← Back to Search

Darolutamide + ADT for Prostate Cancer (ARANOTE Trial)

Phase 3
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
Adequate bone marrow, liver and renal function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 55 months
Awards & highlights

ARANOTE Trial Summary

This trial is testing whether adding the drug darolutamide to standard hormone therapy can help treat metastatic hormone sensitive prostate cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Darolutamide may cause fatigue, pain, blood disorders, liver enzyme changes, rash, and fractures. Side effects vary by individual and should be discussed with a healthcare provider.

ARANOTE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am able to care for myself and perform daily activities.
Select...
My bone marrow, liver, and kidneys are functioning well.
Select...
I started hormone therapy for cancer not more than 12 weeks ago.
Select...
My prostate cancer was confirmed by a lab test.
Select...
My cancer has spread to other parts of my body.

ARANOTE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 55 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 55 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiological progression-free survival (rPFS)
Secondary outcome measures
Number of participants with adverse events as a measure of safety
Overall survival (OS)
PSA undetectable rates (<0.2 ng/mL)
+4 more

Side effects data

From 2022 Phase 3 trial • 1209 Patients • NCT01715285
38%
Hypertension
24%
Hypokalaemia
20%
Back Pain
17%
Alanine Aminotransferase Increased
16%
Arthralgia
15%
Hot Flush
15%
Aspartate Aminotransferase Increased
14%
Fatigue
14%
Hyperglycaemia
14%
Bone Pain
12%
Pain in Extremity
11%
Constipation
10%
Anaemia
10%
Oedema Peripheral
9%
Weight Increased
8%
Headache
8%
Nasopharyngitis
7%
Nausea
7%
Upper Respiratory Tract Infection
7%
Blood Lactate Dehydrogenase Increased
7%
Urinary Tract Infection
7%
Cough
7%
Vomiting
7%
Influenza
6%
Diarrhoea
5%
Asthenia
5%
Insomnia
5%
Musculoskeletal Pain
4%
Abdominal Pain
4%
Decreased Appetite
2%
Spinal Cord Compression
2%
Pneumonia
2%
Urinary Retention
1%
Pyrexia
1%
Cardiac Failure
1%
Acute Coronary Syndrome
1%
Angina Pectoris
1%
Myocardial Infarction
1%
Bronchitis
1%
Bronchopneumonia
1%
Renal Failure
1%
Deep Vein Thrombosis
1%
Haematuria
1%
Urinary Tract Obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate
Abiraterone Acetate+Prednisone+ADT
Placebo + ADT

ARANOTE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Darolutamide+ADTExperimental Treatment2 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+ADTPlacebo Group2 Interventions
Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darolutamide (Nubeqa, BAY1841788)
2014
Completed Phase 3
~2380

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,228 Previous Clinical Trials
25,324,500 Total Patients Enrolled
39 Trials studying Prostate Cancer
25,919 Patients Enrolled for Prostate Cancer
Orion Corporation, Orion PharmaIndustry Sponsor
136 Previous Clinical Trials
44,042 Total Patients Enrolled
5 Trials studying Prostate Cancer
407 Patients Enrolled for Prostate Cancer

Media Library

Androgen Deprivation Therapy (ADT) Clinical Trial Eligibility Overview. Trial Name: NCT04736199 — Phase 3
Prostate Cancer Clinical Trial 2023: Androgen Deprivation Therapy (ADT) Highlights & Side Effects. Trial Name: NCT04736199 — Phase 3
Androgen Deprivation Therapy (ADT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04736199 — Phase 3
Prostate Cancer Research Study Groups: Darolutamide+ADT, Placebo+ADT

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the risk profile associated with Androgen deprivation therapy (ADT)?

"There is both anecdotal and scientific evidence in support of Androgen Deprivation Therapy (ADT), so it was given a safety rating of 3."

Answered by AI

Are there any more places open for patients in this clinical trial?

"Yes. This trial, which was originally posted on February 23rd, 2021, is currently looking for participants, according to the information available on clinicaltrials.gov. The last update to the posting was on October 6th, 2022."

Answered by AI

Have similar trials been conducted before?

"Androgen deprivation therapy (ADT) has been studied since 2016. The first clinical trial was sponsored by Orion Corporation and conducted that same year. After the initial Phase 3 study in 2016, Androgen deprivation therapy (ADT) was approved as a medication. As of now, there are 25 ongoing trials in 44 countries and 530 cities."

Answered by AI

In how many different trial locations is this study being conducted today?

"There are 5 available sites for this trial in Granby, Burlington, and Montreal, as well as other 5 locations."

Answered by AI

How many people are recruited to participate in this clinical trial?

"That is correct, the listing on clinicaltrials.gov indicates that this study is actively recruiting patients. This particular trial was first posted on February 23rd, 2021 and was last updated on October 6th, 2022. The research is hoping to enroll 665 patients from 5 different locations."

Answered by AI

Does the literature on Androgen deprivation therapy (ADT) date back far?

"Currently, there are 25 active clinical trials studying Androgen deprivation therapy (ADT), with 9 of them in Phase 3. Although several of these trials are based in Toronto, Ontario, there are 1,385 total locations running trials for Androgen deprivation therapy (ADT) across the world."

Answered by AI
~162 spots leftby Mar 2025