Study on JSB462 (Luxdegalutamide) and Abiraterone for Treating Metastatic Hormone-Sensitive Prostate Cancer in Men

Program Overview

The purpose of this Phase II study is to evaluate how well a combination of two drugs, JSB462 (luxdegalutamide) and Abiraterone, works in treating men with metastatic hormone-sensitive prostate cancer (mHSPC). Researchers will compare this combination to other standard treatments to see if it is more effective and safe. The study will also help decide the best dose to use in future studies.

Description

The study involves several stages for each participant:

• Screening Period (28 days): Participants will undergo tests and evaluations to ensure they meet the study criteria.

• Treatment Period: Participants will take JSB462 daily by mouth, either 100 mg or 300 mg, along with Abiraterone or Enzalutamide, until the cancer progresses, side effects become unacceptable, or the participant or doctor decides to stop. The treatment continues as long as it is effective and safe.

• Post-Treatment Safety Follow-Up (30 days): After stopping the study treatment, participants will have at least one follow-up visit to check for any side effects. Further treatments may be given based on the doctor's decision.

• Long-Term Follow-Up: After the safety follow-up, participants will be monitored for their health, treatment effectiveness, and survival until the study ends.

Eligibility Criteria

Locations