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

Dongkook Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Advanced Prostate Cancer

Treatments: Drug: DKF-MA102

Study type: Interventional

Funder types: Industry

Identifiers

NCT06490328

DKF-MA102-P3-1

Details and patient eligibility

About

A phase 3, multi-center, single-group, open-label study to evaluate the efficacy and safety of DKF-MA102 in patients with prostate cancer.

Full 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.

Enrollment: 154 estimated patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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154 participants in 1 patient group

DKF-MA102

Experimental group

Description:

Leuprorelin acetate

Treatment:

Drug: DKF-MA102