Evaluating DKF-MA102 for treating advanced 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

This study is testing a new treatment called DKF-MA102 to see if it can help men with advanced prostate cancer by looking at changes in their testosterone levels.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 19 Years and up
• Sex: Male
• Sponsor: Dongkook Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Seoul)
• Trial ID: NCT06490328 on ClinicalTrials.gov

What this trial studies

This phase 3, multi-center, single-group, open-label study aims to assess the efficacy and safety of DKF-MA102 in patients diagnosed with advanced prostate cancer. The study will measure changes in serum testosterone levels to confirm the pharmacodynamic effects of the treatment. Adult males aged 19 or older with confirmed prostate cancer will be enrolled, while those with certain medical histories or conditions will be excluded. The trial is designed to provide insights into the potential benefits of DKF-MA102 for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adult males aged 19 or older with histologically or cytologically-confirmed prostate cancer and specific serum testosterone levels.

Not a fit: Patients with hormone-independent prostate cancer or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced prostate cancer.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in targeting hormone levels in prostate cancer treatment.

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

Where this trial is running

Seoul

• Ewha Womans University mokdong Hospital — Seoul, South Korea (RECRUITING)

Study contacts

• Principal investigator: Choung-Soo Kim, M.D.,Ph.D — Ewha Womans University Mokdong Hospital
• Study coordinator: Seo hyun Kim, Bachelor

Conditions: Advanced Prostate Cancer