NCT06490328 Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
| NCT ID | NCT06490328 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Dongkook Pharmaceutical Co., Ltd. |
| Condition | Advanced Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2024-05-30 |
| Primary Completion | 2025-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 154 participants in total. It began in 2024-05-30 with a primary completion date of 2025-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Choung-Soo Kim, M.D.,Ph.D
PRINCIPAL INVESTIGATOR
Ewha Womans University Mokdong Hospital
Frequently Asked Questions
Who can join the NCT06490328 clinical trial?
This trial is open to male participants only, aged 19 Years or older, studying Advanced Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06490328 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 154 participants.
Is NCT06490328 currently recruiting?
Yes, NCT06490328 is actively recruiting participants. Contact the research team at ksh29@dkpharm.co.kr for enrollment information.
Where is the NCT06490328 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06490328 clinical trial?
NCT06490328 is sponsored by Dongkook Pharmaceutical Co., Ltd.. The principal investigator is Choung-Soo Kim, M.D.,Ph.D at Ewha Womans University Mokdong Hospital. The trial plans to enroll 154 participants.
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