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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

Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Must not have

Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Patient must not have any previous treatment with androgen deprivation therapy (ADT), chemotherapy, or other physician prescribed systemic therapy for treatment of their prostate cancer

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

Pivotal Trial

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.

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.

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 had hepatitis C but am cured, or I'm being treated with no detectable virus.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses or conditions that are not under control.

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I have not received hormone therapy, chemotherapy, or any other systemic treatment for my prostate cancer.

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My cancer has not spread to the lymph nodes in my pelvis.

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Metastasis-free survival (MFS)

Secondary study objectives

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 study objectives

Change in cognitive function

Cognitive function

Decipher scores

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~1600

Leuprolide Acetate

2002

Completed Phase 3

~1890