check_circleStudy Completed
Non-metastatic castration-resistant prostate cancer
Bayer Identifier:
22625
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
An observational cohort study to describe and compare the use of Darolutamide, Enzalutamide and Apalutamide and how well these work in men with non-metastatic castration-resistant prostate cancer (nmCRPC) in real world settings
Trial purpose
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. .
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. .
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
1375Trial Dates
August 2023 - June 2024Phase
N/ACould I Receive a placebo
NoProducts
Nubeqa (Darolutamide, BAY1841788)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Not yet recruiting | Bayer | Whippany, 07981, United States |
Primary Outcome
- Time to ARI treatment discontinuationdate_rangeTime Frame:Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Secondary Outcome
- Reasons for ARI treatment discontinuationdate_rangeTime Frame:Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
- Proportion of patients, who switched to another ARI therapydate_rangeTime Frame:Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
- Frequency of adverse eventsdate_rangeTime Frame:Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
- Time to progression to mCRPCdate_rangeTime Frame:Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
- Dose modification of initial ARIdate_rangeTime Frame:Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A