A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive prostate cancer (mHSPC). Treatment for mHSPC has advanced significantly, with new standards of care involving androgen deprivation therapy (ADT) combined with drugs known as androgen receptor pathway inhibitors (ARPIs), sometimes alongside chemotherapy like docetaxel. Darolutamide is an ARPI that is approved by the FDA for treating mHSPC in a "triplet" combination with ADT and docetaxel. It is also used in a "doublet" combination with ADT alone. However, there is limited information on how darolutamide is used in real-world clinical settings for this condition, which creates a gap in knowledge for making treatment decisions. This study aims to fill that gap by analyzing real-world data from electronic medical records. The primary goal is to describe the characteristics of patients with newly diagnosed mHSPC who are treated with darolutamide (either as a doublet or triplet) in urology clinics across the US. The study will also examine drug use patterns and clinical outcomes for these patients. Additionally, the study will explore the characteristics of patients treated with other ARPIs (abiraterone acetate, enzalutamide, and apalutamide) and assess the feasibility of creating matched patient groups for future comparative research. Data will be collected retrospectively from a large network of community urology practices in the US.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyźni z nowo zdiagnozowanym, zaawansowanym rakiem prostaty wrażliwym na hormony.
- •Pacjenci, którzy rozpoczęli leczenie lekiem z grupy ARPI w określonym czasie od diagnozy.
- •Pacjenci, którzy rozpoczęli leczenie hormonami i/lub chemioterapią (docetaksel) w określonym czasie.
- •Pacjenci w wieku 18 lat lub starsi.
✗ Disqualifies
- •Pacjenci z innymi poważnymi chorobami nowotworowymi w przeszłości (z wyjątkiem raka skóry).
- •Pacjenci, którzy wcześniej przyjmowali inne leki przeciwnowotworowe (inne niż docetaksel) lub byli poddawani immunoterapii.
- •Pacjenci z zaawansowanym rakiem prostaty, który nie reaguje już na leczenie hormonalne (rak oporny na kastrację).
- •Pacjenci uczestniczący w innych badaniach klinicznych w trakcie trwania tego badania.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 7, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company
Cleveland, United States
Trial contact
Bayer Clinical Trials Contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/8/2026.
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