AzTrials
AzTrials

Adenocarcinoma of the ProstatePhase 3NCT01949337

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

A Phase 3 study testing enzalutamide, abiraterone and prednisone in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 539 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
enzalutamide, abiraterone and prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,311 participants
Where
539 sitesin 3 countries
Study dates
22 Jan 2014to 31 Aug 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Eligibility Criteria:

  1. 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
  2. Patients must have measurable or non-measurable disease:
  3. Measurable Disease - For visceral or extra nodal lesions to be considered measurable, they must be ≥ 10 mm in one dimension, using spiral CT. For lymph nodes to be considered measurable (ie, target or evaluable lesions), they must be ≥ 20 mm in at least one dimension, using spiral CT.
  4. 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 bone lesions (only).
  5. Patients with node only disease (ie, no presence of visceral, extra nodal lesions or bone lesions) must have node(s) that measure ≥ 15 mm in short axis.
  6. 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. For patients enrolling on the basis of soft tissue or bone progression, the baseline scan must show progression relative to a comparison scan. If the comparison scan is not available, the baseline scan report must reference the previous scan to document progression.
  7. 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 documented by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination such that at least the second of these rises is ≥ 4 weeks since last flutamide, bicalutamide or nilutamide. The PSA value at the screening should be ≥ 2 µg/L (2 ng/mL) .
  8. Soft tissue disease progression defined by the protocol
  9. Bone disease progression defined by the Prostate Cancer Working Group 2 (PCWG2) with two or more new lesions on bone scan
  10. Prior Treatment
  11. 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
  1. No prior enzalutamide, abiraterone or other novel antiandrogen or androgen synthesis inhibitor
  2. No treatment with any of the following for prostate cancer within 4 weeks prior to enrollment:
  • Hormonal therapy (e.g., androgen receptor [AR] antagonists, 5 alpha reductase inhibitors, estrogens) Note: Treatment with bicalutamide and nilutamide within 4 weeks prior to enrollment is not allowed. Treatment with flutamide within 4 weeks prior to enrollment is not allowed. Treatment with all other gonadotropin- releasing hormone (GnRH) analogues or antagonists is allowed.
  • Chemotherapy
  • Biologic therapy
  • Investigational therapy
  • Immunotherapy
  1. No use of herbal products that may decrease PSA levels within 4 weeks prior to enrollment
  2. No use of systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment
  3. No prior use of ketoconazole for greater than 7 days
  4. No prior radiation therapy or radionuclide therapy for the treatment of metastasis within four weeks prior to enrollment
  5. Patients receiving bisphosphonate therapy or denosumab must have been on a stable dose for at least 4 weeks prior to enrollment
  6. Patients must maintain ongoing androgen deprivation therapy with a GnRH analogue, antagonist, or bilateral orchiectomy (i.e., surgical or medical castration)
  7. Patient History
  8. No known or suspected brain metastases (NOTE: patients with treated epidural disease are allowed)
  9. No planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
  10. No structurally unstable bone lesions suggesting impending fracture
  11. 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
  12. 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 multigated 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)
  1. No gastrointestinal (GI) disorder that negatively affects absorption
  2. No major surgery within 4 weeks prior to enrollment
  3. Age and performance status
  4. Age ≥ 18 years of age
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  6. Asymptomatic or mildly symptomatic from prostate cancer
  7. Required Initial Laboratory Values
  8. Granulocytes ≥ 1,500/µL
  9. Platelet count ≥ 100,000/µL
  10. Hemoglobin ≥ 9 g/dL
  11. Creatinine ≤ 2 x upper limits of normal (ULN)
  12. Bilirubin ≤ 1.5 x ULN
  13. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2 x ULN
  14. Albumin ≥ 3 g/dl
  15. Total testosterone ≤ 50 ng/dL (1.7 nmol/L)

Trial locations and contacts

539 sites in 3 countries.

312 sites in 3 countries

United States300 sites

  • Hawaii Oncology Inc-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Avera Cancer Institute-Aberdeen

    Aberdeen, South Dakota, 57401

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Christus Saint Frances Cabrini Hospital

    Alexandria, Louisiana, 71301

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92807

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Summa Barberton Hospital

    Barberton, Ohio, 44203

  • Memorial Sloan Kettering Cancer Center at Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Hematology/Oncology Clinic LLP

    Baton Rouge, Louisiana, 70809

  • Ochsner Health Center-Summa

    Baton Rouge, Louisiana, 70809

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Sanford Clinic North-Bemidgi

    Bemidji, Minnesota, 56601

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Hematology Oncology Associates-Quad Cities

    Bettendorf, Iowa, 52722

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • Kings County Hospital

    Brooklyn, New York, 11203

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Veterans Affairs Western New York Health Care System-Buffalo

    Buffalo, New York, 14215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • University of Vermont College of Medicine

    Burlington, Vermont, 05405

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Mercy Medical Center

    Canton, Ohio, 44708

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Geaugra Hospital

    Chardon, Ohio, 44024

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Charleston Hematology Oncology Associates-Roper

    Charleston, South Carolina, 29403

  • Lowcountry Hematology Oncology PA-North Charleston

    Charleston, South Carolina, 29406

  • Bon Secours Saint Francis Hospital

    Charleston, South Carolina, 29414

  • Charleston Hematology Oncology Associates PA-St. Francis

    Charleston, South Carolina, 29414

  • Lowcountry Hematology Oncology PA-West Ashley

    Charleston, South Carolina, 29414

  • West Virginia University Charleston

    Charleston, West Virginia, 25304

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Oncology Specialists of Charlotte

    Charlotte, North Carolina, 28207

  • Southern Oncology Specialists-Charlotte

    Charlotte, North Carolina, 28262

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • University of Cincinnati/Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Memorial Hospital Colorado Springs

    Colorado Springs, Colorado, 80909

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Memorial Sloan Kettering Cancer Center Commack

    Commack, New York, 11725

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • The West Clinic - Corinth

    Corinth, Mississippi, 38834

  • Good Samaritan Hospital

    Corvallis, Oregon, 97330

  • Barnes-Jewish West County Hospital

    Creve Coeur, Missouri, 63141

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Cancer Care Center of Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Wentworth-Douglass Hospital

    Dover, New Hampshire, 03820

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Durham Veterans Affairs Medical Center

    Durham, North Carolina, 27705

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Greenville Health System Cancer Institute-Easley

    Easley, South Carolina, 29640

  • Veterans Adminstration New Jersey Health Care System

    East Orange, New Jersey, 07018-1095

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701

  • Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • The Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Arnot Ogden Medical Center/Falck Cancer Center

    Elmira, New York, 14905

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Newman Regional Health

    Emporia, Kansas, 66801

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49829

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

  • Sanford Medical Center-Fargo

    Fargo, North Dakota, 58122

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Orion Cancer Care

    Findlay, Ohio, 45840

  • Simonds-Sinon Regional Cancer Center

    Fitchburg, Massachusetts, 01420

  • Saint Agnes Hospital/Agnesian Cancer Center

    Fond du Lac, Wisconsin, 54935

  • Kaiser Permanente Hospital

    Fontana, California, 92335

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Fort Wayne Medical Oncology and Hematology Inc - Jefferson Boulevard

    Fort Wayne, Indiana, 46804

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • University Oncology Associates

    Fresno, California, 93701

  • California Cancer Center - North Fresno

    Fresno, California, 93720

  • Kaiser Permanente

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Saint Catherine Hospital

    Garden City, Kansas, 67846

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • The West Clinic - Wolf River

    Germantown, Tennessee, 38138

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Saint Rose Ambulatory and Surgery Center

    Great Bend, Kansas, 67530

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Greenwich Hospital

    Greenwich, Connecticut, 06830

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Virginia Oncology Associates-Hampton

    Hampton, Virginia, 23666

  • Kaiser Permanente - Harbor City

    Harbor City, California, 90710

  • Memorial Sloan-Kettering Cancer Center West Harrison

    Harrison, New York, 10604

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Hays Medical Center

    Hays, Kansas, 67601

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • Hines Veterans Administration Hospital

    Hines, Illinois, 60141

  • Hawaii Cancer Care Inc-POB II

    Honolulu, Hawaii, 96813

  • Hawaii Oncology Inc-POB I

    Honolulu, Hawaii, 96813

  • Island Urology

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • Hawaii Oncology Inc-Kuakini

    Honolulu, Hawaii, 96817

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • New Hampshire Oncology Hematology PA-Hooksett

    Hooksett, New Hampshire, 03106

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Lake Norman Hematology Oncology Specialists-Huntersville

    Huntersville, North Carolina, 28078

  • Southern Oncology Specialists-Huntersville

    Huntersville, North Carolina, 28078

  • Saint Mary's Medical Center

    Huntington, West Virginia, 25702

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Iowa City VA Healthcare System

    Iowa City, Iowa, 52246

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Mercy Health System

    Janesville, Wisconsin, 53547

  • Capital Region Medical Center-Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Fowler Family Center for Cancer Care

    Jonesboro, Arkansas, 72401

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center-West

    Kansas City, Kansas, 66112

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • The University of Kansas Cancer Center-South

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • The University of Kansas Cancer Center-North

    Kansas City, Missouri, 64154

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Ochsner Medical Center Kenner

    Kenner, Louisiana, 70065

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Novant Health Oncology Specialists-Kernersville

    Kernersville, North Carolina, 27284

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Kinston Medical Specialists PA

    Kinston, North Carolina, 28501

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • LRGHealthcare-Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Carolina Blood and Cancer Care Associates PA-Lancaster

    Lancaster, South Carolina, 29720

  • Saint Mary Medical and Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Memorial Medical Center - Las Cruces

    Las Cruces, New Mexico, 88011

  • HealthCare Partners Medical Group Oncology/Hematology-San Martin

    Las Vegas, Nevada, 89113

  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • The University of Kansas Cancer Center-Lee's Summit

    Lee's Summit, Missouri, 64064

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Nebraska Hematology and Oncology

    Lincoln, Nebraska, 68506

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Veteran's Administration Medical Center

    Little Rock, Arkansas, 72205

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Kaiser Permanente-Cadillac

    Los Angeles, California, 90034

  • Lynchburg Hematology-Oncology Clinic

    Lynchburg, Virginia, 24501

  • Medical Center of Central Georgia

    Macon, Georgia, 31201

  • William S Middleton VA Medical Center

    Madison, Wisconsin, 53705

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Norris Cotton Cancer Center-Manchester

    Manchester, New Hampshire, 03102

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Mayo Clinic Health Systems-Mankato

    Mankato, Minnesota, 56001

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio, 44906

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Vince Lombardi Cancer Clinic-Marinette

    Marinette, Wisconsin, 54143

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • Memorial Hospital Of Martinsville

    Martinsville, Virginia, 24115

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Novant Health Cancer Specialists-Matthews

    Matthews, North Carolina, 28105

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Ireland Cancer Center Landerbrook Health Center

    Mayfield Heights, Ohio, 44124

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia, 23116

  • Summa Health Center at Lake Medina

    Medina, Ohio, 44256

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38163

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

Other trials in United States

Canada9 sites

  • Cambridge Memorial Hospital

    Cambridge, Ontario, N1R 3G2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Grand River Regional Cancer Centre at Grand River Hospital

    Kitchener, Ontario, N2G 1G3

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • The Vitalite Health Network - Dr Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Atlantic Health Sciences Corporation-Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Doctor H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Puerto Rico3 sites

  • San Juan Veterans Affairs Medical Center

    San Juan, 00921-3201

  • Fundacion De Investigacion de Diego

    San Juan, 00927

  • San Juan City Hospital

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer

This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, 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.

Read the detailed description

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 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.
Being tested
enzalutamide, abiraterone, prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • enzalutamideDrug

    Enzalutamide 160 mg daily, orally

  • abirateroneDrug

    abiraterone 1000 mg daily, orally

  • prednisoneDrug

    prednisone 5 mg twice daily, orally

Study groups in NCT01949337
Study groupRoleWhat they receive
Arm A: (enzalutamide)ExperimentalPatients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
Receives: Drug: enzalutamide
Arm B: (enzalutamide, abiraterone, prednisone)ExperimentalPatients 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.
Receives: Drug: enzalutamide; Drug: abiraterone; Drug: prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall survival is defined as the time from study registration to death due to any cause.

    Measured: Up to 5 years post treatment

Secondary outcomes (6)

  1. 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)

    The 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)

    Measured: Up to 5 years post treatment

  2. Decline in Prostate Specific Antigen (PSA)

    Measured: Up to 5 years post treatment

  3. Progression Free Survival (PFS)

    Measured: Up to 5 years post treatment

  4. Objective Response Rate

    Measured: Up to 5 years post treatment

  5. Radiographic Progression Free Survival (rPFS)

    Measured: Up to 5 years post treatment

  6. Tumor Burden and Bone Activity

    Measured: Up to 5 years post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2013 (estimated)
  2. Study start22 Jan 2014
  3. Primary completion2 Nov 2018
  4. Study completion31 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,311 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01949337
Sponsor's protocol ID
A031201
Other IDs
U10CA031946, NCI-2013-01737
Status last verified
Sep 2023
First submitted
20 Sep 2013
Last updated
28 Sep 2023
Data monitoring committee
Yes

Publications

  • Norton N, Larson NB, Jenkins GD, Beumer JH, Langevin B, Gobbaru J, Morris MJ, Nakamura Y, Kroetz DL, Zhu HJ, O'Donnell PH, Lewis LD, Hertz DL. Association of SULT2A1 Locus With Abiraterone Clearance in the Alliance A031201: Randomized Phase III Study of Enzalutamide Compared With Enzalutamide Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer. Clin Transl Sci. 2025 Dec;18(12):e70425. doi: 10.1111/cts.70425.

    PubMed 41346252

  • Knutson TP, Luo B, Kobilka A, Lyman J, Guo S, Munro SA, Li Y, Heer R, Gaughan L, Morris MJ, Beltran H, Ryan CJ, Antonarakis ES, Armstrong AJ, Halabi S, Dehm SM. AR alterations inform circulating tumor DNA detection in metastatic castration resistant prostate cancer patients. Nat Commun. 2024 Dec 11;15(1):10648. doi: 10.1038/s41467-024-54847-1.

    PubMed 39663356

  • Morris MJ, Heller G, Hillman DW, Bobek O, Ryan C, Antonarakis ES, Bryce AH, Hahn O, Beltran H, Armstrong AJ, Schwartz L, Lewis LD, Beumer JH, Langevin B, McGary EC, Mehan PT, Goldkorn A, Roth BJ, Xiao H, Watt C, Taplin ME, Halabi S, Small EJ. Randomized Phase III Study of Enzalutamide Compared With Enzalutamide Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer (Alliance A031201 Trial). J Clin Oncol. 2023 Jun 20;41(18):3352-3362. doi: 10.1200/JCO.22.02394. Epub 2023 Mar 30.

    PubMed 36996380

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing enzalutamide, abiraterone and prednisone in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 539 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 539 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to 5 years post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01949337, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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