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NCT Number: NCT06334120

An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea

This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.

This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.

To learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.

During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.

Each participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events.

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Key information

Conditions

Non-metastatic Castration-resistant Prostate Cancer Metastatic Hormone-sensitive Prostate Cancer

Age range

19 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Multiple locations

Multiple Locations, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darolutamide (Nubeqa, BAY1841788)

Drug

The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.

Primary outcomes

  1. Number, severity of adverse events (including SAEs)

    Time frame: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)

    SAE stands for serious adverse event. An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  2. Number, severity of adverse drug reactions (including SADRs)

    Time frame: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)

    SADR stands for serious adverse drug reaction. An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide.

  3. The outcome of (serious) adverse events

    Time frame: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)

    An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  4. The outcome of (serious) adverse drug reactions

    Time frame: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)

    An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide.

Secondary outcomes

  1. Metastasis-free survival (MFS) by nmCRPC indication

    Time frame: Up to 52 weeks

    MFS is defined as the time (months) from the initiation of Darolutamide treatment to the date of first observed metastasis.

  2. Time to first symptomatic skeletal event (SSE) by nmCRPC indication

    Time frame: Up to 52 weeks

    Time to SSE is defined as the time (months) from the initiation of Darolutamide treatment to the date of first diagnosed skeletal-related event.

  3. Time to prostate-specific antigen (PSA) progression by nmCRPC indication

    Time frame: Up to 52 weeks

    Time to PSA progression is defined as the time (months) from the initiation of Darolutamide treatment to the date at which PSA is recorded at ≥25% increase above the nadir (lowest screening or baseline) value along with an increase in absolute value of ≥2 ng/mL above nadir.

  4. Overall survival by nmCRPC indication

    Time frame: Up to 52 weeks

    Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause.

  5. Time to Castration-Resistant Prostate Cancer (CRPC) by mHSPC indication

    Time frame: Up to 52 weeks

    Time to mCRPC, defined as the time to PSA progression with serum testosterone being at castrate level <0.50 ng/mL, or the time to progression by soft tissue/visceral lesions or time to progression by bone lesions, whatever comes first.

  6. Time to first symptomatic skeletal event (SSE) by mHSPC indication

    Time frame: Up to 52 weeks

    Time to SSE is defined as the time (months) from the initiation of Darolutamide treatment to the date of first diagnosed skeletal-related event.

  7. Time to prostate-specific antigen (PSA) progression by mHSPC indication

    Time frame: Up to 52 weeks

    Time to PSA progression is defined as the time (months) from the initiation of Darolutamide treatment to the date at which PSA is recorded at ≥25% increase above the nadir (lowest screening or baseline) value along with an increase in absolute value of ≥2 ng/mL above nadir.

  8. Overall survival by mHSPC indication

    Time frame: Up to 52 weeks

    Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause.

  9. Time to initiation of subsequent anti-cancer therapy by mHSPC indication

    Time frame: Up to 52 weeks

    Time to initiation of subsequent anti-cancer therapy is defined as the time (months) from the initiation of Darolutamide treatment to the date of first administration of any subsequent anti-cancer therapy after discontinuation of Darolutamide.

  10. Radiological progression (Soft tissue/ Bone metastasis) by mHSPC indication

    Time frame: Up to 52 weeks

    Radiological progression is defined as the time (months) from the start of Darolutamide treatment to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first.

  11. Radiological Progression-Free Survival (rPFS) by mHSPC indication

    Time frame: Up to 52 weeks

    Radiographic Progression-Free Survival (rPFS) is defined as the time (months) from the initiation of Darolutamide treatment to the date of the first radiologically confirmed disease progression or death from any cause, whichever occurs first.

  12. Duration of Darolutamide treatment

    Time frame: Up to 52 weeks

    Duration of Darolutamide treatment is defined as the time (months) from the start of Darolutamide treatment to the day of permanent discontinuation of Darolutamide (including death).

  13. Reasons for ending Darolutamide

    Time frame: Up to 52 weeks

  14. Dosage and dose modification of Darolutamide

    Time frame: Up to 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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