Prostate Cancer
Conditions
Interventions
SYH9016 injection:Subcutaneous injection
Enantone:Subcutaneous injection
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old; 2. Patients with prostate cancer diagnosed by pathological histology or cytology, which are judged by the investigator to be suitable for endocrine therapy alone, including patients who have received radical therapy (surgical resection, external beam radiation therapy or cryotherapy) and are suitable for endocrine therapy; 3. Serum testosterone > = 150 ng/dL (1.50 ng/mL or 5.2 nmol/L) (based on test results from the research center); 4. Expected survival of at least 12 months; 5. ECOG score 0~1 points; 6. Major organ and bone marrow function within 7 days prior to treatment, meeting the following criteria (no blood transfusion, EPO, G-CSF, GM-CSF or other medical supportive therapy within 7 days prior to study drug administration): System laboratory test values Complete blood count White blood cell count >=3.0×10^9/L ANC >=1.5×10^9/L Platelets >=100×10^9/L Hemoglobin >=90 g/L kidney Serum creatinine 50 mL/min liver Total bilirubin <=1.5×ULN, and <=3×ULN for liver metastases AST and ALT <=2.5×ULN, and liver metastases <=5×ULN Clotting INR or PT <=1.5×ULN APTT <=1.5×ULN 7. Understand and voluntarily sign the ICF; 8. Male participants are required to use adequate non-pharmacological contraception from the start of ICF signing until 180 days after the last dose and are not allowed to donate sperm.
Exclusion criteria
Exclusion criteria: 1. Evidence of brain metastases, spinal cord compression, or urinary tract obstruction; History of other malignancies within 2.5 years or concomitant other active malignancies. Exclude cured localized tumors, such as basal cell or squamous cell carcinoma of the skin, superficial bladder cancer or carcinoma in situ of the breast, etc.; 3. Those who have undergone any major surgery (including but not limited to transurethral resection of the prostate, radical prostatectomy, etc.) within 4 weeks before the screening visit, or who have undergone major surgery during the planned trial; 4. Previous adrenalectomy, pituitary resection or pituitary lesions; 5. Received radiotherapy within 2 weeks before the first dose; 6. Prostate cancer patients who have undergone or are undergoing endocrine therapy (surgical castration or other endocrine therapy including GnRH receptor agonists, GnRH receptor antagonists, antiandrogens, estrogen, megestrol acetate, etc.), except for prostate cancer patients undergoing prostatectomy, radiotherapy or cryotherapy, if they have received neoadjuvant endocrine therapy/adjuvant endocrine therapy for no more than 6 months, except for those who have terminated the above treatment for more than 6 months before screening; 7. Patients with confirmed or suspected hormone-resistant prostate cancer; 8. Those who have used 5-a reductase inhibitors (finasteride, dutasteride, erristeride, etc.) within 3 months before randomization; 9. Patients who are using or plan to use traditional Chinese medicine, proprietary Chinese medicine, health care products and drugs that may affect serum testosterone concentration during the trial period, if the indications or functional indications of traditional Chinese medicine, Chinese patent medicine, and health care products include the words "treatment of prostate cancer", "affecting androgen levels", "aphrodisiac", etc., the first dose should be discontinued >=4 weeks; 10. Have received an investigational drug, investigational biological product, or investigational medical device, and have discontinued the drug within 1 month before the first dose or within 5 half-lives of the corresponding drug, whichever is longer; 11. HBsAg positive and HBV-DNA higher than the lower measurable limit, HCV antibody positive and HCV-RNA higher than the lower measurable limit; Positive anti-HIV antibody initial screening; 12. Have a history of severe cardiovascular disease, including but not limited to: (1) Have severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular block, etc.; (2) At rest, the QTcF of 12-lead ECG examination >450 ms; (3) Acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events of grade 3 or above within 6 months prior to screening; (4) NYHA cardiac function class>=II.; (5) poorly controlled hypertension (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg during the screening period); (6) Any factor that increases the risk of QTc prolongation or arrhythmia: such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in a first-degree relative younger than 40 years of age; (7) Those who use drugs that prolong the QT interval or drugs that can induce torsade de pointes within 4 weeks or 5 half-lives (whichever is longer) before screening, including but not limited to: quinidine, procaina
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;MTD;Optimal recommended dosage; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK indicator;PD indicator;The cumulative probability of maintaining castration levels of serum testosterone (serum testosterone = 50 ng/dL) from the end of the first dose of PK indicator to the end of 28 days after the last dose.; | — |
Countries
China
Contacts
Public ContactQiang Wei/Ping Feng
West China Hospital, Sichuan University
Outcome results
None listed