Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Dongkook Pharmaceutical Co., Ltd.
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.
Age
19–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
