Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Leuprolide acetate for depot suspension 7.5 mg for 1-month administration: 7.5 mg intramuscular injection, to be administer at a dosing interval of 28 (±2 days) for period of 4 months (
Sponsors
Pharmathen
Cliantha Research limited
Eligibility
Inclusion criteria
Inclusion criteria: Patient will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male of age 18-85 years with histologically proven carcinoma of the prostate (undergoing initial therapy of leuprolide acetate), who require leuprolide treatment as per investigator judgement. 2. Life expectancy of at least 1 year at the time of screening as judged by the investigator. 3. Patient with Body Mass Index (BMI) = 18.5 to = 32 kg/m2 at screening and randomization visit. 4. PSA level should be greater than 4 mg/mL. 5. Patient having adequate hematologic reserve. a. Hemoglobin = 9 gm/dL b. WBC (white blood cells) =4000/mm3 c. Absolute neutrophils count =1500/mm3 d. Platelets =1,00,000/mm3 (Patient who is on coumarin anticoagulants must have Platelets count =1,50,000/mm3) 6. World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1, or 2. 7. Adequate renal function at screening as defined by serum creatinine = 1.6 times the ULN (Upper Limit of Normal) for the clinical laboratory. 8. Adequate and stable hepatic function as defined by bilirubin = 1.5 times the ULN (upper limit of normal) and transaminases (i.e., SGOT, SGPT) = 2.5 times the ULN (upper limit of normal) for the clinical laboratory at screening. Note: For patient with liver metastasis, bilirubin = 2 times the ULN (upper limit of normal) and transaminases (i.e., SGOT, SGPT) = 5 times the ULN (upper limit of normal) is allowed. 9. Patient agrees to use acceptable contraceptive methods during study. 10. Patient with adequate muscle mass to receive the intramuscular injection according to the investigator. 11. Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations. 12. Patient willing to provide informed consent to participate in the study. 13. Non-smoker or ex-smoker who has not used any nicotine containing products in the last 6 months before Day 0 of study treatment.
Exclusion criteria
Exclusion criteria: Patient will not be eligible for inclusion in this study if any of the following criteria apply: 1. Patient with hypersensitivity to GnRH, GnRH agonist analogs including any LHRH analogues, or any excipients of the study formulation. 2. Patient with anaphylactic reactions to synthetic GnRH or GnRH agonist analogs. 3. Patient with history or presence of hypogonadism, or receipt of exogenous testosterone supplementation within 6 months of screening visit. 4. Patient requiring additional treatment for prostatic cancer (i.e. radiotherapy). 5. Participated in any other clinical investigation using experimental drug/donated blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in past 90 days before screening visit. 6. Consumption of any grapefruit juice and its products (pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices), red wine, seville oranges, and seville orange juice and its products within 07 days prior to randomization (Day 0) to throughout the study duration. 7. Patient with evidence of brain metastases, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms. 8. Patient with evidence of spinal cord compression, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms. 9. Patient with evidence of severe urinary tract obstruction with threatening urinary retention, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms. 10. Patient with excruciating, severe pain from extensive osseous deposits, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms. 11. Testosterone levels less than 1.5 ng/mL at screening and randomization visit. 12. Patient with previous orchiectomy, adrenalectomy or hypophysectomy. 13. Patient with previous prostatic surgery (e.g., radical prostatectomy, transurethral resection of the prostate [TUR-P]) within 2 weeks from screening visit or not recovered from any undesirable or harmful effects of surgery. 14. Patient with previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g., antibody therapies, tumor-vaccines), biological response modifiers (e.g., cytokines) within 2 months from screening visit. 15. Patient who has received prior hormonal therapy for treatment of prostate cancer, such as luteinizing hormone-releasing hormone (LHRH) analogues (e.g., Leuprorelin acetate, Goserelin etc.) [No washout allowed]. 16. Patient who has received anti-androgen treatment (i.e., androgen receptor antagonist like Bicalutamide, Flutamide, Megestrol, cyproterone acetate) [No washout allowed]. 17. Administration of 5-alpha-reductase inhibitors (Proscar®, Avodart®, Propecia®) within 6 months before screening visit. 18. Over-the-counter (OTC) or alternative medical therapies which have an estrogenic or antiandrogenic effect (i.e., PC-SPES, saw palmetto, Glycyrrhiza®, Urinozinc®, dehydroepiandrosterone [DHEA]) within the 3 months before randomization visit. 19. Patient with co-existent malignancy, according to the Investigators opinion. 20. Patient with abnormal or prolonged QTc interval (Bazetts formula greater than 450 msec, Appendix II), uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure (e.g
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the bioequivalence between Leuprolide acetate for depot suspension 7.5 mg 1- month administration of Pharmathen S.A. Greece and Lupron Depot® 7.5 mg for 1-month administration in adult male patients with prostate carcinoma undergoing initial therapy of Leuprolide Acetate.Timepoint: 35 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of the patients.Timepoint: 35 Weeks | — |
Countries
India
Contacts
Public ContactMr Jitendra Panda
Cliantha Research limited
Outcome results
None listed