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

NCT06490328 | Completed Phase 3

• 1 other identifier: DKF-MA102-P3-1
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 8

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.

Conditions

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Serum luteinizing hormone(LH) levels

  Week 24

• Serum prostate specific antigens(PSA)

  Week 24

• Percentage of participants

  Week 24

• Quality of life(FACT-P)

  Week 24

Study Arms (1)

DKF-MA102

EXPERIMENTAL

Leuprorelin acetate

Drug: DKF-MA102

Interventions

DKF-MA102 DRUG

Administered twice at 12-week intervals

Also known as: Leuprorelin acetate

DKF-MA102

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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
• 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

Sponsors & Collaborators

• Dongkook Pharmaceutical Co., Ltd.: lead

Study Sites (8)

National Cancer Center

Gyeonggi-do, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Ewha Womans University mokdong Hospital

Seoul, South Korea

Location

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Seoul Saint. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Leuprolide

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Choung-Soo Kim, M.D.,Ph.D

  Ewha Womans University Mokdong Hospital

  PRINCIPAL INVESTIGATOR

• Jae Young Joung, M.D.,Ph.D

  Center for Prostate Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do 10408, Republic of Korea

  PRINCIPAL INVESTIGATOR

• Sung Kyu Hong, M.D.,Ph.D

  Department of Urology, Seoul National University Bundang Hospital, 82, Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 463-707, Korea

  PRINCIPAL INVESTIGATOR

• Seong Soo Jeon, M.D.,Ph.D

  Department of Urology, Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul 135-710, Korea

  PRINCIPAL INVESTIGATOR

• Cheol Kwak, M.D.,Ph.D

  Department of Urology, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul 03080, Korea

  PRINCIPAL INVESTIGATOR

• Kyo Chul Koo, M.D.,Ph.D

  Department of Urology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

• Bumjin Lim, M.D.

  Department of Urology, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea

  PRINCIPAL INVESTIGATOR

• Ji Youl Lee, M.D.,Ph.D

  Department of Urology, Seoul Saint. Mary's Hospital, 222 Banpo-daero, Seocho-gu, Seoul 06591, South Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Advanced Prostate Cancer

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 8, 2024
• Study Start: May 30, 2024
• Primary Completion: January 21, 2026
• Study Completion: March 9, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)