Trial intelligence / Profile preview

Rezvilutamide plus ADT with or without Docetaxel in mHSPC

NCT05983783Phase 3

Key facts

Status: Recruiting
Start: Aug 2023
Primary completion: Dec 2025
Countries: 1
Sponsor: Jiangsu Provincial People's Hospital
Modality: Small Molecules

Drugs: docetaxel
Conditions: prostate cancer (PCa)

Overview

Phase 3, randomised, open-label trial of docetaxel in prostate cancer (PCa) (2 arms), sponsored by Jiangsu Provincial People's Hospital. Primary endpoint: Radiographic Progression-Free Survival at 36 months. Started Aug 2023; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Rezvilutamide+ADT+Docetaxel
Rezvilutamide 240 mg QD + ADT + Docetaxel (6 cycles)
Rezvilutamide+ADT
Rezvilutamide 240 mg QD + ADT

Who it enrols

Patients with histologically confirmed metastatic hormone-sensitive prostate cancer (mHSPC) and high tumor burden (>=4 bone lesions or visceral metastases). Patients must be eligible for ADT and Docetaxel and have an ECOG status of 0-1.

Endpoints

Primary

Radiographic Progression-Free Survival36 months

Secondary

Overall Survival36 months
Prostate-Specific Antigen Response Rate36 months
Time to Castration-Resistant Prostate Cancer36 months

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