Target disease: Treatment-naïve or on stable treatment for prostate cancer
Conditions
Interventions
Test Group (T) :Leuprorelin Acetate Microspheres for Injection
Reference Group (R):Leuprorelin Acetate Microspheres for Injection
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign the informed consent form; 2. Body mass index (BMI) between 18.0–30.0 kg/m^2 (inclusive), body weight >= 50.0 kg; 3. Age between 18–75 years (including 18 and 75); 4. Participants with histologically confirmed prostate cancer, suitable for endocrine therapy, and meeting one of the following conditions: 1) Have not previously received LHRH-a analog therapy; 2) Currently receiving stable treatment with leuprorelin acetate microspheres 3.75 mg injection. 5. ECOG score: 0–2; 6. Laboratory test indicators at screening meet the following standards: 1) Blood tests: absolute neutrophil count >= 1.5×10^9/L, platelet count >= 80×10^9/L, white blood cell count >= 3×10^9/L, hemoglobin >= 80 g/L; 2) Liver function: total bilirubin = 50 mL/min (calculated according to Cockcroft-Gault formula). 7. Participants and their partners (if of reproductive potential) must agree to use effective contraception during the study and for 6 months after D0 administration.
Exclusion criteria
Exclusion criteria: 1.Prior receipt of or ongoing castration therapy for prostate cancer, including surgical castration or other medical castration (excluding leuprorelin acetate microspheres 3.75 mg). 2.Known or suspected central nervous system metastases from prostate cancer. 3.History of other malignancies within 5 years, or concurrent active malignancies. Exceptions include localized tumors that have been cured, such as basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, or breast carcinoma in situ, etc . 4.History of adrenalectomy or hypophysectomy, or presence of pituitary lesions. 5.History of surgery that, as determined by the investigator, may significantly affect drug absorption, distribution, metabolism, or excretion, or planned surgery during the study period. 6.Suspected or confirmed spinal cord compression or urinary tract obstruction, or risk of developing these conditions. 7.History of severe central nervous system disorders or diseases; history of epilepsy, seizures, or conditions that may predispose to seizures. 8.History of severe cardiovascular disease, including but not limited to: 1)Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block. 2)QTcF > 450 ms on 12-lead electrocardiogram at rest. 3)Acute coronary syndrome, congestive heart failure, stroke, or other Grade 3 or higher cardiovascular events within 6 months prior to screening. 4)New York Heart Association (NYHA) functional class >= II. 5)Uncontrolled hypertension (systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg at screening). 6)Any factors that increase the risk of QTc prolongation or arrhythmias, such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in a first-degree relative under 40 years of age. Use of medications that prolong the QT interval or may induce torsade de pointes within 4 weeks or 5 half-lives (whichever is longer) prior to screening, including but not limited to quinidine, procainamide, amiodarone, and sotalol. 9.Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (glycated hemoglobin HbA1c > 8.0% at screening). 10.History of (non-infectious) pneumonia requiring systemic corticosteroid therapy, or current pneumonia/interstitial lung disease. 11.Positive hepatitis B surface antigen (HBsAg) with HBV-DNA above the lower limit of quantification, or positive hepatitis C virus (HCV) antibody with HCV-RNA above the lower limit of quantification; positive initial screen for HIV antibody. 12.History of severe asthma, anaphylactic reactions, or severe urticaria and/or angioedema. 13.Hypersensitivity to any component of leuprorelin acetate microspheres for injection, or to synthetic LHRH or LHRH derivatives. 14.Alcoholism, drug addiction, or positive drug abuse at screening. Alcoholism is defined as consumption of more than 14 units of alcohol per week within 3 months prior to screening (1 unit of alcohol ˜ 360 mL of beer with 5% alcohol, 45 mL of spirits with 40% alcohol, or 150 mL of wine with 12% alcohol). 15.Participation in another clinical trial of an investigational product (excluding leuprorelin acetate microspheres 3.75 mg) or device within 3 months prior to enrollment. 16.Difficulty with venous blood collection due to vascular conditions or other factors. 17.Any other condition that, as determined by the investigator, ma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Cmax of leuprolide in plasma;The AUC7-28D of leuprolide in plasma;The AUC0-28D of leuprolide in plasma; | — |
Secondary
| Measure | Time frame |
|---|---|
| Parameters of Leuprolide PK: Tmax,;Parameters of Leuprolide PK: t1/2;Parameters of Leuprolide PK: ?z;Parameters of Leuprolide PK: CL/F;Parameters of Leuprolide PK: Vd/F, etc; | — |
Countries
China
Contacts
Public ContactPingFeng Qiang Wei
West China Hospital of Sichuan University
Outcome results
None listed