Status:
COMPLETED
A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely
Lead Sponsor:
Bayer
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
This is an observational study in which patient data from the past on men with prostate cancer are studied. Cancer is a condition in which the body cannot control the growth of cells and tumors may f...
Eligibility Criteria
Inclusion
- Have at least 1 prescription claims for enzalutamide (National Drug Code \[NDC\]: 00469-0125-99, 00469-0625-99, 00469-0725-60), apalutamide (NDC: 59676-600-12, 59676-600-56, 59676-600-99) or darolutamide (NDC: 50419-395-01, 50419-395-72) during the index identification period.
- \-- The date of the earliest SGARI claim to occur during this period will be defined as the index date with the corresponding SGARI as the index treatment.
- Have ≥1 diagnosis of prostate cancer (ICD-10 code C61.) during the overall baseline period.
- Age ≥18 years and male gender on the index date.
- Have continuous health plan enrollment with medical and pharmacy benefits for at least 6 months prior to the index date.
- Have continuous health plan enrollment with medical and pharmacy benefits for at least 3 months after the index date and throughout the follow-up period.
Exclusion
- Since patients should not be prescribed more than one SGARI when initiating treatment, patients with more than one SGARI prescribed on the index date will be excluded from the study. This will allow each patient to be assigned to a single study cohort.
- In order to select patients who are initiating SGARI treatment, patients with the index SGARI treatment during the 1 year baseline period will be excluded from the study.
Key Trial Info
Start Date :
January 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 15 2025
Estimated Enrollment :
13779 Patients enrolled
Trial Details
Trial ID
NCT05202301
Start Date
January 15 2022
End Date
July 15 2025
Last Update
August 11 2025
Active Locations (1)
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1
Bayer
Whippany, New Jersey, United States, 07981