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

Launched by DONGKOOK PHARMACEUTICAL CO., LTD. · Jul 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called DKF-MA102 for men with advanced prostate cancer. The goal is to find out how effective and safe this treatment is for patients who meet certain health requirements. If you are a man aged 19 or older, have been diagnosed with prostate cancer, and have specific testosterone levels, you might be eligible to participate. However, there are some important health conditions that could prevent you from joining, such as having had certain surgeries or treatments for cancer in the past.

If you decide to participate, you'll be part of a group that receives the DKF-MA102 treatment, and you'll be monitored closely for its effects on your health. The trial is currently looking for participants, so if you or someone you know is interested, it could be a chance to contribute to important research that may help others with prostate cancer in the future.

Gender

MALE

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. 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