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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 (DAROL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04122976
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : June 22, 2022
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Drug: Darolutamide(Nubeqa, BAY1841788)

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
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.
Drug: 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.

Primary Outcome Measures :
  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 Outcome Measures :
  1. Subject's demographics [ Time Frame: Up to 5.7 years ]
  2. Subject's characteristics [ Time Frame: Up to 5.7 years ]
  3. Co-morbidities [ Time Frame: Up to 5.7 years ]
  4. Disease course and progression (including performance status) [ Time Frame: Up to 5.7 years ]
  5. Concomitant medication/treatment (including opioids) [ Time Frame: Up to 5.7 years ]
  6. Dosage and dose modification of darolutamide [ Time Frame: Up to 5.7 years ]
  7. Reasons for ending treatment and/or observation/follow-up [ Time Frame: Up to 5.7 years ]
  8. Metastasis-Free Survival (MFS) [ Time Frame: Up to 5.7 years ]
  9. Time to Symptomatic Skeletal Event (TSSE) [ Time Frame: Up to 5.7 years ]
  10. Time to Prostate-Specific Antigen (PSA) progression [ Time Frame: Up to 5.7 years ]
  11. Survival rate [ Time Frame: Up to 5.7 years ]
  12. Duration of darolutamide therapy [ Time Frame: Up to 5.7 years ]
  13. Imaging exams used to define tumor status [ Time Frame: Up to 5.7 years ]
  14. Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding) [ Time Frame: Up to 5.7 years ]
  15. Prior and post - darolutamide treatments for prostate cancer [ Time Frame: Up to 5.7 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male patients with a diagnosis of nmCRPC will be enrolled after the decision for treatment with darolutamide has been made by the investigator.

Inclusion Criteria:

  • Men over the age of 18 years
  • Histologically or cytologically confirmed adenocarcinoma CRPC (Castration-Resistant Prostate Cancer) defined by disease progression despite ADT (Androgen-Deprivation Therapy) and may present as a confirmed rise in serum PSA levels (as defined by PCWG3 (Prostate Cancer Working Group 3): Rising PSA values at a minimum of 1-week intervals, and a baseline PSA value ≥ 1.0 ng/mL).
  • No evidence of metastasis based on imaging assessment obtained within 3 months prior to first dose of darolutamide
  • 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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04122976

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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937

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United States, Indiana
First Urology, PSC Recruiting
Jeffersonville, Indiana, United States, 47130
Sponsors and Collaborators
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Responsible Party: Bayer Identifier: NCT04122976    
Other Study ID Numbers: 20590
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases