Advanced Prostate Cancer
Conditions
Brief summary
A phase 3, multi-center, single-group, open-label study to evaluate the efficacy and safety of DKF-MA102 in patients with prostate cancer.
Detailed description
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.
Interventions
DRUGDKF-MA102
Administered twice at 12-week intervals
Sponsors
Dongkook Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Advanced Prostate Cancer
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants | Week 4 | Percentage of participants with testosterone suppression(≤ 50ng/dL) at Week 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum luteinizing hormone(LH) levels | Week 24 | Changes in serum luteinizing hormone(LH) levels from baseline to Weeks 4, 12 and 24 |
| Serum prostate specific antigens(PSA) | Week 24 | Changes in serum prostate specific antigens(PSA) from baseline to Weeks 4, 12 and 24 |
| Percentage of participants | Week 24 | Percentage of participants with testosterone suppression(≤ 20ng/dL) from Week 4 to Week 24 |
| Quality of life(FACT-P) | Week 24 | Comparative evaluation of quality of life(FACT-P) of subjects from baseline to Weeks 4, 12 and 24 |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORChoung-Soo Kim, M.D.,Ph.D
Ewha Womans University Mokdong Hospital
PRINCIPAL_INVESTIGATORJae Young Joung, M.D.,Ph.D
Center for Prostate Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do 10408, Republic of Korea
PRINCIPAL_INVESTIGATORSung Kyu Hong, M.D.,Ph.D
Department of Urology, Seoul National University Bundang Hospital, 82, Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 463-707, Korea
PRINCIPAL_INVESTIGATORSeong Soo Jeon, M.D.,Ph.D
Department of Urology, Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul 135-710, Korea
PRINCIPAL_INVESTIGATORCheol Kwak, M.D.,Ph.D
Department of Urology, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul 03080, Korea
PRINCIPAL_INVESTIGATORKyo Chul Koo, M.D.,Ph.D
Department of Urology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
PRINCIPAL_INVESTIGATORBumjin Lim, M.D.
Department of Urology, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea
PRINCIPAL_INVESTIGATORJi Youl Lee, M.D.,Ph.D
Department of Urology, Seoul Saint. Mary's Hospital, 222 Banpo-daero, Seocho-gu, Seoul 06591, South Korea
Outcome results
None listed