RecruitingPhase 3NCT05983783

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)


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

200 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for men with newly diagnosed metastatic hormone-sensitive prostate cancer (prostate cancer that has spread but still responds to hormone therapy): rezvilutamide (a newer androgen blocker) plus hormone therapy alone versus rezvilutamide plus hormone therapy plus docetaxel chemotherapy. **You may be eligible if:** - You are a man aged 40–80 with confirmed prostate cancer that has spread to other parts of the body - Your cancer is high-burden (4 or more bone metastases, or spread to organs) - You are eligible for hormone therapy and chemotherapy - Your hormone therapy was started no more than 12 weeks ago - Your blood counts and organ function meet minimum requirements **You may NOT be eligible if:** - You have previously received advanced hormone blockers (e.g., enzalutamide, abiraterone, darolutamide) - You have had prior treatment with docetaxel for metastatic prostate cancer - You have uncontrolled heart disease, severe liver problems, or active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDocetaxel

This is Triple drug regimen for mHSPC

DRUGRezvilutamide

This is doubling drug regimen for mHSPC


Locations(1)

Urology dpt, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT05983783


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