Actively Recruiting
An Observational Study of Darolutamide with Standard Androgen Deprivation Therapy and Docetaxel in Japanese Men with Low-Volume Metastatic Hormone-Sensitive Prostate Cancer
Led by Bayer · Updated on 2026-05-19
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Japanese men with low-volume metastatic hormone-sensitive prostate cancer (mHSPC) who receive a combination treatment of darolutamide, androgen deprivation therapy (ADT), and docetaxel. This observational study aims to better understand the safety and effects of this combination therapy in routine medical care. Low-volume mHSPC means the cancer has spread to three or fewer bones but not to organs like the lungs or liver, and it still responds to hormone therapy. Participants receive darolutamide combined with ADT and docetaxel as prescribed by their doctors during regular treatment. Darolutamide blocks signals that help cancer grow, ADT lowers testosterone levels to slow cancer growth, and docetaxel is chemotherapy that stops cancer cells from spreading. The study only observes routine medical care without changing treatments or advising participants. Participants' medical records will be reviewed for about seven years, from October 2024 to June 2031. Researchers will assess prostate-specific antigen (PSA) levels after 12 months to see how many return to normal and track any adverse events related to the treatments. Other outcomes include time to disease progression, therapy changes, and symptom development. No extra visits are required beyond usual care, and data comes solely from medical records.
CONDITIONS
Brief Title
A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed adenocarcinoma of prostate.
- Diagnosis of low-volume metastatic disease confirmed by bone scan or CT/MRI scans.
- Diagnosis of metastatic hormone-sensitive prostate cancer.
- Decision to treat with darolutamide combined with docetaxel and ADT made by the physician.
- Started androgen deprivation therapy within 6 months before or at the study start.
- Signed informed consent or consent from legal representative if deceased.
You will not qualify if you...
- Prior treatment with docetaxel before starting darolutamide.
- Participation in investigational programs outside of routine clinical practice.
- Contraindications to darolutamide, docetaxel, or ADT as per local guidelines.
- Participation in the PASS study of darolutamide in mHSPC patients (DADOX).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants who undergo routine medical care with darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) are observed to assess safety and treatment effectiveness.
Visit schedule as per routine medical care
Trial Site Locations
Total: 1 location
1
Many locations
Multiple Locations, Japan
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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