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Prostate cancer drug darolutamide under Real-World microscope

NCT ID NCT04122976

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This study follows over 800 men with non-metastatic castration-resistant prostate cancer who are already taking darolutamide as part of their normal care. Researchers are tracking side effects and how well the drug controls the cancer in real-world conditions, outside of a strict clinical trial. The goal is to see if the drug's benefits seen in earlier studies hold up in everyday practice.

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)
What this could lead to
If successful, this study could confirm that darolutamide is safe and effective for delaying cancer progression in everyday medical practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient differences. It does not test a new treatment but monitors existing use.

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

805 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Oct 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

Male patients with a diagnosis of nmCRPC will be enrolled after the decision for treatment with darolutamide has been made by the investigator.

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: * Men over the age of 18 years * Histologically or cytologically confirmed adenocarcinoma CRPC defined by disease progression despite ADT and may present as a confirmed rise in serum PSA levels (as defined by PCWG3: Rising PSA values at a minimum of 1-week intervals, and a baseline PSA value ≥ 1.0 ng/mL). For patients with a prior ARi treatment (Enzalutamide or Apalutamide), there is no baseline PSA value required * No evidence of metastasis based on conventional imaging. An imaging assessment needs to be obtained prior to the 1st dose of darolutamide. For patients with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC, M0 status with no evidence of disease progression should be confirmed within 3 months of ARi discontinuation * Decision to initiate treatment with darolutamide was made as per investigator's routine treatment practice prior to enrollment in the study * Signed informed consent * Life expectancy of ≥3 months * For a patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for less than one year, all toxic effects from prior use of any ARi treatment have to be resolved at the time of enrollment and prior to the 1st dose of darolutamide Exclusion Criteria: * Participation in an investigational program with interventions outside of routine clinical practice * Contraindications according to the local marketing authorization * Previous treatment with darolutamide (more than 3 days prior to enrollment) * Patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for more than one year

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma prostate cancer

As listed by the trial registrant

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

Prostate cancer

Contacts and locations

Locations

  • Advanced Urology Institute

    Daytona Beach, Florida, 32114, United States

  • Arizona Institute of Urology

    Tucson, Arizona, 85704, United States

  • Associated Medical Professional Urology

    Syracuse, New York, 13210, United States

  • Associated Urologists of NC

    Raleigh, North Carolina, 27612, United States

  • Baylor Scott & White Medical Center - Temple

    Temple, Texas, 76508, United States

  • Beacon Cancer Care

    Beacon, New York, 83814, United States

  • First Urology, PSC

    Jeffersonville, Indiana, 47130, United States

  • Genesis Comprehensive Prostate Cancer Center

    San Diego, California, 92123, United States

  • Integrated Medical Professionals, PLLC

    North New Hyde Park, New York, 11042, United States

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17601, United States

  • Manatee Medical Research Institute

    Bradenton, Florida, 34205, United States

  • Many locations

    Multiple Locations, Argentina

  • Many locations

    Multiple Locations, Austria

  • Many locations

    Multiple Locations, Belgium

  • Many locations

    Multiple Locations, Brazil

  • Many locations

    Multiple Locations, Canada

  • Many locations

    Multiple Locations, China

  • Many locations

    Multiple Locations, Colombia

  • Many locations

    Multiple Locations, Denmark

  • Many locations

    Multiple Locations, France

  • Many locations

    Multiple Locations, Germany

  • Many locations

    Multiple Locations, Greece

  • Many locations

    Multiple Locations, Italy

  • Many locations

    Multiple Locations, Japan

  • Many locations

    Multiple Locations, Russia

  • Many locations

    Multiple Locations, Spain

  • Many locations

    Multiple Locations, Taiwan

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington, 98405, United States

  • New Jersey Urology

    Englewood, Colorado, 07631, United States

  • Oregon Urology Institute

    Springfield, Massachusetts, 01106, United States

  • Premier Medical Group of the Hudson Valley, PC

    Poughkeepsie, New York, 12603, United States

  • Research by Design, LLC

    Chicago, Illinois, 60643, United States

  • Southcoast Centers for Cancer Care

    Fairhaven, Massachusetts, 02719, United States

  • The Urology Center of Colorado

    Denver, Colorado, 80211, United States

  • University of Washington

    Seattle, Washington, 98101, United States

  • Urology Centers of Alabama

    Homewood, Alabama, 35209, United States

  • Urology San Antonio

    San Antonio, Texas, 78229, United States

  • Urology of Virginia

    Virginia Beach, Virginia, 23462, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203, United States

  • Wichita Urology Group

    Wichita, Kansas, 67206, United States

More trials for these conditions

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