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NCT04484818 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study
A Phase 3 study of Prostate Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 3
- Development phase
- 27
- Enrollment target
- 20
- Study locations
NCT04484818 is a Phase 3 study of Prostate Carcinoma that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 27 participants, below the 1,501-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT04484818, a Phase 3 study of Prostate Carcinoma, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 27 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Darolutamide
- DRUG Placebo Administration
- DRUG Goserelin Acetate
- DRUG Leuprolide Acetate
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Los Angeles County-USC Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Stanford Cancer Institute Palo Alto - Palo Alto
- VA Palo Alto Health Care System - Palo Alto
- City of Hope South Pasadena - South Pasadena
- City of Hope Upland - Upland
Hawaii
- Hawaii Cancer Care Inc - Waterfront Plaza - Honolulu
- Queen's Cancer Cenrer - POB I - Honolulu
- Queen's Medical Center - Honolulu
- Straub Clinic and Hospital - Honolulu
- Queen's Cancer Center - Kuakini - Honolulu
- The Cancer Center of Hawaii-Liliha - Honolulu
- Pali Momi Medical Center - ‘Aiea
Florida
- GenesisCare USA - Lakewood Ranch - Lakewood Rch
- Mount Sinai Medical Center - Miami Beach
- GenesisCare USA - Plantation - Plantation
Illinois
- Rush - Copley Medical Center - Aurora
- Illinois CancerCare-Bloomington - Bloomington
Connecticut
- Hartford Hospital - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04484818
The ClinicalTrials.gov registry entry for NCT04484818 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,501-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (98% lower). The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04484818 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Hawaii, Florida.
Frequently Asked Questions
What is clinical trial NCT04484818 about?
NCT04484818 is a clinical study titled "Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study". 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 chara...
What is the current status of trial NCT04484818?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 27 participants. The study started on 2021-03-01. Estimated completion is 2028-05-31.
What conditions does trial NCT04484818 study?
This clinical trial studies the following conditions: Prostate Carcinoma.
What interventions are being tested in trial NCT04484818?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Darolutamide (DRUG), Placebo Administration (DRUG), Goserelin Acetate (DRUG), Leuprolide Acetate (DRUG).
Who is sponsoring clinical trial NCT04484818?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04484818 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Hawaii, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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