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

Zhujiang Hospital

Status: Invitation-only

Conditions: Pathological and Imaging Examinations Confirmed Metastatic Prostate Cancer

Treatments: Combination Product: Rezvilutamide combined with docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT07112209

2023-KY-203-02

Details and patient eligibility

About

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.).

5. Laboratory tests:

6. Blood routine and urine routine tests;

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

Full 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.).

5. Laboratory tests:

6. Blood routine and urine routine tests;

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

Enrollment: 20 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Rivelutamide combined with docetaxel and castration therapy

Experimental group

Description:

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

Treatment:

Combination Product: Rezvilutamide combined with docetaxel