RecruitingPhase 3NCT07241416

A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer

A Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Study of Rezvilutamide Combined With Androgen Deprivation Therapy (ADT) Versus Enzalutamide Combined With ADT for Treating Low-volume Metastatic Hormone Sensitive Prostate Cancer (mHSPC)


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

156 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to compare the efficacy and safety of rezvilutamide with enzalutamide in the treatment of patients with low-volume metastatic hormone sensitive prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase III study is testing rezvilutamide — an anti-androgen pill (a drug that blocks male hormones that fuel prostate cancer) — combined with standard hormone-lowering therapy (ADT) for men with prostate cancer that has spread but still responds to hormone treatment. **You may be eligible if...** - You are 18 years or older with a confirmed diagnosis of prostate cancer (adenocarcinoma type) - Your cancer has spread to other parts of the body (metastatic) but is still responding to hormone therapy (hormone-sensitive) - You are in good physical condition (ECOG score 0 or 1) - You are planning to receive and maintain hormone-lowering therapy (ADT) throughout the study - Your liver, kidneys, heart, and blood counts are in acceptable range **You may NOT be eligible if...** - Your cancer is neuroendocrine or small cell prostate cancer - You are not hormone-sensitive (castration-resistant) - You are not receiving ADT 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

DRUGRezvilutamide Tablets

Rezvilutamide tablets, oral administration.

DRUGEnzalutamide Soft Capsules

Enzalutamide soft capsules, oral administration.


Locations(1)

The First Medical Center of the Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, China

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NCT07241416


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