Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC
NCT05983783 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2023-08-09
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.
Conditions
- Metastatic Prostate Cancer
- Hormone Sensitive Prostate Cancer
- Chemotherapy Effect
Interventions
- DRUG
-
This is Triple drug regimen for mHSPC
- DRUG
-
Rezvilutamide
This is doubling drug regimen for mHSPC
Sponsors & Collaborators
-
The First Affiliated Hospital with Nanjing Medical University
lead OTHER
Principal Investigators
-
Lixxin Hua · Urology Dpt, First Affiliated Hospital of Nanjing Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-01
- Primary Completion
- 2025-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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