Locally advanced or metastatic prostate cancer
Conditions
Interventions
experimental group:tripraline acetate microspheres by Intramuscular injection
Sponsors
The First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. The subjects or their legal representatives voluntarily sign the written informed consent; 2. Male, aged 18 years and above; 3. Patients who were diagnosed as locally advanced or metastatic prostate cancer and were judged by the researchers to be suitable for endocrine therapy; 4. Total prostate specific antigen (TPSA) >= 4.0 ng / ml; 5. Patients with total testosterone >= 150 ng / dl; 6. Patients with expected survival >= 6 months; 7. Patients with ECoG score of 0 or 1; 8. Hematopoiesis and main organ function indexes meet the following standards: Neutrophil absolute value >= 1.5 x 10 9 / L Platelet >= 75 x 10 9 / L Hemoglobin >= 90g / L Total bilirubin = 50 ml / min (calculated by Cockcroft Gault formula) 9. Fertile subjects must agree to use reliable contraceptive methods (barrier method or abstinence) with their partners during the study and at least 90 days after the last medication; 10. Consent to medication and evaluation in accordance with protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who have received or are receiving endocrine therapy (including GnRH agonists, GnRH antagonists, antiandrogens, estrogens, medroxyprogesterone acetate, etc.) before, but for patients who have received prostatectomy, radiotherapy or cryotherapy before, the cumulative amount of new adjuvant / adjuvant endocrine therapy shall not exceed 6 Months, except for those who terminated the treatment for more than 6 months at the time of signing the informed consent; 2. Patients who have undergone any major surgery within 1 month before signing the informed consent, or any surgery during the planned study period; 3. Patients who had received 5-a reductase inhibitors (finasteride, dutasteride, iristeride, etc.) within one month before signing the informed consent; 4. Participate in the clinical trial as the subject within 3 months before signing the informed consent (whether receiving the trial drug or corresponding treatment or not); 5. Patients with other malignant tumors (except skin basal or squamous cell carcinoma removed by operation); 6. Patients with known or suspected spinal cord compression caused by spinal cord metastasis; 7. Patients with definite symptoms and signs of brain metastasis or with definite diagnosis of brain metastasis; 8. Patients who are in an allergic state, or have a history of allergy to GnRH agonists and / or any excipients; 9. Type I diabetes; type II diabetes with poor blood glucose control (HbA1c >= 9%) or positive urine ketone body; 10. Patients with HIV antibody, HBsAg, HCV antibody and Syphilis Serological Test; 11. Patients who have previously undergone hypophysectomy or adrenalectomy; twelve Any mental disease, severe or unstable known disease that may affect the safety and outcome of the study or the test drug, including but not limited to active infection, severe respiratory system disease, cardiovascular system disease (including but not limited to symptomatic congestive heart failure, myocardial infarction, coronary heart disease, serious arrhythmia, deep vein thrombosis Poor control of hypertension (systolic blood pressure >= 160 mmHg and / or diastolic blood pressure >= 100 mmHg), clinically significant vascular diseases, etc; 13. At baseline, 12 lead ECG showed QTc >= 450 ms, or drugs that may prolong QT / QTc interval were expected to be used during the trial, or congenital long QT syndrome; 14. The researcher thinks that other circumstances are not suitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose testosterone reached castration level at the end of 28 days after the first administration (total serum testosterone < 50 ng / dl), and who maintained the castration level at the end of 28 days after the second and third administration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose testosterone reached castration Level 3 and 7 days after the second and third administration;Proportion of subjects whose TPSA decreased by more than 90% from baseline and the degree of decrese at the end of 28 days after the first, second and third administration;Tmax,sd, Cmax,sd, AUC0-28,sd; | — |
Countries
China
Contacts
Public ContactJianzhong Shentu/ Baiye Jin
The First Affiliated Hospital of Zhejiang University Medical College
Outcome results
None listed