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Enzalutamide With or Without Abiraterone Acetate and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherA031201
U10CA031946, NCI-2013-01737, NCT01949337

Trial Description

Summary

This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone acetate, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

Further Study Information

Patients are randomized to one of two treatment groups: enzalutamide or enzalutamide, abiraterone and prednisone. Treatment will continue until disease progression or unacceptable toxicity. Patients are followed for clinical outcomes for a maximum of 5 years post study treatment. The primary and secondary objectives are described below.

1. Primary Objective:

To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer (CRPC) treated with either enzalutamide only or enzalutamide with abiraterone (abiraterone acetate) and prednisone

2. Secondary Objectives:

  • To assess the grade 3 or higher toxicity profile and compare safety by treatment arm.
  • To assess and compare post-treatment prostate-specific antigen (PSA) declines by treatment arm.
  • To compare radiographic progression free survival defined by Prostate Cancer Working Group 2 (PCWG2), and objective response rate, by treatment arm.
  • To test for radiographic progression free survival (rPFS) treatment interaction in predicting overall survival.
  • To assess pre- and post-treatment measures of tumor burden and bone activity using sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT) and technetium (Tc) methylene diphosphonate (MDP) bone scintigraphy and correlate these measures with overall survival.
  • To develop and validate prognostic and predictive models of overall survival that include baseline clinical and molecular markers.

Eligibility Criteria

Eligibility Criteria:

Documentation of Disease:

  • Progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • Patients must have measurable or non-measurable disease
  • Measurable Disease - Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral computed tomography (CT) scan
  • Non-Measurable Disease - All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions.

Lesions that are considered non-measurable include the following:

  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Cancer-related pleural/pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions

Progressive Disease:

  • Patients must have progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy:
  • PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide). The PSA value at the screening should be ≥ 2 µg/L (2 ng/mL)
  • Soft tissue disease progression defined by Response Evaluation Criteria in Solid tumors (RECIST) 1.1
  • Bone disease progression defined by the Prostate Cancer Working Group 2 (PCWG2) with two or more new lesions on bone scan

Prior Treatment:

  • No treatment with prior taxane-based chemotherapy for metastatic disease
  • Patients who received prior taxane-based chemotherapy as neoadjuvant or adjuvant therapy for local disease, or who received taxane-based therapy in the PSA clinical (non-metastatic) state is allowable provided that the total duration of exposure was six cycles or less and chemotherapy was completed more than 6 months prior to registration
  • Taxane-based chemotherapy that was aborted due to allergic reactions or intolerance to chemotherapy and therefore received one cycle of prior therapy is allowable
  • No treatment with hormonal therapy (e.g., androgen receptor [AR] antagonists, 5 alpha reductase inhibitors, estrogens) other than gonadotropin-releasing hormone (GnRH) analogues or antagonists, chemotherapy, biologic therapy, investigational therapy, or immunotherapy for prostate cancer within 4 weeks of enrollment
  • No prior enzalutamide, abiraterone, or other novel antiandrogen or androgen synthesis inhibitor
  • No use of herbal products that may decrease PSA levels within 4 weeks prior to enrollment
  • No use of systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment
  • No prior use of ketoconazole for greater than 7 days
  • No prior radiation therapy or beta-emitting radionuclide therapy for the treatment of metastasis within four weeks prior to enrollment
  • Patients receiving bisphosphonate therapy or denosumab must have been on a stable dose for at least 4 weeks prior to enrollment
  • Patients must maintain ongoing androgen deprivation therapy with a GnRH analogue, antagonist, or bilateral orchiectomy (i.e., surgical or medical castration)

Patient History:

  • No known or suspected brain metastases (NOTE: patients with treated epidural disease are allowed)
  • No planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
  • No structurally unstable bone lesions suggesting impending fracture
  • No history of seizure or any condition that may increase the patient's seizure risk (e.g., prior cortical stroke, significant brain trauma); no history of transient ischemic attack (TIA) within 12 months of enrollment
  • No clinically significant cardiovascular disease including:
  • Myocardial infarction (MI) within 6 months
  • Uncontrolled angina within 3 months
  • Congestive heart failure (CHF) with New York Heart Association (NYHA) class 3 or 4, or patients with NYHA class 3 or 4 in the past, unless a screening echocardiogram (echo) or multi gated acquisition scan (MUGA) performed within three months demonstrates an ejection fraction (EF) > 45%
  • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
  • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
  • Hypotension (systolic blood pressure [BP] < 86 mmHg) or bradycardia (< 50 bpm) at screening
  • Uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 105 mmHg at screening)
  • No gastrointestinal (GI) disorder that negatively affects absorption
  • No major surgery within 4 weeks prior to enrollment

Age and performance status:

  • Age ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Asymptomatic or mildly symptomatic from prostate cancer

Required Initial Laboratory Values:

  • Granulocytes ≥ 1,500/µL
  • Platelet count ≥ 100,000/µL
  • Hemoglobin ≥ 9 g/dL
  • Creatinine ≤ 2 x upper limits of normal (ULN)
  • Bilirubin ≥ 1.5 x ULN
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2 x ULN
  • Albumin ≥ 3 g/dl

Trial Contact Information

Trial Lead Organizations/Sponsors

Alliance for Clinical Trials in Oncology

National Cancer Institute

Astellas Pharma US, Incorporated

Biologics

Michael MorrisStudy Chair

Trial Sites

U.S.A.
California
  LA Jolla
 Rebecca and John Moores UCSD Cancer Center
 James M Randall Ph: 858-822-5354
  Email: cancercto@ucsd.edu
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
Florida
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
  Pensacola
 Sacred Heart Cancer Center at Sacred Heart Hospital
 James F Watkins Ph: 850-416-4611
 Sacred Heart Medical Oncology Group
 James F Watkins Ph: 850-416-4611
Illinois
  Chicago
 Cancer and Leukemia Group B
 Michael Morris Ph: 646-422-4469
  Email: morrism@mskcc.org
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Daniel A Vaena Ph: 800-237-1225
Maine
  Augusta
 Harold Alfond Center for Cancer Care
 Thomas Henry Openshaw Ph: 207-973-4274
  Bangor
 CancerCare of Maine at Eastern Maine Medical Center
 Thomas Henry Openshaw Ph: 207-973-4274
Maryland
  Frederick
 Frederick Memorial Hospital Regional Cancer Therapy Center
 Elhamy Eskander Ph: 240-566-3584
  Email: clinicaltrials@fmh.org
Michigan
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-3456
Missouri
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Donald C Doll Ph: 573-882-7440
  Saint Louis
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Joel Picus Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Montana
  Billings
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nevada
  Las Vegas
 HealthCare Partners Medical Group Oncology/Hematology-San Martin
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-Tenaya
 John Allan Ellerton Ph: 702-384-0013
New Hampshire
  Laconia
 Lakes Region General Hospital
 Frederick M. Briccetti Ph: 800-339-6484
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Richard C Lauer Ph: 505-272-6972
  Las Cruces
 Memorial Medical Center
 Richard C Lauer Ph: 505-272-6972
  Santa Fe
 New Mexico Cancer Care Associates
 Richard C Lauer Ph: 505-272-6972
New York
  Brooklyn
 Maimonides Cancer Center at Maimonides Medical Center
 Kevin Becker Ph: 203-785-5702
  New York
 Memorial Sloan-Kettering Cancer Center
 Michael Morris Ph: 212-639-7202
North Carolina
  Asheboro
 Randolph Hospital
 James M Granfortuna Ph: 336-832-0821
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 James M Granfortuna Ph: 336-832-0821
  Reidsville
 Annie Penn Cancer Center
 James M Granfortuna Ph: 336-832-0821
Oklahoma
  Lawton
 Cancer Centers of Southwest Oklahoma, LLC - Lawton
 Nadim F. Nimeh Ph: 877-231-4440
  Oklahoma City
 Oklahoma University Cancer Institute
 Sindhu Singh Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Corvallis
 Good Samaritan Hospital
 Kimberly A McGregor Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
Pennsylvania
  Gettysburg
 Adams Cancer Center
 Amir Tabatabai Ph: 877-441-7957
  York
 WellSpan Health
 Amir Tabatabai Ph: 877-441-7957

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01949337
ClinicalTrials.gov processed this data on March 17, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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