Prostate cancer
Conditions
Interventions
Experimental Group 1:Standard ADT treatment: Receive castration therapy with gonadotropin-releasing hormone analogues (GnRHa)
Rivelulamide: 240 mg each time, once a day, orally before or after breakfa
2:Rezvilutamide: 240 mg/time, once daily, taken orally before breakfast or after meals
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. The ECOG score is 0 or 1; 3. Diagnosed as prostate adenocarcinoma by histological pathology; 4. Radiotherapy is not suitable or not accepted after RP surgery. 5. At least 4 weeks after RP surgery, PSA=0.2ng/m or PSA shows two consecutive increases (time intervals >=2 weeks); 6. The organ function level must meet the following requirements (no blood transfusion or hematopoietic growth factor treatment has been received within two weeks before the blood routine screening) : •ANC>=1.5×10^9/L; PLT>=100×10^9/L; •Hb>=90 g/L; •TBIL=50%; •QTcF = 450 ms. 7. Subjects whose partners are fertile women should undergo surgical sterilization or agree to use effective contraceptive methods during the trial and for three months after the last administration of the study drug. 8. The subjects voluntarily joined this study, signed the written informed consent form, and were expected to have good compliance with the research protocol.
Exclusion criteria
Exclusion criteria: 1. Have previously received any endocrine therapy for prostate cancer (including but not limited to goserelin, leuprorelin, degarex, bicalutamide, abiraterone acetate, darotamide, apatamide, enzalutamide, etc.) or radiotherapy and chemotherapy; 2. The postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features; 3. Had received other clinical trial drug treatments and major surgeries within 4 weeks prior to the enrollment of this study; 4. There are conditions such as inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect the administration and absorption of the drug; 5. Have a history of epilepsy, or have experienced diseases that can induce epileptic seizures within 12 months prior to randomization (including a history of transient ischemic attack, stroke, or brain trauma with consciousness disorder requiring hospitalization); 6. Active heart disease was present within 6 months prior to randomization, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure (grade III or IV cardiac function), and ventricular arrhythmias requiring drug treatment; 7. There are active HBV and HCV infections (HBsAg positive with viral copy number >=500 IU/mL, HCV antibody positive with HCV RNA above the detection limit of the analytical method); 8. Those who have a history of allergy to rivelulamide and LHRHa drugs and their components; 9. Have a history of congenital immune deficiency or organ transplantation, or be an HIV-positive subject and meet one or more of the following conditions: • Not received highly active antiretroviral therapy; • Change antiretroviral therapy within 6 months prior to the start of screening; • Currently undergoing antiretroviral therapy that may interfere with the investigational drug (the sponsor can be consulted before enrollment); • CD4 count < 350/mm^3 during screening; • An opportunistic infection that meets the definition of acquired immune deficiency syndrome occurred within 12 months prior to the start of screening. 10. Having suffered from other malignant tumors within 3 years prior to enrollment (except for completely reacted carcinoma in situ and malignant tumors determined by the investigator to have a slow progression); 11. The researchers determined that the subjects with ejaculation ability and sexual activity were unwilling to take the contraceptive measures stipulated in the protocol throughout the study treatment period and within 3 months after the last administration. 12. According to the researcher's judgment, there are concomitant diseases (such as poorly controlled hypertension, severe diabetes, neurological or mental disorders, etc.) or any other conditions that seriously endanger patient safety, may confuse research results, or affect the completion of this study by the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 cycles of PSA response rate (PSA <= 0.2 ng/ml); | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year no biochemical recurrence rate (BCR);2-year progression free survival (rPFS);2-year metastasis free survival rate (MFS); | — |
Countries
China
Contacts
Public ContactJi Lu
The First Bethune Hospital of Jilin University
Outcome results
None listed