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

StatusRecruiting
PhasePhase 3
Started2023-06-20
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 21, 2023 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT05956639
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Enrollment 100 participants
Start Date 2023-06-20
Primary Completion 2025-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2023-07-21