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

Overview

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.

Full Title of Study: “Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 30, 2025

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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, outcome, and causality assessment
  • 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
  • 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 Measures

  • Subject’s demographics
    • Time Frame: Up to 5 years
  • Subject’s characteristics
    • Time Frame: Up to 5 years
  • Dosage and dose modification of darolutamide
    • Time Frame: Up to 5 years
  • Initiation and termination dates of darolutamide
    • Time Frame: Up to 5 years
    • Duration of darolutamide treatment
  • Reasons for ending treatment and/or observation/follow-up
    • Time Frame: Up to 5 years
  • Reasons for discontinuations or changes of treatments
    • Time Frame: Up to 5 years
  • Metastasis-Free Survival (MFS)
    • Time Frame: Up to 5 years
  • Time to Symptomatic Skeletal Event (TSSE)
    • Time Frame: Up to 5 years
  • Time to Prostate-Specific Antigen (PSA) progression
    • Time Frame: Up to 5 years
  • Survival rate
    • Time Frame: Up to 5 years
  • Imaging exams used to define tumor status
    • Time Frame: Up to 5 years
  • Prior and post – darolutamide treatments for prostate cancer
    • Time Frame: Up to 5 years

Participating in This Clinical Trial

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)).
  • 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)

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Bayer Clinical Trials Contact, (+)1-888-84 22937, clinical-trials-contact@bayer.com

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