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NCT04122976

A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

805 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-30

Study Completion Date

2026-10-07

Brief Summary

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The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Men with nmCRPC

Men with nmCRPC for whom a decision to treat with darolutamide has been made before enrollment, and who have signed informed consent, will be eligible for the study.

Darolutamide(Nubeqa, BAY1841788)

Intervention Type DRUG

The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.

Interventions

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Darolutamide(Nubeqa, BAY1841788)

The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

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Australia Finland Hong Kong India Ireland Mexico Netherlands Norway Slovakia Sweden Turkey (Türkiye) United Kingdom United States Argentina Austria Belgium Brazil Canada China Colombia Denmark France Germany Greece Italy Japan Russia Spain Taiwan

Other Identifiers

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20590

Identifier Type: -

Identifier Source: org_study_id

A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Men with nmCRPC

Darolutamide(Nubeqa, BAY1841788)

Interventions

Darolutamide(Nubeqa, BAY1841788)

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Bayer

Responsible Party

Locations

Urology Centers of Alabama

Arizona Institute of Urology

Genesis Comprehensive Prostate Cancer Center

The Urology Center of Colorado

Manatee Medical Research Institute

Advanced Urology Institute

Research by Design, LLC

First Urology, PSC

Wichita Urology Group

Southcoast Centers for Cancer Care

New Jersey Urology

Beacon Cancer Care

Integrated Medical Professionals, PLLC

Premier Medical Group of the Hudson Valley, PC

Associated Medical Professional Urology

Dukes Cancer Intitute Center for Prostate and Urologic Cancers

Associated Urologists of NC

Oregon Urology Institutue

Keystone Urology Specialists

Vanderbilt University Medical Center

Urology San Antonio

Baylor Scott & White Medical Center - Temple

Urology of Virginia

University of Washington

MultiCare Institute for Research & Innovation

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Countries

Other Identifiers

20590