prostate cancer
Conditions
Interventions
Experimental:rezvilutamide+ADT+docetaxel:Rezvilutamide: Specifications of 80 mg
orally, once a day
Docetaxel:75mg/m2, administered intravenously every three weeks for a total of 6 cycles (each cycle lasting 3 weeks)
ADT: ADT can be achieved through medical castration or surgical
Comparator:rezvilutamide+ADT:Rezvilutamide: Specifications of 80 mg
orally, once a day
ADT: ADT can be achieved through medical castration or surgical castration.
Sponsors
Tianjin Medical University Institute and Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age?18 year; 2. ECOG performance scale 0 to 1; 3. Histologically or cytological confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features ; 4. high-volume metastatic hormone-sensitive prostate cancer (mHSPC); 5. Participants with PSA level >0.2 ng/mL after 6 months of treatment with rezvilutamide and ADT; 6. Plan to continue receiving treatment with ADT and enzalutamide; 7. Suitable for docetaxel chemotherapy 8.Adequate hepatic, renal, heart, and hematological functions; 9.Left ventricular ejection fraction (LVEF) >= 50% 10.Ability to comply with the trial protocol as judged by the investigator; 11.For male subjects whose partners are women of childbearing potential, they should be surgically sterilized or agree to use effective contraception during the trial period and for three months after the last administration of enzalutamide or the last chemotherapy treatment. Sperm donation is not allowed during the study period; 12.Patients have given voluntary written informed consent
Exclusion criteria
Exclusion criteria: 1. History using of second-generation AR inhibitor (such as enzalutamide, apalutamide, darolutamide), abiraterone acetate, or other investigational drugs that inhibit androgen synthesis for the treatment of prostate cancer; 2. History of receiving docetaxel during the metastatic phase; 3. Confirmed brain tumor lesions diagnosed by imaging; 4. Planning to receive any other anti-tumor treatment during this trial period; 5.Individuals allergic to the components of the study drug; 6.Individuals with an inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect the intake and absorption of medication; 7.History of epilepsy, or occurrence of diseases that can induce seizures within 12 months prior to C1D1; 8. Having active cardiac disease within 6 months prior to C1D1; 9. Having any other malignant tumor within 5 years prior to C1D1; 10. Active HBV, HCV infection; 11. History of immunodeficiency (including HIV test positive, other acquired or congenital immunodeficiency diseases) or organ transplant history; 12. Based on the investigator's judgment, there are coexisting diseases that pose a serious risk to the patient's safety, may confound the study results, or affect the patient's ability to complete this study (such as poorly controlled hypertension, severe diabetes, neurological or psychiatric diseases, etc.), or any other conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic progression-free survival (rPFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) ;Clinical Symptom Improvement Indicators;Serum Prostate Specific Antigen (PSA) Evaluations ;safety; | — |
Countries
China
Contacts
Public ContactXin Yao
Tianjin Medical University Institute and Hospital
Outcome results
None listed