Prostate CancerDAROLNCT04122976
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
An observational study of Prostate Cancer, run by Bayer at 40 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Darolutamide(Nubeqa, BAY1841788)
- How many people
- 805 participants
- Where
- 40 sitesin 17 countries
- Study dates
- 30 Jan 2020to 7 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
40 sites in 17 countries.
40 sites in 17 countries
United States24 sites
Beacon Cancer Care
Beacon, New York, 83814
Manatee Medical Research Institute
Bradenton, Florida, 34205
Research by Design, LLC
Chicago, Illinois, 60643
Advanced Urology Institute
Daytona Beach, Florida, 32114
The Urology Center of Colorado
Denver, Colorado, 80211
New Jersey Urology
Englewood, Colorado, 07631
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, 02719
Urology Centers of Alabama
Homewood, Alabama, 35209
First Urology, PSC
Jeffersonville, Indiana, 47130
Keystone Urology Specialists
Lancaster, Pennsylvania, 17601
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Integrated Medical Professionals, PLLC
North New Hyde Park, New York, 11042
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, 12603
Associated Urologists of NC
Raleigh, North Carolina, 27612
Urology San Antonio
San Antonio, Texas, 78229
Genesis Comprehensive Prostate Cancer Center
San Diego, California, 92123
University of Washington
Seattle, Washington, 98101
Oregon Urology Institute
Springfield, Massachusetts, 01106
Associated Medical Professional Urology
Syracuse, New York, 13210
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508
Arizona Institute of Urology
Tucson, Arizona, 85704
Urology of Virginia
Virginia Beach, Virginia, 23462
Wichita Urology Group
Wichita, Kansas, 67206
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- Darolutamide(Nubeqa, BAY1841788)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide(Nubeqa, BAY1841788)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Darolutamide(Nubeqa, BAY1841788) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment-emergent adverse events (TEAEs)
Including severity, seriousness and outcome.
Measured: 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)
Measured: 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
Measured: Up to 30 days after last dose of darolutamide within the patient's observation period
Secondary outcomes (15)
Subject's demographics
Measured: Up to 7 years
Subject's characteristics
Measured: Up to 7 years
Co-morbidities
Measured: Up to 7 years
Disease course and progression (including performance status)
Measured: Up to 7 years
Concomitant medication/treatment (including opioids)
Measured: Up to 7 years
Dosage and dose modification of darolutamide
Measured: Up to 7 years
Reasons for ending treatment and/or observation/follow-up
Measured: Up to 7 years
Metastasis-Free Survival (MFS)
Measured: Up to 7 years
Time to Symptomatic Skeletal Event (TSSE)
Measured: Up to 7 years
Time to Prostate-Specific Antigen (PSA) progression
Measured: Up to 7 years
Survival rate
Measured: Up to 7 years
Duration of darolutamide therapy
Measured: Up to 7 years
Imaging exams used to define tumor status
Measured: Up to 7 years
Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding)
Measured: Up to 7 years
Prior and post - darolutamide treatments for prostate cancer
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start30 Jan 2020
- Primary completion20 Jul 2026
- Study completion7 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122976
- Sponsor's protocol ID
- 20590
- Acronym
- DAROL
- Status last verified
- Aug 2026
- First submitted
- 9 Oct 2019
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later 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.vivli.org 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 member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT04122976
- Acronym / sponsor ID
- DAROL / 20590
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 805 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 7 Oct 2026 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men with nmCRPC | – | Drug: Darolutamide(Nubeqa, BAY1841788)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Men with nmCRPC |
Primary outcome
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.
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
15 secondary outcomes
Subject's demographics
Time frame: Up to 7 years
Subject's characteristics
Time frame: Up to 7 years
Co-morbidities
Time frame: Up to 7 years
Disease course and progression (including performance status)
Time frame: Up to 7 years
Concomitant medication/treatment (including opioids)
Time frame: Up to 7 years
Dosage and dose modification of darolutamide
Time frame: Up to 7 years
Reasons for ending treatment and/or observation/follow-up
Time frame: Up to 7 years
Metastasis-Free Survival (MFS)
Time frame: Up to 7 years
Time to Symptomatic Skeletal Event (TSSE)
Time frame: Up to 7 years
Time to Prostate-Specific Antigen (PSA) progression
Time frame: Up to 7 years
Survival rate
Time frame: Up to 7 years
Duration of darolutamide therapy
Time frame: Up to 7 years
Imaging exams used to define tumor status
Time frame: Up to 7 years
Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding)
Time frame: Up to 7 years
Prior and post - darolutamide treatments for prostate cancer
Time frame: Up to 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later 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.vivli.org 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 member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Bayer at 40 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Argentina, Austria, Belgium, Brazil and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment-emergent adverse events (TEAEs) (time frame: Up to 30 days after last dose of darolutamide within the patient's observation period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.