Non-metastatic Castration-resistant Prostate CancerDEAR-EXTNCT06013475
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
An observational study of Non-metastatic Castration-resistant Prostate Cancer, run by Bayer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Non-metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Apalutamide, Darolutamide (BAY 1841788) and Enzalutamide
- How many people
- 1,375 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to 28 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Evidence of metastatic disease before or 30 days after treatment start
- Prior history of other primary cancers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Darolutamide, Enzalutamide and Apalutamide for Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) - EXTension of the DEAR Real-world Study (NCT05362149)
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. .
- Being tested
- Apalutamide, Darolutamide (BAY 1841788), Enzalutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApalutamideDrug
Decision by the treating physician
Darolutamide (BAY 1841788)Drug
Also called Nubeqa
Decision by the treating physician
EnzalutamideDrug
Decision by treating physician
| Study group | Role | What they receive |
|---|---|---|
| Apalutamide | Not described Receives: Drug: Apalutamide | |
| Darolutamide | Not described Receives: Drug: Darolutamide (BAY 1841788) | |
| Enzalutamide | Not described Receives: Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ARI treatment discontinuation
Measured: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Secondary outcomes (5)
Reasons for ARI treatment discontinuation
Measured: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Proportion of patients, who switched to another ARI therapy
Measured: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Frequency of adverse events
Measured: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Time to progression to mCRPC
Measured: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Dose modification of initial ARI
Measured: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start31 Aug 2023
- Primary completion28 Jun 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013475
- Sponsor's protocol ID
- 22625
- Acronym
- DEAR-EXT
- Status last verified
- Jun 2025
- First submitted
- 18 Aug 2023
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Shore 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.
PubMed 41851476
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Darolutamide, Enzalutamide and Apalutamide for Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) - EXTension of the DEAR Real-world Study (NCT05362149)
- ClinicalTrials.gov ID
- NCT06013475
- Acronym / sponsor ID
- DEAR-EXT / 22625
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,375 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Apalutamide | – | Drug: Apalutamide |
| Darolutamide | – | Drug: Darolutamide (BAY 1841788) |
| Enzalutamide | – | Drug: Enzalutamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Evidence of metastatic disease before or 30 days after treatment start
- Prior history of other primary cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApalutamideDecision by the treating physician | Drug | Apalutamide |
| Darolutamide (BAY 1841788)Also: NubeqaDecision by the treating physician | Drug | Darolutamide |
| EnzalutamideDecision by treating physician | Drug | Enzalutamide |
Primary outcome
Time to ARI treatment discontinuation
Time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
5 secondary outcomes
Reasons for ARI treatment discontinuation
Time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Proportion of patients, who switched to another ARI therapy
Time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Frequency of adverse events
Time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Time to progression to mCRPC
Time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Dose modification of initial ARI
Time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 41851476Shore 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.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-metastatic Castration-resistant Prostate Cancer, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to ARI treatment discontinuation (time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06013475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.