Phase 3 Prostate Cancer Trial, Recruiting NCT06490328 Sponsor: Dongkook Pharmaceutical Co., Ltd. Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT06490328
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adult males aged 19 or older
  • People whose prostate cancer has been confirmed through a tissue or cell sample (biopsy or lab test)
  • People whose testosterone (a hormone) level in the blood is above 150 ng/dL
  • People who are reasonably active and able to care for themselves — specifically, those with an ECOG performance score of 2 or lower (confirm with trial site)
  • People with a life expectancy of at least one year

Who may not be able to join:

  • People who have had surgery to remove the testicles, adrenal glands, or pituitary gland
  • People who have previously received hormone therapy for their condition
  • People who have previously taken a type of medication called a 5α-reductase inhibitor (such as finasteride or dutasteride)
  • People who have previously had radical radiation therapy
  • People who have previously had adjuvant male hormone-blocking treatment
  • People with severe liver failure
  • People whose kidney function blood test (serum creatinine) is 1.5 times above the normal upper limit or higher
  • People whose prostate cancer no longer responds to hormone treatment (hormone-independent prostate cancer)
  • People who have been diagnosed with a pituitary gland tumour (pituitary adenoma)
  • People whose cancer has spread to the brain or is pressing on the spinal cord
  • People who are expected to need prostate surgery, radiation, chemotherapy, or anti-androgen therapy during the trial period
  • People who have a blockage in the urinary tract
  • People with cardiovascular (heart or blood vessel) disease
  • People with significant problems affecting the digestive, respiratory, hormonal, or central nervous systems
  • People with diabetes that is not well controlled
  • People who have had an allergic or hypersensitivity reaction to any ingredient in the study drug, or to synthetic GnRH or GnRH-related medications (confirm with trial site)
  • People with severe asthma, severe swelling under the skin (angioedema), or severe hives
  • People with a serious active infection
  • People who are unable to make their own decisions due to a psychiatric condition
  • People who are currently taking part in another interventional clinical trial
  • People who are pregnant or who are unwilling to use medically approved contraception
  • People the trial investigator considers unsuitable for participation for any other reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Choung-Soo Kim, M.D.,Ph.D, Ewha Womans University Mokdong Hospital

Phone: +82221919374

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Dongkook Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
30 May 2024
Est. completion
20 May 2025

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

Percentage of participants; Percentage of participants

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov