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NCT07406282 · ClinicalTrials.gov registry record
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
A clinical trial of Prostatic Neoplasms and Metastatic Hormone-sensitive Prostate Cancer, sponsored by Bayer.
- Recruiting
- Registry status
- 1,400
- Enrollment target
- 1
- Study location
NCT07406282: Recruiting study of Prostatic Neoplasms and Metastatic Hormone-sensitive Prostate Cancer, sponsored by Bayer.
NCT07406282 is a study of Prostatic Neoplasms and Metastatic Hormone-sensitive Prostate Cancer that is actively recruiting participants, run by Bayer. The registered enrollment target is 1,400 participants, above the 493-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (184% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07406282, a study of Prostatic Neoplasms and Metastatic Hormone-sensitive Prostate Cancer, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- 1,400 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Age will be documented in years to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Conditions Studied
Interventions
- DRUG Darolutamide
- DRUG Apalutamide
- DRUG Enzalutamide
- DRUG Abiraterone acetate
Study Locations (1)
Ohio
- Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,400 participants |
| Start Date | 2025-07-22 |
| Est. Completion | 2026-02-28 |
What NCT07406282 shows while recruiting
NCT07406282 is an observational study that tracks outcomes without assigning an intervention. Its 1,400 participants enrollment target places it among the larger protocols in the corpus, above the 493-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (184% higher).
The record links to 2 conditions, with Prostatic Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Darolutamide is the first listed.
NCT07406282 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07406282 about?
NCT07406282 is a clinical study titled "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". 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, wit...
What is the current status of trial NCT07406282?
This trial is currently recruiting. The enrollment target is 1,400 participants. The study started on 2025-07-22. Estimated completion is 2026-02-28.
What conditions does trial NCT07406282 study?
This clinical trial studies the following conditions: Prostatic Neoplasms, Metastatic Hormone-sensitive Prostate Cancer.
What interventions are being tested in trial NCT07406282?
The interventions under investigation include: Darolutamide (DRUG), Apalutamide (DRUG), Enzalutamide (DRUG), Abiraterone acetate (DRUG).
Who is sponsoring clinical trial NCT07406282?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07406282 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07406282's enrollment target sits among peer trials
1,400 5th of 65 higher than 61 of 65 other Prostatic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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