Tests darolutamide with hormone therapy in men whose prostate cancer progressed after bicalutamide
Observes darolutamide plus hormone therapy in men whose prostate cancer grew after bicalutamide.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Multiple Locations, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has not spread but has stopped responding to ADT plus bicalutamide, and who start darolutamide plus ADT as part of routine care.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Non-metastatic castration-resistant prostate cancer (nmCRPC), with no spread seen on CT/MRI and bone scan
- Earlier treatment
- Must have had at least 6 months of ADT plus bicalutamide at the non-metastatic hormone-sensitive stage. Must not have had 2nd-generation ARIs, CYP17 inhibitors, radiopharmaceuticals, immunotherapy or other investigational treatment for nmCRPC.
- Biomarker or test result
- Serum testosterone below 1.7 nmol/L
Main reasons for not taking part
- Cancer has spread to distant parts of the body, including the central nervous system
- Symptomatic local or regional lesions needing medical intervention, such as moderate or severe urinary tract obstruction
- Severe or unstable heart problems, such as angina, heart attack or heart failure with symptoms
- Gastrointestinal disease that affects absorption
- Taking part in an investigational program outside routine clinical practice
Read by machine on 12 November 2026.
Where in China
- Many LocationsMultiple Locations, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Bayer
- Trial code
- NCT07538843
- Record updated
- 18 August 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: 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; 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).