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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-metastatic Castration-resistant Prostate Cancer; Metastatic Hormone-sensitive Prostate Cancer
• Intervention / Treatment: Drug: Darolutamide (Nubeqa, BAY1841788)

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• South Korea
  • Multiple Locations, South Korea
    • Recruiting
    • Multiple locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Male patients with nmCRPC or mHSPC; Male patients with a diagnosis of non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC) will be enrolled after the decision for treatment with Darolutamide has been made by the investigator.	Drug: Darolutamide (Nubeqa, BAY1841788); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number, severity of adverse events (including SAEs)	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.	From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
Number, severity of adverse drug reactions (including SADRs)	SADR stands for serious adverse drug reaction. An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide.	From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
The outcome of (serious) adverse events	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.	From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
The outcome of (serious) adverse drug reactions	An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide.	From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Darolutamide treatment	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).	Up to 52 weeks
Reasons for ending Darolutamide		Up to 52 weeks
Dosage and dose modification of Darolutamide		Up to 52 weeks
Metastasis-free survival (MFS) by nmCRPC indication	MFS is defined as the time (months) from the initiation of Darolutamide treatment to the date of first observed metastasis.	Up to 52 weeks
Time to first symptomatic skeletal event (SSE) by nmCRPC indication	Time to SSE is defined as the time (months) from the initiation of Darolutamide treatment to the date of first diagnosed skeletal-related event.	Up to 52 weeks
Time to prostate-specific antigen (PSA) progression by nmCRPC indication	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.	Up to 52 weeks
Overall survival by nmCRPC indication	Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause.	Up to 52 weeks
Time to Castration-Resistant Prostate Cancer (CRPC) by mHSPC indication	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.	Up to 52 weeks
Time to first symptomatic skeletal event (SSE) by mHSPC indication	Time to SSE is defined as the time (months) from the initiation of Darolutamide treatment to the date of first diagnosed skeletal-related event.	Up to 52 weeks
Time to prostate-specific antigen (PSA) progression by mHSPC indication	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.	Up to 52 weeks
Overall survival by mHSPC indication	Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause.	Up to 52 weeks
Time to initiation of subsequent anti-cancer therapy by mHSPC indication	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.	Up to 52 weeks
Radiological progression (Soft tissue/ Bone metastasis) by mHSPC indication	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.	Up to 52 weeks
Radiological Progression-Free Survival (rPFS) by mHSPC indication	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.	Up to 52 weeks

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; darolutamide
• Other Study ID Numbers: 20654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No