Darolutamide plus ADT for men with non-metastatic prostate cancer that progressed after prior ADT+bicalutamide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study conducted in China evaluating the use of darolutamide in combination with ongoing ADT for men with non-metastatic castration-resistant prostate cancer. Eligible participants are adults with good performance status and confirmed nmCRPC without metastasis, who are starting or continuing ADT plus darolutamide as part of routine clinical care. The study collects safety and real-world treatment data to understand outcomes in this specific treatment context. No randomization or experimental assignment is involved; data reflects standard practice and physician decisions. Key endpoints are safety signals and disease control in a real-world setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Many locations
  Multiple Locations, China Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 18888422937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Observing the safety of darolutamide in Korean men with prostate cancer

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• Evaluating the safety and effectiveness of Darolutamide with standard hormone therapy for prostate cancer

  This study is testing if adding Darolutamide to standard hormone therapy can help men with high-risk prostate cancer that keeps progressing even when testosterone is low.

  Recruiting at 11 sites Phase 4 Bayer · Nadiād, Gujarat and 14 other locations · NCT05348876

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.