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.
NCT ID: NCT05059236
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
223 participants
INTERVENTIONAL
2021-11-04
2026-06-05
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Darolutamide+ADT
Participants will receive darolutamide plus ADT in the ARASEC treatment arm. The control arm for the study will be derived from the participants treated with ADT alone in the CHAARTED trial using a matching approach
Darolutamide (BAY1841788, Nubeqa)
300 mg per tablet, oral administration with food
ADT
LHRH agonist/antagonist or orchiectomy
Interventions
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Darolutamide (BAY1841788, Nubeqa)
300 mg per tablet, oral administration with food
ADT
LHRH agonist/antagonist or orchiectomy
Eligibility Criteria
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Inclusion Criteria
* Metastatic disease and will be stratified by presence of high volume or low volume disease.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
* Adequate bone marrow, liver and renal function within 4 weeks of enrollment
* At least 4 weeks since prior major surgery and recovered from all toxicity from such surgery prior to enrollment
* Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following criteria are met:
* Therapy was discontinued ≥ 12 months ago AND there was a clinical state without evidence of disease at least 12 months after completing adjuvant or neoadjuvant hormonal therapy, as defined by 1 of the following:
* PSA \< 0.1 ng/mL after prostatectomy plus hormonal therapy
* PSA \< 0.5 ng/mL and has not doubled above nadir after radiotherapy plus hormonal therapy
* Therapy lasted no more than 24 months
* Prior palliative radiotherapy allowed for participants, if commenced within 30 days before starting androgen deprivation.
* Bicalutamide, nilutamide or flutamide are allowed as single-agent therapy ≤ 28 days before medical castration to prevent flare.
Exclusion Criteria
* History of malignancy in the past 5 years, with the exception of basal cell and squamous cell carcinoma of the skin.
* Had any of the following within 6 months before randomization: myocardial infarction, severe/unstable angina pectoris, congestive heart failure, hospitalization for any cardiac event, including conduction abnormalities
* Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate
* Known brain/ leptomeningeal metastases
* An active viral hepatitis (defined as Hepatitis B surface antigen \[HBsAg\] reactive or detectable \[qualitative\] HBV DNA defined as HCV Ribonucleic Acid \[RNA\] \[qualitative\] is detected), known human immunodeficiency virus infection with detectable viral load, or chronic liver disease with a need of treatment
* Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management
* A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug
* Any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the participant and/or his compliance with study procedures or may interfere with the participant's participation in the study or evaluation of the study results.
* Prior hormone therapy in the metastatic setting
* Prior chemotherapy in the adjuvant or neoadjuvant setting
* Concurrent use or previous exposure of 5-alpha reductase inhibitors (within 28 days before the start of darolutamide or 5 half-lives of the drug, whichever is longer)
* Any Prior treatment with second-generation androgen receptor (AR) inhibitors such as enzalutamide, apalutamide, darolutamide, or other investigational AR inhibitors, Cytochrome P17 enzyme inhibitor such as abiraterone acetate or other investigational CYP 17 as antineoplastic treatment for prostate cancer
* Previous (within 28 days before the start of darolutamide or 5 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).
* Contraindication to both CT and MRI contrast agent
* Hypersensitivity to any of the study treatments, study treatment classes, or excipients in the formulation of the study treatments
* Inability to swallow oral medications
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Urology Centers of Alabama, PC
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
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
UM Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute - Detroit Headquarters
Detroit, Michigan, United States
Michigan Institute of Urology - Troy - Town Center Building
Troy, Michigan, United States
AMR - Kansas City
Kansas City, Missouri, United States
GU Research Network, LLC - Oncology radiology
Omaha, Nebraska, United States
XCancer Omaha
Omaha, Nebraska, United States
New Jersey Urology - Clifton
Clifton, New Jersey, United States
New Jersey Urology - Voorhees
Voorhees Township, New Jersey, United States
New Mexico Cancer Center - Albuquerque
Albuquerque, New Mexico, United States
Mount Sinai Doctors - Faculty Practice
New York, New York, United States
Mount Sinai Faculty Practice Associates
New York, New York, United States
Associated Medical Professionals of NY Syracuse
Syracuse, New York, United States
The Urology Group - Norwood Surgery Center
Cincinnati, Ohio, United States
Columbus Prostate Cancer Center / Radiation Oncology Clinic
Gahanna, Ohio, United States
MidLantic Urology - Bala Cynwyd
Bala-Cynwyd, Pennsylvania, United States
Carolina Urological Research Center
Myrtle Beach, South Carolina, United States
Urology Associates, PC
Nashville, Tennessee, United States
Houston Methodist Research Institute
Houston, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Spokane Urology PS
Spokane, Washington, United States
Countries
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References
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McKay RR, Ross AE, Preston MA, Gregg JR, Salami SS, Littleton N, Constantinovici N, Srinivasan S, Verholen F, Shore ND. Darolutamide plus androgen-deprivation therapy: propensity score matching of ARASEC and historic clinical trial patients. Future Oncol. 2025 May;21(11):1365-1375. doi: 10.1080/14796694.2025.2482360. Epub 2025 Apr 1.
Related Links
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Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.
Other Identifiers
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21516
Identifier Type: -
Identifier Source: org_study_id