Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Japan / NCT06010914
Active, not recruiting Observational

A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer

NCT06010914 · tracked via the Priya Life Science Japan tracker
Sponsor
Bayer
Phase
Observational
Started
2023-10-09
Last updated
2026-06-18

Condition(s) studied

Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Investigational drug(s) / intervention(s)

No Intervention

No Intervention: Following the manner of observational study, no intervention will be provided in the study. The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.

Study summary

This is an observational study in which only data are collected from participants receiving their usual treatment.

In this study, data will be collected and studied from men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Metastatic means that the cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with hormone-therapy such as androgen deprivation therapy (ADT). ADT lowers the level of testosterone, a male hormone, and slows down the growth of cancer cells.

Men with mHSPC and who have been decided by their own doctors to be treated with darolutamide in combination with ADT and docetaxel can join this study. Darolutamide works by blocking the testosterone signals to slow the growth of the cancer cells. Docetaxel is a medicine used to treat different types of cancer. It works by stopping the growth and spread of cancer cells.

Darolutamide in combination with docetaxel and ADT is an approved treatment for men with mHSPC. It was approved based on a study called ARASENS. More information is needed on how safe darolutamide is when given with ADT and docetaxel in Japanese men with mHSPC.

The main purpose of this study is to collect information about the safety of this combination treatment in Japanese participants with mHSPC under real-world conditions.

The main information that researchers will collect:

Number and severity of heart-related medical problems participants have during the treatment

Other information that researchers will collect:

Number and severity of all medical problems participants have during the study

Age and other information about the participants such as their illness, medical history, and other medicines taken at the same time

Treatment pattern of darolutamide such as the amount of medicine given, the duration for which it is given, and any changes made to the treatment

Data will be collected from August 2023 to July 2026. Researchers will observe participants from the start of darolutamide treatment until 30 days after they receive their last dose of docetaxel, which is expected to be approximately 6 months for each participant.

In this study, data from regular health visits will be collected. No visits or tests are required as part of this study.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Men over the age of 18 years * Histologically or cytologically confirmed adenocarcinoma prostate cancer * Metastatic disease confirmed either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan * Patients diagnosed with mHSPC by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with darolutamide plus ADT and docetaxel therapy by the investigator under routine clinical practice * ADT (GnRH agonist/antagonist or orchiectomy) before or simultaneous treatment with darolutamide * Signed informed consent Exclusion Criteria: * Participation in an investigational program with interventions outside of routine clinical practice * Contraindications according to the local marketing authorization * Previous treatment with darolutamide

Primary outcome measure(s)

  • Number of participants with cardiac treatment-emergent adverse events (TEAEs) — From the start of darolutamide treatment to 30 days after the last dose of docetaxel
    Incidence of cardiac disorders (TEAEs based on MedDRA SOC), including severity, seriousness, onset date and outcome.
  • Outcomes of cardiac TEAEs — From the start of darolutamide treatment to 30 days after the last dose of docetaxel
    Causal relationship (i.e. if a specific AE is related to daroluatmide) between darolutamide and cardiac disorders.
  • Dose modifications due to cardiac TEAEs — From the start of darolutamide treatment to 30 days after the last dose of docetaxel
    Action taken related to darolutamide (dose modifications and time periods).

Trial sites (1)

FacilityCityRegionStatus
Many Locations Multiple Locations Japan

More Bayer trials in Japan

A Study to Collect Data on the Use of Eylea in Babies Born Too Early Who Have a Condition of the Eye Where Blood Vessels Grow Abnormally in the Retina (Retinopathy of Prematurity) Active, not recruiting
Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer Active, not recruiting
A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies Active, not recruiting
NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes Recruiting
A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) Recruiting

Other trials for the same condition

Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05) Recruiting
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 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06010914 on ClinicalTrials.gov ↗ ← All trials in Japan