Darolutamide + ADT for Prostate Cancer

(ARANOTE Trial)

Recruiting at 180 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bayer

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a drug called darolutamide combined with a common hormone-lowering therapy in patients whose prostate cancer has spread but still responds to hormones. The goal is to see if this combination can effectively and safely slow down the cancer's growth. Darolutamide was approved in 2019 for a specific type of prostate cancer.

Eligibility Criteria

Men with confirmed metastatic hormone-sensitive prostate cancer, who have started ADT within the last 12 weeks and are in good physical condition (ECOG PS of 0-2) can join. They must not have had certain heart conditions or other cancer treatments like chemotherapy for prostate cancer in the past 6 months.

Inclusion Criteria

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

My bone marrow, liver, and kidneys are functioning well.

I started hormone therapy for cancer not more than 12 weeks ago.

Exclusion Criteria

I have not had radiotherapy in the last 2 weeks.

I cannot swallow pills.

I have not used specific hormone therapies, chemotherapy, or other treatments for prostate cancer recently.

Treatment Details

Interventions

• Androgen Deprivation Therapy (ADT) (Hormone Therapy)
• Darolutamide (Antiandrogen)

Trial Overview The trial is testing if adding Darolutamide to standard ADT improves outcomes for men with metastatic hormone-sensitive prostate cancer compared to ADT alone. Participants will either receive Darolutamide or a placebo alongside their regular ADT treatment.

Participant Groups

Group I: Darolutamide+ADT Experimental Treatment 2 Interventions

Participants will receive darolutamide 600 mg (2 tablets of 300 mg) twice daily with food and ADT of investigator's choice as standard therapy

Group II: Placebo+ADT Placebo Group 2 Interventions

Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy

Androgen Deprivation Therapy (ADT) is already approved in Canada for the following indications:

Approved in Canada as Androgen Deprivation Therapy for:

• Prostate cancer
• Metastatic prostate cancer
• Non-metastatic high-risk prostate cancer

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

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

Orion Corporation, Orion Pharma

Industry Sponsor

Trials

140

Recruited

45,200+

Liisa Hurme

Orion Corporation, Orion Pharma

Chief Executive Officer since 2022

PhD in Biochemistry, University of Helsinki

Hilpi Rautelin

Orion Corporation, Orion Pharma

Chief Medical Officer since 2023

MD, University of Turku