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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Decline in Prostate Specific Antigen (PSA)
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)
Objective Response Rate
+3 more

Side effects data

From 2021 Phase 4 trial • 255 Patients • NCT02485691
22%
Back Pain
21%
Asthenia
21%
Nausea
17%
Fatigue
16%
Arthralgia
15%
Decreased Appetite
11%
Anaemia
11%
Vomiting
10%
Pain In Extremity
10%
Constipation
9%
Oedema Peripheral
7%
Cancer Pain
6%
Disease Progression
6%
Weight Decreased
6%
Pyrexia
6%
Bone Pain
6%
Diarrhoea
6%
Hypokalaemia
6%
Hypertension
5%
Pain
4%
Haematuria
4%
Dysgeusia
3%
Acute Kidney Injury
3%
Urinary Tract Infection
2%
Atrioventricular Block Complete
2%
Abdominal Pain
2%
Dyspnoea
2%
Dehydration
2%
Spinal Cord Compression
2%
Upper Gastrointestinal Haemorrhage
2%
Renal Failure
2%
General Physical Health Deterioration
2%
Neuropathy Peripheral
2%
Stomatitis
2%
Urinary Tract Obstruction
2%
Cardiac Failure
1%
Hypocalcaemia
1%
Angina Pectoris
1%
Device Dislocation
1%
Erysipelas
1%
Neutropenia
1%
Ileus Paralytic
1%
Enterobacter Sepsis
1%
Herpes Zoster
1%
Hydronephrosis
1%
Leukopenia
1%
Pelvic Pain
1%
Pleural Effusion
1%
Urinary Retention
1%
Lymphoedema
1%
Urinary Tract Infection Bacterial
1%
Pneumonia
1%
Pulmonary Sepsis
1%
Tooth Infection
1%
Hyperfibrinolysis
1%
Thrombocytopenia
1%
Acute Coronary Syndrome
1%
Cerebral Haemorrhage
1%
Paraparesis
1%
Chronic Obstructive Pulmonary Disease
1%
Pulmonary Embolism
1%
Duodenal Ulcer
1%
Proctalgia
1%
Spinal Compression Fracture
1%
Pyelocaliectasis
1%
Oncologic Complication
1%
Pathological Fracture
1%
Hypertensive Crisis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enzalutamide or Abiraterone
Cabazitaxel

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

Find a Location

Who is running the clinical trial?

Biologics, Inc.Industry Sponsor
4 Previous Clinical Trials
247 Total Patients Enrolled
Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
9,931 Total Patients Enrolled
12 Trials studying Prostate Cancer
668 Patients Enrolled for Prostate Cancer
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
216,315 Total Patients Enrolled
30 Trials studying Prostate Cancer
5,924 Patients Enrolled for Prostate Cancer
~116 spots leftby Jun 2025
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