Actively Recruiting
A Phase 3, Multi-center, Single-group, Open-label Study to Evaluate the 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of DKF-MA102 on patients with advanced prostate cancer. This phase 3, multi-center, open-label trial aims to confirm how well DKF-MA102 works and how safe it is by monitoring changes in serum testosterone levels. The study is sponsored by Dongkook Pharmaceutical Co., Ltd. and focuses on understanding the drug's pharmacodynamic impact in this patient population. Participants will receive DKF-MA102 administered twice, with each dose given 12 weeks apart. This single-group study uses leuprorelin acetate as the treatment under evaluation. The design allows researchers to observe outcomes such as hormone levels and quality of life during the treatment period. During the study, participants will have their serum testosterone, luteinizing hormone (LH), and prostate-specific antigen (PSA) levels checked at weeks 4 and 24. Quality of life will also be assessed at week 24 using the FACT-P questionnaire. Researchers will monitor safety and efficacy throughout the trial, which is expected to continue until May 2025.
CONDITIONS
Brief 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 performance status grade 2 or less
- Life expectancy of at least 1 year
You will not qualify if you...
- History of testicular, adrenal, or pituitary resection surgery
- Previous hormone therapy
- Previous use of 5α-reductase inhibitors
- History of radical radiation therapy
- Prior adjuvant male hormone block therapy
- Severe liver failure
- Serum creatinine level 1.5 times or more above the upper limit of normal
- Hormone-independent prostate cancer
- Diagnosed pituitary adenoma
- Brain metastasis or spinal cord compression
- Need for prostatectomy, radiation, 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 study drug ingredients or GnRH analogs
- Severe asthma, vascular edema, or 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
- Considered inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 weeks
Participants receive two doses of DKF-MA102, administered 12 weeks apart.
2 visits for drug administration plus additional assessment visits
Trial Site Locations
Total: 1 location
1
Ewha Womans University mokdong Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
Seo hyun Kim, Bachelor
D
Dami Jeon, Bachelor
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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