Pathological and Imaging Examinations Confirmed Metastatic Prostate CancerNCT07112209
Clinical Study of Rezvilutamide Combined With Docetaxel Chemotherapy in the Treatment of Abiraterone-Resistant Prostate Cancer
A study testing Rezvilutamide combined with docetaxel in people with Pathological and Imaging Examinations Confirmed Metastatic Prostate Cancer, run by Zhujiang Hospital at 1 site in China.
Trial summary
Emphasize the main 4 points. 1. Trial Name: Evaluate the efficacy and safety of Rezvilutamide combined with docetaxel in the treatment of abiraterone-resistant prostate cancer. 2. Inclusion criteria: ① Adult males over 18 years old, excluding healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pathological and Imaging Examinations Confirmed Metastatic Prostate Cancer
- What is being tested?
- Rezvilutamide combined with docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2023to 6 Nov 2027
- Phase
- Interventional
- 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
- Adult males over 18 years old, excluding healthy volunteers. ② Pathological and imaging confirmed as metastatic prostate cancer, who have been receiving abiraterone and castration therapy but have experienced serological or imaging progression; ③ Agree to receive Rezvilutamide combined with docetaxel chemotherapy;
- ECOG score of 0-1, with a physical condition capable of tolerating chemotherapy; ⑤ Voluntarily sign the informed consent for the clinical trial.
Who cannot join
- Having other tumor diseases that require treatment;
- Having a history of epilepsy or any condition that may cause an epileptic seizure; ③ Having severely impaired liver or kidney function, severe cardiovascular or cerebrovascular diseases, or systemic immune system disorders; ④ Having poor physical condition and being unable to tolerate chemotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Efficacy and Safety of Rezvilutamide Combined With Docetaxel in the Treatment of Abiraterone-resistant Prostate Cancer.
Emphasize the main 4 points.
- Trial Name: Evaluate the efficacy and safety of Rezvilutamide combined with docetaxel in the treatment of abiraterone-resistant prostate cancer.
- Inclusion criteria: ① Adult males over 18 years old, excluding healthy volunteers.
Read more
- Pathological and imaging confirmed as metastatic prostate cancer, who have been receiving abiraterone and castration therapy but have experienced serological or imaging progression; ③ Agree to receive Rezvilutamide combined with docetaxel chemotherapy;
- ECOG score of 0-1, with a physical condition capable of tolerating chemotherapy; ⑤ Voluntarily sign the informed consent for the clinical trial. Exclusion criteria:
- Having other tumor diseases that require treatment;
- Having a history of epilepsy or any condition that may cause an epileptic seizure; ③ Having severely impaired liver or kidney function, severe cardiovascular or cerebrovascular diseases, or systemic immune system disorders; ④ Having poor physical condition and being unable to tolerate chemotherapy.
- ain clinical studies: Rezvilutamide: 240mg (3 tablets) each time, once daily, orally; Androgen deprivation therapy: treated with gonadotropin-releasing hormone analogues or having undergone bilateral orchiectomy; Docetaxel chemotherapy: 75mg/m2 of body surface area by intravenous infusion, once every 3 weeks; simultaneously, oral prednisone was taken twice daily, 5mg each time.
- The follow-up period is 2 years. Follow-up will be conducted according to the follow-up plan at 1, 3, 6, 9, 12, 16, 18, 21, 24 months after treatment. Patients need to undergo regular examinations (family members and the research supervisor will remind them): 1. General physical examination (height, weight, body temperature, blood pressure, heart rate, pulse, etc.) and important physical sign examination (such as urinary system and other special clinical examinations, etc.).
- Laboratory tests:
- Blood routine and urine routine tests;
- Biochemical tests and liver function tests; 3. Adverse events (AE) and serious adverse events (SAE)
Read the detailed description
Emphasize the main 4 points.
- Trial Name: Evaluate the efficacy and safety of Rezvilutamide combined with docetaxel in the treatment of abiraterone-resistant prostate cancer.
- Inclusion criteria: ① Adult males over 18 years old, excluding healthy volunteers.
- Pathological and imaging confirmed as metastatic prostate cancer, who have been receiving abiraterone and castration therapy but have experienced serological or imaging progression; ③ Agree to receive Rezvilutamide combined with docetaxel chemotherapy;
- ECOG score of 0-1, with a physical condition capable of tolerating chemotherapy; ⑤ Voluntarily sign the informed consent for the clinical trial. Exclusion criteria:
- Having other tumor diseases that require treatment;
- Having a history of epilepsy or any condition that may cause an epileptic seizure; ③ Having severely impaired liver or kidney function, severe cardiovascular or cerebrovascular diseases, or systemic immune system disorders; ④ Having poor physical condition and being unable to tolerate chemotherapy.
- ain clinical studies: Rezvilutamide: 240mg (3 tablets) each time, once daily, orally; Androgen deprivation therapy: treated with gonadotropin-releasing hormone analogues or having undergone bilateral orchiectomy; Docetaxel chemotherapy: 75mg/m2 of body surface area by intravenous infusion, once every 3 weeks; simultaneously, oral prednisone was taken twice daily, 5mg each time.
- The follow-up period is 2 years. Follow-up will be conducted according to the follow-up plan at 1, 3, 6, 9, 12, 16, 18, 21, 24 months after treatment. Patients need to undergo regular examinations (family members and the research supervisor will remind them): 1. General physical examination (height, weight, body temperature, blood pressure, heart rate, pulse, etc.) and important physical sign examination (such as urinary system and other special clinical examinations, etc.).
- Laboratory tests:
- Blood routine and urine routine tests;
- Biochemical tests and liver function tests; 3. Adverse events (AE) and serious adverse events (SAE)
- Being tested
- Rezvilutamide combined with docetaxel
- Keywords
- abiraterone, PCa, Rezvilutamide, drug resistant, docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezvilutamide combined with docetaxelCombination product
Intervention Description:
Drug:Rivarestatine Description: 240mg, po, qd Drug:Docetaxel Description:75mg/m2，ivgtt q3w Drug:Prednisone Description:5mg,po,bid
| Study group | Role | What they receive |
|---|---|---|
| Rivelutamide combined with docetaxel and castration therapy | Experimental | Drug:Rivarestatine Description: 240mg, po, qd Drug:Docetaxel Description:75mg/m2，ivgtt q3w Drug:Prednisone Description:5mg,po,bid Receives: Combination Product: Rezvilutamide combined with docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start6 Nov 2023
- Primary completion10 Jun 2027 (estimated)
- Study completion6 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological and Imaging Examinations Confirmed Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112209
- Sponsor's protocol ID
- 2023-KY-203-02
- Status last verified
- Jun 2025
- First submitted
- 15 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Rezvilutamide Combined With Docetaxel in the Treatment of Abiraterone-resistant Prostate Cancer.
- ClinicalTrials.gov ID
- NCT07112209
- Acronym / sponsor ID
- 2023-KY-203-02
- Keywords
- abiraterone, PCa, Rezvilutamide, drug resistant, docetaxel
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 10 Jun 2027 (estimated)
- Study completion
- 6 Nov 2027 (estimated)
- First posted
- 8 Aug 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.
Emphasize the main 4 points.
- Trial Name: Evaluate the efficacy and safety of Rezvilutamide combined with docetaxel in the treatment of abiraterone-resistant prostate cancer.
- Inclusion criteria: ① Adult males over 18 years old, excluding healthy volunteers.
- Pathological and imaging confirmed as metastatic prostate cancer, who have been receiving abiraterone and castration therapy but have experienced serological or imaging progression; ③ Agree to receive Rezvilutamide combined with docetaxel chemotherapy;
- ECOG score of 0-1, with a physical condition capable of tolerating chemotherapy; ⑤ Voluntarily sign the informed consent for the clinical trial. Exclusion criteria:
- Having other tumor diseases that require treatment;
- Having a history of epilepsy or any condition that may cause an epileptic seizure; ③ Having severely impaired liver or kidney function, severe cardiovascular or cerebrovascular diseases, or systemic immune system disorders; ④ Having poor physical condition and being unable to tolerate chemotherapy.
- ain clinical studies: Rezvilutamide: 240mg (3 tablets) each time, once daily, orally; Androgen deprivation therapy: treated with gonadotropin-releasing hormone analogues or having undergone bilateral orchiectomy; Docetaxel chemotherapy: 75mg/m2 of body surface area by intravenous infusion, once every 3 weeks; simultaneously, oral prednisone was taken twice daily, 5mg each time.
- The follow-up period is 2 years. Follow-up will be conducted according to the follow-up plan at 1, 3, 6, 9, 12, 16, 18, 21, 24 months after treatment. Patients need to undergo regular examinations (family members and the research supervisor will remind them): 1. General physical examination (height, weight, body temperature, blood pressure, heart rate, pulse, etc.) and important physical sign examination (such as urinary system and other special clinical examinations, etc.).
- Laboratory tests:
- Blood routine and urine routine tests;
- Biochemical tests and liver function tests; 3. Adverse events (AE) and serious adverse events (SAE)
Detailed description
Emphasize the main 4 points.
- Trial Name: Evaluate the efficacy and safety of Rezvilutamide combined with docetaxel in the treatment of abiraterone-resistant prostate cancer.
- Inclusion criteria: ① Adult males over 18 years old, excluding healthy volunteers.
- Pathological and imaging confirmed as metastatic prostate cancer, who have been receiving abiraterone and castration therapy but have experienced serological or imaging progression; ③ Agree to receive Rezvilutamide combined with docetaxel chemotherapy;
- ECOG score of 0-1, with a physical condition capable of tolerating chemotherapy; ⑤ Voluntarily sign the informed consent for the clinical trial. Exclusion criteria:
- Having other tumor diseases that require treatment;
- Having a history of epilepsy or any condition that may cause an epileptic seizure; ③ Having severely impaired liver or kidney function, severe cardiovascular or cerebrovascular diseases, or systemic immune system disorders; ④ Having poor physical condition and being unable to tolerate chemotherapy.
- ain clinical studies: Rezvilutamide: 240mg (3 tablets) each time, once daily, orally; Androgen deprivation therapy: treated with gonadotropin-releasing hormone analogues or having undergone bilateral orchiectomy; Docetaxel chemotherapy: 75mg/m2 of body surface area by intravenous infusion, once every 3 weeks; simultaneously, oral prednisone was taken twice daily, 5mg each time.
- The follow-up period is 2 years. Follow-up will be conducted according to the follow-up plan at 1, 3, 6, 9, 12, 16, 18, 21, 24 months after treatment. Patients need to undergo regular examinations (family members and the research supervisor will remind them): 1. General physical examination (height, weight, body temperature, blood pressure, heart rate, pulse, etc.) and important physical sign examination (such as urinary system and other special clinical examinations, etc.).
- Laboratory tests:
- Blood routine and urine routine tests;
- Biochemical tests and liver function tests; 3. Adverse events (AE) and serious adverse events (SAE)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivelutamide combined with docetaxel and castration therapy | Experimental | Combination Product: Rezvilutamide combined with docetaxelDrug:Rivarestatine Description: 240mg, po, qd Drug:Docetaxel Description:75mg/m2，ivgtt q3w Drug:Prednisone Description:5mg,po,bid |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult males over 18 years old, excluding healthy volunteers. ② Pathological and imaging confirmed as metastatic prostate cancer, who have been receiving abiraterone and castration therapy but have experienced serological or imaging progression; ③ Agree to receive Rezvilutamide combined with docetaxel chemotherapy;
Key exclusion criteria (2 listed)
- Having other tumor diseases that require treatment;
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 combined with docetaxelIntervention Description: Drug:Rivarestatine Description: 240mg, po, qd Drug:Docetaxel Description:75mg/m2，ivgtt q3w Drug:Prednisone Description:5mg,po,bid | Combination product | Rivelutamide combined with docetaxel and castration therapy |
Primary outcome
PSA response rate
Time frame: one year
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 8 Aug 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rezvilutamide combined with docetaxel in people with Pathological and Imaging Examinations Confirmed Metastatic Prostate Cancer, run by Zhujiang Hospital 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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 8 Aug 2025. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA response rate (time frame: one year). 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 8 Aug 2025.