New combo therapy aims to slow prostate cancer spread

NCT ID NCT05059236

Ongoing Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

First seen Oct 31, 2025 · Last updated May 07, 2026 · Updated 27 times

Summary

This study tests whether adding darolutamide to standard hormone therapy (ADT) can delay cancer worsening in men with metastatic hormone-sensitive prostate cancer. About 223 men will receive darolutamide plus ADT, and their results will be compared to a similar group that got ADT alone. The goal is to see if the combination extends the time before the cancer progresses.

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Contacts and locations

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Locations

AMR - Kansas City

Kansas City, Missouri, 64132, United States
Arizona Urology Specialists - Tucson - W Orange Grove

Tucson, Arizona, 85741, United States
Associated Medical Professionals of NY Syracuse

Syracuse, New York, 13210, United States
Barbara Ann Karmanos Cancer Institute - Detroit Headquarters

Detroit, Michigan, 48201, United States
Brigham and Women's Hospital (BWH) - Surgery Urology

Atlanta, Georgia, 30318, United States
Carolina Urological Research Center

Myrtle Beach, South Carolina, 29579, United States
Columbus Prostate Cancer Center / Radiation Oncology Clinic

Gahanna, Ohio, 43230, United States
GU Research Network, LLC - Oncology radiology

Omaha, Nebraska, 68130, United States
Houston Methodist Research Institute

Houston, Texas, 77030, United States
Inova Schar Cancer Institute (vendor)

Fairfax, Virginia, 22031, United States
Lieutenant Colonel Charles S. Kettles VA Medical Center - Oncology

Ann Arbor, Michigan, 48105, United States
Michigan Institute of Urology - Troy - Town Center Building

Troy, Michigan, 48084, United States
MidLantic Urology - Bala Cynwyd

Bala-Cynwyd, Pennsylvania, 19004, United States
Mount Sinai Doctors - Faculty Practice

New York, New York, 10029, United States
Mount Sinai Faculty Practice Associates

New York, New York, 10029, United States
New Jersey Urology - Clifton

Clifton, New Jersey, 07013, United States
New Jersey Urology - Voorhees

Voorhees Township, New Jersey, 08043, United States
New Mexico Cancer Center - Albuquerque

Albuquerque, New Mexico, 87109, United States
Northwestern Medicine - Urology

Chicago, Illinois, 60611, United States
Northwestern University's Feinberg School of Medicine

Chicago, Illinois, 60611, United States
Piedmont Cancer Institute - Atlanta

Atlanta, Georgia, 30318, United States
Providence Saint John's Cancer Institute

Santa Monica, California, 90404, United States
Spokane Urology PS

Spokane, Washington, 99202, United States
The Urology Group - Norwood Surgery Center

Cincinnati, Ohio, 45212, United States
Tower Urology

Los Angeles, California, 90048, United States
UC San Diego Health - Moores Cancer Center

San Diego, California, 92037, United States
UCI Health Center for Urological Care

Orange, California, 92868, United States
UM Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States
Urology Associates, PC - Nashville

Nashville, Tennessee, 37209, United States
Urology Centers of Alabama, PC - Homewood

Homewood, Alabama, 35209, United States
XCancer Omaha

Omaha, Nebraska, 68130, United States

Conditions

Explore the condition pages connected to this study.

METASTATIC HORMONE-SENSITIVE PROSTATE CANCER