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Tests treatment safety and results for Advanced Prostate Cancer
Official title Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
ClinicalTrials.gov ID: NCT06490328
What this study is testing
What is DKF-MA102?
DKF-MA102 is an investigational medicine, being studied as a potential treatment for advanced prostate cancer.
Also referred to as Leuprorelin acetate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A phase 3, multi-center, single-group, open-label study to evaluate the efficacy and safety of DKF-MA102 in patients with prostate cancer.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older, men only
You may be able to join if
- 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 likely can't join if
- 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
See the full eligibility criteria
- 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
- 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 treatment clinical trial
- Pregnant or unwilling to use medically approved contraception
- Deemed inappropriate to participate in this clinical trial by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.