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New hope for men with resistant prostate cancer: darolutamide combo tested

NCT ID NCT07538843

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 19, 2026 · Updated 5 times

Summary

This study looks at how well darolutamide (Nubeqa) plus standard hormone therapy works in Chinese men whose prostate cancer has become resistant to earlier treatment but hasn't spread. About 800 men will take part, and researchers will track PSA levels to see if the cancer is controlled. The goal is to understand if this combination can delay cancer progression in real-world settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Darolutamide (Nubeqa) plus androgen deprivation therapy (ADT)
What this could lead to
If successful, this could show that darolutamide plus ADT effectively controls cancer progression in men whose prostate cancer has become resistant to earlier treatments.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The cancer may still progress despite treatment, and side effects are possible.

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 800 people

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

Started

Jul 2026

Expected to finish

Jan 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 diagnosed with nmCRPC, as determined by their treating physician, fulfilling the inclusion and exclusion criteria

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: * Males Age ≥ 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Patients receiving ≥6 m ADT+Bicalutamide in nmHSPC, progressed to nmCRPC judged by investigators. * Serum testosterone level\<1.7 nmol/L. * Decision to initiate treatment with ADT + Darolutamide as per investigator's routine treatment practice. * No evidence of metastasis as assessed by computed tomography (CT)/magnetic resonance imaging (MRI) for soft tissue disease and whole-body radionuclide bone scan for bone disease. * The informed consent form must be signed by the patient or his legal guardian (as applicable). * Patients who are fertile must use an effective method of contraception during the study and must refrain from donating sperm during the study or for 3 months after the end of treatment, unless they have undergone a radical prostatectomy. Exclusion Criteria: * Participation in an investigational program with interventions outside of routine clinical practice. * Presence of distant metastases, including involvement of the Central Nervous System (CNS) and vertebral or meningeal involvement. * Symptomatic local or regional lesions requiring medical intervention (moderate or severe urinary tract obstruction or hydronephrosis caused by the primary tumor). * Previous treatment with 2nd-generation ARIs. * Previous treatment with CYP17 inhibitors. * Previous treatment with radiopharmaceuticals, immunotherapy, or other investigational treatment for nmCRPC. * Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias. * Gastrointestinal diseases affecting absorption.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma

As listed by the trial registrant

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

Non-metastatic castration-resistant prostate cancer

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

  • Many locations

    RECRUITING

    Multiple Locations, China

More trials for these conditions

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