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

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