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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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)]
• 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)]
• 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)]
• 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)]

Secondary outcome measures (12)

• Metastasis-free survival (MFS) by nmCRPC indication [Time frame: Up to 52 weeks]
• Time to first symptomatic skeletal event (SSE) by nmCRPC indication [Time frame: Up to 52 weeks]
• Time to prostate-specific antigen (PSA) progression by nmCRPC indication [Time frame: Up to 52 weeks]
• Overall survival by nmCRPC indication [Time frame: Up to 52 weeks]
• Time to Castration-Resistant Prostate Cancer (CRPC) by mHSPC indication [Time frame: Up to 52 weeks]
• Time to first symptomatic skeletal event (SSE) by mHSPC indication [Time frame: Up to 52 weeks]
• Time to prostate-specific antigen (PSA) progression by mHSPC indication [Time frame: Up to 52 weeks]
• Overall survival by mHSPC indication [Time frame: Up to 52 weeks]
• Time to initiation of subsequent anti-cancer therapy by mHSPC indication [Time frame: Up to 52 weeks]
• Radiological progression (Soft tissue/ Bone metastasis) by mHSPC indication [Time frame: Up to 52 weeks]
• Radiological Progression-Free Survival (rPFS) by mHSPC indication [Time frame: Up to 52 weeks]
• Duration of Darolutamide treatment [Time frame: Up to 52 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

South Korea · 1 center

• Many locations — Multiple Locations

Identifiers

NCT: NCT06334120 · 20654

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗