Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer
Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Prostate
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 - 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.
- 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).
- 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.
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.
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) .
- Soft tissue disease progression defined by the protocol
- 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 prior enzalutamide, abiraterone or other novel antiandrogen or androgen synthesis inhibitor
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
- 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 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 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)
- 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
- Total testosterone ≤ 50 ng/dL (1.7 nmol/L)
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Southern Cancer Center PC-Providence
- Katmai Oncology Group
- Providence Alaska Medical Center
- Mayo Clinic in Arizona
- University of Arizona Cancer Center-Orange Grove Campus
- University of Arizona Cancer Center-North Campus
- The University of Arizona Medical Center-University Campus
- Fowler Family Center for Cancer Care
- University of Arkansas for Medical Sciences
- Veteran's Administration Medical Center
- Kaiser Permanente-Anaheim
- Kaiser Permanente-Deer Valley Medical Center
- Kaiser Permanente-Baldwin Park
- Kaiser Permanente-Bellflower
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- City of Hope Comprehensive Cancer Center
- Kaiser Permanente Hospital
- Kaiser Permanente-Fremont
- University Oncology Associates
- California Cancer Center - North Fresno
- Kaiser Permanente
- Marin Cancer Care Inc
- Kaiser Permanente - Harbor City
- Kaiser Permanente-Irvine
- UC San Diego Moores Cancer Center
- Loma Linda University Medical Center
- Kaiser Permanente Los Angeles Medical Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Kaiser Permanente-Cadillac
- Fremont - Rideout Cancer Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- USC Norris Oncology/Hematology-Newport Beach
- Kaiser Permanente-Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Kaiser Permanente - Panorama City
- Feather River Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Riverside
- Kaiser Permanente-Roseville
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Saint Helena Hospital
- Kaiser Permanente-San Diego Zion
- Sharp Memorial Hospital
- Naval Medical Center -San Diego
- Veterans Administration-San Diego Medical Center
- Kaiser Permanente-San Francisco
- UCSF Medical Center-Mount Zion
- Veterans Affairs Medical Center - San Francisco
- UCSF Medical Center-Mission Bay
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Marcos
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente-South San Francisco
- Saint Joseph's Medical Center
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- Kaiser Permanente
- Rocky Mountain Cancer Centers-Boulder
- Memorial Hospital Colorado Springs
- Kaiser Permanente-Franklin
- Southwest Oncology PC
- The Shaw Regional Cancer Center
- Poudre Valley Hospital
- Rocky Mountain Cancer Centers-Lakewood
- Greenwich Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- Middlesex Hospital
- Norwalk Hospital
- Eastern Connecticut Hematology and Oncology Associates
- Stamford Hospital/Bennett Cancer Center
- Veterans Affairs Connecticut Healthcare System-West Haven Campus
- Medical Oncology Hematology Consultants PA
- MedStar Georgetown University Hospital
- Sibley Memorial Hospital
- Veterans Affairs Medical Center -Washington DC
- Baptist MD Anderson Cancer Center
- Lakeland Regional Cancer Center
- Mount Sinai Medical Center
- Florida Hospital Orlando
- UF Cancer Center at Orlando Health
- Sacred Heart Hospital
- Northside Hospital
- John B Amos Cancer Center
- Atlanta VA Medical Center
- Medical Center of Central Georgia
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- South Georgia Medical Center/Pearlman Cancer Center
- Hawaii Oncology Inc-Pali Momi
- Pali Momi Medical Center
- Hawaii Cancer Care Inc-POB II
- Hawaii Oncology Inc-POB I
- Island Urology
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Hawaii Oncology Inc-Kuakini
- Kuakini Medical Center
- Kaiser Permanente Moanalua Medical Center
- Tripler Army Medical Center
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Kootenai Cancer Center
- Rush - Copley Medical Center
- Illinois CancerCare-Bloomington
- Mount Sinai Hospital Medical Center
- Northwestern University
- Rush University Medical Center
- Weiss Memorial Hospital
- Advocate Illinois Masonic Medical Center
- Cancer Care Center of Decatur
- Decatur Memorial Hospital
- Crossroads Cancer Center
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- Northwestern Medicine Cancer Center Delnor
- NorthShore University HealthSystem-Glenbrook Hospital
- Ingalls Memorial Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Hines Veterans Administration Hospital
- Loyola University Medical Center
- Illinois CancerCare-Peoria
- Quincy Medical Group-Clinic
- West Suburban Medical Center
- OSF Saint Anthony Medical Center
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Memorial Medical Center
- Carle Cancer Center
- Northwestern Medicine Cancer Center Warrenville
- Fort Wayne Medical Oncology and Hematology Inc - Jefferson Boulevard
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Michiana Hematology Oncology PC-Mishawaka
- The Community Hospital
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-Westville
- McFarland Clinic PC-William R Bliss Cancer Center
- Hematology Oncology Associates-Quad Cities
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Genesis Medical Center - East Campus
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- University of Iowa/Holden Comprehensive Cancer Center
- Iowa City VA Healthcare System
- Mercy Medical Center - North Iowa
- Siouxland Regional Cancer Center
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Newman Regional Health
- Cancer Center of Kansas - Fort Scott
- Saint Catherine Hospital
- Saint Rose Ambulatory and Surgery Center
- Hays Medical Center
- Cancer Center of Kansas-Independence
- University of Kansas Cancer Center-West
- University of Kansas Cancer Center
- Cancer Center of Kansas-Kingman
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - Newton
- Olathe Medical Center
- Menorah Medical Center
- University of Kansas Cancer Center-Overland Park
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Via Christi Hospital-Pittsburg
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Saint Francis Hospital and Medical Center - Topeka
- Cancer Center of Kansas - Wellington
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Wichita
- Cancer Center of Kansas - Winfield
- Saint Joseph Hospital East
- Christus Saint Frances Cabrini Hospital
- Hematology/Oncology Clinic LLP
- Ochsner Health Center-Summa
- Ochsner Medical Center Kenner
- East Jefferson General Hospital
- Tulane University Health Sciences Center
- Ochsner Medical Center Jefferson
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Penobscot Bay Medical Center
- University of Maryland/Greenebaum Cancer Center
- Sinai Hospital of Baltimore
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Frederick Memorial Hospital
- Montgomery General Hospital-Olney
- William E Kahlert Regional Cancer Center/Sinai Hospital
- Tufts Medical Center
- Simonds-Sinon Regional Cancer Center
- Newton-Wellesley Hospital
- Baystate Medical Center
- University of Massachusetts Medical School
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Green Bay Oncology - Escanaba
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Green Bay Oncology - Iron Mountain
- West Michigan Cancer Center
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Spectrum Health Reed City Hospital
- Saint Mary's of Michigan
- Munson Medical Center
- Sanford Clinic North-Bemidgi
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Saint Luke's Hospital of Duluth
- Fairview-Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Mayo Clinic Health Systems-Mankato
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Minneapolis Veterans Medical Center
- Health Partners Inc
- Mayo Clinic
- Coborn Cancer Center at Saint Cloud Hospital
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Minnesota Oncology Hematology PA-Woodbury
- The West Clinic - Corinth
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- University of Missouri - Ellis Fischel
- Barnes-Jewish West County Hospital
- Capital Region Medical Center-Goldschmidt Cancer Center
- Truman Medical Center
- Saint Luke's Hospital of Kansas City
- Kansas City Veterans Affairs Medical Center
- The University of Kansas Cancer Center-South
- Research Medical Center
- The University of Kansas Cancer Center-North
- The University of Kansas Cancer Center-Lee's Summit
- Saint Luke's East - Lee's Summit
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Mercy Hospital Springfield
- Community Hospital of Anaconda
- Saint Vincent Healthcare
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Kalispell Regional Medical Center
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Nebraska Hematology and Oncology
- Southeast Nebraska Cancer Center
- Nebraska Methodist Hospital
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Comprehensive Cancer Centers of Nevada
- Comprehensive Cancer Centers of Nevada - Central Valley
- New Hampshire Oncology Hematology PA-Concord
- Wentworth-Douglass Hospital
- New Hampshire Oncology Hematology PA-Hooksett
- LRGHealthcare-Lakes Region General Hospital
- Dartmouth Hitchcock Medical Center
- Norris Cotton Cancer Center-Manchester
- Saint Joseph Hospital
- Norris Cotton Cancer Center-Nashua
- Portsmouth Regional Hospital
- Memorial Sloan Kettering Cancer Center at Basking Ridge
- Veterans Adminstration New Jersey Health Care System
- Hackensack University Medical Center
- Virtua Memorial
- The Valley Hospital-Luckow Pavilion
- Virtua Voorhees
- Valley Health System-Hematology/Oncology
- University of New Mexico Cancer Center
- Memorial Medical Center - Las Cruces
- Christus Saint Vincent Regional Cancer Center
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center - Moses Campus
- Bronx Veterans Administration Medical Center
- Kings County Hospital
- Maimonides Medical Center
- Veterans Affairs Western New York Health Care System-Buffalo
- Roswell Park Cancer Institute
- Memorial Sloan Kettering Cancer Center Commack
- Arnot Ogden Medical Center/Falck Cancer Center
- Memorial Sloan-Kettering Cancer Center West Harrison
- North Shore-LIJ Health System/Center for Advanced Medicine
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Columbia University/Herbert Irving Cancer Center
- Memorial Sloan-Kettering Cancer Center
- Weill Medical College of Cornell University
- University of Rochester
- Memorial Sloan Kettering Cancer Center Rockville Centre
- Memorial Sloan Kettering Cancer Center Sleepy Hollow
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Syracuse Veterans Administration Medical Center
- Randolph Hospital
- Cone Health Cancer Center at Alamance Regional
- UNC Lineberger Comprehensive Cancer Center
- Novant Health Presbyterian Medical Center
- Oncology Specialists of Charlotte
- Southern Oncology Specialists-Charlotte
- Durham Veterans Affairs Medical Center
- Duke University Medical Center
- Wayne Memorial Hospital
- Cone Health Cancer Center
- Lake Norman Hematology Oncology Specialists-Huntersville
- Southern Oncology Specialists-Huntersville
- Novant Health Oncology Specialists-Kernersville
- Kinston Medical Specialists PA
- Novant Health Cancer Specialists-Matthews
- Lake Norman Hematology Oncology Specialists-Mooresville
- Novant Health Oncology Specialists-Mount Airy
- Annie Penn Memorial Hospital
- Carolina Oncology Associates PA
- Veterans Administration Medical Center
- Novant Health Oncology Specialists-Statesville
- Novant Health Oncology Specialists-Davidson County
- Marion L Shepard Cancer Center at Vidant Beaufort Hospital
- Novant Health Oncology Specialists-Wilkesboro
- Novant Health Forsyth Medical Center
- Novant Health Oncology Specialists
- Winston-Salem Health Care
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Sanford Clinic North-Fargo
- Sanford Medical Center-Fargo
- Altru Cancer Center
- Trinity Cancer Care Center
- Summa Akron City Hospital/Cooper Cancer Center
- Summa Barberton Hospital
- UHHS-Chagrin Highlands Medical Center
- Mercy Medical Center
- Dayton Physicians LLC-Miami Valley South
- Geaugra Hospital
- University of Cincinnati/Barrett Cancer Center
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Samaritan North Health Center
- Hematology Oncology Center Incorporated
- Mercy Cancer Center-Elyria
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Cleveland Clinic Cancer Center Independence
- Greater Dayton Cancer Center
- Cleveland Clinic Cancer Center Mansfield
- Toledo Clinic Cancer Centers-Maumee
- Hillcrest Hospital Cancer Center
- Ireland Cancer Center Landerbrook Health Center
- Summa Health Center at Lake Medina
- Lake University Ireland Cancer Center
- Southwest General Health Center Ireland Cancer Center
- University Hospitals Parma Medical Center
- Southern Ohio Medical Center
- Ireland Cancer Center at Firelands Regional Medical Center
- North Coast Cancer Care
- Cleveland Clinic Cancer Center Strongsville
- University of Toledo
- Toledo Clinic Cancer Centers-Toledo
- University Hospitals Sharon Health Center
- South Pointe Hospital
- University Pointe
- Saint Ann's Hospital
- UH-Seidman Cancer Center at Saint John Medical Center
- UHHS-Westlake Medical Center
- Cleveland Clinic Wooster Family Health and Surgery Center
- Wright-Patterson Medical Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Good Samaritan Hospital
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente Northwest
- Abington Memorial Hospital
- Lehigh Valley Hospital-Cedar Crest
- Lehigh Valley Hospital - Muhlenberg
- Geisinger Medical Center
- Adams Cancer Center
- Saint Mary Medical and Regional Cancer Center
- Allegheny Valley Hospital
- Allegheny General Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- WellSpan Health-York Hospital
- Roger Williams Medical Center
- Roper Hospital
- Charleston Hematology Oncology Associates-Roper
- Lowcountry Hematology Oncology PA-North Charleston
- Bon Secours Saint Francis Hospital
- Charleston Hematology Oncology Associates PA-St. Francis
- Lowcountry Hematology Oncology PA-West Ashley
- Greenville Health System Cancer Institute-Easley
- Saint Francis Hospital
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Saint Francis Cancer Center
- Greenville Health System Cancer Institute-Eastside
- Greenville Health System Cancer Institute-Greer
- Carolina Blood and Cancer Care Associates PA-Lancaster
- Lowcountry Hematology Oncology PA-Mount Pleasant
- Greenville Health System Cancer Institute-Seneca
- Greenville Health System Cancer Institute-Spartanburg
- Avera Cancer Institute-Aberdeen
- Rapid City Regional Hospital
- Sanford Cancer Center-Oncology Clinic
- Avera Cancer Institute
- The West Clinic - Wolf River
- University of Tennessee Health Science Center
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- UT Southwestern/Simmons Cancer Center-Fort Worth
- University of Texas Medical Branch
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Ben Taub General Hospital
- UTMB Cancer Center at Victory Lakes
- University of Texas Health Science Center at San Antonio
- University of Vermont College of Medicine
- White River Junction Veteran Administration Medical Center
- University of Virginia Cancer Center
- Virginia Oncology Associates-Hampton
- Lynchburg Hematology-Oncology Clinic
- Memorial Hospital Of Martinsville
- Bon Secours Memorial Regional Medical Center
- Bon Secours Saint Francis Medical Center
- Virginia Cancer Institute
- Virginia Commonwealth University/Massey Cancer Center
- Shenandoah Oncology Associates PC
- PeaceHealth Saint Joseph Medical Center
- Providence Regional Cancer Partnership
- Swedish Cancer Institute-Issaquah
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Minor and James Medical PLLC
- Swedish Medical Center-First Hill
- West Virginia University Charleston
- Saint Mary's Medical Center
- Langlade Hospital and Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- Marshfield Clinic Cancer Center at Sacred Heart
- Mayo Clinic Health System-Eau Claire Clinic
- Sacred Heart Hospital
- Saint Agnes Hospital/Agnesian Cancer Center
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Mercy Health System
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- William S Middleton VA Medical Center
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Vince Lombardi Cancer Clinic-Marinette
- Marshfield Clinic
- Saint Joseph's Hospital
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Froedtert and the Medical College of Wisconsin
- Aurora Sinai Medical Center
- Zablocki Veterans Administration Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- ProHealth Oconomowoc Memorial Hospital
- Green Bay Oncology - Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Wheaton Franciscan Cancer Care - All Saints
- Aurora Cancer Care-Racine
- Marshfield Clinic-Rice Lake Center
- HSHS Saint Nicholas Hospital
- Vince Lombardi Cancer Clinic-Sheboygan
- Marshfield Clinic Cancer Care at Saint Michael's Hospital
- Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Waukesha
- ProHealth Waukesha Memorial Hospital
- Aspirus Regional Cancer Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Diagnostic and Treatment Center
- Marshfield Clinic - Weston Center
- Aspirus UW Cancer Center
- Cross Cancer Institute
- BCCA-Vancouver Cancer Centre
- The Moncton Hospital
- The Vitalite Health Network - Dr Leon Richard Oncology Centre
- Atlantic Health Sciences Corporation-Saint John Regional Hospital
- Doctor H. Bliss Murphy Cancer Centre
- Cambridge Memorial Hospital
- Grand River Regional Cancer Centre at Grand River Hospital
- Allan Blair Cancer Centre
- San Juan Veterans Affairs Medical Center
- Fundacion De Investigacion de Diego
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm A: (enzalutamide)
Arm B: (enzalutamide, abiraterone, prednisone)
Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
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.