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.
Public ClinicalTrials.gov record NCT05059236. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open-label Study of Androgen Receptor Inhibition With dArolutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Men With Metastatic Hormone-Sensitive Prostate Cancer Using an External Control Arm
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05059236
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 223 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 3, 2021
- Primary completion
- May 29, 2025
- Completion
- Jun 4, 2026
- Last update posted
- Apr 30, 2026
2021 – 2026
United States locations
- U.S. sites
- 31
- U.S. states
- 19
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Urology Centers of Alabama, PC - Homewood | Homewood | Alabama | 35209 | — |
| Arizona Urology Specialists - Tucson - W Orange Grove | Tucson | Arizona | 85741 | — |
| Tower Urology | Los Angeles | California | 90048 | — |
| UCI Health Center for Urological Care | Orange | California | 92868 | — |
| UC San Diego Health - Moores Cancer Center | San Diego | California | 92037 | — |
| Providence Saint John's Cancer Institute | Santa Monica | California | 90404 | — |
| Brigham and Women's Hospital (BWH) - Surgery Urology | Atlanta | Georgia | 30318 | — |
| Piedmont Cancer Institute - Atlanta | Atlanta | Georgia | 30318 | — |
| Northwestern Medicine - Urology | Chicago | Illinois | 60611 | — |
| Northwestern University's Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| UM Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | — |
| Lieutenant Colonel Charles S. Kettles VA Medical Center - Oncology | Ann Arbor | Michigan | 48105 | — |
| Barbara Ann Karmanos Cancer Institute - Detroit Headquarters | Detroit | Michigan | 48201 | — |
| Michigan Institute of Urology - Troy - Town Center Building | Troy | Michigan | 48084 | — |
| AMR - Kansas City | Kansas City | Missouri | 64132 | — |
| GU Research Network, LLC - Oncology radiology | Omaha | Nebraska | 68130 | — |
| XCancer Omaha | Omaha | Nebraska | 68130 | — |
| New Jersey Urology - Clifton | Clifton | New Jersey | 07013 | — |
| New Jersey Urology - Voorhees | Voorhees Township | New Jersey | 08043 | — |
| New Mexico Cancer Center - Albuquerque | Albuquerque | New Mexico | 87109 | — |
| Mount Sinai Doctors - Faculty Practice | New York | New York | 10029 | — |
| Mount Sinai Faculty Practice Associates | New York | New York | 10029 | — |
| Associated Medical Professionals of NY Syracuse | Syracuse | New York | 13210 | — |
| The Urology Group - Norwood Surgery Center | Cincinnati | Ohio | 45212 | — |
| Columbus Prostate Cancer Center / Radiation Oncology Clinic | Gahanna | Ohio | 43230 | — |
| MidLantic Urology - Bala Cynwyd | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Carolina Urological Research Center | Myrtle Beach | South Carolina | 29579 | — |
| Urology Associates, PC - Nashville | Nashville | Tennessee | 37209 | — |
| Houston Methodist Research Institute | Houston | Texas | 77030 | — |
| Inova Schar Cancer Institute (vendor) | Fairfax | Virginia | 22031 | — |
| Spokane Urology PS | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05059236, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 30, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05059236 live on ClinicalTrials.gov.