Phase II Study of Luxdegalutamide JSB462 Combined With Abiraterone or Enzalutamide in Adult Men With Metastatic Hormone-sensitive Prostate Cancer

What this Trial Is About

Researchers are evaluating the combination of JSB462 luxdegalutamide with abiraterone compared to an androgen receptor pathway inhibitor ARPI, which includes abiraterone or enzalutamide, in adult males with metastatic hormone-sensitive prostate cancer mHSPC. This Phase II study aims to assess the effectiveness and safety of two doses of JSB462 100 mg and 300 mg daily combined with abiraterone and to select the recommended dose for future Phase III trials. The study will analyze overall treatment response, safety, tolerability, and pharmacokinetics. Participants will undergo a screening period of 28 days before starting treatment. During treatment, they will receive daily oral doses of JSB462 at either 100 mg or 300 mg combined with abiraterone 1000 mg, or they will receive abiraterone 1000 mg or enzalutamide 160 mg alone. Treatment continues until disease progression, unacceptable side effects, death, or decision by the participant or investigator. After treatment ends, there is a 30-day safety follow-up visit, followed by a long-term follow-up period to collect ongoing safety, efficacy, and survival information until the study concludes. Throughout the study, participants will have regular assessments including prostate-specific antigen PSA levels, imaging scans, adverse event monitoring, dose adjustments, and pharmacokinetic sampling. Patient-reported outcomes and various survival and response rates will be evaluated up to approximately 83 months. Safety follow-up visits occur about 30 days after treatment stops, and long-term monitoring continues until the studys end, ensuring comprehensive data collection on treatment effects and participant well-being.

An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)