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Active, Not Recruiting

NCT Number: 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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, Multiple Locations, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darolutamide(Nubeqa, BAY1841788)

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.

Primary outcomes

  1. Occurrence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 30 days after last dose of darolutamide within the patient's observation period

    Including severity, seriousness and outcome.

  2. Reasonable causal relationship between darolutamide and an adverse event (AE)

    Time frame: Up to 30 days after last dose of darolutamide within the patient's observation period

  3. Action taken related to darolutamide treatment

    Time frame: Up to 30 days after last dose of darolutamide within the patient's observation period

    Dose modifications and time periods

Secondary outcomes

  1. Subject's demographics

    Time frame: Up to 7 years

  2. Subject's characteristics

    Time frame: Up to 7 years

  3. Co-morbidities

    Time frame: Up to 7 years

  4. Disease course and progression (including performance status)

    Time frame: Up to 7 years

  5. Concomitant medication/treatment (including opioids)

    Time frame: Up to 7 years

  6. Dosage and dose modification of darolutamide

    Time frame: Up to 7 years

  7. Reasons for ending treatment and/or observation/follow-up

    Time frame: Up to 7 years

  8. Metastasis-Free Survival (MFS)

    Time frame: Up to 7 years

  9. Time to Symptomatic Skeletal Event (TSSE)

    Time frame: Up to 7 years

  10. Time to Prostate-Specific Antigen (PSA) progression

    Time frame: Up to 7 years

  11. Survival rate

    Time frame: Up to 7 years

  12. Duration of darolutamide therapy

    Time frame: Up to 7 years

  13. Imaging exams used to define tumor status

    Time frame: Up to 7 years

  14. Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding)

    Time frame: Up to 7 years

  15. Prior and post - darolutamide treatments for prostate cancer

    Time frame: Up to 7 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients

Acronym: DAROL

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2019
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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