What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as androgen deprivation therapy (ADT) combined with androgen receptor inhibitors like darolutamide, enzalutamide, and abiraterone, as well as chemotherapy agents like docetaxel, are associated with various side effects. ADT can lead to hot flashes, decreased libido, and fatigue. Androgen receptor inhibitors may cause additional side effects such as hypertension, hypokalemia, seizures (notably with enzalutamide), and increased risk of cardiovascular events. Docetaxel, a chemotherapy agent, is associated with myelosuppression, increased risk of infections, and other severe adverse events. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several androgen receptor inhibitors for the treatment of prostate cancer. Enzalutamide (Xtandi) is approved for metastatic castration-resistant prostate cancer (CRPC) and has shown to increase median survival. Apalutamide is approved for both nonmetastatic and metastatic castration-sensitive prostate cancer (CSPC). Darolutamide, another androgen receptor inhibitor, has been approved for nonmetastatic CRPC and is being studied in combination with androgen deprivation therapy (ADT) and docetaxel for metastatic CSPC. These drugs work by inhibiting the androgen receptor pathway, which is crucial for the growth of prostate cancer cells.

What other types of research exist?

Promising alternatives to Darolutamide for prostate cancer patients in 2024 include Enzalutamide and Abiraterone Acetate. Enzalutamide has shown improved survival and quality of life in metastatic hormone-sensitive prostate cancer. Abiraterone Acetate, often combined with prednisone, is effective in both hormone-sensitive and castration-resistant prostate cancer. Additionally, novel therapies like Lutetium-177-PSMA-617, a radioligand therapy, have shown promise in metastatic castration-resistant prostate cancer.

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Darolutamide + ADT for Prostate Cancer (ARANOTE Trial)

Q: What is the mechanism of action of this treatment?

Prostate cancer treatments often target the androgen receptor pathway, which is critical for the growth and survival of prostate cancer cells. Androgen deprivation therapy (ADT) reduces the levels of androgens (male hormones) in the body, thereby limiting the stimulation of prostate cancer cells. Androgen receptor inhibitors, such as darolutamide, block the androgen receptors on cancer cells, preventing androgens from binding and activating these cells. This dual approach is effective in slowing disease progression and improving survival rates. Understanding these mechanisms helps patients appreciate the rationale behind their treatment plans and the importance of adhering to them.

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

Histologically or cytologically confirmed adenocarcinoma of prostate

Must not have

Treatment with radiotherapy within 2 weeks before randomization

Inability to swallow oral medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 55 months

Awards & highlights

Pivotal Trial

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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My prostate cancer was confirmed by a lab test.

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My cancer has spread to other parts of my body.

Exclusion Criteria

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

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I have not had radiotherapy in the last 2 weeks.

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I cannot swallow pills.

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

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I haven't had a stroke, heart attack, severe heart issues, or heart surgery in the last 6 months.

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My blood pressure is high (over 160/100) despite taking medication.

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I have a GI condition or had surgery that may affect how I absorb medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 55 months

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

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

Primary study objectives

Radiological progression-free survival (rPFS)

Secondary study objectives

Overall survival (OS)

PSA undetectable rates (<0.2 ng/mL)

Time to PSA progression

+3 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%

Aspartate Aminotransferase Increased

15%

Hot Flush

14%

Fatigue

14%

Hyperglycaemia

14%

Bone Pain

12%

Pain in Extremity

11%

Constipation

10%

Oedema Peripheral

10%

Anaemia

Weight Increased

Nasopharyngitis

Headache

Influenza

Upper Respiratory Tract Infection

Urinary Tract Infection

Nausea

Vomiting

Blood Lactate Dehydrogenase Increased

Cough

Diarrhoea

Asthenia

Musculoskeletal Pain

Insomnia

Abdominal Pain

Decreased Appetite

Pneumonia

Spinal Cord Compression

Urinary Retention

Angina Pectoris

Myocardial Infarction

Bronchitis

Acute Coronary Syndrome

Cardiac Failure

Pyrexia

Bronchopneumonia

Haematuria

Renal Failure

Urinary Tract Obstruction

Deep Vein Thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + ADT

DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate

Abiraterone Acetate+Prednisone+ADT

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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)

2024

Completed Phase 3

~4180

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments often target the androgen receptor pathway, which is critical for the growth and survival of prostate cancer cells. Androgen deprivation therapy (ADT) reduces the levels of androgens (male hormones) in the body, thereby limiting the stimulation of prostate cancer cells. Androgen receptor inhibitors, such as darolutamide, block the androgen receptors on cancer cells, preventing androgens from binding and activating these cells. This dual approach is effective in slowing disease progression and improving survival rates. Understanding these mechanisms helps patients appreciate the rationale behind their treatment plans and the importance of adhering to them.