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

This study is conducted to confirm the pharmacodynamic effects, efficacy, and safety of DKF-MA102 in prostate cancer patients by measuring the changes in serum testosterone levels.

Inclusion criteria

• Adult male aged 19 or older
• Histologically or cytologically-confirmed prostate cancer
• Serum testosterone level >150 ng/dL
• ECOG PS grade ≤ 2
• Life expectancy of at least 1 year

Exclusion criteria

• History of surgical procedures such as testicular resection, adrenal resection, and pituitary resection
• History of hormone therapy
• History of 5α-reductase inhibitor
• History of radical radiation therapy
• History of adjuvant male hormone block therapy
• Severe liver failure
• Serum creatinine ≥1.5 times the ULN
• Hormone-independent prostate cancer
• Diagnosed pituitary adenoma
• Brain metastasis or spinal cord compression
• Requires prostatectomy, radiation therapy, chemotherapy, and anti-androgen therapy during the clinical trial period
• Urinary tract obstruction
• Cardiovascular disease
• Significant impairments in the digestive system, respiratory system, endocrine system, and central nervous system
• Uncontrolled diabetes
• Allergic reaction or hypersensitivity to any ingredient of the investigational product or to a synthetic GnRH or GnRH analogs
• Severe asthma, severe vascular edema, and severe hives
• Significant infection
• Lack of self-determination due to psychiatric illness
• Participating in another interventional clinical trial
• Pregnant or unwilling to use medically approved contraception
• Deemed inappropriate to participate in this clinical trial by the investigator