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New combo therapy may slow prostate cancer spread

NCT ID NCT05059236

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 2 times

Summary

This study tests whether adding darolutamide to standard hormone therapy (ADT) can delay cancer worsening in men with metastatic hormone-sensitive prostate cancer. About 223 men will receive darolutamide plus ADT, and their results will be compared to men from an earlier study who got ADT alone. The goal is to see if the combination extends the time before the cancer progresses.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

223 people

The number who actually took part.

Started

Nov 2021

Finished

Jun 2026

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.

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: * Histologically or cytologically confirmed adenocarcinoma of prostate. Participants may have begun androgen-deprivation therapy (up to 120 days prior to enrollment). Note: Relugolix is not permitted as ADT in this study. * Metastatic disease and will be stratified by presence of high volume or low volume disease. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2 * Adequate bone marrow, liver and renal function within 4 weeks of enrollment * At least 4 weeks since prior major surgery and recovered from all toxicity from such surgery prior to enrollment * Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following criteria are met: * Therapy was discontinued ≥ 12 months ago AND there was a clinical state without evidence of disease at least 12 months after completing adjuvant or neoadjuvant hormonal therapy, as defined by 1 of the following: * PSA \< 0.1 ng/mL after prostatectomy plus hormonal therapy * PSA \< 0.5 ng/mL and has not doubled above nadir after radiotherapy plus hormonal therapy * Therapy lasted no more than 24 months * Prior palliative radiotherapy allowed for participants, if commenced within 30 days before starting androgen deprivation. * Bicalutamide, nilutamide or flutamide are allowed as single-agent therapy ≤ 28 days before medical castration to prevent flare. Exclusion Criteria: * PSA met criteria for PSA progression * History of malignancy in the past 5 years, with the exception of basal cell and squamous cell carcinoma of the skin. * Had any of the following within 6 months before randomization: myocardial infarction, severe/unstable angina pectoris, congestive heart failure, hospitalization for any cardiac event, including conduction abnormalities * Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate * Known brain/ leptomeningeal metastases * An active viral hepatitis (defined as Hepatitis B surface antigen \[HBsAg\] reactive or detectable \[qualitative\] HBV DNA defined as HCV Ribonucleic Acid \[RNA\] \[qualitative\] is detected), known human immunodeficiency virus infection with detectable viral load, or chronic liver disease with a need of treatment * Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management * A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug * Any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the participant and/or his compliance with study procedures or may interfere with the participant's participation in the study or evaluation of the study results. * Prior hormone therapy in the metastatic setting * Prior chemotherapy in the adjuvant or neoadjuvant setting * Concurrent use or previous exposure of 5-alpha reductase inhibitors (within 28 days before the start of darolutamide or 5 half-lives of the drug, whichever is longer) * Any Prior treatment with second-generation androgen receptor (AR) inhibitors such as enzalutamide, apalutamide, darolutamide, or other investigational AR inhibitors, Cytochrome P17 enzyme inhibitor such as abiraterone acetate or other investigational CYP 17 as antineoplastic treatment for prostate cancer * Previous (within 28 days before the start of darolutamide or 5 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s). * Contraindication to both CT and MRI contrast agent * Hypersensitivity to any of the study treatments, study treatment classes, or excipients in the formulation of the study treatments * Inability to swallow oral medications

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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

  • AMR - Kansas City

    Kansas City, Missouri, 64132, United States

  • Arizona Urology Specialists - Tucson - W Orange Grove

    Tucson, Arizona, 85741, United States

  • Associated Medical Professionals of NY Syracuse

    Syracuse, New York, 13210, United States

  • Barbara Ann Karmanos Cancer Institute - Detroit Headquarters

    Detroit, Michigan, 48201, United States

  • Brigham and Women's Hospital (BWH) - Surgery Urology

    Atlanta, Georgia, 30318, United States

  • Carolina Urological Research Center

    Myrtle Beach, South Carolina, 29579, United States

  • Columbus Prostate Cancer Center / Radiation Oncology Clinic

    Gahanna, Ohio, 43230, United States

  • GU Research Network, LLC - Oncology radiology

    Omaha, Nebraska, 68130, United States

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • Inova Schar Cancer Institute (vendor)

    Fairfax, Virginia, 22031, United States

  • Lieutenant Colonel Charles S. Kettles VA Medical Center - Oncology

    Ann Arbor, Michigan, 48105, United States

  • Michigan Institute of Urology - Troy - Town Center Building

    Troy, Michigan, 48084, United States

  • MidLantic Urology - Bala Cynwyd

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Mount Sinai Doctors - Faculty Practice

    New York, New York, 10029, United States

  • Mount Sinai Faculty Practice Associates

    New York, New York, 10029, United States

  • New Jersey Urology - Clifton

    Clifton, New Jersey, 07013, United States

  • New Jersey Urology - Voorhees

    Voorhees Township, New Jersey, 08043, United States

  • New Mexico Cancer Center - Albuquerque

    Albuquerque, New Mexico, 87109, United States

  • Northwestern Medicine - Urology

    Chicago, Illinois, 60611, United States

  • Northwestern University's Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

  • Piedmont Cancer Institute - Atlanta

    Atlanta, Georgia, 30318, United States

  • Providence Saint John's Cancer Institute

    Santa Monica, California, 90404, United States

  • Spokane Urology PS

    Spokane, Washington, 99202, United States

  • The Urology Group - Norwood Surgery Center

    Cincinnati, Ohio, 45212, United States

  • Tower Urology

    Los Angeles, California, 90048, United States

  • UC San Diego Health - Moores Cancer Center

    San Diego, California, 92037, United States

  • UCI Health Center for Urological Care

    Orange, California, 92868, United States

  • UM Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201, United States

  • Urology Associates, PC - Nashville

    Nashville, Tennessee, 37209, United States

  • Urology Centers of Alabama, PC - Homewood

    Homewood, Alabama, 35209, United States

  • XCancer Omaha

    Omaha, Nebraska, 68130, United States

More trials for these conditions

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