Metastatic Hormonesensitive Prostate Cancer (mHSPC)TARANCT07223372
An Observational Study to Learn More About How Medicines That Block Male Hormones Are Used in People With Prostate Cancer in Australia
An observational study of Metastatic Hormonesensitive Prostate Cancer (mHSPC), run by Bayer at 1 site in Australia.
Trial summary
This is a retrospective, observational study looking at real-world prescription data in Australia. The study focuses on adult men with metastatic hormone-sensitive prostate cancer (mHSPC), a type of prostate cancer that has spread but still responds to hormone therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormonesensitive Prostate Cancer (mHSPC)
- How many people
- 1,000 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Oct 2025to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This study is a retrospective, observational analysis of prescription data collected in Australia from real-world data sources: the Pharmaceutical Benefits Scheme (PBS) 10% sample data and NostraData. Target population were adult male mHSPC patients who initiated ARPI therapy within the study period, either in doublet or triplet therapy with ADT and/or docetaxel.
Who may be able to join
- Male patients with evidence of mHSPC at any point during the study period.
- At least one dispensing of darolutamide or enzalutamide or apalutamide or abiraterone acetate/methylprednisolone, initiated for the first time during the patient identification period for mHSPC
- Age ≥18 years at index date.
- At least 12 months of data prior to index date (a sensitivity analysis will also be conducted using 6 months pre-index period)
- At least 3 months of data after index date (a sensitivity analysis will also be conducted using 6 months post-index period)
Who cannot join
- Evidence of prior use of ARPI, including darolutamide, enzalutamide, apalutamide, or abiraterone/methylprednisolone, before the index date
- Evidence of castration resistant prostate cancer (CRPC), either metastatic or nonmetastatic, before or on the index date, proxied by timing of medications in use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Treatment Patterns and Characteristics of Patients Receiving Androgen Receptor Pathway Inhibitors in a Real-world Setting in -Australia: A Retrospective Prescriptions Data Study (TARA)
This is a retrospective, observational study looking at real-world prescription data in Australia. The study focuses on adult men with metastatic hormone-sensitive prostate cancer (mHSPC), a type of prostate cancer that has spread but still responds to hormone therapy. The main goal is to understand the treatment patterns, characteristics, and outcomes for patients who are receiving a class of drugs called Androgen Receptor Pathway Inhibitors (ARPIs), such as darolutamide, enzalutamide, apalutamide, or abiraterone. These drugs are often used in combination with standard Androgen Deprivation Therapy (ADT). The research will use two large, de-identified Australian prescription databases: the Pharmaceutical Benefits Scheme (PBS) and the NostraData retail pharmacy dataset. By analyzing this information, the study aims to describe how these treatments are being used over time, including what proportion of patients receive doublet therapy (ARPI + ADT) or triplet therapy (ARPI + ADT + docetaxel chemotherapy). It will also describe the characteristics of the patients receiving these therapies, such as their age and location. Secondary goals include understanding how well patients adhere to their prescribed ARPI treatment and tracking any changes in medication dosage over time. Since the study uses existing, anonymized data, there is no direct contact with patients and individual patient consent is not required. The findings will provide valuable real-world insights into the use of ARPIs in Australia, which can help inform clinical practice and improve care for men with mHSPC.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients who received darolutamide | |
| Cohort 2 | Patients who received enzalutamide | |
| Cohort 3 | Patients who received apalutamide | |
| Cohort 4 | Patients who received abiraterone/methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of patients taking each ARPI as a percentage of total study population.
Measured: Retrospective analysis from December 2022 to June 2025
Demographic characteristics of mHSPC patients
Measured: Retrospective analysis from December 2022 to June 2025
Secondary outcomes (2)
Proportion of days covered (PDC) to understand adherence
Evaluation of treatment adherence from treatment initiation using a proportion of days covered (PDC) analysis. PDC is calculated as the number of days with medication available divided by the total number of days in the observations period, starting from ARPI (Andorgen receptor pathway inhibitor) initiation
Measured: Retrospective analysis from December 2022 to June 2025
Starting dose and change in dose over time
Measured: Retrospective analysis from December 2022 to June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start10 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormonesensitive Prostate Cancer (mHSPC)Studies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223372
- Sponsor's protocol ID
- 23084
- Acronym
- TARA
- Status last verified
- Jul 2026
- First submitted
- 24 Oct 2025
- Last updated
- 6 Jul 2026
- Results posted
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Characteristics of Patients Receiving Androgen Receptor Pathway Inhibitors in a Real-world Setting in -Australia: A Retrospective Prescriptions Data Study (TARA)
- ClinicalTrials.gov ID
- NCT07223372
- Acronym / sponsor ID
- TARA / 23084
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 31 Oct 2025 (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 a retrospective, observational study looking at real-world prescription data in Australia. The study focuses on adult men with metastatic hormone-sensitive prostate cancer (mHSPC), a type of prostate cancer that has spread but still responds to hormone therapy. The main goal is to understand the treatment patterns, characteristics, and outcomes for patients who are receiving a class of drugs called Androgen Receptor Pathway Inhibitors (ARPIs), such as darolutamide, enzalutamide, apalutamide, or abiraterone. These drugs are often used in combination with standard Androgen Deprivation Therapy (ADT). The research will use two large, de-identified Australian prescription databases: the Pharmaceutical Benefits Scheme (PBS) and the NostraData retail pharmacy dataset. By analyzing this information, the study aims to describe how these treatments are being used over time, including what proportion of patients receive doublet therapy (ARPI + ADT) or triplet therapy (ARPI + ADT + docetaxel chemotherapy). It will also describe the characteristics of the patients receiving these therapies, such as their age and location. Secondary goals include understanding how well patients adhere to their prescribed ARPI treatment and tracking any changes in medication dosage over time. Since the study uses existing, anonymized data, there is no direct contact with patients and individual patient consent is not required. The findings will provide valuable real-world insights into the use of ARPIs in Australia, which can help inform clinical practice and improve care for men with mHSPC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Patients who received darolutamide |
| Cohort 2 | – | –Patients who received enzalutamide |
| Cohort 3 | – | –Patients who received apalutamide |
| Cohort 4 | – | –Patients who received abiraterone/methylprednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a retrospective, observational analysis of prescription data collected in Australia from real-world data sources: the Pharmaceutical Benefits Scheme (PBS) 10% sample data and NostraData. Target population were adult male mHSPC patients who initiated ARPI therapy within the study period, either in doublet or triplet therapy with ADT and/or docetaxel.
Key inclusion criteria (5 listed)
- Male patients with evidence of mHSPC at any point during the study period.
- At least one dispensing of darolutamide or enzalutamide or apalutamide or abiraterone acetate/methylprednisolone, initiated for the first time during the patient identification period for mHSPC
- Age ≥18 years at index date.
- At least 12 months of data prior to index date (a sensitivity analysis will also be conducted using 6 months pre-index period)
- At least 3 months of data after index date (a sensitivity analysis will also be conducted using 6 months post-index period)
Key exclusion criteria (2 listed)
- Evidence of prior use of ARPI, including darolutamide, enzalutamide, apalutamide, or abiraterone/methylprednisolone, before the index date
- Evidence of castration resistant prostate cancer (CRPC), either metastatic or nonmetastatic, before or on the index date, proxied by timing of medications in use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number and proportion of patients taking each ARPI as a percentage of total study population.
Time frame: Retrospective analysis from December 2022 to June 2025
Demographic characteristics of mHSPC patients
Time frame: Retrospective analysis from December 2022 to June 2025
2 secondary outcomes
Proportion of days covered (PDC) to understand adherence
Time frame: Retrospective analysis from December 2022 to June 2025
Starting dose and change in dose over time
Time frame: Retrospective analysis from December 2022 to June 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- 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.
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.
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 Metastatic Hormonesensitive Prostate Cancer (mHSPC), run by Bayer at 1 site in Australia.
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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. 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 Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of patients taking each ARPI as a percentage of total study population. (time frame: Retrospective analysis from December 2022 to June 2025). 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 6 Jul 2026.