Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
Trial Parameters
Brief Summary
A phase 3, multi-center, single-group, open-label study to evaluate the efficacy and safety of DKF-MA102 in patients with prostate cancer.
Eligibility Criteria
Inclusion Criteria: 1. Adult male aged 19 or older 2. Histologically or cytologically-confirmed prostate cancer 3. Serum testosterone level \>150 ng/dL 4. ECOG PS grade ≤ 2 5. Life expectancy of at least 1 year Exclusion Criteria: 1. History of surgical procedures such as testicular resection, adrenal resection, and pituitary resection 2. History of hormone therapy 3. History of 5α-reductase inhibitor 4. History of radical radiation therapy 5. History of adjuvant male hormone block therapy 6. Severe liver failure 7. Serum creatinine ≥1.5 times the ULN 8. Hormone-independent prostate cancer 9. Diagnosed pituitary adenoma 10. Brain metastasis or spinal cord compression 11. Requires prostatectomy, radiation therapy, chemotherapy, and anti-androgen therapy during the clinical trial period 12. Urinary tract obstruction 13. Cardiovascular disease 14. Significant impairments in the digestive system, respiratory system, endocrine system, and central nervous system 15. Uncontrolled diabetes 16.