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

NCT07241416 | Recruiting Phase 3

• 1 other identifier: MA-PCa-III-021
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Outcome Measures

Primary Outcomes (1)

• Prostate Specific Antigen (PSA) undetectable rate based on central laboratory.

  Defined as the proportion of subjects with a total PSA level below 0.2 ng/mL in central laboratory testing within 6 months after randomization.

  6 months after randomization.

Secondary Outcomes (8)

• PSA response rate based on local laboratory.

  Up to approximately 5 years.

• PSA undetectable rate based on local laboratory.

  6 months after randomization.

• Objective response rate (ORR).

  Up to approximately 5 years.

• Radiographic progression-free survival (rPFS).

  Up to approximately 5 years.

• Time to PSA progression based on local laboratory.

  Up to approximately 5 years.

Study Arms (2)

Rezvilutamide Tablets Group

EXPERIMENTAL

Drug: Rezvilutamide Tablets

Enzalutamide Soft Capsules Group

ACTIVE COMPARATOR

Drug: Enzalutamide Soft Capsules

Interventions

Rezvilutamide Tablets DRUG

Rezvilutamide tablets, oral administration.

Rezvilutamide Tablets Group

Enzalutamide Soft Capsules DRUG

Enzalutamide soft capsules, oral administration.

Enzalutamide Soft Capsules Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participates in this clinical trial, with an understanding of the study procedures and signed informed consent;
• Age ≥ 18 years;
• Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine differentiation or small cell features;
• Metastatic hormone sensitive prostate cancer;
• ECOG PS: 0-1;
• Planned to receive and maintain ADT during the study period;
• Adequate hepatic, renal, heart, and hematological functions;
• Determined by the investigator to be able to comply with the study protocol;
• Fertile subjects must use effective contraception or abstain from sexual activity and sperm donation until 3 months after last exposure to rezvilutamide or enzalutamide. Subjects must use condoms plus an additional effective contraceptive method during sexual activity with a fertile female partner throughout treatment and for 3 months post-treatment.

You may not qualify if:

• Prior treatment with ADT, chemotherapy, surgery, external-beam radiotherapy, brachytherapy, radiopharmaceuticals, or investigational local therapy for metastatic prostate cancer, except as specifically allowed by the protocol;
• Previous use of second-generation androgen receptor antagonists, ketoconazole, abiraterone acetate, or other investigational drugs inhibiting androgen synthesis for prostate cancer treatment; or plans to use any second-generation androgen receptor antagonist other than the study drug during the study treatment period;
• Total PSA has decreased to undetectable levels at baseline;
• Have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks before randomization: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease PSA levels;
• Planned to initiate any other anti-tumor therapies during the study;
• Known history of hypersensitivity to rezvilutamide, enzalutamide, or any of their components;
• Unable to swallow, chronic diarrhea or intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
• History of seizure or certain conditions that may predispose to seizure;
• Presence of clinically significant cardiovascular diseases within 6 months prior to randomization;
• Any other malignancy within 5 years prior to randomization (except as specifically allowed by the protocol);
• Active HBV or HCV infection;
• History of immunodeficiency (including HIV-positive status, other acquired or congenital immunodeficiency disorders) or organ transplantation;
• Any concomitant condition that, in the opinion of the investigator, would seriously jeopardize patient safety, confound study findings, or compromise the patient's ability to complete the study (e.g., hypertension inadequately controlled despite medication, severe diabetes, neurologic or psychiatric disorders, etc.) or any other circumstance.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100853, China

RECRUITING

Central Study Contacts

Jia Hui

CONTACT

+86-0518-82342973; jiahui@aidiyan.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

CN (1)