Non-metastatic Castration-resistant Prostate CancerDARENCT07538843
An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment
An observational study of Non-metastatic Castration-resistant Prostate Cancer, run by Bayer at 1 site in China.
Trial summary
In this observational study, participants receive darolutamide: a treatment that is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Non-metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Darolutamide and ADT
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2026to 30 Jan 2030
- 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 diagnosed with nmCRPC, as determined by their treating physician, fulfilling the inclusion and exclusion criteria
Who may be able to join
- Males Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Patients receiving ≥6 m ADT+Bicalutamide in nmHSPC, progressed to nmCRPC judged by investigators.
- Serum testosterone level<1.7 nmol/L.
- Decision to initiate treatment with ADT + Darolutamide as per investigator's routine treatment practice.
- No evidence of metastasis as assessed by computed tomography (CT)/magnetic resonance imaging (MRI) for soft tissue disease and whole-body radionuclide bone scan for bone disease.
- The informed consent form must be signed by the patient or his legal guardian (as applicable).
- Patients who are fertile must use an effective method of contraception during the study and must refrain from donating sperm during the study or for 3 months after the end of treatment, unless they have undergone a radical prostatectomy.
Who cannot join
- Participation in an investigational program with interventions outside of routine clinical practice.
- Presence of distant metastases, including involvement of the Central Nervous System (CNS) and vertebral or meningeal involvement.
- Symptomatic local or regional lesions requiring medical intervention (moderate or severe urinary tract obstruction or hydronephrosis caused by the primary tumor).
- Previous treatment with 2nd-generation ARIs.
- Previous treatment with CYP17 inhibitors.
- Previous treatment with radiopharmaceuticals, immunotherapy, or other investigational treatment for nmCRPC.
- Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias.
- Gastrointestinal diseases affecting absorption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Many locations
Multiple Locations
Bayer Clinical Trials Contact, (+)1-888-84 22937, clinical-trials-contact@bayer.com
About this study
Official title: A Multicenter, Real-world Study Evaluating the Effectiveness of Darolutamide Plus ADT in Patients Progressing to nmCRPC After Bicalutamide Plus ADT Treatment During nmHSPC Stage
In this observational study, participants receive darolutamide: a treatment that is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC).
Prostate cancer is a common cancer in men, and the number of cases is rising, especially in China. Many men are diagnosed at a late stage, which makes treatment more difficult. Standard treatment for prostate cancer often includes lowering the levels of male hormones (androgens) in the body, as these hormones can help the cancer grow. This is called androgen deprivation therapy (ADT). Sometimes, medicines like bicalutamide are added to ADT, but over time, the cancer can become resistant to these treatments. When this happens and the cancer has not yet spread to other parts of the body, it is called nmCRPC. Newer agents, such as darolutamide, have demonstrated efficacy in controlling the disease and delaying progression, with a more favorable safety profile and fewer severe adverse events than conventional therapies.
Read more
This study wants to observe how effective darolutamide plus ADT is at controlling the cancer in Chinese men with nmCRPC who have already been treated with bicalutamide plus ADT during an earlier stage of their disease, known as non-metastatic hormone-sensitive prostate cancer (nmHSPC), but whose cancer has since progressed despite that treatment.
The study will look at how many participants have their prostate-specific antigen (PSA) levels drop to undetectable levels within 6 months of starting darolutamide (in the main group of 800 participants). PSA is a protein made by the prostate, and high levels can be a sign of prostate cancer. In a smaller group of 100 participants, the study will also look at how many men remain free from PSA progression (a sign that the cancer is not getting worse) after 12 months.
To learn more about the safety of darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.
- Being tested
- Darolutamide, ADT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarolutamideDrug
Also called Nubeqa, BAY1841788
Darolutamide administered per local standard of care in combination with ADT.
ADTDrug
Androgen deprivation therapy administered per local standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Master-cohort (6 months follow-up) | Male patients receiving ADT+Bicalutamide for ≥ 6 months in non-metastatic hormone-sensitive prostate cancer (nmHSPC), that progressed to non-metastatic castration-resistant prostate cancer (nmCRPC) Receives: Drug: Darolutamide; Drug: ADT | |
| Sub-cohort (12 months follow-up) | Male patients receiving ADT+Bicalutamide for ≥ 6 months in non-metastatic hormone-sensitive prostate cancer (nmHSPC), that progressed to non-metastatic castration-resistant prostate cancer (nmCRPC) Receives: Drug: Darolutamide; Drug: ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with prostatic specific antigen (PSA) undetectable within 6 months (Master Cohort)
The proportion of patients with undetectable PSA at any time within the 6 months after treatment initiation, undetectable PSA is defined as an absolute PSA level <0.2 ng/ml
Measured: up to 6 months
Proportion of patients with PSA Progression Free Survival (PSA-PFS) rate at 12 months (Sub-cohort)
The proportion of patients who remain PSA progression free by 12 months. PSA progression: (i) PSA increase of≥ 25% and an absolute increase of≥2 ng/mL above the nadir, which is confirmed by a second value obtained 3 or more weeks later, in case of decline, or (ii) a PSA increase of≥25%, and an absolute increase of≥ 2 ng/mL after 12 weeks in case of no decline from the baseline.
Measured: up to 12 months
Secondary outcomes (9)
Proportion of patients with PSA50 within 3 months (Master cohort)
The proportion of patients who achieve 50% or more decline from baseline PSA, at any time within 3 months of treatment initiation
Measured: Up to 3 months
Proportion of patients with PSA50 within 6 months (Master cohort)
The proportion of patients who achieve 50% or more decline from baseline PSA, at any time within 6 months of treatment initiation
Measured: Up to 6 months
Proportion of patients with PSA90 within 3 months (Master cohort)
The proportion of patients who achieve 90% or more decline from baseline PSA, at any time within 3 months of treatment initiation
Measured: Up to 3 months
Proportion of patients with PSA90 within 6 months (Master cohort)
The proportion of patients who achieve 90% or more decline from baseline PSA, at any time within 6 months of treatment initiation
Measured: Up to 6 months
Proportion of patients with PSA undetectable within 3 months (Master cohort)
The proportion of patients with undetectable PSA at any time within the 3 months of treatment initiation, undetectable PSA is defined as an absolute PSA level <0.2 ng/ml
Measured: Up to 3 months
Proportion of patients with PSA50/90 within 12 months (Sub-cohort)
The proportion of patients who achieve 50%/90% or more decline from baseline PSA, at any time within the 12 months of treatment initiation
Measured: Up to 12 months
Proportion of patients with PSA undetectable within 12 months (Sub-cohort)
The proportion of patients with undetectable PSA at any time within the 12 months of treatment initiation, undetectable PSA is defined as an absolute PSA level <0.2 ng/ml
Measured: Up to 12 months
Metastasis-free survival (MFS) rate at 12 months (Sub-cohort)
The proportion of patients who remain metastasis-free by 12 months. MFS is defined as time between the start of the first darolutamide treatment and evidence of metastasis (bone metastasis, visceral metastasis, distant lymph node metastasis) or death from any cause
Measured: Up to 12 months
Proportion of patients with Treatment Emergent Adverse Events (Master and Sub-cohort)
Frequency and severity according to CTCAE v.6, seriousness, causality and action taken related to darolutamide treatment
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start31 Jul 2026
- Primary completion1 Nov 2029 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-metastatic Castration-resistant 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538843
- Sponsor's protocol ID
- 23126
- Acronym
- DARE
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The 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 the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Real-world Study Evaluating the Effectiveness of Darolutamide Plus ADT in Patients Progressing to nmCRPC After Bicalutamide Plus ADT Treatment During nmHSPC Stage
- ClinicalTrials.gov ID
- NCT07538843
- Acronym / sponsor ID
- DARE / 23126
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 20 Apr 2026 (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.
In this observational study, participants receive darolutamide: a treatment that is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC).
Prostate cancer is a common cancer in men, and the number of cases is rising, especially in China. Many men are diagnosed at a late stage, which makes treatment more difficult. Standard treatment for prostate cancer often includes lowering the levels of male hormones (androgens) in the body, as these hormones can help the cancer grow. This is called androgen deprivation therapy (ADT). Sometimes, medicines like bicalutamide are added to ADT, but over time, the cancer can become resistant to these treatments. When this happens and the cancer has not yet spread to other parts of the body, it is called nmCRPC. Newer agents, such as darolutamide, have demonstrated efficacy in controlling the disease and delaying progression, with a more favorable safety profile and fewer severe adverse events than conventional therapies.
This study wants to observe how effective darolutamide plus ADT is at controlling the cancer in Chinese men with nmCRPC who have already been treated with bicalutamide plus ADT during an earlier stage of their disease, known as non-metastatic hormone-sensitive prostate cancer (nmHSPC), but whose cancer has since progressed despite that treatment.
The study will look at how many participants have their prostate-specific antigen (PSA) levels drop to undetectable levels within 6 months of starting darolutamide (in the main group of 800 participants). PSA is a protein made by the prostate, and high levels can be a sign of prostate cancer. In a smaller group of 100 participants, the study will also look at how many men remain free from PSA progression (a sign that the cancer is not getting worse) after 12 months.
To learn more about the safety of darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Master-cohort (6 months follow-up) | – | Drug: Darolutamide, Drug: ADTMale patients receiving ADT+Bicalutamide for ≥ 6 months in non-metastatic hormone-sensitive prostate cancer (nmHSPC), that progressed to non-metastatic castration-resistant prostate cancer (nmCRPC) |
| Sub-cohort (12 months follow-up) | – | Drug: Darolutamide, Drug: ADTMale patients receiving ADT+Bicalutamide for ≥ 6 months in non-metastatic hormone-sensitive prostate cancer (nmHSPC), that progressed to non-metastatic castration-resistant prostate cancer (nmCRPC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients diagnosed with nmCRPC, as determined by their treating physician, fulfilling the inclusion and exclusion criteria
Key inclusion criteria (8 listed)
- Males Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Patients receiving ≥6 m ADT+Bicalutamide in nmHSPC, progressed to nmCRPC judged by investigators.
- Serum testosterone level<1.7 nmol/L.
- Decision to initiate treatment with ADT + Darolutamide as per investigator's routine treatment practice.
Key exclusion criteria (8 listed)
- Participation in an investigational program with interventions outside of routine clinical practice.
- Presence of distant metastases, including involvement of the Central Nervous System (CNS) and vertebral or meningeal involvement.
- Symptomatic local or regional lesions requiring medical intervention (moderate or severe urinary tract obstruction or hydronephrosis caused by the primary tumor).
- Previous treatment with 2nd-generation ARIs.
- Previous treatment with CYP17 inhibitors.
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 |
|---|---|---|
| DarolutamideAlso: Nubeqa, BAY1841788Darolutamide administered per local standard of care in combination with ADT. | Drug | Master-cohort (6 months follow-up), Sub-cohort (12 months follow-up) |
| ADTAndrogen deprivation therapy administered per local standard of care. | Drug | Master-cohort (6 months follow-up), Sub-cohort (12 months follow-up) |
Primary outcome
Proportion of patients with prostatic specific antigen (PSA) undetectable within 6 months (Master Cohort)
Time frame: up to 6 months
The proportion of patients with undetectable PSA at any time within the 6 months after treatment initiation, undetectable PSA is defined as an absolute PSA level <0.2 ng/ml
Proportion of patients with PSA Progression Free Survival (PSA-PFS) rate at 12 months (Sub-cohort)
Time frame: up to 12 months
The proportion of patients who remain PSA progression free by 12 months. PSA progression: (i) PSA increase of≥ 25% and an absolute increase of≥2 ng/mL above the nadir, which is confirmed by a second value obtained 3 or more weeks later, in case of decline, or (ii) a PSA increase of≥25%, and an absolute increase of≥ 2 ng/mL after 12 weeks in case of no decline from the baseline.
9 secondary outcomes
Proportion of patients with PSA50 within 3 months (Master cohort)
Time frame: Up to 3 months
Proportion of patients with PSA50 within 6 months (Master cohort)
Time frame: Up to 6 months
Proportion of patients with PSA90 within 3 months (Master cohort)
Time frame: Up to 3 months
Proportion of patients with PSA90 within 6 months (Master cohort)
Time frame: Up to 6 months
Proportion of patients with PSA undetectable within 3 months (Master cohort)
Time frame: Up to 3 months
Proportion of patients with PSA50/90 within 12 months (Sub-cohort)
Time frame: Up to 12 months
Proportion of patients with PSA undetectable within 12 months (Sub-cohort)
Time frame: Up to 12 months
Metastasis-free survival (MFS) rate at 12 months (Sub-cohort)
Time frame: Up to 12 months
Proportion of patients with Treatment Emergent Adverse Events (Master and Sub-cohort)
Time frame: Up to 12 months
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 18 Aug 2026.
- Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The 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 the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-metastatic Castration-resistant Prostate Cancer, run by Bayer at 1 site in China.
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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 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 1 site in China. 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?
Contact Bayer Clinical Trials Contact (18888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with prostatic specific antigen (PSA) undetectable within 6 months (Master Cohort) (time frame: up to 6 months). The study lists 2 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 18 Aug 2026.