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Advanced Prostate CancerPhase 3NCT06490328

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

A Phase 3 study testing DKF-MA102 in people with Advanced Prostate Cancer, run by Dongkook Pharmaceutical Co., Ltd. at 8 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older, men only
Conditions the study is for
Advanced Prostate Cancer
What is being tested?
DKF-MA102
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
8 sitesSouth Korea
Study dates
30 May 2024to 9 Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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
  • Allergic reaction or hypersensitivity to any ingredient of the investigational product or to a synthetic GnRH or GnRH analogs
  • Severe asthma, severe vascular edema, and severe hives
  • Significant infection
  • Lack of self-determination due to psychiatric illness
  • Participating in another interventional clinical trial
  • Pregnant or unwilling to use medically approved contraception
  • Deemed inappropriate to participate in this clinical trial by the investigator

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

South Korea8 sites

  • National Cancer Center

    Gyeonggi-do

  • Seoul National University Bundang Hospital

    Gyeonggi-do

  • Asan Medical Center

    Seoul

  • Ewha Womans University mokdong Hospital

    Seoul

  • Gangnam Severance Hospital, Yonsei University College of Medicine

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Seoul Saint. Mary's Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Phase 3, Multi-center, Single-group, Open-label Study to Evaluate the Efficacy and Safety of DKF-MA102 in Patients With 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.

Read the 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.

Being tested
DKF-MA102

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DKF-MA102Drug

    Also called Leuprorelin acetate

    Administered twice at 12-week intervals

Study groups in NCT06490328
Study groupRoleWhat they receive
DKF-MA102ExperimentalLeuprorelin acetate
Receives: Drug: DKF-MA102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants

    Percentage of participants with testosterone suppression(≤ 50ng/dL) at Week 4

    Measured: Week 4

  2. Percentage of participants

    Percentage of participants with testosterone suppression(≤ 50ng/dL) from Week 4 to Week 24

    Measured: Week 24

Secondary outcomes (4)

  1. Serum luteinizing hormone(LH) levels

    Changes in serum luteinizing hormone(LH) levels from baseline to Weeks 4, 12 and 24

    Measured: Week 24

  2. Serum prostate specific antigens(PSA)

    Changes in serum prostate specific antigens(PSA) from baseline to Weeks 4, 12 and 24

    Measured: Week 24

  3. Percentage of participants

    Percentage of participants with testosterone suppression(≤ 20ng/dL) from Week 4 to Week 24

    Measured: Week 24

  4. Quality of life(FACT-P)

    Comparative evaluation of quality of life(FACT-P) of subjects from baseline to Weeks 4, 12 and 24

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2024
  2. Study start30 May 2024
  3. Primary completion21 Jan 2026
  4. Study completion9 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Advanced Prostate Cancer
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06490328
Sponsor's protocol ID
DKF-MA102-P3-1
Status last verified
Aug 2026
First submitted
13 Jun 2024
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be made publicly available.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DKF-MA102 in people with Advanced Prostate Cancer, run by Dongkook Pharmaceutical Co., Ltd. at 8 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06490328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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