Status:
RECRUITING
Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
Lead Sponsor:
Dongkook Pharmaceutical Co., Ltd.
Conditions:
Advanced Prostate Cancer
Eligibility:
MALE
19+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Adult male aged 19 or older
- Histologically or cytologically-confirmed prostate cancer
- Serum testosterone level \>150 ng/dL
- ECOG PS grade ≤ 2
- Life expectancy of at least 1 year
Exclusion
- History of surgical procedures such as testicular resection, adrenal resection, and pituitary resection
- History of hormone therapy
- History of 5α-reductase inhibitor
- History of radical radiation therapy
- History of adjuvant male hormone block therapy
- Severe liver failure
- Serum creatinine ≥1.5 times the ULN
- Hormone-independent prostate cancer
- Diagnosed pituitary adenoma
- Brain metastasis or spinal cord compression
- Requires prostatectomy, radiation therapy, chemotherapy, and anti-androgen therapy during the clinical trial period
- Urinary tract obstruction
- Cardiovascular disease
- Significant impairments in the digestive system, respiratory system, endocrine system, and central nervous system
- Uncontrolled diabetes
- Allergic reaction or hypersensitivity to any ingredient of the investigational product or to a synthetic GnRH or GnRH analogs
- Severe asthma, severe vascular edema, and severe hives
- Significant infection
- Lack of self-determination due to psychiatric illness
- Participating in another interventional clinical trial
- Pregnant or unwilling to use medically approved contraception
- Deemed inappropriate to participate in this clinical trial by the investigator
Key Trial Info
Start Date :
May 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2025
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT06490328
Start Date
May 30 2024
End Date
May 20 2025
Last Update
July 8 2024
Active Locations (1)
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1
Ewha Womans University mokdong Hospital
Seoul, South Korea