prostate cancer
Conditions
Interventions
experimental group:estramustine and LHRH for 6 months before radical prostatectomy
Control group:radical prostatectomy directly
Sponsors
Department of Urology, Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years; 2. Histological examination confirmed that prostate adenocarcinoma was suitable for radical prostatectomy. It conforms to the definition of high-risk prostate cancer. That is to say, it meets any of the following criteria: 1) Gleason score =8; 2) PSA value = 20ng/ml; 3) clinical grade = T2c. 3. ECOG score 0 or 1; 4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin were in the normal range (WNL). 5. Serum creatinine within the normal range (WNL); 6. Platelets and hemoglobin were within the normal range. No blood transfusion and/or growth factor transfusion were performed within 3 months before randomized grouping. 7. Contraception during the study period and 3 months after medication.
Exclusion criteria
Exclusion criteria: 1. Imaging diagnosis of lymph node metastasis (N+); 2. Distant metastasis (clinical stage M1); 3. Recent radiotherapy for prostate cancer; 4. Received treatment for prostate cancer; 5. Bilateral orchiectomy; 6. History of pelvic radiotherapy; 7. Any experimental drugs were used within the first four weeks of randomized grouping. 8. Major operations were performed within the first four weeks of randomization. 9. Any of the following events during the first six months of the follow-up period: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolism (e.g., pulmonary embolism, cerebrovascular accident, including transient ischemic attack), or clinically significant ventricular arrhythmia or New York Heart Association (NYHA) Grade II to IV heart disease, deep venous thrombosis Formation (DVT). 10. Abnormal coagulation mechanism; 11. Aspirin contraindications; 12. Obvious edema; 13. Active infections requiring systematic treatment, such as human immunodeficiency virus (HIV), active or symptomatic viral hepatitis or chronic liver disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| biochemical recurrence-free survival of 1st year and 2nd year; | — |
Countries
China
Contacts
Public ContactXing Nianzeng
Department of Urology, Cancer Institute & Hospital,Chinese Academy of Medical Sciences
Outcome results
None listed