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Study identifier: NCT05794906 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Active Not Recruiting

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

Condition: Biochemically Recurrent Prostate Cancer  ·  Sponsor: Bayer

PhasePhase 3
Planned participants985
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

About this study

Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen \[PSMA\] positron emission tomography \[PET\]) /computed tomography \[CT\]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors …

This description comes directly from the study's public registry record.

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Locations (226)

Mayo Clinic Hospital - Phoenix - CardiologyPhoenix, Arizona, United States
City of Hope - Duarte Cancer CenterDuarte, California, United States
USC Norris Comprehensive Cancer CenterLos Angeles, California, United States
Tower UrologyLos Angeles, California, United States
UCLA Clark Urology CenterLos Angeles, California, United States
UCSF Bakar Precision Cancer Medicine Building - GenitourinarySan Francisco, California, United States
Colorado Urology - St. Anthony Hospital CampusLakewood, Colorado, United States
Northwestern Medicine - UrologyChicago, Illinois, United States
Chesapeake Urology Associates - TowsonBaltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center - Johns HopkinsBaltimore, Maryland, United States
Dana-Farber Cancer Institute - Oncology DepartmentBoston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute - Detroit HeadquartersDetroit, Michigan, United States

+ 214 more locations — full list on the registry record.

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