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New study tracks Darolutamide's Real-World impact on advanced prostate cancer

NCT ID NCT07344779

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 08, 2026 · Updated 2 times

Summary

This observational study follows about 1,600 men with metastatic hormone-sensitive prostate cancer who are taking darolutamide plus hormone therapy, with or without chemotherapy. Researchers will track how many men have undetectable PSA levels after one year, as well as overall survival and side effects. The goal is to see how well this treatment works in everyday medical practice.

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 1,600 people

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

Started

Jan 2026

Expected to finish

Jun 2030

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

Male patients with a diagnosis of metastatic hormone-sensitive prostate cancer (mHSPC) for whom a decision to treat with darolutamide has been made by the treating physician prior to enrollment.

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 patient with a diagnosis of mHSPC * Male aged ≥18 years (or country's legal age of adulthood if \>18 years) * Histologically or cytologically confirmed adenocarcinoma of prostate; may have begun ADT (up to 120 days prior to enrollment) * Metastatic disease by conventional or new generation imaging * Decision to initiate treatment with darolutamide with or without docetaxel made prior to enrollment * Signed informed patient consent before start of data collection * Life expectancy of ≥3 months based on clinical judgment Exclusion Criteria: * Participation in an investigational program with interventions outside of routine clinical practice * Contraindications according to local marketing authorization * Any prior treatment with second-generation AR inhibitors (enzalutamide, apalutamide, or investigational AR inhibitors), CYP17 inhibitors (abiraterone acetate or investigational CYP17 inhibitors) as antineoplastic treatment for prostate cancer * Prior hormone therapy in the metastatic setting * Treatment with darolutamide initiated more than 7 days prior to enrollment

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

Metastatic hormone sensitive prostate cancer

Contacts and locations

Locations

  • Many Locations

    Multiple Locations, Belgium

  • Many Locations

    Multiple Locations, Finland

  • Many Locations

    Multiple Locations, France

  • Many Locations

    Multiple Locations, Germany

  • Many Locations

    Multiple Locations, Greece

  • Many Locations

    Multiple Locations, Israel

  • Many Locations

    Multiple Locations, Italy

  • Many Locations

    Multiple Locations, Lithuania

  • Many Locations

    Multiple Locations, Norway

  • Many Locations

    Multiple Locations, Poland

  • Many Locations

    Multiple Locations, Portugal

  • Many Locations

    Multiple Locations, Saudi Arabia

  • Many Locations

    Multiple Locations, Spain

  • Many Locations

    Multiple Locations, Sweden

  • Many Locations

    Multiple Locations, Switzerland

  • Many Locations

    Multiple Locations, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.