NCT05956639

Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC

A Multi-center, Randomized, Open-label Clinical Trial Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in High Tumor Burden mHSPC

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To explore whether a 6-month course of Rezvilutamide in the triple therapy regimen is non-inferior to long-term Rezvilutamide treatment in improving radiographic progression-free survival (rPFS) in patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC). Secondary Objectives: To evaluate and compare the time to prostate-specific antigen (PSA) progression, time to next bone-related event, time to initiation of subsequent anti-prostate cancer treatment, and objective response rate (ORR) between the 6-month and long-term course of Rezvilutamide with androgen deprivation therapy (ADT) plus docetaxel in patients with high tumor burden mHSPC. To assess and compare the incidence of adverse events between the 6-month and long-term course of Rezvilutamide with ADT plus docetaxel in patients with high tumor burden mHSPC. Exploratory Objectives: To observe the circulating tumor cell status at 6 months, 12 months, 18 months, and 24 months in patients with high tumor burden mHSPC receiving the triple therapy regimen.

Detailed description

Primary Study Endpoints: Radiographic progression-free survival (rPFS) Secondary Study Endpoints: Time to prostate-specific antigen (PSA) progression Time to next bone-related event (including fractures, spinal cord compression, radiation therapy, or surgery targeting the bones) Time to initiation of subsequent anti-prostate cancer treatment Objective response rate (ORR) Quality of life assessment scores

Conditions

• Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Interventions

Type	Name	Description
DRUG	6-month course of antiandrogen drugs	6-month course of Rezvilutamide and ADT + chemotherapy
DRUG	Long-term course of antiandrogen drugs	Long-term course of Rezvilutamide and ADT + chemotherapy

Timeline

• Start date: 2023-06-20
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2023-07-21
• Last updated: 2023-07-21

Locations

1 site across 1 country: China