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 (DARE)

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Non-metastatic Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: ADT; Drug: Darolutamide

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

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

Study Locations

• China
  • Multiple Locations, China
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male patients diagnosed with nmCRPC, as determined by their treating physician, fulfilling the inclusion and exclusion criteria

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Drug: ADT; Androgen deprivation therapy administered per local standard of care.; Drug: Darolutamide; Darolutamide administered per local standard of care in combination with ADT.; Other Names: Nubeqa, BAY1841788
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)	Drug: ADT; Androgen deprivation therapy administered per local standard of care.; Drug: Darolutamide; Darolutamide administered per local standard of care in combination with ADT.; Other Names: Nubeqa, BAY1841788

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	Up to 12 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): January 30, 2030

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: darolutamide
• Other Study ID Numbers: 23126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

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