Non-metastatic Prostate CancerARENANCT06204302
An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States
An observational study of Non-metastatic Prostate Cancer and Non-metastatic Castration-resistant Prostate Cancer, run by Bayer at 1 site in United States.
Trial summary
This is an observational study in which data will be collected and studied from men with non-metastatic prostate cancer (nmPC) who received their usual treatment with '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 Prostate Cancer, Non-metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Darolutamide (Nubeqa, BAY1841788), Enzalutamide and Apalutamide
- How many people
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2024to 4 Apr 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: Men diagnosed with nmPC who were prescribed a novel ARI for the first time will be identified from Komodo Research Dataset (KRD) in the US.
Who may be able to join
- Men diagnosed with prostate cancer (≥1 claim for prostate cancer).
- Treatment with apalutamide, darolutamide or enzalutamide initiated for the first time in the nmPC stage during the patient identification period.
- Age ≥ 18 years at index date
- At least 6 months of continuous eligibility in medical and pharmacy benefits prior to the index date
- At least 6-months of continuous eligibility only in pharmacy benefits after the index date unless patient died before 6 months.
Who cannot join
- Patients with multiple ARIs recorded at index date
- Use of an ARI agent or abiraterone acetate prior to the index date
- Other cancer diagnosis (except prostate and skin cancer) during the 6-month baseline period
- Evidence of metastatic disease any time before or 30 days after index date.
- No claim with a diagnosis for hormone sensitive malignancy status (Z19.1) during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ARI Treatment Use and Outcomes in Non-metastatic Prostate Cancer (nmPC) Patients in the US
This is an observational study in which data will be collected and studied from men with non-metastatic prostate cancer (nmPC) who received their usual treatment with 'androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide.
Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Non-metastatic means that cancer has not yet spread to other parts of the body.
Read more
Darolutamide, enzalutamide, and apalutamide are already approved ARIs for nmPC in the United States (US). They work by blocking androgens (male sex hormones including testosterone) from attaching to proteins in cancer cells in the prostate. This helps to slow down the growth of the cancer cells. The participants will receive their treatments as prescribed by their doctors during routine medical care according to the approved product information.
Researchers want to know more about the use of ARIs and how they affect men with nmPC in the real world. Researchers will only include men who have not been treated with any new type of medication that blocks the action of male sex hormones.
The main purpose of this study is to collect and study information from men with nmPC about:
- the length of time they continued treatment with an ARI as prescribed by their doctors.
- the length of time from the start of the treatment with an ARI until the cancer spreads to other parts of the body.
Data will come from the participants' information stored in a database called Komodo Research Dataset (KRD) in the US.
The data collected will be from May 2019 to June 2023.
Researchers will only track data of eligible US men with nmPC and will follow them for a minimum of 6 months or until the end of the study.
- Being tested
- Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide
- Keywords
- nmPC, nmCRPC
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 Komodo Research Database (KRD)
EnzalutamideDrug
Retrospective cohort analysis, using Komodo Research Database (KRD)
ApalutamideDrug
Retrospective cohort analysis, using Komodo Research Database (KRD)
| Study group | Role | What they receive |
|---|---|---|
| Darolutamide | Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Darolutamide as initial treatment. Receives: Drug: Darolutamide (Nubeqa, BAY1841788) | |
| Enzalutamide | Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Enzalutamide as initial treatment. Receives: Drug: Enzalutamide | |
| Apalutamide | Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Apalutamide as initial treatment. Receives: Drug: Apalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ARI discontinuation (days) for apalutamide, darolutamide, and enzalutamide
Measured: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023
Time to progression to metastatic prostate cancer (mPC) (days) for apalutamide, darolutamide, and enzalutamide
Measured: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023
Secondary outcomes (6)
Descriptive summary of patient characteristics by cohort during baseline
Measured: Retrospective analysis from index date 01 May 2019 up to 31 Dec 2022
Descriptive summary of initiating prescribed daily dose of apalutamide, darolutamide, and enzalutamide
Measured: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Descriptive summary of initiating prescribed daily dose intensity of apalutamide, darolutamide, and enzalutamide
Measured: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Initiating dose changes (increase/decrease) of apalutamide, darolutamide, and enzalutamide (yes/no)
Measured: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Switching between apalutamide, darolutamide, and enzalutamide (yes/no)
Measured: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Proportion of days covered (PDC)
PDC is calculated by dividing the total non-overlapping days of supply by the length of a fixed time interval (6, 12, 18, 24 months) and by the patient specific treatment duration.
Measured: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start5 Jan 2024
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-metastatic 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
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204302
- Sponsor's protocol ID
- 22704
- Acronym
- ARENA
- Status last verified
- Apr 2024
- First submitted
- 3 Jan 2024
- Last updated
- 9 Apr 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARI Treatment Use and Outcomes in Non-metastatic Prostate Cancer (nmPC) Patients in the US
- ClinicalTrials.gov ID
- NCT06204302
- Acronym / sponsor ID
- ARENA / 22704
- Keywords
- nmPC, nmCRPC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 12 Jan 2024 (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 data will be collected and studied from men with non-metastatic prostate cancer (nmPC) who received their usual treatment with 'androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide.
Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Non-metastatic means that cancer has not yet spread to other parts of the body.
Darolutamide, enzalutamide, and apalutamide are already approved ARIs for nmPC in the United States (US). They work by blocking androgens (male sex hormones including testosterone) from attaching to proteins in cancer cells in the prostate. This helps to slow down the growth of the cancer cells. The participants will receive their treatments as prescribed by their doctors during routine medical care according to the approved product information.
Researchers want to know more about the use of ARIs and how they affect men with nmPC in the real world. Researchers will only include men who have not been treated with any new type of medication that blocks the action of male sex hormones.
The main purpose of this study is to collect and study information from men with nmPC about:
- the length of time they continued treatment with an ARI as prescribed by their doctors.
- the length of time from the start of the treatment with an ARI until the cancer spreads to other parts of the body.
Data will come from the participants' information stored in a database called Komodo Research Dataset (KRD) in the US.
The data collected will be from May 2019 to June 2023.
Researchers will only track data of eligible US men with nmPC and will follow them for a minimum of 6 months or until the end of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Darolutamide | – | Drug: Darolutamide (Nubeqa, BAY1841788)Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Darolutamide as initial treatment. |
| Enzalutamide | – | Drug: EnzalutamideParticipants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Enzalutamide as initial treatment. |
| Apalutamide | – | Drug: ApalutamideParticipants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Apalutamide as initial treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men diagnosed with nmPC who were prescribed a novel ARI for the first time will be identified from Komodo Research Dataset (KRD) in the US.
Key inclusion criteria (5 listed)
- Men diagnosed with prostate cancer (≥1 claim for prostate cancer).
- Treatment with apalutamide, darolutamide or enzalutamide initiated for the first time in the nmPC stage during the patient identification period.
- Age ≥ 18 years at index date
- At least 6 months of continuous eligibility in medical and pharmacy benefits prior to the index date
- At least 6-months of continuous eligibility only in pharmacy benefits after the index date unless patient died before 6 months.
Key exclusion criteria (5 listed)
- Patients with multiple ARIs recorded at index date
- Use of an ARI agent or abiraterone acetate prior to the index date
- Other cancer diagnosis (except prostate and skin cancer) during the 6-month baseline period
- Evidence of metastatic disease any time before or 30 days after index date.
- No claim with a diagnosis for hormone sensitive malignancy status (Z19.1) 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 Komodo Research Database (KRD) | Drug | Darolutamide |
| EnzalutamideRetrospective cohort analysis, using Komodo Research Database (KRD) | Drug | Enzalutamide |
| ApalutamideRetrospective cohort analysis, using Komodo Research Database (KRD) | Drug | Apalutamide |
Primary outcome
Time to ARI discontinuation (days) for apalutamide, darolutamide, and enzalutamide
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023
Time to progression to metastatic prostate cancer (mPC) (days) for apalutamide, darolutamide, and enzalutamide
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023
6 secondary outcomes
Descriptive summary of patient characteristics by cohort during baseline
Time frame: Retrospective analysis from index date 01 May 2019 up to 31 Dec 2022
Descriptive summary of initiating prescribed daily dose of apalutamide, darolutamide, and enzalutamide
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Descriptive summary of initiating prescribed daily dose intensity of apalutamide, darolutamide, and enzalutamide
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Initiating dose changes (increase/decrease) of apalutamide, darolutamide, and enzalutamide (yes/no)
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Switching between apalutamide, darolutamide, and enzalutamide (yes/no)
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Proportion of days covered (PDC)
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
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 9 Apr 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 Prostate Cancer and 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 9 Apr 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?
Time to ARI discontinuation (days) for apalutamide, darolutamide, and enzalutamide (time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023). The study lists 2 primary outcomes in all. 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 9 Apr 2024.