Can a new injection tame prostate cancer by cutting testosterone?
NCT ID NCT06490328
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This phase 3 trial is testing an investigational drug called DKF-MA102 (leuprorelin acetate) in men with advanced prostate cancer. The goal is to see if two injections, given 12 weeks apart, can safely lower testosterone levels to a target range, which may help control the cancer. The study will also monitor changes in PSA and luteinizing hormone levels over 24 weeks. Participants are adult men with confirmed prostate cancer and elevated testosterone levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- leuprorelin acetate (DKF-MA102), a hormone therapy given as an injection
- What this could lead to
- If successful, this could offer a new treatment option to control advanced prostate cancer by suppressing testosterone, potentially slowing disease progression.
- What could go wrong
- This is an early-stage, single-group study without a comparison group, so results may not be definitive. Hormone therapy can cause side effects like hot flashes, fatigue, and loss of libido.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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161 people
The number who actually took part.
- Started
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May 2024
- Finished
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Mar 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Asan Medical Center
Seoul, South Korea
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Ewha Womans University mokdong Hospital
Seoul, South Korea
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Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
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National Cancer Center
Gyeonggi-do, South Korea
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Samsung Medical Center
Seoul, South Korea
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Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
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Seoul National University Hospital
Seoul, South Korea
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Seoul Saint. Mary's Hospital
Seoul, South Korea
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Other studies related to the condition(s) this trial covers.
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