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

NCT06490328 | Recruiting Phase 3

• 1 other identifier: DKF-MA102-P3-1
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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 (1)

Ewha Womans University mokdong Hospital

Seoul, South Korea

RECRUITING

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

Central Study Contacts

Seo hyun Kim, Bachelor

CONTACT

+82221919374; ksh29@dkpharm.co.kr

Dami Jeon, Bachelor

CONTACT

+82221919394; jdm@dkpharm.co.kr

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: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)