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.

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

223

Participants

Timeline

Start Date

November 4, 2021

Primary Completion Date

May 30, 2025

Study Completion Date

June 5, 2026

Conditions
Metastatic Hormone-sensitive Prostate Cancer
Interventions
DRUG

Darolutamide (BAY1841788, Nubeqa)

300 mg per tablet, oral administration with food

OTHER

ADT

LHRH agonist/antagonist or orchiectomy

Trial Locations (31)

10029

Mount Sinai Doctors - Faculty Practice, New York

Mount Sinai Faculty Practice Associates, New York

13210

Associated Medical Professionals of NY Syracuse, Syracuse

19004

MidLantic Urology - Bala Cynwyd, Bala-Cynwyd

21201

UM Greenebaum Comprehensive Cancer Center, Baltimore

22031

Inova Schar Cancer Institute, Fairfax

29579

Carolina Urological Research Center, Myrtle Beach

30318

Brigham and Women's Hospital (BWH) - Surgery Urology, Atlanta

Piedmont Cancer Institute - Atlanta, Atlanta

35209

Urology Centers of Alabama, PC, Homewood

37209

Urology Associates, PC, Nashville

43230

Columbus Prostate Cancer Center / Radiation Oncology Clinic, Gahanna

45212

The Urology Group - Norwood Surgery Center, Cincinnati

48084

Michigan Institute of Urology - Troy - Town Center Building, Troy

48105

VA Ann Arbor Healthcare System, Ann Arbor

48201

Barbara Ann Karmanos Cancer Institute - Detroit Headquarters, Detroit

60611

Northwestern Medicine - Urology, Chicago

Northwestern University's Feinberg School of Medicine, Chicago

64132

AMR - Kansas City, Kansas City

68130

GU Research Network, LLC - Oncology radiology, Omaha

XCancer Omaha, Omaha

77030

Houston Methodist Research Institute, Houston

85741

Arizona Urology Specialists - Tucson - W Orange Grove, Tucson

87109

New Mexico Cancer Center - Albuquerque, Albuquerque

90048

Tower Urology, Los Angeles

90404

Providence Saint John's Cancer Institute, Santa Monica

92037

UC San Diego Health - Moores Cancer Center, San Diego

92868

UCI Health Center for Urological Care, Orange

99202

Spokane Urology PS, Spokane

07013

New Jersey Urology - Clifton, Clifton

08043

New Jersey Urology - Voorhees, Voorhees Township

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY