Phase 3 Study of HC-1119 Soft Capsules for Treating Metastatic Castration-Resistant Prostate Cancer in Men Who Have Tried Abiraterone Acetate and Docetaxel

What this Trial Is About

Researchers are evaluating the effects of HC-1119 soft capsules compared to a placebo in men with metastatic castration-resistant prostate cancer mCRPC who have not responded to or cannot tolerate treatments with abiraterone acetate and docetaxel, or who are unsuitable for docetaxel treatment. This Phase 3, multicenter, randomized, double-blind study aims to assess the safety and efficacy of HC-1119 in this patient population. The study is sponsored by Hinova Pharmaceuticals Inc. Participants will be randomly assigned to receive either HC-1119 soft capsules or a matching placebo, both given orally at a dose of 80 mg. The treatments will be administered in a double-blind manner so neither the participants nor the researchers know which treatment is given. The study includes a screening period followed by treatment and monitoring phases lasting up to approximately 30 months. During the study, participants will undergo regular assessments including imaging scans to monitor disease progression, blood tests, and evaluations of prostate-specific antigen PSA levels. Researchers will measure outcomes such as radiographic progression-free survival, overall survival, time to progression, objective response rate, disease control rate, and adverse events. Safety and treatment effects will be closely monitored throughout the study period.

A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).