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, andpituitary 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 therapyduring the clinical trial period

12. Urinary tract obstruction

13. Cardiovascular disease

14. Significant impairments in the digestive system, respiratory system, endocrinesystem, and central nervous system

15. Uncontrolled diabetes

16. Allergic reaction or hypersensitivity to any ingredient of the investigationalproduct 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