Non-metastatic Castration-resistant Prostate Cancer
Conditions
Brief summary
This is an observational cohort study in men with non-metastatic castration-resistant prostate cancer who received their usual treatment, which is 'Androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide. The main purpose of this study is to collect data on the length of time men with nmCRPC continued treatment with darolutamide, enzalutamide, or apalutamide as prescribed by their doctors. Researchers will only include men who had not been treated with any new type of medication that blocks the action of hormones. The data will come from an electronic health record database called Precision Point Specialty (PPS) Prostate Cancer Electronic Medical Record (EMR) for men in the United States of America. EMR data will be verified and supplemented via patient chart review. Data collected will be from January 2019 to September 2023. .
Interventions
DRUGApalutamide
Decision by the treating physician
Decision by the treating physician
DRUGEnzalutamide
Decision by treating physician
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men diagnosed with prostate cancer. 2. Diagnosis of nmCRPC prior to or within 90 days after the first ARI treatment initiation 3. Treatment with Darolutamide, Enzalutamide, or Apalutamide initiated for the first time 4. Age ≥ 18 years at treatment start 5. At least 6 months of Electro-Medical-Record activity after the treatment start unless the patient died earlier than 6 months.
Exclusion criteria
1. Evidence of metastatic disease before or 30 days after treatment start 2. Prior history of other primary cancers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to ARI treatment discontinuation | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 |
Secondary
| Measure | Time frame |
|---|---|
| Reasons for ARI treatment discontinuation | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 |
| Proportion of patients, who switched to another ARI therapy | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 |
| Frequency of adverse events | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 |
| Time to progression to mCRPC | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 |
| Dose modification of initial ARI | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 |
Countries
United States
Outcome results
None listed