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Australian data dive reveals Real-World prostate cancer treatment trends

NCT ID NCT07223372

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study analyzes anonymous prescription records from Australian databases to see how men with advanced prostate cancer are actually treated. Researchers will look at which drugs are used, patient ages, and how well people stick to their medication. The goal is to learn from real-world practice to help doctors make better treatment decisions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic hormonesensitive prostate cancer (MHSPC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bayer

    RECRUITING

    Pymble, New South Wales, 875, Australia