Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Luphere® Depot 7.5 mg PDS (Leuprorelin Acetate): Subjects will receive their 7.5 mg of
Leuprorelin acetate for depot suspension as an intramuscular
injection as per the randomization s
Sponsors
Daewoong Pharmaceutical Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males of age 40-85 years (inclusive both) with histologically proven metastatic carcinoma of the prostate. 2. Subject who are judged by the investigator to be a candidate for the androgen ablation therapy. 3. Subject with life expectancy of at least 3 months. 4. Subject with Body Mass Index (BMI) >= 18 to 5. Subject with adequate hematological reserve • Hemoglobin >= 9 gm/dL • WBC (white blood cells) >=4000/mm3 • Absolute neutrophils count >=1500/mm3 • Platelets >=1,00,000/mm3 (subject who is on coumarin anticoagulants must have Platelets count >=1,50,000/mm3) 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 7. Subject with adequate renal function at screening as defined by serum creatinine 8. Subject with adequate and stable hepatic function as defined by bilirubin Note: For subjects with liver metastasis, bilirubin limit of normal) and transaminases (i.e. SGOT, SGPT) (upper limit of normal) is allowed. 9. Subject agrees to use acceptable contraceptive methods during study. 10. Able to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study. 11. PSA level should be > 4 ng/mL. 12. Subject and/or LAR who is/are able to understand and provide written informed consent prior to study entry.
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria should be excluded: 1. Subject with history or known allergy or hypersensitivity to GnRH, GnRH agonist analogs including any LHRH analogues, or any excipients of the study formulation. 2. Subject who has participated in any other clinical investigation using experimental drug/donated blood in past 90 days before thedate of start of study. 3. Subject with evidence of brain metastases, in the opinion of the Investigator, taking into account medical history, lab/radiological investigations or clinical observations and symptoms. 4. Subject with evidence of spinal cord compression, in the opinion of the Investigator, taking into account medical history, lab/radiological investigations or clinical observations and symptoms. 5. Subject with evidence of severe urinary tract obstruction with threatening urinary retention, in the opinion of the Investigator, taking into account medical history, lab/radiological investigations or clinical observations and symptoms. 6. Subject with excruciating severe pain from extensive osseous deposits, in the opinion of the Investigator, taking into account medical history, lab/radiological investigations or clinical observations and symptoms. 7. Subject with testosterone levels screening. 8. Subject with history or presence of hypogonadism, or receipt of exogenous testosterone supplementation within 6 months of screening. 9. Current use of systemic corticosteroids at a dose >10 mg/d (prednisolone equivalent). 10. Subject who has received previous cancer systemic therapy such as chemotherapy, cryotherapy, immunotherapy (e.g. antibody therapies, tumor-vaccines), biological response modifiers (e.g. cytokines) within 3 months of check-in. 11. Subject who have 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]. 12. Subject who has received anti-androgen treatment (i.e. androgen receptor antagonist like Bicalutamide, Flutamide, Megestrol, cyproterone acetate) [No washout allowed]. 13. Subject with history of previous orchiectomy, adrenalectomy or hypophysectomy. 14. Subject with history of any major surgery including prostatic surgery (e.g. radical prostatectomy, transurethral resection of the prostate [TUR-P]) within 4 weeks of check-in. 15. Subject with history of local therapy to the primary tumor with a curative attempt other than surgery (external beam radiotherapy, brachytherapy, thermotherapy, cryotherapy) within 2 weeks of check-in. 16. Subject who has received 5-alpha-reductase inhibitors (Finasteride, dutasteride) within 3 months prior to screening. 17. Subject who has received Over the counter (OTC) medications or other alternative medical therapies which have an estrogenic or anti-androgenic effect (i.e., PC-SPES, saw palmetto, Glycyrrhiza® (Liquorice), Urinozinc® (supplementation), dehydroepiandrosterone [DHEA]) within the 3 months before screening. 18. Subject with any other Co-existent malignancy, according to the Investigators opinion. 19. Subject with abnormal or prolonged QTc interval, congestive heart failure, myocardial infarction or a coronary vascular procedure (e.g. balloon angioplasty, coronary artery bypass graft) or sig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioavailability of Luphere® Depot 7.5 mg PDS (Leuprorelin acetate) with that of Lucrin Depot® 7.5 mg PDS (Leuprorelin acetate) Timepoint: Bioavailability of Luphere® Depot 7.5 mg PDS (Leuprorelin acetate) with that of Lucrin Depot® 7.5 mg PDS (Leuprorelin acetate) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the subjectsTimepoint: Day 42±4 days after ramdomization visit. | — |
Countries
India
Contacts
Public ContactMr Deepak Chawla
Cliantha Research Limited
Outcome results
None listed