Prostate CancerNCT05202301
A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely
An observational study of 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 prostate cancer are studied. Cancer is a condition in which the body cannot control the growth of cells and tumors may form. If tumors form in the prostate, male sex hormones (androgens) can sometimes help the cancer spread and grow. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Darolutamide (Nubeqa, BAY1841788), Enzalutamide and Apalutamide
- How many people
- 13,779 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2022to 15 Jul 2025
- 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: All patients diagnosed with Prostate Cancer who newly initiate Second Generation Androgen Receptor Inhibitors treatment in United States from 01 Aug 2019 to 31 Mar 2021.
Who may be able to join
- Have at least 1 prescription claims for enzalutamide (National Drug Code [NDC]: 00469-0125-99, 00469-0625-99, 00469-0725-60), apalutamide (NDC: 59676-600-12, 59676-600-56, 59676-600-99) or darolutamide (NDC: 50419-395-01, 50419-395-72) during the index identification period.
- -- The date of the earliest SGARI claim to occur during this period will be defined as the index date with the corresponding SGARI as the index treatment.
- Have ≥1 diagnosis of prostate cancer (ICD-10 code C61.) during the overall baseline period.
- Age ≥18 years and male gender on the index date.
- Have continuous health plan enrollment with medical and pharmacy benefits for at least 6 months prior to the index date.
- Have continuous health plan enrollment with medical and pharmacy benefits for at least 3 months after the index date and throughout the follow-up period.
Who cannot join
- Since patients should not be prescribed more than one SGARI when initiating treatment, patients with more than one SGARI prescribed on the index date will be excluded from the study. This will allow each patient to be assigned to a single study cohort.
- In order to select patients who are initiating SGARI treatment, patients with the index SGARI treatment during the 1 year baseline period will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication Adherence and Discontinuation Among Patients With Prostate Cancer Who Initiated Second Generation Androgen Receptor Inhibitors
This is an observational study in which patient data from the past on men with prostate cancer are studied.
Cancer is a condition in which the body cannot control the growth of cells and tumors may form. If tumors form in the prostate, male sex hormones (androgens) can sometimes help the cancer spread and grow. Cancer that spreads to other parts of the body is called metastasis.
Read more
Androgens are mainly made in the testicles. There are treatments available for men with prostate cancer to lower the levels of these hormones in the body. These treatments are called androgen deprivation therapy (ADT). Some men with prostate cancer respond to ADT, but in some cases, prostate cancer may overcome the therapy and worsen despite low androgens levels.
Second generation androgen receptor inhibitors (SGARIs) including darolutamide, apalutamide, and enzalutamide are available for the treatment of prostate cancer in addition to ADT. SGARIs work by blocking androgens from attaching to proteins in cancer cells in the prostate.
Clinical studies have shown that men with prostate cancer benefit from these treatments. But besides benefits, unfavorable reactions related to these treatments also influence which treatment is chosen, if the treatment is taken as intended or if it is even stopped.
Unfavorable reactions observed for darolutamide, apalutamide, and enzalutamide differ from each other. In clinical trials, severe unfavorable reactions occurred less often for darolutamide.
But information on how unfavorable reactions of each treatment influence their intake in actual or "real-world" prostate cancer treatment is missing.
The main aim of this observational study is to learn to what extent SGARI treatments are taken as prescribed and how often their intake is completely stopped. To find this out, researchers will collect available treatment data of adult men with prostate cancer from the United States who started SGARI treatments between August 2019 and March 2021. The data will be drawn from the IQVIA database.
For each man, data from up to 1 year prior SGARI treatment until at least 3 months after treatment start (up to the 30 June 2021) will be collected.
The researchers will look at the percentage of men who:
- completely stopped to take their treatment or
- took the treatment as prescribed.
The results for each treatment (darolutamide, apalutamide, and enzalutamide) will then be compared to find possible differences.
There will be no required visits with a study doctor or required tests in this study since only patient data from the past are studied.
- Conditions
- Prostate Cancer
- Being tested
- Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide
- Medical subject headings
- Prostatic Neoplasms
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 the IQVIA Real-World Data Adjudicated Claims, US claims database
EnzalutamideDrug
Retrospective cohort analysis, using the IQVIA Real-World Data Adjudicated Claims, US claims database
ApalutamideDrug
Retrospective cohort analysis, using the IQVIA Real-World Data Adjudicated Claims, US claims database
| Study group | Role | What they receive |
|---|---|---|
| Darolutamide cohort (Daro) | Participants received Second Generation Androgen Receptor Inhibitor (SGARI) Darolutamide as initial treatment Receives: Drug: Darolutamide (Nubeqa, BAY1841788) | |
| Enzalutamide cohort (Enza) | Participants received Second Generation Androgen Receptor Inhibitor (SGARI) Enzalutamide as initial treatment Receives: Drug: Enzalutamide | |
| Apalutamide cohort (Apa) | Participants received Second Generation Androgen Receptor Inhibitor (SGARI) Apalutamide as initial treatment Receives: Drug: Apalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discontinuation rate of SGARI treatment
The proportion of patients who discontinue their index SGARI treatment at 3 months, 6 months, 1 year and acutely (discontinuation within 90 days) will be evaluated. In addition, time to discontinuation will be assessed.
Discontinuation will be defined as a gap of ≥60 days from the end of the days of supply (DOS) of a prescription claim for the index SGARI to the date of the next prescription claim. The date of the last day of supply for the prescription claim that occurs immediately prior to the gap will be defined as the date of discontinuation.
Discontinuation rate will be defined as the proportion of patients with discontinuation within a set time period (3 months, 6 months, 1 year).
Measured: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
Time to discontinuation (days) of SGARI treatment
Time to discontinuation will be assessed over the entire observation period
Measured: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
Adherence of SGARI treatment
Medication adherence will be assessed using medication possession ratio (MPR) and proportion of days covered (PDC)
Measured: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
Secondary outcomes (10)
Treatment duration of SGARI treatment
Continuous treatment duration will be defined as the number of days from the index date to the date of discontinuation or the censoring date, whichever is earlier
Measured: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
Risk factors for treatment discontinuation
Sociodemographic and clinical patient characteristics will be assessed to identify risk factors associated with the discontinuation of index SGARI treatment using multivariable logistic regression models.
Measured: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
The proportion of patients who had evidence of dose modification of their index SGARI treatment
Dose modifications will be measured using relative dose intensity (RDI) calculated as the ratio of the delivered dose intensity to the standard dose intensity as recommended for each SGARI
Measured: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
Time to first dose modification (days) of index SGARI treatment
Measured: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
Descriptive summary of the baseline demographics of Prostate Cancer (PC) patients treated with SGARIs
Patient demographics evaluated on the index date will consist of age, race, region, insurance and health plan type when available
Measured: Retrospective analysis during index identification period, from 01-Aug-2018 up to 31-Mar-2021
Descriptive summary of the Comorbid conditions
For each qualified patient, the twelve-month baseline period or on the index date will be examined in order to compile patient histories
Measured: Retrospective analysis from 01-Aug-2018 up to 31-Mar-2021
Descriptive summary of the Charlson Comorbidity Index (CCI)
Charlson Comorbidity Index (CCI): The CCI is a method of estimating the one-year mortality for a patient with certain comorbid conditions. Each comorbid condition is given a score of 1, 2, 3 or 6 based on the degree of mortality attributed to the condition. The scores are summed to yield a total index score which can be used to predict long-term survival. The CCI will be calculated for each patient based on all diagnoses during the 1 year baseline period and the index date
Measured: Retrospective analysis from 01-Aug-2018 up to 31-Mar-2021
The proportion of patients who received different PC related medications
PC related medications: Androgen Deprivation Therapy (ADT) alone; First-generation antiandrogens; Second-generation androgen receptor inhibitors (SGARI); Chemotherapy; Other chemotherapy; Immunotherapy; Bone health agents; Radiopharmaceutical
Measured: Retrospective analysis from 01-Aug-2018 up to 30-Jun-2021
Descriptive summary of the baseline SGARI-class exposure status
SGARI-class exposure status: SGARI-class naïve; SGARI-class experienced
Measured: Retrospective analysis from 01-Aug-2018 up to 31-Mar-2021
Descriptive summary of the baseline Hormone sensitivity status
Hormone sensitivity status: Hormone-sensitive PC; Castration-resistant PC; Unknown
Measured: Retrospective analysis from 01-Aug-2018 up to 31-Mar-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start15 Jan 2022
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 13,779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202301
- Sponsor's protocol ID
- 22053
- Status last verified
- Aug 2025
- First submitted
- 10 Jan 2022
- Last updated
- 11 Aug 2025
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Adherence and Discontinuation Among Patients With Prostate Cancer Who Initiated Second Generation Androgen Receptor Inhibitors
- ClinicalTrials.gov ID
- NCT05202301
- Acronym / sponsor ID
- 22053
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,779 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 21 Jan 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 prostate cancer are studied.
Cancer is a condition in which the body cannot control the growth of cells and tumors may form. If tumors form in the prostate, male sex hormones (androgens) can sometimes help the cancer spread and grow. Cancer that spreads to other parts of the body is called metastasis.
Androgens are mainly made in the testicles. There are treatments available for men with prostate cancer to lower the levels of these hormones in the body. These treatments are called androgen deprivation therapy (ADT). Some men with prostate cancer respond to ADT, but in some cases, prostate cancer may overcome the therapy and worsen despite low androgens levels.
Second generation androgen receptor inhibitors (SGARIs) including darolutamide, apalutamide, and enzalutamide are available for the treatment of prostate cancer in addition to ADT. SGARIs work by blocking androgens from attaching to proteins in cancer cells in the prostate.
Clinical studies have shown that men with prostate cancer benefit from these treatments. But besides benefits, unfavorable reactions related to these treatments also influence which treatment is chosen, if the treatment is taken as intended or if it is even stopped.
Unfavorable reactions observed for darolutamide, apalutamide, and enzalutamide differ from each other. In clinical trials, severe unfavorable reactions occurred less often for darolutamide.
But information on how unfavorable reactions of each treatment influence their intake in actual or "real-world" prostate cancer treatment is missing.
The main aim of this observational study is to learn to what extent SGARI treatments are taken as prescribed and how often their intake is completely stopped. To find this out, researchers will collect available treatment data of adult men with prostate cancer from the United States who started SGARI treatments between August 2019 and March 2021. The data will be drawn from the IQVIA database.
For each man, data from up to 1 year prior SGARI treatment until at least 3 months after treatment start (up to the 30 June 2021) will be collected.
The researchers will look at the percentage of men who:
- completely stopped to take their treatment or
- took the treatment as prescribed.
The results for each treatment (darolutamide, apalutamide, and enzalutamide) will then be compared to find possible differences.
There will be no required visits with a study doctor or required tests in this study since only patient data from the past are studied.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Darolutamide cohort (Daro) | – | Drug: Darolutamide (Nubeqa, BAY1841788)Participants received Second Generation Androgen Receptor Inhibitor (SGARI) Darolutamide as initial treatment |
| Enzalutamide cohort (Enza) | – | Drug: EnzalutamideParticipants received Second Generation Androgen Receptor Inhibitor (SGARI) Enzalutamide as initial treatment |
| Apalutamide cohort (Apa) | – | Drug: ApalutamideParticipants received Second Generation Androgen Receptor Inhibitor (SGARI) 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
- All patients diagnosed with Prostate Cancer who newly initiate Second Generation Androgen Receptor Inhibitors treatment in United States from 01 Aug 2019 to 31 Mar 2021.
Key inclusion criteria (6 listed)
- Have at least 1 prescription claims for enzalutamide (National Drug Code [NDC]: 00469-0125-99, 00469-0625-99, 00469-0725-60), apalutamide (NDC: 59676-600-12, 59676-600-56, 59676-600-99) or darolutamide (NDC: 50419-395-01, 50419-395-72) during the index identification period.
- -- The date of the earliest SGARI claim to occur during this period will be defined as the index date with the corresponding SGARI as the index treatment.
- Have ≥1 diagnosis of prostate cancer (ICD-10 code C61.) during the overall baseline period.
- Age ≥18 years and male gender on the index date.
- Have continuous health plan enrollment with medical and pharmacy benefits for at least 6 months prior to the index date.
Key exclusion criteria (2 listed)
- Since patients should not be prescribed more than one SGARI when initiating treatment, patients with more than one SGARI prescribed on the index date will be excluded from the study. This will allow each patient to be assigned to a single study cohort.
- In order to select patients who are initiating SGARI treatment, patients with the index SGARI treatment during the 1 year baseline period will be excluded from the study.
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 the IQVIA Real-World Data Adjudicated Claims, US claims database | Drug | Darolutamide cohort (Daro) |
| EnzalutamideRetrospective cohort analysis, using the IQVIA Real-World Data Adjudicated Claims, US claims database | Drug | Enzalutamide cohort (Enza) |
| ApalutamideRetrospective cohort analysis, using the IQVIA Real-World Data Adjudicated Claims, US claims database | Drug | Apalutamide cohort (Apa) |
Primary outcome
Discontinuation rate of SGARI treatment
Time frame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
The proportion of patients who discontinue their index SGARI treatment at 3 months, 6 months, 1 year and acutely (discontinuation within 90 days) will be evaluated. In addition, time to discontinuation will be assessed. Discontinuation will be defined as a gap of ≥60 days from the end of the days of supply (DOS) of a prescription claim for the index SGARI to the date of the next prescription claim. The date of the last day of supply for the prescription claim that occurs immediately prior to the gap will be defined as the date of discontinuation. Discontinuation rate will be defined as the proportion of patients with discontinuation within a set time period (3 months, 6 months, 1 year).
Time to discontinuation (days) of SGARI treatment
Time frame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
Time to discontinuation will be assessed over the entire observation period
Adherence of SGARI treatment
Time frame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
Medication adherence will be assessed using medication possession ratio (MPR) and proportion of days covered (PDC)
10 secondary outcomes
Treatment duration of SGARI treatment
Time frame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
Risk factors for treatment discontinuation
Time frame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
The proportion of patients who had evidence of dose modification of their index SGARI treatment
Time frame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
Time to first dose modification (days) of index SGARI treatment
Time frame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
Descriptive summary of the baseline demographics of Prostate Cancer (PC) patients treated with SGARIs
Time frame: Retrospective analysis during index identification period, from 01-Aug-2018 up to 31-Mar-2021
Descriptive summary of the Comorbid conditions
Time frame: Retrospective analysis from 01-Aug-2018 up to 31-Mar-2021
Descriptive summary of the Charlson Comorbidity Index (CCI)
Time frame: Retrospective analysis from 01-Aug-2018 up to 31-Mar-2021
The proportion of patients who received different PC related medications
Time frame: Retrospective analysis from 01-Aug-2018 up to 30-Jun-2021
Descriptive summary of the baseline SGARI-class exposure status
Time frame: Retrospective analysis from 01-Aug-2018 up to 31-Mar-2021
Descriptive summary of the baseline Hormone sensitivity status
Time frame: Retrospective analysis from 01-Aug-2018 up to 31-Mar-2021
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 11 Aug 2025.
- 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 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 6 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 11 Aug 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?
Discontinuation rate of SGARI treatment (time frame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021). The study lists 3 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 11 Aug 2025.