Clinical trial NCT06334120: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-metastatic Castration-resistant Prostate Cancer
Metastatic Hormone-sensitive Prostate Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 600
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been prescribed Darolutamide for a medically appropriate use will be eligible to be enrolled.

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.


Eligibility criteria: Inclusion Criteria:

* Male aged ≥19 years
* Patients with high risk nmCPRC

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

Primary outcomes:
measure: Number, severity of adverse events (including SAEs)
timeFrame: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
measure: Number, severity of adverse drug reactions (including SADRs)
timeFrame: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
measure: The outcome of (serious) adverse events
timeFrame: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
measure: The outcome of (serious) adverse drug reactions
timeFrame: 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:
measure: Metastasis-free survival (MFS)
timeFrame: Up to 52 weeks
measure: Time to symptomatic skeletal event (SSE)
timeFrame: Up to 52 weeks
measure: Time to prostate-specific antigen (PSA) progression
timeFrame: Up to 52 weeks
measure: Number of patients with metastasis of castration-resistant prostate cancer (mCRPC)
timeFrame: Up to 52 weeks
measure: Overall survival
timeFrame: Up to 52 weeks
measure: Duration of Darolutamide treatment
timeFrame: Up to 52 weeks
measure: Reasons for ending Darolutamide
timeFrame: Up to 52 weeks
measure: Dosage and dose modification of Darolutamide
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
facility: Multiple locations
Study officials:
References: