account_circleRecruiting

Non-metastatic castration-resistant prostate cancer, Metastatic hormone-sensitive prostate cancer

Bayer Identifier:

20654

ClinicalTrials.gov Identifier:

NCT06334120

EudraCT Number:

Not Available

EU CT Number:

Not Available
An observational study to learn more about the safety of Darolutamide in men with prostate cancer in Korea

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

19 - N/A
  • - 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

Trial summary

Enrollment Goal
600
Trial Dates
September 2024 - June 2026
Phase
Phase 4
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Multiple locationsMultiple locations, Korea, Republic Of

Primary Outcome

  • 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.
    date_rangeTime 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)
    SADR stands for serious adverse drug reaction. An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide.
    date_rangeTime 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
    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.
    date_rangeTime 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
    An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide.
    date_rangeTime 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

  • Metastasis-free survival (MFS)
    MFS is defined as the time (months) from the initiation of Darolutamide treatment to the date of first observed metastasis.
    date_rangeTime Frame:
    Up to 52 weeks
  • 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.
    date_rangeTime Frame:
    Up to 52 weeks
  • 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.
    date_rangeTime Frame:
    Up to 52 weeks
  • 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.
    date_rangeTime Frame:
    Up to 52 weeks
  • Overall survival
    Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause.
    date_rangeTime Frame:
    Up to 52 weeks
  • 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).
    date_rangeTime Frame:
    Up to 52 weeks
  • Reasons for ending Darolutamide
    date_rangeTime Frame:
    Up to 52 weeks
  • Dosage and dose modification of Darolutamide
    date_rangeTime Frame:
    Up to 52 weeks

Trial design

Post-marketing surveillance study for approved Darolutamide use in Korean patients
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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