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Darolutamide + ADT for Prostate Cancer

Phase 3
Waitlist Available
Led By Alicia K Morgans
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
For patients who did not have a Decipher score previously performed by Decipher Biosciences, patients must also have a CAPRA-S score >= 3. The CAPRA-S score is calculated by assigning points for PSA in ng/mL, surgical margin status, seminal vesicle invasion, and extra-capsular extension. Lymph node involvement will serve as an exclusion criteria and will not count towards CAPRA-S inclusion score. A CAPRA-S score is not required for patients who had a Decipher score previously performed by Decipher Biosciences
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to any of the mfs events, pelvic lymph node recurrence or detectable prostate-specific antigen (psa) (psa >= 0.2 ng/ml, confirmed by a second psa of the same level or higher), whichever occurs first, assessed up to 36 months
Awards & highlights

Study Summary

This trial is testing if adding darolutamide to ADT (a treatment to reduce testosterone levels) is more effective than ADT alone in treating high-risk prostate cancer.

Who is the study for?
Men with high-risk prostate cancer who've had surgery (radical prostatectomy) can join this trial. They should have a good performance status, no major health issues that could affect the study, and no previous prostate cancer treatments. Their PSA levels must be undetectable and they need to meet specific criteria based on tests like Decipher score and CAPRA-S score.Check my eligibility
What is being tested?
The ERADICATE Study is testing if adding Darolutamide to standard hormonal therapy (ADT) after surgery is more effective than ADT alone in men with high-risk prostate cancer. It's a phase III trial aiming to see if this combination better reduces or eliminates the risk of cancer returning.See study design
What are the potential side effects?
Possible side effects include fatigue, hot flashes, decreased sex drive, erectile dysfunction, digestive issues, and potential liver function changes due to hormone therapy. Darolutamide may also cause nausea, skin rash, and heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I have a CAPRA-S score of 3 or higher and no lymph node involvement.
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My prostate cancer tissue from surgery is available for testing.
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I had a surgery to remove my prostate and it's been 6 to 16 weeks since then.
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I am HIV positive, on treatment, and my viral load is undetectable.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I have had cancer before, but it won't affect this trial's treatment.
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My Decipher score from the prostate surgery is 0.6 or higher.
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My hepatitis B virus load is undetectable with treatment.
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My Decipher score is 0.6 or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to any of the mfs events, pelvic lymph node recurrence or detectable prostate-specific antigen (psa) (psa >= 0.2 ng/ml, confirmed by a second psa of the same level or higher), whichever occurs first, assessed up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to any of the mfs events, pelvic lymph node recurrence or detectable prostate-specific antigen (psa) (psa >= 0.2 ng/ml, confirmed by a second psa of the same level or higher), whichever occurs first, assessed up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Metastasis-free survival (MFS)
Secondary outcome measures
Change in Functional Assessment of Cancer Therapy (FACT) - Prostate score
Change in quality of life: Functional Assessment of Cancer Therapy (FACT)
Event-free survival
+6 more
Other outcome measures
Change in cognitive function
Cognitive function
Decipher scores
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (ADT, darolutamide)Experimental Treatment5 Interventions
Patients receive goserelin acetate, leuprolide acetate, or triptorelin via injection every 3 months for 12 months (4 injections), every 4 months for 12 months (3 injections), or every month for 12 months (12 injections) in the absence of disease progression or unacceptable toxicity. Patients also receive darolutamide QID for 52 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (ADT, placebo)Active Control5 Interventions
Patients receive goserelin acetate, leuprolide acetate, or triptorelin via injection every 3 months for 12 months (4 injections), every 4 months for 12 months (3 injections), or every month for 12 months (12 injections) in the absence of disease progression or unacceptable toxicity. Patients also receive a placebo four times daily (QID) for 52 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triptorelin
2017
Completed Phase 4
~1370
Leuprolide Acetate
2002
Completed Phase 3
~1890
Darolutamide
2018
Completed Phase 2
~100
Goserelin Acetate
2007
Completed Phase 3
~1040

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
115 Previous Clinical Trials
176,795 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,895 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,608 Previous Clinical Trials
40,915,305 Total Patients Enrolled
559 Trials studying Prostate Cancer
507,127 Patients Enrolled for Prostate Cancer
Alicia K MorgansPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Darolutamide Clinical Trial Eligibility Overview. Trial Name: NCT04484818 — Phase 3
Prostate Cancer Research Study Groups: Arm B (ADT, darolutamide), Arm A (ADT, placebo)
Prostate Cancer Clinical Trial 2023: Darolutamide Highlights & Side Effects. Trial Name: NCT04484818 — Phase 3
Darolutamide 2023 Treatment Timeline for Medical Study. Trial Name: NCT04484818 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the most common purposes for Darolutamide?

"Darolutamide can be used as an amino acid supplementation therapy, a skin irritation treatment, and an anger management therapy."

Answered by AI

How many medical facilities are running this experiment?

"To date, this clinical trial has recruited patients from 100 different sites. While the specific locations of Danville, San Antonio and Des Moines are mentioned, there are 100 other sites where this trial is being conducted. If you are interested in participating, it might be best to choose a location close to you to reduce travel requirements."

Answered by AI

Has Darolutamide been cleared by the FDA?

"Since this is a phase 3 trial, there is already some evidence of Darolutamide's efficacy and it has undergone multiple rounds of testing for safety, so we've given it a score of 3."

Answered by AI

Are there any precedents for Darolutamide's use in medical treatment?

"The first clinical trials testing darolutamide were done in 2000 at Centre de Recherche Clinique du CHUS. So far, 1151 have completed. As of right now, there are 271 clinical trials underway, with a significant amount happening in Danville, Pennsylvania."

Answered by AI

To the best of your knowledge, has anything like this been done before?

"There are 271 ongoing studies involving Darolutamide in 65 countries and 1820 cities. The first trial began in 2000 and, after reaching Phase 3, was approved. 1,151 total studies have been completed as of now."

Answered by AI
~16 spots leftby May 2028