Observing the safety and effectiveness of darolutamide with hormone therapy and chemotherapy for Japanese men with low-volume metastatic prostate cancer

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 observational study collects and analyzes medical records of Japanese men diagnosed with low-volume metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with a combination of darolutamide, androgen deprivation therapy (ADT), and docetaxel. The aim is to understand the safety and effectiveness of this treatment regimen in routine medical care. Darolutamide is known to block androgen signals, while ADT lowers testosterone levels, and docetaxel is a chemotherapy agent that inhibits cancer cell growth. By studying these patients, the research seeks to improve treatment decisions for this specific cancer population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of prostate.
* Patients have low-volume of metastatic disease documented by either by a positive bone scan, or for soft tissue either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigator. Low-volume metastasis criteria is defined as "not" meeting the high-volume criteria of the CHAARTED trial; high-volume meet the presence of visceral metastases, or four or more bone lesions including at least one outside the vertebral column or pelvis.
* Documented diagnosis of mHSPC.
* Patients on triplet regimen previously decided by the investigator irrespective of enrollment in the study.
* Start ADT within 6 months before or at the index date.
* Signed informed consent: If an eligible patient is deceased at the time of study initiation, informed consent from the legally representative(s) of the patient is required. Opt-out consent is acceptable in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects only when it is difficult to obtain signed informed consent from the patient or their legal representative.

Exclusion Criteria:

* Patients treated with docetaxel before darolutamide start.
* Participation in an investigational program with interventions outside of routine clinical practice.
* Contra-indications to darolutamide, docetaxel and ADT according to the local marketing authorization.
* Participation in the PASS of darolutamide in patients with mHSPC (DADOX \[NCT06010914\]).

Where it's running

• Many locations
  Many Locations, Japan Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 0018888422937

Similar studies

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

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• Tulmimetostat with darolutamide or abiraterone for metastatic hormone-sensitive prostate cancer

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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.