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

Metastatic Hormone-sensitive Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334120
• Other study ID #: 20654
• Status: Not yet recruiting
• Start date: September 30, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: March 31, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Male aged =19 years

• Patients with high risk nmCPRC

• Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dL])

• 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 and 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

Related Conditions & MeSH terms

• Metastatic Hormone-sensitive Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Multiple locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Metastasis-free survival (MFS)	MFS is defined as the time (months) from the initiation of Darolutamide treatment to the date of first observed metastasis.	Up to 52 weeks
Secondary	Time to symptomatic skeletal event (SSE)	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
Secondary	Time to prostate-specific antigen (PSA) progression	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
Secondary	Number of patients with metastasis of castration-resistant prostate cancer (mCRPC)	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
Secondary	Overall survival	Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause.	Up to 52 weeks
Secondary	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
Secondary	Reasons for ending Darolutamide		Up to 52 weeks
Secondary	Dosage and dose modification of Darolutamide		Up to 52 weeks

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