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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:
â‘ 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; â‘¢ Agree to receive Rezvilutamide combined with docetaxel chemotherapy;
Exclusion criteria:
Having other tumor diseases that require treatment;
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.).
2. Laboratory tests:
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:
â‘ 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; â‘¢ Agree to receive Rezvilutamide combined with docetaxel chemotherapy;
Exclusion criteria:
Having other tumor diseases that require treatment;
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.).
2. Laboratory tests:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezvilutamide combined with docetaxel | Combination Product | Intervention Description: Drug:Rivarestatine Description: 240mg, po, qd Drug:Docetaxel Description:75mg/m2,ivgtt q3w Drug:Prednisone Description:5mg,po,bid |
| Measure | Description | Time Frame |
|---|---|---|
| PSA response rate | one year |
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Inclusion Criteria:
Adult males over 18 years old, excluding healthy volunteers. â‘¡ Pathological and imaging confirmed as metastatic prostate cancer, who have been receiving abiraterone and castration therapy but have experienced serological or imaging progression; â‘¢ Agree to receive Rezvilutamide combined with docetaxel chemotherapy;
Exclusion Criteria:
Having other tumor diseases that require treatment;
Adult males over the age of 18
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Medical University | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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