Clinical Study of Rezvilutamide Combined With Docetaxel Chemotherapy 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.

• 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)

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.