Prostate cancer
Conditions
Interventions
Experimental Group:Subjects who meet the inclusion criteria will be treated with rezvilutamide in combination with docetaxel and ADT during the treatment period. After 6 cycles of use, they will enter
Sponsors
The First Bethune Hospital of Jilin University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. ECOG score is 0-2; 3. Patients diagnosed with high tumor burden metastatic hormone sensitive prostate cancer for the first time, who have not undergone endocrine therapy or chemotherapy; 4. Imaging reveals >= 4 bone metastases, of which = 1 bone metastasis is located outside the pelvic cavity or spine, or there is visceral metastasis, or lymph node metastasis; 5. The organ function level must meet the following requirements (no blood transfusion or hematopoietic growth factor treatment received within 2 weeks before blood routine screening): (1)ANC>=1.5×10^9/L; (2)PLT>=100×10^9/L; (3)Hb>=90 g/L; (4)TBIL =50%; (8)QTcF<=450 ms. 6. Subjects whose partners are fertile women should undergo surgical sterilization or agree to use effective contraception methods during the trial period and within 3 months after the last administration of the study drug; 7. The subjects voluntarily joined this study, signed a written informed consent form, and are expected to have good compliance with the research protocol.
Exclusion criteria
Exclusion criteria: 1. Have previously received any endocrine therapy (including but not limited to goserelin, leuprorelin, digaramide, bicalutamide, abiraterone acetate, darotamine, apatamide, enzalutamide, etc.) or radiochemotherapy for prostate cancer; 2. Individuals with a known history of allergies to rezvilutamide, LHRHa drugs, docetaxel, and their components; 3. Received other clinical trial drug treatments and major surgeries within the 4 weeks prior to enrollment in this study; 4. There are factors such as inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect medication intake and absorption; 5. Have a history of epilepsy or have experienced diseases that can trigger epileptic seizures within the 12 months prior to enrollment (including a history of transient ischemic attacks, stroke, traumatic brain injury with consciousness disorders requiring hospitalization); 6. Within the first 6 months of enrollment, there were active heart diseases, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure (heart function class III or IV), and drug-induced ventricular arrhythmias; 7. Individuals with active HBV and HCV infection (HBsAg positive and virus copy number = 500 IU/mL, HCV antibody positive and HCV RNA above the detection limit of the analytical method); 8. Individuals with a history of congenital immunodeficiency or organ transplantation, or HIV positive subjects who meet one or more of the following criteria: (1)Not receiving highly effective antiretroviral therapy; (2)Change antiretroviral therapy within 6 months prior to the start of screening; (3)Undertaking antiretroviral therapy that may interfere with the investigational drug (please consult the sponsor before enrollment); (4)CD4 count<350/mm^3 during screening; (5)Opportunistic infections that meet the definition of acquired immunodeficiency syndrome occurred within 12 months prior to the start of screening. 9. Within the past 3 years prior to enrollment, the patient has suffered from other malignant tumors (excluding in situ cancer that has been completely relieved and malignant tumors that have been diagnosed by researchers as progressing slowly); 10. The researchers determined that participants with ejaculation ability and sexual activity were unwilling to use the contraceptive measures specified in the protocol throughout the entire study treatment period and within 3 months after the last dose; 11. According to the judgment of the investigator, there are concomitant diseases (such as poorly controlled hypertension, serious diabetes, neurological or mental diseases, etc.) or any other conditions that seriously endanger the safety of the patient, may confuse the research results, or affect the subject to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month PSA undetectable rate (PSA = 0.2ng/ml); | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging progression free survival (rPFS);Disease Control Rate (DCR);Overall survival (OS);PSA response rate indicators: PSA50, PSA90;Safety;Quality of Life Evaluation; | — |
Countries
China
Contacts
Public ContactLei Yang
The First Bethune Hospital of Jilin University
Outcome results
None listed