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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)

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ClinicalTrials.gov Identifier: NCT04122976
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : March 23, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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)

Study Design
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Study Type : Observational
Estimated Enrollment : 800 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 : December 30, 2026
Estimated Study Completion Date : March 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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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.


Outcome Measures
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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 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 ]

Eligibility Criteria
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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.
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04122976


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Sponsors and Collaborators
Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04122976    
Other Study ID Numbers: 20590
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
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 www.clinicalstudydatarequest.com 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
Neoplasms
Prostatic Diseases