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)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Darolutamide(Nubeqa, BAY1841788)

• Study Type: Observational
• Enrollment (Actual): 805

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Argentina
  • Multiple Locations, Argentina
    • Many Locations
• Austria
  • Multiple Locations, Austria
    • Many Locations
• Belgium
  • Multiple Locations, Belgium
    • Many Locations
• Brazil
  • Multiple Locations, Brazil
    • Many Locations
• Canada
  • Multiple Locations, Canada
    • Many Locations
• China
  • Multiple Locations, China
    • Many Locations
• Colombia
  • Multiple Locations, Colombia
    • Many Locations
• Denmark
  • Multiple Locations, Denmark
    • Many Locations
• France
  • Multiple Locations, France
    • Many Locations
• Germany
  • Multiple Locations, Germany
    • Many Locations
• Greece
  • Multiple Locations, Greece
    • Many Locations
• Italy
  • Multiple Locations, Italy
    • Many Locations
• Japan
  • Multiple Locations, Japan
    • Many Locations
• Russian Federation
  • Multiple Locations, Russian Federation
    • Many Locations
• Spain
  • Multiple Locations, Spain
    • Many Locations
• Taiwan
  • Multiple Locations, Taiwan
    • Many Locations
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Urology Centers Of Alabama
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Arizona Institute of Urology
  • California
    • San Diego, California, United States, 92123
      • Genesis Comprehensive Prostate Cancer Center
  • Colorado
    • Denver, Colorado, United States, 80211
      • The Urology Center of Colorado
  • Florida
    • Bradenton, Florida, United States, 34205
      • Manatee Medical Research Institute
    • Daytona Beach, Florida, United States, 32114
      • Advanced Urology Institute
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Research by Design, LLC
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology, PSC
  • Kansas
    • Wichita, Kansas, United States, 67206
      • Wichita Urology Group
  • Massachusetts
    • Fairhaven, Massachusetts, United States, 02719
      • Southcoast Centers for Cancer Care
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • New Jersey Urology
  • New York
    • Beacon, New York, United States, 83814
      • Beacon Cancer Care
    • N. New Hyde Park, New York, United States, 11042
      • Integrated Medical Professionals, PLLC
    • Poughkeepsie, New York, United States, 12603
      • Premier Medical Group of the Hudson Valley, PC
    • Syracuse, New York, United States, 13210
      • Associated Medical Professional Urology
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Dukes Cancer Intitute Center for Prostate and Urologic Cancers
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologists of NC
  • Oregon
    • Springfield, Oregon, United States, 01106
      • Oregon Urology Institutue
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Keystone Urology Specialists
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Medical Center - Temple
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia
  • Washington
    • Seattle, Washington, United States, 98101
      • University of Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research & Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of treatment-emergent adverse events (TEAEs)	Including severity, seriousness and outcome.	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)		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	Up to 30 days after last dose of darolutamide within the patient's observation period

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Estimated): July 7, 2026
• Study Completion (Estimated): October 7, 2026

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 20590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No