Metastatic prostate cancer. Malignant neoplasm of prostate
Conditions
Interventions
Intervention 1: Intervention group: Goserelin acetate 3.6 mg Varian Pharmed. Intervention 2: Control group: Goserelin acetate 3.6 mg AstraZeneca (Zoladex).
Sponsors
Varian pharmed company
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Age: 18 - 85 years Patients with locally advanced or metastatic prostate cancer Serum testosterone level: = 150 ng/dL (1.5 ng/mL or 5.2 nmol/L) at the time of the screening visit Life expectancy: at least 9 months ECOG performance status >2 Absolute neutrophil count (ANC) = 1.5 × 10^9/l Platelet count = 90 × 10^9/L White blood cell count = 3 × 10^9/L Hemoglobin = 90 g/L Total bilirubin (TBIL) = 1.5 × ULN ALT and AST = 2.5×ULN (or = 5.0×ULN for patients with liver metastases) Creatinine clearance > 50 mL/min Fertile individuals must use a reliable method of contraception for their female partners during the study period and for at least 3 months after the last dose of the study drug. Patients must sign the Ethics Committee (EC) approved informed consent form before any study-related activities, adhere to the study limitations, and complete all assigned examinations.
Exclusion criteria
Exclusion criteria: Patients with prostate cancer who have received prior or current hormonal therapy (surgical castration or other hormonal therapies including GnRH agonists or antagonists, anti-androgens, estrogens, megastore acetate, etc.), excluding patients who have undergone prostatectomy, radiotherapy, or cryotherapy and have received a maximum of 6 months of neoadjuvant or adjuvant hormonal therapy and discontinued treatment more than 6 months prior to screening Patients with hormone-resistance prostate cancer (confirmed or suspected) Patients who have undergone prostate surgery within 4 weeks prior to the first dose or have planned major surgery during the study Patients who have previously undergone hypophysectomy or adrenalectomy, or have a pituitary lesion or adrenal gland disorder History of severe asthma, anaphylaxis, or severe urticaria and/or angioedema Other malignancies diagnosed within 5 years prior to the screening visit, with the exception of treated basal cell or squamous cell skin carcinoma The following medical history within 6 months prior to the screening visit: stroke, transient ischemic attack (TIA), myocardial infarction, unstable angina, coronary artery revascularization, NYHA Class = II heart failure, severe unstable arrhythmia Patients with poorly controlled hypertension (SBP = 160 mmHg or DBP = 100 mmHg at screening visit). Patients with type 1 or type 2 diabetes with poor glycemic control (HbA1c > 8% at screening visit) Patients who have received treatment with 5-a reductase inhibitors (finasteride, dutasteride, enzalutamide, Epristeride, etc.) within 4 weeks prior to the first dose Patients who have previously received Goserelin Patients with congenital long QT syndrome or QT/QTc interval prolongation (QTc = 450 ms) at screening visit; or receiving medications that may prolong QT/QTc Known hypersensitivity to the active pharmaceutical ingredient or any Excipient of GnRH agonists or bicalutamide Patients who are seropositive for Hepatitis B surface antigen (HBsAg) and must meet both of the following conditions simultaneously: HBV DNA level: For HBeAg-positive patients, = 20,000 IU/mL (equivalent to 10^5 copies/mL); for HBeAg-negative patients, = 2,000 IU/mL (equivalent to 10^4 copies/mL)ALT = 2 × ULN. This also includes patients who are seropositive for HIV antibody. Alcoholics or substance abusers. Alcoholics are defined as individuals who consumed more than 14 units of alcohol per week during the 3 months prior to the screening visit (1 unit = 350 mL of beer, or 45 mL of spirits, or 150 mL of wine) Participation in any clinical trial of an investigational drug or medical device and discontinuation of it less than 1 month or 5 half-lives of the relevant drug prior to the screening visit (whichever is longer). Other conditions that the investigator deems unsuitable for entry into the study (e.g., spinal cord compression due to prostate metastatic lesions, interstitial lung disease, or other serious illnesses)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The evaluated of Cmax, Tmax and AUC. Timepoint: Blood sampling after drug injection, at specific times as follows: First day: 30 minutes before injection and at 0.25, 0.5, 1, 6, and 8 hours, then in the morning of days 2, 4, 7, 10, 13, 16, 19, 22, 25, 29, 36. Method of measurement: The LC-MS-MS liquid chromatography-mass spectrometer method is used, which is capable of analyzing various compounds with high accuracy. In fact, a liquid chromatography-mass spectrometer (LC-MS-MS) device is a liquid chromatography device with two mass spectrometers that can separate the compounds in a liquid sample with high accuracy, and the mass spectrometer is used to examine the chemical composition of each of the chemical components in the sample. If this is not possible, the Goserelin ELISA assay Kit method will be used to measure the serum level of the drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| The evaluated of serum levels of testosterone, PSA, LH, FSH hormones. Timepoint: Blood sampling after drug injection, at specific times as follows: First day: 30 minutes before injection and at 0.25, 0.5, 1, 6, and 8 hours, then in the morning of days 2, 4, 7, 10, 13, 16, 19, 22, 25, 29, 36. Method of measurement: Serum levels are checked by ELISA kits. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehdi Nazari Dehkori
Varian pharmed company
Outcome results
None listed