prostate cancer
Conditions
Interventions
Experimental group:Usage and dosage of rezvilutamide: oral, once a day, 240mg each time. Medication duration: once a day, 28 days a week.
ADT: digalaric acetate for injection, 240mg, is used. It is in
Sponsors
The First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. age = 18 years old. 2. localized / locally advanced prostate cancer confirmed by pathology or Histocytology. 3. the investigator judged that the subject who was suitable and intended to undergo radical prostatectomy. 4. ECoG physical status score is 0 or 1. 5. meet one of the following high-risk factors: ? multi parameter MRI or PSMA pet/ct showed that the clinical stage of the primary tumor was = T3a. ? Gleason score of primary tumor = 7. ? prostate specific antigen (PSA) = 20ng/ml. ? lymph nodes 1.5 x ULN, direct and indirect bilirubin measurement. If direct bilirubin = 1.5 x ULN, subjects may be eligible) ? aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 2.5 x ULN ? serum albumin = 3.0 g/dl ? serum creatinine <2.0 x ULN ? partial thromboplastin time PTT = 60 7. patients with fertility must be willing to use efficient contraception during the study period and within 120 days after the last dose of treatment. 8. be able to swallow pills normally. 9. sign the informed consent and voluntarily join this study.
Exclusion criteria
Exclusion criteria: 1. patients with small cell or sarcomatoid pathological features are not eligible. 2. patients with low or moderate risk localized prostate cancer. 3. patients with clinical or radiological evidence of bone metastasis or visceral metastasis (any M1) were ineligible. 4. patients who have previously received androgen deprivation therapy (medical or surgical) or local treatment, radiotherapy, chemotherapy for prostate cancer are not eligible. 5. this study had received other clinical trial drug treatment and major surgery within 4 weeks before randomization. 6. there are other factors such as inability to swallow, chronic diarrhea and intestinal obstruction, or affecting drug administration and absorption. 7. those who are known to have a history of allergy to shr3680 tablets, abiraterone and GnRHa drugs and their components. 8. patients with severe or uncontrolled concurrent infections are not eligible. 9. have a history of epilepsy, or have a disease that can induce seizures within 12 months before randomization. 10. have a history of congenital immune deficiency or organ transplantation, or HIV positive subjects. 11. have suffered from other malignant tumors within 3 years before randomization (except for carcinoma in situ that has completely remitted and malignant tumors that the investigator judged to progress slowly). 12. at the time of screening, patients must not have New York Heart Association class III or IV congestive heart failure. Patients should not have any thromboembolic events, unstable angina pectoris, myocardial infarction within 6 months before registration. History of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsade de pointes); Fridericia correction formula (QTCF) was used to extend the corrected QT interval >470 ms when screening ECG. 13. uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg). Participants with a history of hypertension can participate, provided that blood pressure is controlled through antihypertensive treatment. 14. patients are participating in other clinical intervention studies. 15. informed consent was not obtained. 16. the investigator judges other situations that are not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive margin (PSM) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| MFS;PSA response rate;proportion of downgrading;time to biochemical recurrence;pCR rate;safety; | — |
Countries
China
Contacts
Public ContactWeijun Qin
The First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed