NCT06490328CompletedPhase 3
A Phase 3, Multi-center, Single-group, Open-label Study to Evaluate the Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
Dongkook Pharmaceutical Co., Ltd.8 sites in 1 country161 target enrollmentStarted: May 30, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 161
- Locations
- 8
- Primary Endpoint
- Percentage of participants
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- •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
Arms & Interventions
DKF-MA102
Experimental
Leuprorelin acetate
Intervention: DKF-MA102 (Drug)
Outcomes
Primary Outcomes
Percentage of participants
Time Frame: Week 4
Percentage of participants with testosterone suppression(≤ 50ng/dL) at Week 4
Percentage of participants
Time Frame: Week 24
Percentage of participants with testosterone suppression(≤ 50ng/dL) from Week 4 to Week 24
Secondary Outcomes
- Serum prostate specific antigens(PSA)(Week 24)
- Quality of life(FACT-P)(Week 24)
- Serum luteinizing hormone(LH) levels(Week 24)
- Percentage of participants(Week 24)
Investigators
Study Sites (8)
Loading locations...
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