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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04122976




Registration number
NCT04122976
Ethics application status
Date submitted
9/10/2019
Date registered
10/10/2019
Date last updated
10/10/2024

Titles & IDs
Public title
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
Scientific title
Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients
Secondary ID [1] 0 0
20590
Universal Trial Number (UTN)
Trial acronym
DAROL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Darolutamide(Nubeqa, BAY1841788)

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.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality or all-stroke
Timepoint [1] 0 0
30 days post procedure
Primary outcome [2] 0 0
Occurrence of treatment-emergent adverse events (TEAEs)
Timepoint [2] 0 0
Up to 30 days after last dose of darolutamide within the patient's observation period
Primary outcome [3] 0 0
Reasonable causal relationship between darolutamide and an adverse event (AE)
Timepoint [3] 0 0
Up to 30 days after last dose of darolutamide within the patient's observation period
Primary outcome [4] 0 0
Action taken related to darolutamide treatment
Timepoint [4] 0 0
Up to 30 days after last dose of darolutamide within the patient's observation period
Secondary outcome [1] 0 0
Subject's demographics
Timepoint [1] 0 0
Up to 7 years
Secondary outcome [2] 0 0
Subject's characteristics
Timepoint [2] 0 0
Up to 7 years
Secondary outcome [3] 0 0
Co-morbidities
Timepoint [3] 0 0
Up to 7 years
Secondary outcome [4] 0 0
Disease course and progression (including performance status)
Timepoint [4] 0 0
Up to 7 years
Secondary outcome [5] 0 0
Concomitant medication/treatment (including opioids)
Timepoint [5] 0 0
Up to 7 years
Secondary outcome [6] 0 0
Dosage and dose modification of darolutamide
Timepoint [6] 0 0
Up to 7 years
Secondary outcome [7] 0 0
Reasons for ending treatment and/or observation/follow-up
Timepoint [7] 0 0
Up to 7 years
Secondary outcome [8] 0 0
Metastasis-Free Survival (MFS)
Timepoint [8] 0 0
Up to 7 years
Secondary outcome [9] 0 0
Time to Symptomatic Skeletal Event (TSSE)
Timepoint [9] 0 0
Up to 7 years
Secondary outcome [10] 0 0
Time to Prostate-Specific Antigen (PSA) progression
Timepoint [10] 0 0
Up to 7 years
Secondary outcome [11] 0 0
Survival rate
Timepoint [11] 0 0
Up to 7 years
Secondary outcome [12] 0 0
Duration of darolutamide therapy
Timepoint [12] 0 0
Up to 7 years
Secondary outcome [13] 0 0
Imaging exams used to define tumor status
Timepoint [13] 0 0
Up to 7 years
Secondary outcome [14] 0 0
Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding)
Timepoint [14] 0 0
Up to 7 years
Secondary outcome [15] 0 0
Prior and post - darolutamide treatments for prostate cancer
Timepoint [15] 0 0
Up to 7 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/10/2026
Actual
Sample size
Target
Accrual to date
Final
805
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Argentina
State/province [19] 0 0
Multiple Locations
Country [20] 0 0
Austria
State/province [20] 0 0
Multiple Locations
Country [21] 0 0
Belgium
State/province [21] 0 0
Multiple Locations
Country [22] 0 0
Brazil
State/province [22] 0 0
Multiple Locations
Country [23] 0 0
Canada
State/province [23] 0 0
Multiple Locations
Country [24] 0 0
China
State/province [24] 0 0
Multiple Locations
Country [25] 0 0
Colombia
State/province [25] 0 0
Multiple Locations
Country [26] 0 0
Denmark
State/province [26] 0 0
Multiple Locations
Country [27] 0 0
France
State/province [27] 0 0
Multiple Locations
Country [28] 0 0
Germany
State/province [28] 0 0
Multiple Locations
Country [29] 0 0
Greece
State/province [29] 0 0
Multiple Locations
Country [30] 0 0
Italy
State/province [30] 0 0
Multiple Locations
Country [31] 0 0
Japan
State/province [31] 0 0
Multiple Locations
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Multiple Locations
Country [33] 0 0
Spain
State/province [33] 0 0
Multiple Locations
Country [34] 0 0
Taiwan
State/province [34] 0 0
Multiple Locations

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04122976
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04122976