Study on Darolutamide and Hormone Therapy for Men with Metastatic Hormone-Sensitive Prostate Cancer
Sponsor: Bayer
ClinicalTrials ID:NCT05059236
This clinical trial is exploring whether adding the drug darolutamide to standard hormone therapy can better control prostate cancer that has spread and is sensitive to hormones. The study will compare these results to a previous study where only hormone therapy was used.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to see if combining darolutamide with hormone therapy (ADT) is more effective than using hormone therapy alone in men with metastatic hormone-sensitive prostate cancer. Researchers will measure how long it takes for the cancer to worsen, which could be through increased symptoms, new cancer spread, rising PSA levels, or death. Participants will continue treatment until their cancer progresses, they experience a medical issue, or they choose to leave the study. The safety of the treatment will also be monitored by recording any medical problems that occur during the study. Darolutamide is a drug that blocks a protein in prostate cancer cells from attaching to a hormone called androgen, which can help control the cancer. ADT is a common treatment that reduces androgen levels in the body.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of prostate cancer.
- May have started hormone therapy (ADT) up to 120 days before joining the study.
- Cancer has spread and will be categorized by the amount of disease present.
- Good overall health with a performance status score of 0, 1, or 2.
- Adequate bone marrow, liver, and kidney function within four weeks before joining.
- At least four weeks since major surgery and recovery from any side effects.
- Previous hormone therapy allowed if it ended over 12 months ago and there was no sign of cancer for at least 12 months after.
- Previous radiation therapy allowed if started within 30 days before beginning hormone therapy.
- Certain medications like bicalutamide, nilutamide, or flutamide allowed before starting hormone therapy.
Exclusion Criteria
- PSA levels indicate cancer progression.
- History of other cancers in the past five years, except for certain skin cancers.
- Recent serious heart problems within six months before joining.
- Certain types of prostate cancer like small cell or neuroendocrine carcinoma.
- Known brain or spinal fluid cancer spread.
- Active viral hepatitis or HIV with detectable viral load.
- Uncontrolled high blood pressure.
- Digestive issues that affect drug absorption.
- Serious or unstable health conditions that could affect safety or study participation.
- Previous hormone therapy for metastatic cancer.
- Previous chemotherapy in certain settings.
- Recent or current use of certain medications like 5-alpha reductase inhibitors.
- Previous treatment with specific prostate cancer drugs like enzalutamide or abiraterone.
- Recent or current participation in another clinical study.
- Allergies to study drugs or inability to swallow pills.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Urology Centers of Alabama, PC - Homewood | 35209 | Homewood | Alabama |
| Arizona Urology Specialists - Tucson - W Orange Grove | 85741 | Tucson | Arizona |
| Tower Urology | 90048 | Los Angeles | California |
| UCI Health Center for Urological Care | 92868 | Orange | California |
| UC San Diego Health - Moores Cancer Center | 92037 | San Diego | California |
| Providence Saint John's Cancer Institute | 90404 | Santa Monica | California |
| Brigham and Women's Hospital (BWH) - Surgery Urology | 30318 | Atlanta | Georgia |
| Piedmont Cancer Institute - Atlanta | 30318 | Atlanta | Georgia |
| Northwestern Medicine - Urology | 60611 | Chicago | Illinois |
| Northwestern University's Feinberg School of Medicine | 60611 | Chicago | Illinois |
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