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

NCT06334120 | Recruiting

• 1 other identifier: 20654
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Metastasis-free survival (MFS) by nmCRPC indication

  Up to 52 weeks

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

  Up to 52 weeks

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

  Up to 52 weeks

• Overall survival by nmCRPC indication

  Up to 52 weeks

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

  Up to 52 weeks

Study Arms (1)

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)

Interventions

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.

Male patients with nmCRPC or mHSPC

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients participating in an investigational program with interventions outside of routine clinical practice
• Participants with contraindication according to the locally approved prescribing information

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Multiple locations

Multiple Locations, South Korea

RECRUITING

MeSH Terms

Interventions

darolutamide

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 27, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)