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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: Active Phase 3 study of Prostate Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary comparison will be an intention-to-treat analysis of all randomized patients. The method of Kaplan and Meier will be used to characterize the time-to-event endpoints, and a logrank test will be used to compare these endpoints across treatments.
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 |
What the registry record for NCT04484818 still lists
NCT04484818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,501-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (98% lower).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04484818's enrollment target sits among peer trials
27 52nd of 59 higher than 8 of 59 other Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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