Non-metastatic Castration-resistant Prostate CancerDEARNCT05362149
An Observational Study, Called DEAR, to Learn More About Treatment With Darolutamide, Enzalutamide and Apalutamide in Men With Non-metastatic Castration-resistant Prostate Cancer 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 study in which patient data from the past on men with non-metastatic castration-resistant prostate cancer are studied. In observational studies, only observations are made without specified advice or interventions. 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?
- Darolutamide (Nubeqa, BAY1841788), Enzalutamide and Apalutamide
- How many people
- 870 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to 30 Jun 2023
- 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 diagnosed with nmCRPC previously untreated with a NAH agent, and starting the first treatment with a SGARI agent in United States community urology practices from August 1st, 2019 to September 30th, 2021.
Who may be able to join
- Men diagnosed with prostate cancer
- Diagnosis of castration-resistant prostate cancer (CRPC) prior to or during the patient identification period
- Treatment with daro, enza, or apa initiated for the first time during the patient identification period for nmCRPC
- Age ≥ 18 years at index date
- At least 6 months of electronic medical records (EMR) activity after the index date unless the patient died earlier than 6 months
Who cannot join
- Evidence of metastatic disease before or 30 days after index date.
- Prior history (within five years before index date) of other primary cancers, except for non-melanoma skin cancer
- Patients with multiple SGARIs recorded at index date
- Use of a NAH agent (daro, enza, apa or abiraterone acetate) prior to the index date
- Evidence of inclusion in clinical trials during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DEAR: Use of Darolutamide, Enzalutamide and Apalutamide in the Real-world for Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)
This is an observational study in which patient data from the past on men with non-metastatic castration-resistant prostate cancer are studied. In observational studies, only observations are made without specified advice or interventions.
Non-metastatic castration-resistant prostate cancer (nmCRPC) is a type of cancer of the prostate that has not yet spread to other parts of the body, but that no longer responds adequately to initial hormone therapy/androgen deprivation therapy (ADT).
Read more
Androgens are male sex hormones such as testosterone. As they stimulate the growth of prostate cancer cells, low androgen levels are needed to reduce or slow the growth of these tumors. To reduce androgen levels in prostate cancer patients, the testes are removed through surgery or radiotherapy and subsequently androgen deprivation therapy (ADT) is started.
In men with nmCRPC, the cancer worsens despite low testosterone levels (also called castration resistant). This worsening is called "biochemical progression" as there is an increase in the blood level of cancer biomarkers, such as prostate specific antigen [PSA] without detectable disease.
PSA is a protein that is made by both normal cells and by cancerous cells in the body. Thus, PSA levels can be taken as a marker for prostate cancer development. Men with nmCRPC usually have higher levels of PSA than normal. They are considered "high risk" if they show signs of quickly increasing PSA levels as this could mean that the tumor is growing and might spread to other parts of the body.
Second generation androgen receptor inhibitors (SGARIs) including Darolutamide, Apalutamide, and Enzalutamide are available for the treatment of nmCRPC in addition to ADT. SGARIs work by blocking androgens from attaching to proteins in cancer cells in the prostate.
It is already known that men with nmCRPC benefit from these treatments, but as men with nmCRPC commonly have no symptoms, an important therapeutic goal is to minimize side effects which can impact the patients' quality of life and potentially lead to the patient stop the treatment.
Comparative studies using data from the same database to show how treatment with Darolutamide, Apalutamide, and Enzalutamide differ from each other, are missing. In addition, there are only limited information regarding using Darolutamide, Apalutamide, and Enzalutamide in real-world settings.
In this study data are collected from the same database to learn how Darolutamide, Enzalutamide and Apalutamide are used and how safe they are under real world conditions in men with nmCRPC, who had not been treated before with SGARI or another drug called abiraterone.
The main purpose is to learn to what extent SGARI treatments are taken as prescribed. To find this out, the researchers will count the number of participants who have stopped their treatment with Darolutamide, Enzalutamide or Apalutamide at or before:
- 6 months
- 12 months
- 18 months of treatment in usual practice. In addition, characteristics of each participant group and the reason for discontinuation (stopping the treatment) will be collected and described.
The researchers will also collect any medical problems during treatment and up to 30 days after stopping the treatment and that may or may not be related to the study treatment. These medical problems are also known as "adverse events" (AE).
The data for this study will come from the US urology EMR ( Electronic Medical Record) database.
This study will include all US patients identified in the Precision Point Specialty (PPS) urology electronic medical record (EMR) database between August 1, 2019 and September 30, 2021. The researchers will collect data from each patient for a minimum of 6 months after initiation of the SGARI treatment and up to the end of the study (March 31, 2022) or latest data cut available at the start of data extraction.
There are no required visits in this study and treatment will not be influenced.
- Being tested
- Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide (Nubeqa, BAY1841788)Drug
Retrospective cohort analysis, using PPS EMR prostate cancer database in the US.
EnzalutamideDrug
Retrospective cohort analysis, using PPS EMR prostate cancer database in the US.
ApalutamideDrug
Retrospective cohort analysis, using PPS EMR prostate cancer database in the US.
| Study group | Role | What they receive |
|---|---|---|
| Darolutamide cohort (daro) | Adult men with nmCRPC previously untreated with a Novel antihormonal (NAH) agent and starting the first treatment with Darolutamide during the study period. Receives: Drug: Darolutamide (Nubeqa, BAY1841788) | |
| Enzalutamide cohort (enza) | Adult men with nmCRPC previously untreated with a Novel antihormonal (NAH) agent and starting the first treatment with Enzalutamide during the study period. Receives: Drug: Enzalutamide | |
| Apalutamide cohort (apa) | Adult men with nmCRPC previously untreated with a Novel antihormonal (NAH) agent and starting the first treatment with Apalutamide during the study period. Receives: Drug: Apalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite event of treatment discontinuation/progression
Measured: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Secondary outcomes (8)
Time to Composite event of discontinuation/progression
Measured: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Treatment Discontinuation (non-composite event) of index treatment
Measured: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Time to treatment discontinuation (days) (non-composite event) of each treatment cohort
Time from index date (first SGARI initiation) to the date medication was discontinued. Patients will be censored if they discontinued from study for any reason other than death or disease progression, e.g., lost to follow-up or end of study period or if patients had their care transferred, or were admitted to hospice.
Measured: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Reason for discontinuation of each treatment cohort
Reasons for discontinuation (if available) will be ascertained from patient charts summarized by SGARI group using frequencies and percentages, and will be grouped into the following categories: AE-related; Cost-related; Metastatic disease; Death; Other; Unknown.
Measured: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Proportion of patients switching to another SGARI therapy of each treatment cohort
Switching will be defined as switching from one SGARI to another, within 60 days from date of discontinuation of the first SGARI. If the structured data or patient charts indicate that another SGARI was prescribed, then the patient would be considered to have discontinued on the previous treatment.
Measured: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Dose changes during the follow-up period of each treatment cohort
All dose reductions or increases prescribed during the follow-up period will be recorded.
Measured: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Dose intensity during the follow-up period of each treatment cohort
Dose intensity will be estimated as the ratio of the actual dose given throughout the follow-up period, divided by the amount that should have been prescribed according to the initial dose.
Measured: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Frequency of all types of AEs of each treatment cohort
AEs during the index treatment will be identified from patient charts and supplemented with diagnosis codes from structured data. Frequency of all AEs, frequency of AEs of special interest (falls, fractures, rash, cognitive disorders, hypertension and fatigue) and of AEs leading to discontinuation will be described.
Measured: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start4 Apr 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 870 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362149
- Sponsor's protocol ID
- 22184
- Acronym
- DEAR
- Status last verified
- Mar 2024
- First submitted
- 13 Apr 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEAR: Use of Darolutamide, Enzalutamide and Apalutamide in the Real-world for Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)
- ClinicalTrials.gov ID
- NCT05362149
- Acronym / sponsor ID
- DEAR / 22184
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 870 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 May 2022 (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 study in which patient data from the past on men with non-metastatic castration-resistant prostate cancer are studied. In observational studies, only observations are made without specified advice or interventions.
Non-metastatic castration-resistant prostate cancer (nmCRPC) is a type of cancer of the prostate that has not yet spread to other parts of the body, but that no longer responds adequately to initial hormone therapy/androgen deprivation therapy (ADT).
Androgens are male sex hormones such as testosterone. As they stimulate the growth of prostate cancer cells, low androgen levels are needed to reduce or slow the growth of these tumors. To reduce androgen levels in prostate cancer patients, the testes are removed through surgery or radiotherapy and subsequently androgen deprivation therapy (ADT) is started.
In men with nmCRPC, the cancer worsens despite low testosterone levels (also called castration resistant). This worsening is called "biochemical progression" as there is an increase in the blood level of cancer biomarkers, such as prostate specific antigen [PSA] without detectable disease.
PSA is a protein that is made by both normal cells and by cancerous cells in the body. Thus, PSA levels can be taken as a marker for prostate cancer development. Men with nmCRPC usually have higher levels of PSA than normal. They are considered "high risk" if they show signs of quickly increasing PSA levels as this could mean that the tumor is growing and might spread to other parts of the body.
Second generation androgen receptor inhibitors (SGARIs) including Darolutamide, Apalutamide, and Enzalutamide are available for the treatment of nmCRPC in addition to ADT. SGARIs work by blocking androgens from attaching to proteins in cancer cells in the prostate.
It is already known that men with nmCRPC benefit from these treatments, but as men with nmCRPC commonly have no symptoms, an important therapeutic goal is to minimize side effects which can impact the patients' quality of life and potentially lead to the patient stop the treatment.
Comparative studies using data from the same database to show how treatment with Darolutamide, Apalutamide, and Enzalutamide differ from each other, are missing. In addition, there are only limited information regarding using Darolutamide, Apalutamide, and Enzalutamide in real-world settings.
In this study data are collected from the same database to learn how Darolutamide, Enzalutamide and Apalutamide are used and how safe they are under real world conditions in men with nmCRPC, who had not been treated before with SGARI or another drug called abiraterone.
The main purpose is to learn to what extent SGARI treatments are taken as prescribed. To find this out, the researchers will count the number of participants who have stopped their treatment with Darolutamide, Enzalutamide or Apalutamide at or before:
- 6 months
- 12 months
- 18 months of treatment in usual practice. In addition, characteristics of each participant group and the reason for discontinuation (stopping the treatment) will be collected and described.
The researchers will also collect any medical problems during treatment and up to 30 days after stopping the treatment and that may or may not be related to the study treatment. These medical problems are also known as "adverse events" (AE).
The data for this study will come from the US urology EMR ( Electronic Medical Record) database.
This study will include all US patients identified in the Precision Point Specialty (PPS) urology electronic medical record (EMR) database between August 1, 2019 and September 30, 2021. The researchers will collect data from each patient for a minimum of 6 months after initiation of the SGARI treatment and up to the end of the study (March 31, 2022) or latest data cut available at the start of data extraction.
There are no required visits in this study and treatment will not be influenced.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Darolutamide cohort (daro) | – | Drug: Darolutamide (Nubeqa, BAY1841788)Adult men with nmCRPC previously untreated with a Novel antihormonal (NAH) agent and starting the first treatment with Darolutamide during the study period. |
| Enzalutamide cohort (enza) | – | Drug: EnzalutamideAdult men with nmCRPC previously untreated with a Novel antihormonal (NAH) agent and starting the first treatment with Enzalutamide during the study period. |
| Apalutamide cohort (apa) | – | Drug: ApalutamideAdult men with nmCRPC previously untreated with a Novel antihormonal (NAH) agent and starting the first treatment with Apalutamide during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men diagnosed with nmCRPC previously untreated with a NAH agent, and starting the first treatment with a SGARI agent in United States community urology practices from August 1st, 2019 to September 30th, 2021.
Key inclusion criteria (5 listed)
- Men diagnosed with prostate cancer
- Diagnosis of castration-resistant prostate cancer (CRPC) prior to or during the patient identification period
- Treatment with daro, enza, or apa initiated for the first time during the patient identification period for nmCRPC
- Age ≥ 18 years at index date
- At least 6 months of electronic medical records (EMR) activity after the index date unless the patient died earlier than 6 months
Key exclusion criteria (5 listed)
- Evidence of metastatic disease before or 30 days after index date.
- Prior history (within five years before index date) of other primary cancers, except for non-melanoma skin cancer
- Patients with multiple SGARIs recorded at index date
- Use of a NAH agent (daro, enza, apa or abiraterone acetate) prior to the index date
- Evidence of inclusion in clinical trials during the study period.
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 |
|---|---|---|
| Darolutamide (Nubeqa, BAY1841788)Retrospective cohort analysis, using PPS EMR prostate cancer database in the US. | Drug | Darolutamide cohort (daro) |
| EnzalutamideRetrospective cohort analysis, using PPS EMR prostate cancer database in the US. | Drug | Enzalutamide cohort (enza) |
| ApalutamideRetrospective cohort analysis, using PPS EMR prostate cancer database in the US. | Drug | Apalutamide cohort (apa) |
Primary outcome
Composite event of treatment discontinuation/progression
Time frame: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
8 secondary outcomes
Time to Composite event of discontinuation/progression
Time frame: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Treatment Discontinuation (non-composite event) of index treatment
Time frame: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Time to treatment discontinuation (days) (non-composite event) of each treatment cohort
Time frame: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Reason for discontinuation of each treatment cohort
Time frame: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Proportion of patients switching to another SGARI therapy of each treatment cohort
Time frame: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Dose changes during the follow-up period of each treatment cohort
Time frame: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Dose intensity during the follow-up period of each treatment cohort
Time frame: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
Frequency of all types of AEs of each treatment cohort
Time frame: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022
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 20 Mar 2024.
- 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 5 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 20 Mar 2024. 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?
Composite event of treatment discontinuation/progression (time frame: Retrospective analysis from 01-Aug-2019 to 31-Mar-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2024.