ClinicalTrials.gov record
Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study
ClinicalTrials.gov ID: NCT04484818
Public ClinicalTrials.gov record NCT04484818. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Double Blinded Study of Early Intervention After RADICAl ProstaTEctomy With Androgen Deprivation Therapy With or Without Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase III trial compares the effect of adding darolutamide to ADT versus ADT alone after surgery for the treatment of high-risk prostate cancer. ADT reduces testosterone levels in the blood. Testosterone is a hormone made mainly in the testes and is needed to develop and maintain male sex characteristics, such as facial hair, deep voice, and muscle growth. It also plays role in prostate cancer development. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. Giving darolutamide with ADT may work better in eliminating or reducing the size of the cancer and/or prevent it from returning compared to ADT alone in patients with prostate cancer.
Study identification
- NCT ID
- NCT04484818
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 27 participants
Conditions and interventions
Conditions
Interventions
- Darolutamide Drug
- Goserelin Acetate Drug
- Leuprolide Acetate Drug
- Placebo Administration Drug
- Quality-of-Life Assessment Other
- Triptorelin Drug
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 1, 2021 (Actual)
- Primary completion
- Jun 9, 2026 (Actual)
- Completion
- May 31, 2028 (Estimated)
- Last update posted
- Jul 28, 2026
2021 – 2028
United States locations
- U.S. sites
- 115
- U.S. states
- 24
- U.S. cities
- 91
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Los Angeles County-USC Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | — |
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | — |
| City of Hope South Pasadena | South Pasadena | California | 91030 | — |
| City of Hope Upland | Upland | California | 91786 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| GenesisCare USA - Lakewood Ranch | Lakewood Rch | Florida | 34202 | — |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| GenesisCare USA - Plantation | Plantation | Florida | 33324 | — |
| Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii | 96813 | — |
| Queen's Cancer Cenrer - POB I | Honolulu | Hawaii | 96813 | — |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | — |
| Straub Clinic and Hospital | Honolulu | Hawaii | 96813 | — |
| Queen's Cancer Center - Kuakini | Honolulu | Hawaii | 96817 | — |
| The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | 96817 | — |
| Pali Momi Medical Center | ‘Aiea | Hawaii | 96701 | — |
| Rush - Copley Medical Center | Aurora | Illinois | 60504 | — |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61704 | — |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | — |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Carle on Vermilion | Danville | Illinois | 61832 | — |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | — |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | — |
| Elmhurst Memorial Hospital | Elmhurst | Illinois | 60126 | — |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | — |
| NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | 60201 | — |
| Illinois CancerCare-Galesburg | Galesburg | Illinois | 61401 | — |
| NorthShore University HealthSystem-Glenbrook Hospital | Glenview | Illinois | 60026 | — |
| NorthShore University HealthSystem-Highland Park Hospital | Highland Park | Illinois | 60035 | — |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | — |
| Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | 60045 | — |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | — |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | — |
| Edward Hospital/Cancer Center | Naperville | Illinois | 60540 | — |
| UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | — |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | — |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | — |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | — |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | — |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Springfield Clinic | Springfield | Illinois | 62702 | — |
| Memorial Medical Center | Springfield | Illinois | 62781 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| The Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| Illinois CancerCare - Washington | Washington | Illinois | 61571 | — |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | 50325 | — |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | — |
| Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | 50309 | — |
| Broadlawns Medical Center | Des Moines | Iowa | 50314 | — |
| Mission Cancer and Blood - Laurel | Des Moines | Iowa | 50314 | — |
| Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | — |
| Methodist West Hospital | West Des Moines | Iowa | 50266-7700 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Beverly Hospital | Beverly | Massachusetts | 01915 | — |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | — |
| Addison Gilbert Hospital | Gloucester | Massachusetts | 01930 | — |
| Lahey Medical Center-Peabody | Peabody | Massachusetts | 01960 | — |
| Winchester Hospital | Winchester | Massachusetts | 01890 | — |
| GenesisCare USA - Clarkston | Clarkston | Michigan | 48346 | — |
| GenesisCare USA - Farmington Hills | Farmington Hills | Michigan | 48334 | — |
| GenesisCare USA - Macomb | Macomb | Michigan | 48044 | — |
| GenesisCare USA - Madison Heights | Madison Heights | Michigan | 48071 | — |
| William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | 48073 | — |
| William Beaumont Hospital - Troy | Troy | Michigan | 48085 | — |
| GenesisCare USA - Troy | Troy | Michigan | 48098 | — |
| Unity Hospital | Fridley | Minnesota | 55432 | — |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | — |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | — |
| Bozeman Deaconess Hospital | Bozeman | Montana | 59715 | — |
| Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | 59405 | — |
| New Hampshire Oncology Hematology PA-Concord | Concord | New Hampshire | 03301 | — |
| Solinsky Center for Cancer Care | Manchester | New Hampshire | 03103 | — |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | — |
| Wake Forest University at Clemmons | Clemmons | North Carolina | 27012 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | — |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | — |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | — |
| University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio | 45219 | — |
| University of Toledo | Toledo | Ohio | 43614 | — |
| University of Cincinnati Cancer Center-West Chester | West Chester | Ohio | 45069 | — |
| Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | 43701 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | — |
| Reading Hospital | West Reading | Pennsylvania | 19611 | — |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | — |
| Ralph H Johnson VA Medical Center | Charleston | South Carolina | 29401 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| UT Southwestern/Simmons Cancer Center-Fort Worth | Fort Worth | Texas | 76104 | — |
| UT Southwestern Clinical Center at Richardson/Plano | Richardson | Texas | 75080 | — |
| Audie L Murphy VA Hospital | San Antonio | Texas | 78229 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | — |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | — |
| William S Middleton VA Medical Center | Madison | Wisconsin | 53705 | — |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | — |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | — |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | — |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04484818, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2026 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04484818 live on ClinicalTrials.gov.