prostatic cancer
Conditions
Interventions
Queue 1 :Riverutamide: From subject enrollment, lasting 24 cycles (cycles 1-24), with each treatment cycle lasting 28 days.
ADT: To be administered simultaneously with reverutamide, the ADT regimen fo
Queue 2:Riverutamide: was enrolled from subjects and lasted for 12 cycles (cycles 1-12), with each treatment cycle lasting 28 days.
ADT: To be administered simultaneously with reverutamide, the ADT re
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be enrolled in this study, patients must meet all of the following criteria: 1. Age =18 years old; 2.ECOG score is 0 or 1; 3. Pathological diagnosis of prostate adenocarcinoma; 4. Postoperative risk factors, that is, meeting at least two of the following conditions: 1) positive margin; 2) pT3-4; 3) gleason score 8-10 or ISUP4-5; 4) PSA>20ng/ml; 5. PSA < 0.1ng/ml within 1 week before enrollment; 6. Have received radical surgery for prostate cancer within the past 3 months and no metastasis has been confirmed by preoperative imaging (CT or MRI); 7. Expected survival time =10 years; 8. The level of organ function must meet the following requirements (no blood transfusion or hematopoietic growth factor treatment within 2 weeks prior to blood routine screening) : •ANC=1.5×10^9/L; •PLT=100×10^9/L; •Hb=90 g/L; •TBIL=1.5×ULN (except subjects with Gilbert syndrome) •ALT and AST=2.5 x ULN; •Cr=1.5×ULN; •LVEF=50%; •QTcF= 430 ms. 9. According to the judgment of the researcher, can comply with the test plan; Cohort 2 patients proposed to receive radiation therapy and cohort 1 patients were not suitable for or refused radiation therapy. 10. Signed a written informed consent, and it is expected that the compliance with the research protocol is good.
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria were excluded from the study: 1. Have previously received any endocrine therapy for prostate cancer (including but not limited to goserrelin, levoprorelin, digarek, bicalutamide, abiraterone acetate, darotamine, apatamide, enzalutamide, etc.) or pelvic radiotherapy; 2. Postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features; 3. Received other investigational drug therapy and major surgery within 4 weeks prior to randomization; 4. Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors affecting the administration and absorption of drugs; 5. Have a history of epilepsy, or have a medical condition that can induce seizures in the 12 months before randomization (including a history of transient ischemic attacks, cerebral stroke, traumatic brain injury with disturbance of consciousness requiring hospitalization); 6. Active heart disease, including severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure (grade III or IV), and medically treatable ventricular arrhythmias, in the 6 months prior to randomization; 7. Patients with active HBV and HCV infection (HBsAg positive and virus copy number =500 IU/mL, HCV antibody positive and HCV RNA higher than the lower limit of detection method); 8. Known allergic history to reverumide and LHRHa drugs and their components; 9. A history of congenital immune deficiency or organ transplantation, or an HIV-positive subject who meets one or more of the following criteria: • Not receiving highly active antiretroviral therapy; • Change of antiretroviral therapy within 6 months before the start of screening; • is receiving antiretroviral therapy that may interfere with study drugs (sponsor may be consulted prior to enrollment); • CD4 count < 350/mm3 at screening; • An opportunistic infection that meets the definition of acquired immunodeficiency syndrome occurs within the 12 months prior to the start of screening. 10. Have had other malignancies within 3 years prior to randomization (except for carcinoma in situ that has been in complete remission and malignancies that have been determined by the investigators to be progressing slowly); 11. Subjects who are sexually active and capable of ejaculation are judged by the investigator to be unwilling to use the contraceptive method prescribed in the protocol throughout the study treatment period and within 3 months after the last dose; 12. In the investigator's judgment, there is a concomitant medical condition (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers patient safety, may confuse the study results, or may interfere with the subject's completion of the study.(YNMT)·
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There was no biochemical recurrence rate in 3 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival without biochemical recurrence; 4-year survival rate without distant metastasis; | — |
Countries
China
Contacts
Public ContactXu Zhang
Chinese PLA General Hospital
Outcome results
None listed