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Antiandrogen

Enzalutamide +/- Abiraterone + Prednisone for Prostate Cancer

Phase 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

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

Must have

Patients must have progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features

Age ≥ 18 years of age

Must not have

History of active malignancy

No treatment with prior taxane-based chemotherapy for metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post treatment

Awards & highlights

All Individual Drugs Already Approved

Approved for 30 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the efficacy of enzalutamide versus abiraterone/prednisone in men with metastatic castration-resistant prostate cancer.

Who is the study for?

Men aged 18+ with castration-resistant metastatic prostate cancer, who have not used certain treatments recently and do not have severe heart conditions, brain metastases, or other specific health issues. Participants must show disease progression despite ongoing androgen deprivation therapy.

What is being tested?

The trial is testing if enzalutamide alone is as effective as a combination of enzalutamide, abiraterone, and prednisone in treating advanced prostate cancer that no longer responds to hormonal therapy aimed at lowering androgens.

What are the potential side effects?

Possible side effects include fatigue, high blood pressure, liver problems, bone pain relief procedures like radiation or surgery may be needed. There's also a risk of seizures for those with certain medical histories.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is worsening despite hormone therapy and has not turned into a more aggressive type.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My cancer is getting worse.

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I am continuing treatment to lower my testosterone levels.

Exclusion Criteria

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

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I have a history of cancer.

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I have not had taxane-based chemotherapy for my advanced cancer.

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I have not taken enzalutamide, abiraterone, or similar prostate cancer drugs.

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My digestive system absorbs nutrients properly.

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I have not had major surgery in the last 4 weeks.

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I have had a condition where my lymphocytes grow abnormally.

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I haven't taken high doses of steroids in the last month.

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My bones do not have any unstable lesions that could lead to fractures.

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I have never had a seizure or conditions that increase seizure risk.

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I do not have any major heart problems.

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I do not have plans for treatments specifically for bone pain relief.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Number of Participants Who Has Experienced at Least One Toxicity (Defined as a Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment)

Side effects data

From 2021 Phase 4 trial • 255 Patients • NCT02485691

40%

Diarrhoea

30%

Anaemia

29%

Fatigue

26%

Asthenia

23%

Nausea

22%

Neutropenia

16%

Back Pain

15%

Constipation

14%

Haematuria

13%

Vomiting

13%

Decreased Appetite

12%

Dysgeusia

Abdominal Pain

Stomatitis

Oedema Peripheral

Urinary Tract Infection

Arthralgia

Cancer Pain

Leukopenia

Pain

Pyrexia

Polyneuropathy

Dyspnoea

Alopecia

Neuropathy Peripheral

Pain In Extremity

Weight Decreased

Hypokalaemia

Hypertension

Febrile Neutropenia

Disease Progression

Bone Pain

Spinal Cord Compression

Pneumonia

Atrial Fibrillation

Acute Kidney Injury

Sepsis

Femoral Neck Fracture

Rectal Haemorrhage

Malaise

Gamma-Glutamyltransferase Increased

Vertigo

Inflammation

Atrial Flutter

Neutropenic Infection

Pathological Fracture

Tumour Pain

Loss Of Consciousness

Diarrhoea Haemorrhagic

General Physical Health Deterioration

Gastroenteritis

Platelet Count Decreased

Flank Pain

Spinal Pain

Oncologic Complication

Transient Ischaemic Attack

Hydronephrosis

Aspiration

Urinary Retention

Hepatitis

Toxicity To Various Agents

Alanine Aminotransferase Increased

Pancytopenia

Neuroendocrine Carcinoma Of The Skin

Carotid Artery Stenosis

Syncope

Haemoptysis

Septic Shock

Device Related Sepsis

Laryngeal Inflammation

Perineal Cellulitis

Urosepsis

Head Injury

Cognitive Disorder

Aspartate Aminotransferase Increased

100%

80%

60%

40%

20%

Study treatment Arm

Cabazitaxel

Enzalutamide or Abiraterone

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 30 Other Conditions

This treatment demonstrated efficacy for 30 other conditions.

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: (enzalutamide, abiraterone, prednisone)Experimental Treatment3 Interventions

Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.

Group II: Arm A: (enzalutamide)Experimental Treatment1 Intervention

Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

FDA approved

Abiraterone

FDA approved

Enzalutamide

FDA approved