Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-metastatic Castration-resistant Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apalutamide | Drug | Apalutamide | ALIAS |
| Darolutamide (BAY 1841788) | Drug | Darolutamide | ALIAS |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- Apalutamide
- interventionNames
- Drug: Apalutamide
- label
- Darolutamide
- interventionNames
- Drug: Darolutamide (BAY 1841788)
- label
- Enzalutamide
- interventionNames
- Drug: Enzalutamide
Primary outcomes (1)
- measure
- Time to ARI treatment discontinuation
- timeFrame
- Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDShore ND, George DJ, Khan N, Constantinovici N, Chen G, Ghadessi M, Hlebec V, Morgans AK. Real-world analysis of androgen receptor inhibitors in US patients with nonmetastatic castration-resistant prostate cancer: DEAR-EXT study. Prostate Cancer Prostatic Dis. 2026 Mar 18. doi: 10.1038/s41391-026-01099-3. Online ahead of print. PMID 41851476