Actively Recruiting
Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
Led by Dongkook Pharmaceutical Co., Ltd. · Updated on 2024-07-08
154
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase 3, multi-center, single-group, open-label study to evaluate the efficacy and safety of DKF-MA102 in patients with prostate cancer.
CONDITIONS
Official Title
Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- History of surgical procedures such as testicular resection, adrenal resection, and pituitary resection
- History of hormone therapy
- History of 5α-reductase inhibitor use
- History of radical radiation therapy
- History of adjuvant male hormone block therapy
- Severe liver failure
- Serum creatinine ≥1.5 times the upper limit of normal
- Hormone-independent prostate cancer
- Diagnosed pituitary adenoma
- Brain metastasis or spinal cord compression
- Requires prostatectomy, radiation therapy, chemotherapy, or anti-androgen therapy during the trial
- Urinary tract obstruction
- Cardiovascular disease
- Significant impairments in digestive, respiratory, endocrine, or central nervous systems
- Uncontrolled diabetes
- Allergic reaction or hypersensitivity to investigational product ingredients or GnRH analogs
- Severe asthma, severe vascular edema, or severe hives
- Significant infection
- Lack of self-determination due to psychiatric illness
- Participation in another interventional clinical trial
- Pregnant or unwilling to use medically approved contraception
- Deemed inappropriate to participate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ewha Womans University mokdong Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
Seo hyun Kim, Bachelor
CONTACT
D
Dami Jeon, Bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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