Clinical trial NCT06013475: 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
Official title: Use of Darolutamide, Enzalutamide and Apalutamide for Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) - EXTension of the DEAR Real-world Study (NCT05362149)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-metastatic Castration-resistant Prostate Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-08-28
Enrollment: 1375
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult men previously not treated with a novel antihormonal agent and starting the initial ARI treatment for nmCRPC during the study period, in US community urology practices

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. .


Eligibility criteria: 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

Primary outcomes:
measure: Time to ARI treatment discontinuation
timeFrame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Secondary outcomes:
measure: Reasons for ARI treatment discontinuation
timeFrame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
measure: Proportion of patients, who switched to another ARI therapy
timeFrame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
measure: Frequency of adverse events
timeFrame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
measure: Time to progression to mCRPC
timeFrame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
measure: Dose modification of initial ARI
timeFrame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Bayer
state: New Jersey
Study officials:
References: