Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
NCT ID: NCT06490328
Last Updated: 2024-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
154 participants
INTERVENTIONAL
2024-05-30
2025-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DKF-MA102
Leuprorelin acetate
DKF-MA102
Administered twice at 12-week intervals
Interventions
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DKF-MA102
Administered twice at 12-week intervals
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
MALE
No
Sponsors
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Dongkook Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Choung-Soo Kim, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Ewha Womans University Mokdong Hospital
Locations
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Ewha Womans University mokdong Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DKF-MA102-P3-1
Identifier Type: -
Identifier Source: org_study_id
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