NCT06013475Completed
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
Use of Darolutamide, Enzalutamide and Apalutamide for Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) - EXTension of the DEAR Real-world Study (NCT05362149)
Source: ClinicalTrials.gov · Last updated 12 Jun 2025
Brief summary (registry, in English)
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. .
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1375 (actual)
- First submitted
- 18 Aug 2023
- Start date
- 31 Aug 2023
- Primary completion date
- 28 Jun 2024
- Lead sponsor
- Bayer
- Diseases
- Prostate cancer
- NCT number
- NCT06013475
What you commit to
- Study type: Observational
- Participants enrolled: 1375
- From 31 Aug 2023 to the primary completion date, 28 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of other primary cancers
Other illness
- Evidence of metastatic disease before or 30 days after treatment start
Who the study is looking for
- Men diagnosed with prostate cancer.
- Diagnosis of nmCRPC prior to or within 90 days after the first ARI treatment initiation
- Treatment with Darolutamide, Enzalutamide, or Apalutamide initiated for the first time
- Age ≥ 18 years at treatment start
- At least 6 months of Electro-Medical-Record activity after the treatment start unless the patient died earlier than 6 months.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bayer Coordinator of this site? Confirm its status | Whippany | United States | Unknown status |
Related publications
- Real-world analysis of androgen receptor inhibitors in US patients with nonmetastatic castration-resistant prostate cancer: DEAR-EXT study.Prostate Cancer Prostatic Dis · 2025 · PMID 41851476
This page is information, not medical advice. Discuss any trial with your doctor.