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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
223
300 mg per tablet, oral administration with food
LHRH agonist/antagonist or orchiectomy
Urology Centers of Alabama, PC - Homewood
Homewood, Alabama, United States
Arizona Urology Specialists - Tucson - W Orange Grove
Tucson, Arizona, United States
Tower Urology
Los Angeles, California, United States
UCI Health Center for Urological Care
Orange, California, United States
UC San Diego Health - Moores Cancer Center
San Diego, California, United States
Progression-free survival (PFS)
Time interval from enrollment to PSA progression, clinical progression or death, whichever occurs first. PSA progression is defined as when the PSA demonstrates an increase that is more than 50% of nadir, taking as reference the lowest recorded PSA level since starting androgen deprivation therapy (ADT). Clinical progression is defined as increasing symptomatic bone metastases, radiographic progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria (v. 1.1) for soft tissue metastases and PCWG3 criteria for bone metastases, or clinical deterioration due to cancer per investigator's opinion.
Time frame: Approximately 12 months after end of enrollment
Overall survival (OS)
Time from the date of enrollment until death resulting from any cause or the date last known alive
Time frame: Approximately 24 months after end of enrollment
Radiographic Progression-free survival (rPFS)
Time from enrollment to investigator-assessed radiographic progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria (v. 1.1) for soft tissue metastases and PCWG3 criteria for bone metastases or death, whichever occurs first
Time frame: Approximately 24 months after end of enrollment
Time to castration-resistant prostate cancer (CRPC)
Time from enrollment until documented clinical or PSA progression with a testosterone level of less than 50 ng per deciliter or documented medical castration or surgical castration
Time frame: Approximately 12 months after end of enrollment
Complete PSA response rate
PSA level of less than 0.2 ng per milliliter on two consecutive measurements at least 4 weeks apart
Time frame: At 6 months after first administration
Number of participants with adverse events
Adverse Events will be assessed by National Cancer Institute-Common Terminology Criteria (NCI CTCAE) v. 5.0
Time frame: From the signing of the informed consent form (ICF) until 30 (+7) days after last administration, approximately 12 months
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Providence Saint John's Cancer Institute
Santa Monica, California, United States
Brigham and Women's Hospital (BWH) - Surgery Urology
Atlanta, Georgia, United States
Piedmont Cancer Institute - Atlanta
Atlanta, Georgia, United States
Northwestern Medicine - Urology
Chicago, Illinois, United States
Northwestern University's Feinberg School of Medicine
Chicago, Illinois, United States
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