Health Condition 1: null- locally advanced and metastatic prostate cancer. Health Condition 2: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: leuprolide acetate, Leuprolide Sun 3.75 mg (Sun Pharmaceutical Industries Limited, India).: The study will consist of a 2-month active treatment period (2 cycles). Eligible subjects wil
Sponsors
Sun Pharma Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologic or cytologic diagnosis of adenocarcinoma of the prostate (stage T1-4 N0-3M0-1). 2.Age >= 18 years. 3.Serum testosterone levels within normal limits (250-1500 ng/dl) at screening. 4.ECOG performance status of 0-2. 5.Estimated life expectancy of at least 8 weeks. 6.Adequate organ and immune system function as indicated by the following laboratory values, obtained AST 1 X 109 /L,Platelet count > 100 X 109/L,Hemoglobin > 10 g/dL 7.HIV non-reactive. 8.Accepts post-therapeutic visits at study site. 9.Willing to use appropriate birth control methods such as surgical sterilization or barrier contraception, men with partners of child bearing potential willing to use appropriate birth control methods, such as surgical sterilization, hormonal birth control (partner), an intrauterine device (partner) or double-barrier method for the entire study period.
Exclusion criteria
Exclusion criteria: 1.Subjects who had- a)An orchiectomy, hypophysectomy, or adrenalectomy. b)Undergone any prostatic surgery (e.g. transurethral resection of the prostate (TURP), radical prostatectomy) within 2 weeks of screening visit. 2.Subjects who had been treated with/used â?? a)Prostate cancer therapies (e.g. radiotherapy, brachytherapy, chemotherapy, immunotherapy, tumor vaccines, biological response modifiers) within 2 months of screening visit. b) Luteinizing hormone-releasing hormone (LHRH) agonists (e.g., Leuprolide, Goserelin, Buserelin) or antagonists (e.g., degarelix) within 12 months of screening visit, and/or exceeding 6 consecutive months at a time. c)Androgen receptor blockers (e.g., Bicalutamide, Flutamide, Megestrol acetate, Cyproterone) within 3 months prior to screening visit. d)5-alpha-reductase inhibitors (e.g., finasteride, dutasteride) within 3 months prior to screening visit. e)Investigational drug or device within 3 months of screening. 3.Subjects with anticipatedâ?? a)Need of concomitant medication (anti-androgens) to prevent or treat flare up reactions such as urinary tract obstruction or spinal cord compression. b)Problems for compliance with the planned follow-up visits for this protocol, in the opinion of the investigator. 4.Subjects with â?? a)Evidence of brain metastases, in the opinion of the investigator, taking into account medical history, clinical observations, and symptoms. b)Clinically significant cardiovascular abnormalities. Serious cardiovascular disorders or procedures (e.g. myocardial infarction, coronary vascular procedure, uncontrolled congestive heart failure) within 6 months of study entry. c)Any symptoms or diseases, which could interfere with the evaluation of local tolerance of the study medication at the injection site (e.g. immunization, flu vaccination, etc). d)Systemic diseases or other conditions (e.g. hematological, renal, hepatic, respiratory, endocrine, psychiatric), which would not allow safe completion of this study protocol in the opinion of the investigator. e)Prior or concurrent malignancy (curatively treated carcinoma-in-situ or basal cell carcinoma or subjects with previously treated malignancies who have been disease-free for at least 5 years are eligible). f)Active hepatitis, HIV (anamnestic evaluation). g)Active bacterial and viral infection. h)Active peptic ulcer or active gastrointestinal bleeding. i)Known hypersensitivity to LHRH, LHRH agonists or any excipients of the study medication (Test, Reference). j)History of substance abuse. 5.Subjects who have not recovered from reversible side effects of previous surgery, chemotherapy or radiation therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achieving a total serum testosterone concentration within the castration range defined as serum testosterone 50 ng/dl on Day 29 (Week 5)Timepoint: Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional efficacy assessments (testosterone, LH, PSA, AP)Timepoint: Day 29;Pharmacokinetic evaluation of leuprolide acetate levels (for a subset of 12 subjects in each arm) Timepoint: Day 29;Safety and tolerability assessment Timepoint: Day 29 | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Ltd
Outcome results
None listed