Status:
COMPLETED
An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States
Lead Sponsor:
Bayer
Conditions:
Non-metastatic Prostate Cancer
Non-metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
This is an observational study in which data will be collected and studied from men with non-metastatic prostate cancer (nmPC) who received their usual treatment with 'androgen receptor inhibitors' (A...
Eligibility Criteria
Inclusion
- Men diagnosed with prostate cancer (≥1 claim for prostate cancer).
- Treatment with apalutamide, darolutamide or enzalutamide initiated for the first time in the nmPC stage during the patient identification period.
- Age ≥ 18 years at index date
- At least 6 months of continuous eligibility in medical and pharmacy benefits prior to the index date
- At least 6-months of continuous eligibility only in pharmacy benefits after the index date unless patient died before 6 months.
Exclusion
- Patients with multiple ARIs recorded at index date
- Use of an ARI agent or abiraterone acetate prior to the index date
- Other cancer diagnosis (except prostate and skin cancer) during the 6-month baseline period
- Evidence of metastatic disease any time before or 30 days after index date.
- No claim with a diagnosis for hormone sensitive malignancy status (Z19.1) during the study period
Key Trial Info
Start Date :
January 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 4 2024
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT06204302
Start Date
January 5 2024
End Date
April 4 2024
Last Update
April 9 2024
Active Locations (1)
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1
Bayer
Whippany, New Jersey, United States, 07981