prostate cancer
Conditions
Interventions
Reference group:Subjects were subcutaneously injected with the reference preparation
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 75 years (including the critical value); 2. The body mass index should be within the range of 19.0~30.0 kg/m^2 (including the critical value), and the body weight should not be less than 50.0kg; 3. Diagnosis of prostate cancer: histopathologically confirmed as prostate cancer, suitable for endocrine therapy, and meeting either of the following two conditions: (1) Patients who have not received luteinizing hormone releasing hormone analogues (LHRH-a); (2) Patients receiving stable subcutaneous injection of leprerelin acetate microspheres 3.75mg for injection; 4. Eastern Cooperative Oncology Group (ECOG) score =1.5x10^9/L, platelet count >=80x10^9/L, white blood cell count >=3x10^9/L, hemoglobin >=80g/L; Total bilirubin =50mL/min; 6. The patient fully understands the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily acts as the patient and signs the informed consent; 7. Patients can communicate well with researchers and complete the experiment according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone or are undergoing prostate cancer-related castration, including surgical castration or other pharmacological castration, except those who are receiving leprerelin acetate microspheres for injection; 2. Patients with past or suspected spinal cord compression or urinary tract obstruction leading to kidney injury or at risk of developing such phenomenon; 3. Patients who have previously received adrenal or pituitary resection or have pituitary disease; 4. Patients who have previously undergone surgery that the investigator determined would significantly affect drug absorption, metabolism, distribution, or excretion, or who are scheduled to undergo surgical treatment during the trial; 5. Patients with known or suspected definite signs and symptoms of brain metastasis or definite diagnosis of brain metastasis or cerebrospinal disease; 6. Type I diabetes mellitus or type II diabetes mellitus with poor glycemic control (HbA1c > 8% at screening); 7. Patients with severe cardiovascular and cerebrovascular diseases, including but not limited to: (1) Patients with poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg under regular medication); (2) Patients with a history of hypertensive crisis or hypertensive encephalopathy; (3) Severe cardiovascular and cerebrovascular diseases such as myocardial infarction within 6 months before the first administration of the trial drug; (4) New York Heart Association classification >=II heart failure; (5) Medically uncontrolled severe arrhythmias (including QTc interval >=450 ms; QTc interval was calculated in Appendix 1) or congenital long QT syndrome; 8. Concurrent malignant neoplasms other than prostate cancer within 5 years, excluding surgically resected basal cell carcinoma or squamous cell carcinoma of the skin; 9. Hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, treponema pallidum antibody any positive; 10. Patients with severe central nervous system disease or history, epilepsy or history of epilepsy, or any condition that may induce epilepsy; 11. Patients who are allergic to or are allergic to any component of leuprelin acetate microspheres for injection or to synthetic LH-RH or LH-RH derivatives (allergic constitution refers to allergy to two or more drugs, foods and pollens); 12. Patients with difficulty in venous blood collection; 13. Use of drugs that prolong the QT interval or induce tip twist ventricular tachycardia within 4 weeks or 5 half-lives (whichever is longer) prior to screening; 14. Those who test positive for alcohol, drug or substance abuse; 15. Patients who participated in other clinical trials and used investigational drugs or devices within 3 months prior to enrollment; 16. Patients or their partners do not wish to use one or more non-drug contraceptive methods (such as barrier contraception or abstinence) for contraception during the study period or plan to have a family within 6 months after the study period; 17. Any other circumstances that the investigator considers might affect the patient's provision of informed consent or adherence to the test protocol, or the patient's participation in the test might affect the test results or his or her own safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the drug concentration time curve from day 7 to day 28;Area under the drug concentration time curve from 0 to day 28;The observed blood peak concentration after administration; | — |
Countries
China
Contacts
Public ContactWei Qiang, Feng Ping
West China Hospital of Sichuan University
Outcome results
None listed