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Darolutamide + ADT for Metastatic Hormone-Sensitive Prostate Cancer (ARASEC Trial)

Phase 2

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

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

Must have

At least 4 weeks since prior major surgery and recovered from all toxicity from such surgery prior to enrollment

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2

Must not have

Uncontrolled hypertension

Known brain/leptomeningeal metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months after first administration

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if adding darolutamide to ADT will be more effective than ADT alone in men with hormone-sensitive prostate cancer that has spread to other parts of the body.

Who is the study for?

Men with metastatic hormone-sensitive prostate cancer who have started ADT up to 120 days before joining. They must have good organ function, no severe recent surgeries, and an ECOG Performance Status of 0-2. Excluded are those with certain other cancers in the last 5 years, brain metastases, uncontrolled hypertension, or previous treatments that could interfere.

What is being tested?

The trial is testing if adding darolutamide to standard ADT improves progression-free survival compared to ADT alone in men with mHSPC. Progression-free survival means how long patients live without their cancer getting worse.

What are the potential side effects?

Possible side effects include issues related to liver and kidney functions, blood pressure changes, gastrointestinal disturbances which might affect drug absorption, allergic reactions to study drugs or their components.

Eligibility Criteria

Inclusion Criteria

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

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It's been over 4 weeks since my last major surgery and I've recovered from it.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

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

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My high blood pressure is not under control.

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I have cancer that has spread to my brain or its coverings.

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My prostate cancer is of a specific type: small cell or neuroendocrine.

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I have received hormone therapy for cancer that has spread.

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I have an active viral infection or chronic liver disease needing treatment.

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I have been treated with specific prostate cancer medications before.

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I have a stomach or intestine problem that affects how I absorb medication.

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I cannot have contrast agents used in CT or MRI scans.

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I cannot swallow pills.

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I have used or am using medication that affects hormone levels.

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I have had chemotherapy before surgery or as an additional treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months after first administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months after first administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months after first administration for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Complete PSA response rate

Number of participants with adverse events

Overall survival (OS)

+2 more

Side effects data

From 2014 Phase 3 trial • 61 Patients • NCT02012218

17%

Dry mouth

17%

Akathisia

Vision blurred

Anxiety

Upper respiratory tract infection

Fatigue

Nasal congestion

Increased appetite

Musculoskeletal chest pain

Back pain

Headache

Extrapyramidal disorder

100%

80%

60%

40%

20%

Study treatment Arm

Group 1A

Group 3

Group 4

Group 1B

Group 2

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Darolutamide+ADTExperimental Treatment2 Interventions

Participants will receive darolutamide plus ADT in the ARASEC treatment arm. The control arm for the study will be derived from the participants treated with ADT alone in the CHAARTED trial using a matching approach

0 / 13Eligibility criteria met