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

A Phase 3, Multi-center, Single-group, Open-label Study to Evaluate the Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer

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 Overview

• Status: Recruiting
• Conditions: Advanced Prostate Cancer
• Intervention / Treatment: Drug: DKF-MA102

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 Type: Interventional
• Enrollment (Estimated): 154
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Seo hyun Kim, Bachelor; Phone Number: +82221919374; Email: ksh29@dkpharm.co.kr
• Study Contact Backup: Name: Dami Jeon, Bachelor; Phone Number: +82221919394; Email: jdm@dkpharm.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Ewha Womans University Mokdong Hospital
    • Contact: Choung-Soo Kim, M.D., Ph.D; Phone Number: +82226505803; Email: cskim37345806@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DKF-MA102; Leuprorelin acetate	Drug: DKF-MA102; Administered twice at 12-week intervals; Other Names: Leuprorelin acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants	Percentage of participants with testosterone suppression(≤ 50ng/dL) at Week 4	Week 4
Percentage of participants	Percentage of participants with testosterone suppression(≤ 50ng/dL) from Week 4 to Week 24	Week 24

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dongkook Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Choung-Soo Kim, M.D.,Ph.D, Ewha Womans University Mokdong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Estimated): May 20, 2025
• Study Completion (Estimated): May 20, 2025

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide
• Other Study ID Numbers: DKF-MA102-P3-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No