NCT06134271

Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer

A Multicenter, Prospective, Cohort Study on the Treatment of Metastatic Hormone-sensitive Prostate Cancer Patients Who Have Progressed After Pre-treatment With Rezvilutamide Combined With Abiraterone

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Jianbin Bi · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, prospective, cohort study enrolled patients with metastatic hormone-sensitive prostate cancer who had been treated with other novel endocrine or systemic regimens (excluding patients treated with pre-order chemotherapy alone or bicalutamide); To observe the efficacy and safety of rezvilutamide alone or in combination with abiraterone in hormone-sensitive prostate cancer patients with PSA progression following prior sequence therapy.

Detailed description

This is a multicenter, prospective, cohort study to observe the efficacy and safety of rezvilutamide alone or in combination with abiraterone in patients with hormone-sensitive prostate cancer who have progressed PSA after prior sequencing therapy. Other novel endocrine or systemic regimens were used in these patients (excluding patients treated with pre-order chemotherapy alone or bicalutamide); and received ongoing gonadotropin-releasing hormone analogue (GnRHa) castration therapy (drug castration) or prior bilateral orchiectomy (surgical castration) over the course of the study; Participants who did not undergo bilateral orchiectomy had to maintain effective pharmacological castration throughout the study period. This study included three cohorts of 160 patients with progressive metastatic hormone-sensitive prostate cancer. 56 patients were included in cohort 1, 56 patients in cohort 2 and 28 patients in cohort 3. Patients in cohort 1 were treated with rezvilutamide, 240 mg/day; Patients in cohort 2 received rezvilutamide at 240 mg/day in combination with abiraterone and hormonal therapy; Patients in cohort 3 maintained promiscuous therapy until disease progression or uncontrolled toxicity. According to PCWG3, the primary endpoint is Time to CRPC. Secondary endpoints included OS, rPFS, time to SEE, liver function assessment, and safety of NCI-TCAE 5.0.

Conditions

• Metastatic Hormone-Sensitive Prostate Cancer

Interventions

Type	Name	Description
DRUG	Rezvilutamide	Rezvilutamide 240mg qd
DRUG	Rezvilutamide plus abiraterone	Rezvilutamide 240mg qd plus abiraterone 1000mg + prednisone 5 mg qd
DRUG	Continue previous treatment	Continue using the previous treatment regimen for treatment.

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-04-30
• Completion: 2026-04-30
• First posted: 2023-11-18
• Last updated: 2023-11-18