Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Leuprolide acetate (Luprodex)
3.75 mg (Depot): Will be administered subcutaneously once a month for two cycles, on day 0 and on day 28/29
Control Intervention1: Leuprolide acetate (Lucr
Sponsors
Bharat serums and Vaccines ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male subjects aged above 18 years 2. Histologically or cytologically confirmed adenocarcinoma of the prostate at stage T1b-4 Nany, Many in subjects, who would benefit from a GnRH agonist 3.Baseline Testosterone of >1.50 ng/mL or >150 ng/dL 4. For subjects with radical prostatectomy, an increase of 0.2 ng/mL or 20 ng/dL in PSA from previous test on two consecutive tests. For subjects with prostate irradiation a rise of greater than or equal to 2.0 ng/mL or 200 ng/dL PSA above the nadir 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 6. Life expectancy of at least 6 months from screening 7. Adequate organ and immune system function as indicated by the following laboratory values, obtained less than equal to 14 days prior to dosing -Absolute Neutrophil Count more than equal to 1500/mm3 -Hb more than equal to 9.0 g/dL -Platelets more than equal to100,000/mm3 -Serum Creatinine less than equal to 1.6 mg/dL -Total Bilirubin less than equal to1.5 mg/dL or less than equal to 2 mg/dL (for liver mets) -AST (SGOT) less than equal to 2.5 × ULN or less than equal to 5 × ULN (for liver mets) -ALT (SGPT) less than equal to2.5 × ULN or less than equal to 5 × ULN (for liver mets) 8. Willing to participate and sign the informed consent as per regulatory requirements
Exclusion criteria
Exclusion criteria: 1. Evidence of brain metastases 2. Evidence of spinal cord compression 3. Evidence of urinary tract obstruction 4. Received prostate cancer therapies like immunotherapy external radiotherapy, brachytherapy, chemotherapy or biological response modifiers within two months of enrolment 5. Undergone any prostate surgery (e.g. transurethral resection of the prostate (TURP), radical prostatectomy) 6. Under the effects of any other hormonal therapy, including anti-androgens for treatment of prostate cancer 7. Received leuprolide previously 8. Had an orchiectomy, adrenalectomy or hypophysectomy 9. Had used any investigational drug, biologic, or device within five half-lives of its physiological action or three months 10. Anticipated to need concomitant hormonal, anti-androgen, radiotherapy, chemotherapy, immunotherapy or surgical therapy for prostate cancer throughout the duration of the study 11. Used over-the-counter (OTC) or alternative medical therapies which has an estrogenic or anti-androgenic effect (e.g., Glycyrrhiza, Dehydroepiandrosterone (DHEA), PC-SPES, saw palmetto) 12. Used finasteride, dutasteride, estrogens, megestrol acetate, anti-androgens (Bicalutamide, Flutamide, or Cyproterone), and ketoconazole 13. Co-existent malignancy or a history of malignancy, with the exception of basal and/or squamous cell carcinomas of the skin. 14. Uncontrolled congestive heart failure within 6 months before baseline 15. Experienced a myocardial infarction or a coronary vascular procedure (e.g. balloon angioplasty, coronary artery bypass graft surgery 16. Significant symptomatic cardiovascular disease 17. Experienced venous thrombosis 18. Uncontrolled hypertension (more than equal to 160/100 mmHg) or symptomatic hypotension 19. Insulin-dependent diabetes mellitus 20. History of drug abuse 21. Serious intercurrent illnesses or diseases that might interfere with the treatment outlined in the protocol. 22. Receiving anticoagulants or antiplatelet medications. Receiving warfarin-derivative anticoagulants with International normalized ratio (INR) outside therapeutic range 23. Known hypersensitivity to GnRH, GnRH agonists or any excipients of Leuprolide 24. Positive test for HIV, HCV, HbsAg at Screening 25. History of: a. Immunization b. Flu shots c. Donation or receipt of blood or blood products d. Anaphylaxis e. Skin disease f. Dermatographism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Testosterone response rate defined as Testosterone values sustained below castration level (0.5 ng/mL or 50 ng/dL) i.e. all Testosterone values at and after Day 28 until Day 57 must be 0.5 ng/mL or 50 ng/dLTimepoint: day 28, day 57 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean number of days of maintaining testosterone castration levelsTimepoint: Day 57 (mean number of castration days);Percentage of breakthrough responses defined as a single total serum Testosterone value of 0.5 ng/mL or 50 ng/dL measured after achieving a castration Testosterone levelTimepoint: Day 28 until 57;Percentage of subjects who have reached castration level of Testosterone at the last visitTimepoint: day 57;Rate of subjects with Testosterone values sustained below 0.2 ng/mLTimepoint: days 28 or 29, 36, 43, 50, 57;Time after first implantation until castration level of Testosterone is achievedTimepoint: Days 7, 14, 21, 28 or 29, 36, 43, 50, 57; Pharmaco-kinetic variables Cmax, AUC0-t, AUC0-infinity, Tmax, T½, Kel for Leuprolide (Leuprorelin) in 12 subjects in Russia Timepoint: Day 0- 5 samples. Day 7, 14, 21, 28/29, 36, 43, 50, 57;Change from baseline in Follicle Stimulating Hormone (FSH) levelsTimepoint: day 28, day 57;Change from baseline in Luteinizing hormone (LH) levelsTimepoint: day 28 , day 57;Change from baseline in Prostate-specific antigen (PSA)Timepoint: day 57;Mean maximum testosterone concentration during the dosing period after reaching the castration levelTimepoint: Day 28 to Day 57 | — |
Countries
India, Russian Federation
Contacts
Public ContactAnirban Roy Chowdhury
Bharat Serums and Vaccines Ltd
Outcome results
None listed