Clinical trial NCT06490328: Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
Official title: A Phase 3, Multi-center, Single-group, Open-label Study to Evaluate the Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Advanced Prostate Cancer
Lead sponsor: Dongkook Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-08
Enrollment: 154
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Advanced Prostate Cancer
Primary purpose: TREATMENT

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 Criteria:

1. Adult male aged 19 or older
2. Histologically or cytologically-confirmed prostate cancer
3. Serum testosterone level \>150 ng/dL
4. ECOG PS grade ≤ 2
5. Life expectancy of at least 1 year

Exclusion Criteria:

1. History of surgical procedures such as testicular resection, adrenal resection, and pituitary resection
2. History of hormone therapy
3. History of 5α-reductase inhibitor
4. History of radical radiation therapy
5. History of adjuvant male hormone block therapy
6. Severe liver failure
7. Serum creatinine ≥1.5 times the ULN
8. Hormone-independent prostate cancer
9. Diagnosed pituitary adenoma
10. Brain metastasis or spinal cord compression
11. Requires prostatectomy, radiation therapy, chemotherapy, and anti-androgen therapy during the clinical trial period
12. Urinary tract obstruction
13. Cardiovascular disease
14. Significant impairments in the digestive system, respiratory system, endocrine system, and central nervous system
15. Uncontrolled diabetes
16. Allergic reaction or hypersensitivity to any ingredient of the investigational product or to a synthetic GnRH or GnRH analogs
17. Severe asthma, severe vascular edema, and severe hives
18. Significant infection
19. Lack of self-determination due to psychiatric illness
20. Participating in another interventional clinical trial
21. Pregnant or unwilling to use medically approved contraception
22. Deemed inappropriate to participate in this clinical trial by the investigator

Primary outcomes:
measure: Percentage of participants
timeFrame: Week 4
measure: Percentage of participants
timeFrame: Week 24
Secondary outcomes:
measure: Serum luteinizing hormone(LH) levels
timeFrame: Week 24
measure: Serum prostate specific antigens(PSA)
timeFrame: Week 24
measure: Percentage of participants
timeFrame: Week 24
measure: Quality of life(FACT-P)
timeFrame: Week 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University mokdong Hospital
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Choung-Soo Kim, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: