Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer

Phase 3

Recruiting

• Conditions: Advanced Prostate Cancer
• Interventions: Drug: DKF-MA102

• Registration Number: NCT06490328
• Lead Sponsor: Dongkook Pharmaceutical Co., Ltd.

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 Timeline

• Study Start: 2024-05-30
• Study First Submitted: 2024-06-13
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-05-20
• Study Completion: 2025-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DKF-MA102	DKF-MA102	Leuprorelin acetate

Primary Outcome Measures

Name	Time	Method
Percentage of participants	Week 24	Percentage of participants with testosterone suppression(≤ 50ng/dL) from Week 4 to Week 24

Secondary Outcome Measures

Name	Time	Method
Serum prostate specific antigens(PSA)	Week 24	Changes in serum prostate specific antigens(PSA) from baseline to Weeks 4, 12 and 24
Quality of life(FACT-P)	Week 24	Comparative evaluation of quality of life(FACT-P) of subjects from baseline to Weeks 4, 12 and 24
Serum luteinizing hormone(LH) levels	Week 24	Changes in serum luteinizing hormone(LH) levels from baseline to Weeks 4, 12 and 24
Percentage of participants	Week 24	Percentage of participants with testosterone suppression(≤ 20ng/dL) from Week 4 to Week 24

Trial Locations

Locations (1)

Ewha Womans University mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of