 antibody, active/high‑risk bleeding, Osler‑Weber‑Rendu.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, open-label study in mCRPC comparing apalutamide vs apalutamide + carotuximab after progression on prior ARSIs. Drugs/interventions: - Apalutamide: second‑generation small‑molecule androgen receptor (AR) antagonist, blocks AR ligand binding, nuclear translocation, and DNA binding to suppress AR signaling in prostate cancer cells. - Carotuximab (TRC105): chimeric IgG1 monoclonal antibody (immunotherapy) against endoglin (CD105), a TGF‑β coreceptor on proliferating tumor endothelium, inhibits TGF‑β/SMAD–mediated angiogenesis and may induce ADCC, interferes with VEGF cross‑talk. Targets/pathways: - AR pathway in prostate tumor cells. - CD105+ tumor-associated endothelial cells, TGF‑β/SMAD and angiogenic pathways (including VEGF interactions). Aim: determine whether adding anti‑angiogenic immunotherapy to AR blockade improves PFS, ORR, and overcomes ARSI resistance.