NCT07406282Recruiting
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
Double-DARE: Analysis of Doublet and Triplet Therapy With Darolutamide and Other Androgen Receptor Pathway Inhibitors in de Novo mHSPC Patients Seen in Urology Clinics in the USA
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1400 (estimated)
- First submitted
- 14 Dec 2025
- Start date
- 22 Jul 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Bayer
- Diseases
- Prostate cancer
- NCT number
- NCT07406282
What you commit to
- Study type: Observational
- Planned participants: 1400
- From 22 Jul 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of PARP inhibitors, chemotherapy (other than docetaxel), immunotherapy or radiopharmaceuticals prior to index date
Other illness
- History of other primary cancers (except non-melanoma skin cancer)
Other
- Evidence of castration resistance (CR) flag in the database any time before the index date or up to 90 days after the de novo mHSPC diagnosis
- Clinical trial participation during the study period.
Who the study is looking for
- Male patients with evidence of de novo mHSPC during the study period
- Initiation of ARPI therapy during the patient identification period and within ±90 days from the mHSPC diagnosis
- Age ≥18 years at index date (ARPI initiation for mHSPC)
- Initiation of ADT and/or docetaxel therapy within ±90 days from index date
- At least 90 days of EMR activity prior to the index date
- At least 90 days of EMR activity post-index, unless the patient died earlier.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.