An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
- Conditions
- Non-metastatic Castration-resistant Prostate CancerMetastatic Hormone-sensitive Prostate Cancer
- Interventions
- Registration Number
- NCT06334120
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 600
-
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
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Participants with contraindication according to the locally approved prescribing information
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Male patients with nmCRPC or mHSPC Darolutamide (Nubeqa, BAY1841788) 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.
- Primary Outcome Measures
Name Time Method The outcome of (serious) adverse events 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.
The outcome of (serious) adverse drug reactions 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.
Number, severity of adverse events (including SAEs) 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.
Number, severity of adverse drug reactions (including SADRs) 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.
- Secondary Outcome Measures
Name Time Method Duration of Darolutamide treatment 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).
Metastasis-free survival (MFS) Up to 52 weeks MFS is defined as the time (months) from the initiation of Darolutamide treatment to the date of first observed metastasis.
Number of patients with metastasis of castration-resistant prostate cancer (mCRPC) 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.
Reasons for ending Darolutamide Up to 52 weeks Dosage and dose modification of Darolutamide Up to 52 weeks Overall survival Up to 52 weeks Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause.
Time to symptomatic skeletal event (SSE) 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.
Time to prostate-specific antigen (PSA) progression 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.
Trial Locations
- Locations (1)
Multiple locations
🇰🇷Multiple Locations, Korea, Republic of