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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
40%
Diarrhoea
30%
Anaemia
29%
Fatigue
26%
Asthenia
23%
Nausea
22%
Neutropenia
16%
Back Pain
15%
Constipation
14%
Haematuria
13%
Decreased Appetite
13%
Vomiting
12%
Dysgeusia
8%
Urinary Tract Infection
8%
Arthralgia
8%
Oedema Peripheral
8%
Abdominal Pain
8%
Stomatitis
7%
Cancer Pain
6%
Pain
6%
Leukopenia
6%
Dyspnoea
6%
Alopecia
6%
Polyneuropathy
6%
Pyrexia
6%
Neuropathy Peripheral
5%
Pain In Extremity
4%
Hypokalaemia
4%
Weight Decreased
4%
Hypertension
3%
Disease Progression
3%
Bone Pain
3%
Febrile Neutropenia
3%
Spinal Cord Compression
3%
Pneumonia
2%
Atrial Fibrillation
2%
Acute Kidney Injury
2%
Sepsis
1%
Rectal Haemorrhage
1%
Hydronephrosis
1%
Atrial Flutter
1%
Vertigo
1%
Spinal Pain
1%
Aspiration
1%
Flank Pain
1%
Transient Ischaemic Attack
1%
Urinary Retention
1%
General Physical Health Deterioration
1%
Inflammation
1%
Femoral Neck Fracture
1%
Oncologic Complication
1%
Gastroenteritis
1%
Pathological Fracture
1%
Neutropenic Infection
1%
Loss Of Consciousness
1%
Gamma-Glutamyltransferase Increased
1%
Tumour Pain
1%
Platelet Count Decreased
1%
Diarrhoea Haemorrhagic
1%
Malaise
1%
Hepatitis
1%
Toxicity To Various Agents
1%
Alanine Aminotransferase Increased
1%
Pancytopenia
1%
Neuroendocrine Carcinoma Of The Skin
1%
Carotid Artery Stenosis
1%
Syncope
1%
Haemoptysis
1%
Septic Shock
1%
Device Related Sepsis
1%
Laryngeal Inflammation
1%
Perineal Cellulitis
1%
Urosepsis
1%
Head Injury
1%
Cognitive Disorder
1%
Aspartate Aminotransferase Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabazitaxel
Enzalutamide or Abiraterone

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
216,327 Total Patients Enrolled
30 Trials studying Prostate Cancer
5,924 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

How many people are included in this clinical trial?

"Currently, this clinical trial is not enrolling patients. However, it was posted on 1/22/2014 and edited on 8/2/2022. If you are looking for other studies, 1298 trials for adenocarcinoma and 453 studies involving enzalutamide are actively enrolling participants."

Answered by AI

Has enzalutamide met the FDA's approval?

"Enzalutamide receives a safety score of 3 from our team at Power. This is due to the fact that this drug has reached Phase 3 in clinical trials, meaning that there is both efficacy data and multiple rounds of safety data supporting its use."

Answered by AI

To what extent has enzalutamide been shown to be effective?

"Enzalutamide is most often used to manage thyroiditis, however the medication can also help patients that suffer from ulcerative colitis, malignant neoplasms, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Could you please provide a brief overview of other research projects that have used enzalutamide?

"Enzalutamide is being studied in 453 clinical trials, with 120 of those still ongoing. Of the ongoing studies, most are Phase 3 trials. The primary location for these studies is Germantown, Tennessee; however, enzalutamide trials can be found at 20917 different medical centres worldwide."

Answered by AI

In how many places is this research being done?

"100 patients are currently enrolled in this study at locations such as Oncology Associates at Mercy Medical Center in Cedar Rapids, Saint Luke's Hospital of Duluth in Duluth, and University of Tennessee Health Science Center in Memphis - amongst 100 other sites."

Answered by AI

Is this study looking for new participants at this time?

"This trial is not recruiting at the moment, according to the latest update on 8/2/2022. If you are interested in other similar studies, 1298 trials for adenocarcinoma and 453 for enzalutamide are both presently looking for participants."

Answered by AI

Who else is applying?

What site did they apply to?
University of Texas Medical Branch
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am taking those hormone drugs and live in Galveston.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer
2014. "Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01949337.
All > Metastatic Prostate Cancer
~117 spots leftby Apr 2025
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