Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer

A phase 3, multi-center, single-group, open-label study to evaluate the efficacy and safety of DKF-MA102 in patients with prostate cancer.

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. Allergic reaction or hypersensitivity to any ingredient of the investigational product or to a synthetic GnRH or GnRH analogs 17. Severe asthma, severe vascular edema, and severe hives 18. Significant infection 19. Lack of self-determination due to psychiatric illness 20. Participating in another interventional clinical trial 21. Pregnant or unwilling to use medically approved contraception 22. Deemed inappropriate to participate in this clinical trial by the investigator