Darolutamide + ADT for Metastatic Hormone-Sensitive Prostate Cancer

(ARASEC Trial)

Recruiting at 46 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bayer

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of the study is to assess if the addition of darolutamide to ADT compared with ADT alone would result in superior clinical efficacy in participants with metastatic hormone-sensitive prostate cancer (mHSPC) by progression-free survival. The researchers want to learn how long it takes for the cancer to get worse (also known as "progression-free survival") by either increasing symptoms, new metastases, PSA rise or death. All participants will be on treatment and take darolutamide with ADT until their cancer spreads, they have a medical problem, or they leave the study. The results will then be compared with patients' results from another study who received ADT alone (CHAARTED). This study will also assess safety by gathering adverse event information throughout the duration of the study. An adverse event is any medical problem, related or not to study treatment that a participant has during a study. The study drug, darolutamide, is already available for doctors to prescribe to patients with prostate cancer that has not yet spread to other parts of the body. It works by blocking a protein called a receptor from attaching to a hormone called androgen that is found in men. This protein can also be found in prostate cancer cells. ADT is a treatment that doctors are currently able to prescribe to patients with mHSPC. ADT is used to lower the amount of the androgen hormone.

Eligibility Criteria

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.

Inclusion Criteria

I have taken medication to prevent flare before starting hormone therapy.

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

I've had hormone therapy before surgery or alongside other treatments, meeting all required conditions.

Exclusion Criteria

I have not had cancer in the last 5 years, except for skin cancer.

My high blood pressure is not under control.

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

Treatment Details

Interventions

• ADT (Hormone Therapy)
• Darolutamide (Antiandrogen)

Trial Overview 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.

Participant Groups

Group I: Darolutamide+ADT Experimental Treatment 2 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

ADT is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Androgen Deprivation Therapy for:

• Prostate Cancer

Approved in Japan as Androgen Deprivation Therapy for:

• Prostate Cancer

Approved in China as Androgen Deprivation Therapy for:

• Prostate Cancer

Approved in Switzerland as Androgen Deprivation Therapy for:

• Prostate Cancer

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

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Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD