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Prostate cancer drug darolutamide under safety watch in korea

NCT ID NCT06334120

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 5 times

Summary

This study monitors the safety and effectiveness of darolutamide (Nubeqa) in 600 Korean men with non-metastatic or metastatic hormone-sensitive prostate cancer. Participants receive the drug as part of their normal care and are followed for one year. Researchers track side effects and how well the drug controls the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
darolutamide (Nubeqa)
What this could lead to
If successful, this study will confirm that darolutamide is safe and works well for Korean men with certain types of prostate cancer.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only includes Korean patients, so findings may not apply to other groups.

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.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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.

Who is studied

Patients who have been prescribed Darolutamide for a medically appropriate use will be eligible to be enrolled.

Ages

19 years and older

Sex

Male participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male aged ≥19 years * Patients with high risk nmCPRC * Castrate level of serum testosterone (\< 1.7 nmol/l \[50 ng/dL\]) * PSA doubling time \< 10 months * Patients with mHSPC * histologically or cytologically confirmed prostate cancer, and metastases detected on bone scanning, contrast-enhanced computed tomography (CT), or magnetic resonance imaging (MRI). * be candidates for androgen-deprivation therapy with/without docetaxel. * Patients for whom the decision to initiate treatment with Darolutamide as a first time was made as per investigator's routine treatment practice * Written informed consent from subject or legal representative; assent from subject when appropriate Exclusion Criteria: * Patients participating in an investigational program with interventions outside of routine clinical practice * Participants with contraindication according to the locally approved prescribing information

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic hormone sensitive prostate cancer Non-metastatic castration-resistant prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Many locations

    RECRUITING

    Multiple Locations, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.