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Hormone Therapy

Darolutamide vs Enzalutamide for Prostate Cancer (ARACOG Trial)

Phase 2

Recruiting

Led By Evanthia Galanis, MD

Research Sponsored by Alliance Foundation Trials, LLC.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3 PSA rises at least 1 week apart, with the last PSA >2 ng/mL

Ability to swallow study tablets whole

Must not have

Prior usage of ENZ or DARO

Active or history of seizures or seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 104 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare cognitive outcomes of men with non-metastatic and metastatic castration-resistant prostate cancer treated with darolutamide or enzalutamide.

Who is the study for?

Men with advanced prostate cancer that's resistant to hormone therapy, either spread (metastatic) or not (non-metastatic). They must be able to swallow pills, have low testosterone from treatment, and be in fairly good health. Men who've had certain treatments like enzalutamide or darolutamide before, brain metastasis, seizures, dementia, or are at risk of falls can't join.

What is being tested?

The study is testing the effects of two drugs on thinking skills in men with advanced prostate cancer. Half will take Darolutamide and half Enzalutamide along with standard hormone-blocking injections. Their cognitive functions will be measured using a special computerized test called CANTAB.

What are the potential side effects?

Both Darolutamide and Enzalutamide can cause fatigue, high blood pressure, memory problems and confusion. There might also be risks like falls due to muscle weakness or dizziness. Each person may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is growing despite hormone therapy, with increasing PSA levels.

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I can swallow pills without any issues.

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My prostate cancer is confirmed and does not have neuroendocrine or small cell features.

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My prostate cancer is either spreading (mCRPC) or not visible on scans (M0CRPC).

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I can perform daily activities with little or no assistance.

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My prostate cancer has spread or has not spread but is resistant to treatment.

Exclusion Criteria

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

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I have previously used ENZ or DARO.

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I have a history of seizures or currently experience them.

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I have untreated or unstable brain metastasis.

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I have used experimental drugs targeting hormone activity before.

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I have previously used apalutamide.

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I am at risk of falling, as shown by taking more than 12 seconds on the TUG test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 104 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~104 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 104 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Kringles

Secondary study objectives

Change in lowest ranking domain

Crossover from enzalutamide to darolutamide and darolutamide to enzalutamide

Improve in cognitive function after crossover

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Darolutamide (DARO)Active Control1 Intervention

Patients will take DARO at a dose of 600 mg (300 mg ×2 tablets) by mouth twice daily beginning on Day 1, of Week 1. Patients will take DARO throughout planned treatment period or withdrawal of consent or progression of disease requiring change in therapy.

Group II: Enzalutamide (ENZ)Active Control1 Intervention

Patients will take ENZ at a dose of 160 mg PO once daily (QD), beginning on Day 1, of Week 1. Patients will take ENZ throughout planned treatment period or withdrawal of consent or progression of disease requiring change in therapy.

0 / 12Eligibility criteria met