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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07241416
- Acronym / sponsor ID
- MA-PCa-III-021
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rezvilutamide Tablets Group | Experimental | Drug: Rezvilutamide Tablets |
| Enzalutamide Soft Capsules Group | Active comparator | Drug: Enzalutamide Soft Capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rezvilutamide TabletsRezvilutamide tablets, oral administration. | Drug | Rezvilutamide Tablets Group |
| Enzalutamide Soft CapsulesEnzalutamide soft capsules, oral administration. | Drug | Enzalutamide Soft Capsules Group |
Primary outcome
Prostate Specific Antigen (PSA) undetectable rate based on central laboratory.
Time frame: 6 months after randomization.
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.
8 secondary outcomes
PSA response rate based on local laboratory.
Time frame: Up to approximately 5 years.
PSA undetectable rate based on local laboratory.
Time frame: 6 months after randomization.
Objective response rate (ORR).
Time frame: Up to approximately 5 years.
Radiographic progression-free survival (rPFS).
Time frame: Up to approximately 5 years.
Time to PSA progression based on local laboratory.
Time frame: Up to approximately 5 years.
Time to castration-resistant prostate cancer (CRPC).
Time frame: Up to approximately 5 years.
Overall survival (OS).
Time frame: Up to approximately 5 years.
Adverse events (AEs).
Time frame: Up to approximately 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daomin Hu (+86-0518-82342973, hudaomin@aidiyan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate Specific Antigen (PSA) undetectable rate based on central laboratory. (time frame: 6 months after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.