Locally advanced or metastatic prostate cancer suitable for endocrine therapy.
Conditions
Interventions
Goserelin acetate sustained release microspheres for injection (LY01022):Goserelin Acetate Sustained-Release Microspheres for Injection (LY01022), Specification: 10.8 mg (calculated as C59H84N18O14),
Norethindrone (Goserelin Acetate Sustained-Release Implant):Zoladex (Goserelin Acetate Sustained-Release Implant), Specification: 10.8 mg/shot (calculated as goserelin). Storage: Keep below 25°C. Manu
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male aged >= 18; 2. Patients with locally advanced or metastatic prostate cancer who are pathologically confirmed and suitable for endocrine therapy, including those who have received radical treatment and are suitable for endocrine therapy; 3. Testosterone >= 150 ng/dl (1.50 ng/ml or 5.2 nmol/l) at screening; 4. The estimated survival time is > 9 months; 5. ECoG score = 1.5 × 10^9 / L, platelet count>= 90 × 10^9 / L, white blood cell count >= 3 × 10^9 / L, hemoglobin >= 90 g / L; 7. Total bilirubin = 50 ml/min at screening (calculated according to Cockcroft Gault formula); 9. Fertile subjects must agree to use reliable contraceptive methods with their partners during the study period and at least 6 months after the last medication; 10. Voluntarily sign the written informed consent before screening, be willing to abide by the research restrictions, and be able to cooperate to complete the specified examinations.
Exclusion criteria
Exclusion criteria: 1. Patients with prostate cancer who have received or are undergoing endocrine therapy (surgical castration or other endocrine therapy, including gonadotropin-releasing hormone (GnRH) receptor agonists, GnRH receptor antagonists, antiandrogens, estrogens, megestrol acetate, etc.), except for patients with prostate cancer who have undergone anterior resection, radiotherapy or cryotherapy, if they have received neoadjuvant endocrine therapy / adjuvant endocrine therapy for no more than 6 months, and have terminated the above treatment for more than 6 months before the screening visit; 2. Patients with confirmed or suspected hormone resistant prostate cancer; 3. Patients who had undergone any prostate surgery or major surgical treatment during the planned trial within 4 weeks before the first administration; 4. Patients who have previously undergone pituitary resection or adrenalectomy or have pituitary lesions or adrenal dysfunction; 5. Have a history of severe asthma, allergic reaction or severe urticaria and / or vasogenic edema; 6. Other malignant tumors diagnosed within 5 years before screening, except for surgically resected skin basal or squamous cell carcinoma; 7. Those with the following medical history within 6 months before screening: stroke, transient ischemic attack (TIA), myocardial infarction, unstable angina pectoris, coronary revascularization history, New York Heart Association (NYHA) grade >= II cardiac insufficiency, severe unstable ventricular arrhythmia; 8. Hypertensive patients with poor blood pressure control (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg at screening visit); 9. Patients with type 1 diabetes or type 2 diabetes with poor glycemic control (HbA1c > 8% at screening visit); 10. Patients who have received 5- a reductase inhibitors (finasteride, dutasteride, Epristeride, etc.) within 2 weeks before the first administration or within 5 drug half lives (whichever is longer); 11. Patients who received coumarin anticoagulants at the time of screening; 12. Patients with prolonged QT/QTc interval (QTc >= 450 ms) or using drugs that may prolong QT/QTc interval, or congenital long QT syndrome at the time of screening; 13. Known to have a history of allergic reaction to GnRH agonist or bicalutamide active ingredient or any excipient; 14. Hepatitis B surface antigen (HBsAg) test positive patients, and meet the following two conditions at the same time: A. hepatitis B virus (HBV) deoxyribonucleic acid (DNA) level: hepatitis B virus e antigen (HBeAg) positive patients, HBV DNA >= 20000 iu/ml (equivalent to 10^5 copies /ml); Or HBeAg negative patients, HBV DNA >= 2000 iu/ml (equivalent to 10^4 copies /ml); b. Alt >= 2 × ULN; 15. Hepatitis C virus (HCV) antibody positive; Human immunodeficiency virus (HIV) antibody positive; 16. Alcoholics or those with a history of drug abuse. Alcoholism was defined as drinking more than 14 units of alcohol per week within 3 months before screening (1 unit = 350 ml of beer, 45 ml of liquor, or 150 ml of wine); 17. Have participated in any clinical study of medical devices or drugs before screening, and have stopped using the study drugs / devices for less than 1 month until the end of the study before screening; 18. The investigator believes that other cases need to be excluded (such as prostate cancer metastasis to the vertebral body leading to spinal cord compression, interstitial lung disease, other serious diseases, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters: Time to maximum concentration, maximum concentration (C???), area under the plasma concentration-time curve, half-life , mean residence time (MRT), plasma clearance (CL/F), and apparent volume of distribution (Vz/F).; | — |
Secondary
| Measure | Time frame |
|---|---|
| PD parameters: Maximum concentration (ECmax), minimum concentration (ECmin), and time to maximum concentration (ETmax) of serum testosterone, LH, and FSH; time to reach castration level of serum testosterone (<=50 ng/dL) (Tcastr); proportion of subjects with serum testosterone at castration level (<=50 ng/dL) on Days 29, 57, and 85, etc.;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactFan Yu
Peking University First Hospital
Outcome results
None listed