Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Phase 3NCT07241416
A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer
A Phase 3 study testing Rezvilutamide Tablets and Enzalutamide Soft Capsules in people with Metastatic Hormone-sensitive Prostate Cancer (mHSPC), run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- What is being tested?
- Rezvilutamide Tablets and Enzalutamide Soft Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2025to Sep 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Medical Center of the Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, 100853
Xu Zhang, +86-010-66937166, xzhang@foxmail.com
Xu Zhang
About this study
Official title: 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)
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.
- Being tested
- Rezvilutamide Tablets, Enzalutamide Soft Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezvilutamide TabletsDrug
Rezvilutamide tablets, oral administration.
Enzalutamide Soft CapsulesDrug
Enzalutamide soft capsules, oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Rezvilutamide Tablets Group | Experimental | Not described Receives: Drug: Rezvilutamide Tablets |
| Enzalutamide Soft Capsules Group | Active comparator | Not described Receives: Drug: Enzalutamide Soft Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after randomization.
Secondary outcomes (8)
PSA response rate based on local laboratory.
Defined as the proportion of subjects who achieved a ≥50% or ≥90% reduction in PSA levels from baseline among those who had not initiated ADT treatment prior to randomization.
Measured: Up to approximately 5 years.
PSA undetectable rate based on local laboratory.
Defined as the proportion of subjects with a total PSA level below 0.2 ng/mL in local laboratory within 6 months after randomization.
Measured: 6 months after randomization.
Objective response rate (ORR).
The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and PCWG3.
Measured: Up to approximately 5 years.
Radiographic progression-free survival (rPFS).
Time from randomisation to radiologically confirmed progressive disease or death due to any cause.
Measured: Up to approximately 5 years.
Time to PSA progression based on local laboratory.
Time from randomisation to the first time of PSA progression according to the criterion of PCGW3.
Measured: Up to approximately 5 years.
Time to castration-resistant prostate cancer (CRPC).
Defined as the time from randomization to the first occurrence of castration-resistant event.
Measured: Up to approximately 5 years.
Overall survival (OS).
Defined as the time from randomization to death due to any cause.
Measured: Up to approximately 5 years.
Adverse events (AEs).
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: Up to approximately 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start5 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Studies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241416
- Sponsor's protocol ID
- MA-PCa-III-021
- Status last verified
- May 2026
- First submitted
- 17 Nov 2025
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided