Clinical Study of Rezvilutamide Combined With Docetaxel Chemotherapy in the Treatment of Abiraterone-Resistant Prostate Cancer

NCT ID: NCT07112209

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2027-11-06

Brief 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.

• 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.

3. 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.

4. 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.).

2. Laboratory tests:

1. Blood routine and urine routine tests;

2. Biochemical tests and liver function tests; 3. Adverse events (AE) and serious adverse events (SAE)

Detailed Description

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.

• 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.

3. 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.

4. 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.).

2. Laboratory tests:

1. Blood routine and urine routine tests;

2. Biochemical tests and liver function tests; 3. Adverse events (AE) and serious adverse events (SAE)

Conditions

Pathological and Imaging Examinations Confirmed Metastatic Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rivelutamide combined with docetaxel and castration therapy

Drug:Rivarestatine Description: 240mg, po, qd Drug:Docetaxel Description:75mg/m2，ivgtt q3w Drug:Prednisone Description:5mg,po,bid

Group Type: EXPERIMENTAL

Rezvilutamide combined with docetaxel

Intervention Type: COMBINATION_PRODUCT

Intervention Description:

Drug:Rivarestatine Description: 240mg, po, qd Drug:Docetaxel Description:75mg/m2，ivgtt q3w Drug:Prednisone Description:5mg,po,bid

Interventions

Rezvilutamide combined with docetaxel

Intervention Description:

Drug:Rivarestatine Description: 240mg, po, qd Drug:Docetaxel Description:75mg/m2，ivgtt q3w Drug:Prednisone Description:5mg,po,bid

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Southern Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2023-KY-203-02

Identifier Type: -

Identifier Source: org_study_id