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A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.
NCT05059236 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of the study is to assess if the addition of darolutamide to ADT compared with ADT alone would result in superior clinical efficacy in participants with metastatic hormone-sensitive prostate cancer (mHSPC) by progression-free survival. The researchers want to learn how long it takes for the cancer to get worse (also known as "progression-free survival") by either increasing symptoms, new metastases, PSA rise or death. All participants will be on treatment and take darolutamide with ADT until their cancer spreads, they have a medical problem, or they leave the study. The results will then be compared with patients' results from another study who received ADT alone (CHAARTED). This study will also assess safety by gathering adverse event information throughout the duration of the study. An adverse event is any medical problem, related or not to study treatment that a participant has during a study. The study drug, darolutamide, is already available for doctors to prescribe to patients with prostate cancer that has not yet spread to other parts of the body. It works by blocking a protein called a receptor from attaching to a hormone called androgen that is found in men. This protein can also be found in prostate cancer cells. ADT is a treatment that doctors are currently able to prescribe to patients with mHSPC. ADT is used to lower the amount of the androgen hormone.
Conditions Studied
Interventions
- DRUG Darolutamide (BAY1841788, Nubeqa)
- OTHER ADT
Study Locations (20)
California
- Tower Urology — Los Angeles
- UCI Health Center for Urological Care — Orange
- UC San Diego Health - Moores Cancer Center — San Diego
- Providence Saint John's Cancer Institute — Santa Monica
Michigan
- Lieutenant Colonel Charles S. Kettles VA Medical Center - Oncology — Ann Arbor
- Barbara Ann Karmanos Cancer Institute - Detroit Headquarters — Detroit
- Michigan Institute of Urology - Troy - Town Center Building — Troy
Georgia
- Brigham and Women's Hospital (BWH) - Surgery Urology — Atlanta
- Piedmont Cancer Institute - Atlanta — Atlanta
Illinois
- Northwestern Medicine - Urology — Chicago
- Northwestern University's Feinberg School of Medicine — Chicago
Nebraska
- GU Research Network, LLC - Oncology radiology — Omaha
- XCancer Omaha — Omaha
New Jersey
- New Jersey Urology - Clifton — Clifton
- New Jersey Urology - Voorhees — Voorhees Township
Alabama
- Urology Centers of Alabama, PC - Homewood — Homewood
Arizona
- Arizona Urology Specialists - Tucson - W Orange Grove — Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2021-11-04 |
| Est. Completion | 2026-06-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05059236
The ClinicalTrials.gov registry entry for NCT05059236 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 223 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metastatic Hormone-sensitive Prostate Cancer appearing as the primary indexed condition, and to 2 interventions — of which Darolutamide (BAY1841788, Nubeqa) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05059236 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Michigan, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05059236 about?
NCT05059236 is a clinical study titled "A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.". The purpose of the study is to assess if the addition of darolutamide to ADT compared with ADT alone would result in superior clinical efficacy in participants with metastatic hormone-sensitive prostate cancer (mHSPC) by progression-free survival. The researchers want to learn how long it takes for...
What is the current status of trial NCT05059236?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 223 participants. The study started on 2021-11-04. Estimated completion is 2026-06-05.
What conditions does trial NCT05059236 study?
This clinical trial studies the following conditions: Metastatic Hormone-sensitive Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05059236?
The interventions under investigation include: Darolutamide (BAY1841788, Nubeqa) (DRUG), ADT (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05059236?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05059236 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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