NCT05983783

Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC

A Prospective Randomized Controlled Study Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the Treatment of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.

Detailed description

To investigate the value of chemotherapy in the treatment of high-burden of mHSPC on the background of next-genertion of AR inhibitors.

Conditions

• Metastatic Prostate Cancer
• Hormone Sensitive Prostate Cancer
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	Docetaxel	This is Triple drug regimen for mHSPC
DRUG	Rezvilutamide	This is doubling drug regimen for mHSPC

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2023-08-09
• Last updated: 2023-08-09

Locations

1 site across 1 country: China