do_not_disturb_altRecruitment Complete

Prostate cancer

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

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
805
Trial Dates
January 2020 - October 2026
Phase
N/A
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many LocationsMany Locations, Argentina
Active, not recruiting
Many LocationsMany Locations, Austria
Withdrawn
Many LocationsMany Locations, Australia
Active, not recruiting
Many LocationsMany Locations, Belgium
Active, not recruiting
Many LocationsMany Locations, Brazil
Active, not recruiting
Many LocationsMany Locations, Canada
Active, not recruiting
Many LocationsMany Locations, China
Active, not recruiting
Many LocationsMany Locations, Colombia
Active, not recruiting
Many LocationsMany Locations, Germany
Active, not recruiting
Many LocationsMany Locations, Denmark
Active, not recruiting
Many LocationsMany Locations, Spain
Withdrawn
Many LocationsMany Locations, Finland
Active, not recruiting
Many LocationsMany Locations, France
Withdrawn
Many LocationsMany Locations, United Kingdom
Active, not recruiting
Many LocationsMany Locations, Greece
Withdrawn
Many LocationsMany Locations, Hong Kong
Withdrawn
Many LocationsMany Locations, Ireland
Withdrawn
Many LocationsMany Locations, India
Active, not recruiting
Many LocationsMany Locations, Italy
Active, not recruiting
Many LocationsMany Locations, Japan
Withdrawn
Many LocationsMany Locations, Mexico
Withdrawn
Many LocationsMany Locations, Netherlands
Withdrawn
Many LocationsMany Locations, Norway
Active, not recruiting
Many LocationsMany Locations, Russia
Withdrawn
Many LocationsMany Locations, Sweden
Withdrawn
Many LocationsMany Locations, Slovakia
Withdrawn
Many LocationsMany Locations, Turkey
Active, not recruiting
Many LocationsMany Locations, Taiwan
Recruiting
Dukes Cancer Intitute Center for Prostate and Urologic CancersDurham, 27710, United States
Recruiting
Arizona Institute of UrologyTucson, 85704, United States
Recruiting
Associated Medical Professional UrologySyracuse, 13210, United States
Recruiting
University of WashingtonSeattle, 98101, United States
Recruiting
Urology San AntonioSan Antonio, 78229, United States
Recruiting
Urology Centers of AlabamaHomewood, 35209, United States
Recruiting
First Urology, PSCJeffersonville, 47130, United States
Recruiting
Keystone Urology SpecialistsLancaster, 17601, United States
Recruiting
Wichita Urology GroupWichita, 67206, United States
Recruiting
Genesis Comprehensive Prostate Cancer CenterSan Diego, 92123, United States
Recruiting
New Jersey UrologyEnglewood, 07631, United States
Recruiting
Manatee Medical Research InstituteBradenton, 34205, United States
Recruiting
Associated Urologists of NCRaleigh, 27612, United States
Recruiting
Oregon Urology InstitutueSpringfield, 01106, United States
Recruiting
Vanderbilt University Medical CenterNashville, 37203, United States
Recruiting
Baylor Scott & White Medical Center - TempleTemple, 76508, United States
Recruiting
Urology of VirginiaVirginia Beach, 23462, United States
Completed
Integrated Medical Professionals, PLLCNorth New Hyde Park, 11042, United States
Recruiting
Advanced Urology InstituteDaytona Beach, 32114, United States
Recruiting
MultiCare Institute for Research & InnovationTacoma, 98405, United States
Recruiting
Premier Medical Group of the Hudson Valley, PCPoughkeepsie, 12603, United States
Recruiting
Southcoast Centers for Cancer CareFairhaven, 02719, United States
Recruiting
The Urology Center of ColoradoDenver, 80211, United States
Recruiting
Beacon Cancer CareBeacon, 83814, United States
Recruiting
Research by Design, LLCChicago, 60643, United States

Primary Outcome

  • Occurrence of treatment-emergent adverse events (TEAEs)
    Including severity, seriousness and outcome.
    date_rangeTime Frame:
    Up to 30 days after last dose of darolutamide within the patient's observation period
  • Reasonable causal relationship between darolutamide and an adverse event (AE)
    date_rangeTime Frame:
    Up to 30 days after last dose of darolutamide within the patient's observation period
  • Action taken related to darolutamide treatment
    Dose modifications and time periods
    date_rangeTime Frame:
    Up to 30 days after last dose of darolutamide within the patient's observation period

Secondary Outcome

  • Subject's demographics
    date_rangeTime Frame:
    Up to 7 years
  • Subject's characteristics
    date_rangeTime Frame:
    Up to 7 years
  • Co-morbidities
    date_rangeTime Frame:
    Up to 7 years
  • Disease course and progression (including performance status)
    date_rangeTime Frame:
    Up to 7 years
  • Concomitant medication/treatment (including opioids)
    date_rangeTime Frame:
    Up to 7 years
  • Dosage and dose modification of darolutamide
    date_rangeTime Frame:
    Up to 7 years
  • Reasons for ending treatment and/or observation/follow-up
    date_rangeTime Frame:
    Up to 7 years
  • Metastasis-Free Survival (MFS)
    date_rangeTime Frame:
    Up to 7 years
  • Time to Symptomatic Skeletal Event (TSSE)
    date_rangeTime Frame:
    Up to 7 years
  • Time to Prostate-Specific Antigen (PSA) progression
    date_rangeTime Frame:
    Up to 7 years
  • Survival rate
    date_rangeTime Frame:
    Up to 7 years
  • Duration of darolutamide therapy
    date_rangeTime Frame:
    Up to 7 years
  • Imaging exams used to define tumor status
    date_rangeTime Frame:
    Up to 7 years
  • Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding)
    date_rangeTime Frame:
    Up to 7 years
  • Prior and post - darolutamide treatments for prostate cancer
    date_rangeTime Frame:
    Up to 7 years

Trial design

Darolutamide Observational Study in non-metastatic castration-resistant prostate cancer patients
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A