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ACTIVE NOT RECRUITING 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

NCT04484818 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 27 participants
Start Date 2021-03-01
Est. Completion 2028-05-31
Phase Phase 3

Sponsor

ECOG-ACRIN Cancer Research Group

52 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04484818 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Hawaii, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04484818?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial