To hear about similar clinical trials, please enter your email below
Trial Title:
Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
NCT ID:
NCT06490328
Condition:
Advanced Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Leuprolide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Advanced Prostate Cancer
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DKF-MA102
Description:
Administered twice at 12-week intervals
Arm group label:
DKF-MA102
Other name:
Leuprorelin acetate
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.
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.
Criteria for 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
Gender:
Male
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ewha Womans University mokdong Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Choung-Soo Kim, M.D., Ph.D
Phone:
+82226505803
Email:
cskim37345806@gmail.com
Start date:
May 30, 2024
Completion date:
May 20, 2025
Lead sponsor:
Agency:
Dongkook Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Dongkook Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06490328
