Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel
Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma in the Soft Tissue
About this trial
This is an interventional treatment trial for Castration Levels of Testosterone
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
- Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer
- Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT/magnetic resonance imaging [MRI] of abdomen/pelvis, bone scintigraphy or NaF PET/CT)
- Ability to swallow abiraterone acetate tablets as a whole
- All patients must be receiving standard of care androgen deprivation treatment (surgical castration versus LHRH agonist or antagonist treatment); subjects receiving LHRH agonist or antagonist must continue treatment throughout the time on this study
- Patients must have castrate serum level of testosterone of < 50 ng/dL (< 1.73 nmol/L)
Patients must have progressive disease while receiving androgen deprivation therapy defined by any one of the following as per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for PSA, measurable disease or non-measurable (bone) disease during treatment with ADT:
- PSA: At least two consecutive rises in serum PSA, obtained at a minimum of 1-week intervals, with the final value >= 2.0 ng/mL
- Measurable disease (by RECIST 1.1): > 20% increase in the sum of the longest diameters of all measurable lesions or the development of new measurable lesions; the short axis of a target lymph node must be more that 15 mm to be assessed for change in size
- Non-measurable (bone) disease: The appearance of two or more new areas of uptake on bone scan (or NaF PET/CT) consistent with metastatic disease compared to previous imaging during castration therapy; the increased uptake of pre-existing lesions on bone scan will not be taken to constitute progression, and ambiguous results must be confirmed by other imaging modalities (e.g. X-ray, CT or MRI)
- Patients may or may not have been treated previously with a nonsteroidal antiandrogen, such as flutamide, bicalutamide or nilutamide; for patients previously treated with an antiandrogen, they must be off treatment for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to registration and must have shown PSA progression after discontinuing the anti-androgen
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Absolute neutrophil count (ANC) >= 1500/mm^3
- Hemoglobin (HgB) >= 9.0 gr/dL
- Platelets >= 100,000/mm^3
- Creatinine < 2.0 mg/dL
- Patients must be informed of the experimental nature of the study and its potential risks, and must sign an Institutional Review Board (IRB)-approved written informed consent form indicating such an understanding
- Patients with resected or irradiated brain metastases or those treated with stereotactic radiation therapy are eligible to enroll, provided that they do not require treatment with steroids that exceeds 10 mg of prednisone daily or equivalent
- Sexually active males must use an accepted and effective method of double barrier contraception or abstain from sexual intercourse for the duration of their participation in the study and for 26 weeks after the last dose of study drug
- NaF PET/CT OPTIONAL SUB-STUDY ELIGIBILITY CRITERIA
- Ability to lie still for imaging
- Weight =< 300 lbs (pounds)
Exclusion Criteria:
- Any prior chemotherapy or androgen receptor (AR)-directed therapy for CRPC, (e.g. docetaxel, cabazitaxel, mitoxantrone, abiraterone acetate, ketoconazole, or enzalutamide); previous treatment with radium-223 or sipuleucel-T is allowed
- Pure small cell or other variant (non-adenocarcinoma) prostate cancer histology for which treatment with abiraterone would not be considered appropriate
- Patients may not be receiving other therapeutic investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy; concurrent treatment with agents to prevent skeletal-related events (such as zoledronic acid or denosumab) will be allowed as long as it was initiated prior to study entry
- Any medical condition for which prednisone (corticosteroid) is contraindicated
If total bilirubin is > upper limit of normal (ULN) (NOTE: in subjects with Gilbert?s syndrome, if total bilirubin is
> ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
- Alanine (ALT) or aspartate (AST) aminotransferase > 1.5 x ULN
- Active infection requiring treatment with antibiotics
- History of adrenal insufficiency or hypoaldosteronism
- Myocardial infarction or arterial thrombotic event within 6 months, heart failure of New York Heart Association class II or higher, uncontrolled angina, severe uncontrolled ventricular arrhythmia
- External beam radiation therapy within 4 weeks of registration
- Prior history of allergic reactions to G-CSF
- Prior history of allergic reactions to docetaxel and/or to medications formulated with polysorbate 80
- History of active malignancy; patients with a history of cancer that has been adequately treated and are free of disease recurrence for 3 years or more are allowed to participate; patients with non-melanoma skin cancers or carcinoma in situ of the bladder that have been adequately excised are eligible to participate
- Life expectancy of < 12 months at screening
- Grade >= 2 neuropathy
Sites / Locations
- Fairbanks Memorial Hospital
- CTCA at Western Regional Medical Center
- Kingman Regional Medical Center
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- John L McClellan Memorial Veterans Hospital
- Kaiser Permanente-Deer Valley Medical Center
- PCR Oncology
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Alta Bates Summit Medical Center-Herrick Campus
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Eden Hospital Medical Center
- Adventist Health Cancer Care Center Chico
- Sutter Davis Hospital
- Epic Care-Dublin
- Kaiser Permanente Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Palo Alto Medical Foundation-Fremont
- Contra Costa Regional Medical Center
- Memorial Medical Center
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Palo Alto Medical Foundation Health Care
- VA Palo Alto Health Care System
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Kaiser Permanente Downtown Commons
- Sutter Medical Center Sacramento
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente-San Rafael
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa Rosa
- Sutter Pacific Medical Foundation
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Epic Care Cyberknife Center
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Cancer Center of Colorado at Sloan's Lake
- Denver Health Medical Center
- National Jewish Health-Main Campus
- The Women's Imaging Center
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western Surgical Care
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- Mountain Blue Cancer Care Center
- National Jewish Health-Western Hematology Oncology
- Saint Mary's Hospital and Regional Medical Center
- Grand Valley Oncology
- North Colorado Medical Center
- Good Samaritan Medical Center
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- National Jewish Health-Northern Hematology Oncology
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital-Derby Care Center
- Smilow Cancer Hospital Care Center-Fairfield
- Greenwich Hospital
- Smilow Cancer Hospital Care Center - Guiford
- Smilow Cancer Hospital Care Center at Saint Francis
- Middlesex Hospital
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale University
- Yale-New Haven Hospital North Haven Medical Center
- Smilow Cancer Hospital Care Center-Trumbull
- Smilow Cancer Hospital-Waterbury Care Center
- Smilow Cancer Hospital Care Center - Waterford
- Bayhealth Hospital Kent Campus
- Beebe Medical Center
- Bayhealth Hospital Sussex Campus
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Nanticoke Memorial Hospital
- Christiana Care Health System-Wilmington Hospital
- Sibley Memorial Hospital
- George Washington University Medical Center
- Grady Health System
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- John B Amos Cancer Center
- Atlanta VA Medical Center
- CTCA at Southeastern Regional Medical Center
- Hawaii Cancer Care - Savio
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc-POB II
- Island Urology
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Kuakini Medical Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Medical Center
- Walter Knox Memorial Hospital
- Idaho Urologic Institute-Meridian
- Saint Alphonsus Medical Center-Nampa
- Kootenai Cancer Center
- Kootenai Cancer Clinic
- Rush - Copley Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern University
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Northwestern Medicine Cancer Center Kishwaukee
- Illinois CancerCare-Dixon
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- NorthShore University HealthSystem-Glenbrook Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Joliet Oncology-Hematology Associates Limited
- Illinois CancerCare-Kewanee Clinic
- Northwestern Medicine Lake Forest Hospital
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Good Samaritan Regional Health Center
- Cancer Care Center of O'Fallon
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- North Shore Medical Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center Warrenville
- Rush-Copley Healthcare Center
- Deaconess Clinic Downtown
- Parkview Hospital Randallia
- Parkview Regional Medical Center
- Indiana University/Melvin and Bren Simon Cancer Center
- Richard L. Roudebush Veterans Affairs Medical Center
- Sidney and Lois Eskenazi Hospital
- Memorial Regional Cancer Center Day Road
- Chancellor Center for Oncology
- Reid Health
- Memorial Hospital of South Bend
- Mary Greeley Medical Center
- McFarland Clinic PC - Ames
- McFarland Clinic PC-Boone
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- McFarland Clinic PC-Trinity Cancer Center
- Trinity Regional Medical Center
- University of Iowa/Holden Comprehensive Cancer Center
- McFarland Clinic PC-Jefferson
- McFarland Clinic PC-Marshalltown
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Coffeyville Regional Medical Center
- University of Kansas Clinical Research Center
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- HaysMed University of Kansas Health System
- University of Kansas Cancer Center-West
- University of Kansas Cancer Center
- Lawrence Memorial Hospital
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Olathe Health Cancer Center
- Menorah Medical Center
- University of Kansas Cancer Center-Overland Park
- Ascension Via Christi - Pittsburg
- Salina Regional Health Center
- University of Kansas Health System Saint Francis Campus
- University of Kansas Hospital-Westwood Cancer Center
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Wichita
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- University of Kentucky/Markey Cancer Center
- Saint Joseph London
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- Jewish Hospital Medical Center Northeast
- Jewish Hospital Medical Center South
- East Jefferson General Hospital
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Veteran's Administration Medical Center - New Orleans
- Harold Alfond Center for Cancer Care
- Waldo County General Hospital
- MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
- Stephens Memorial Hospital
- Penobscot Bay Medical Center
- MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
- Maine Medical Partners - South Portland
- Anne Arundel Medical Center
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Walter Reed National Military Medical Center
- Simonds-Sinon Regional Cancer Center
- Baystate Medical Center
- UMass Memorial Medical Center - University Campus
- Hickman Cancer Center
- Bronson Battle Creek
- McLaren Cancer Institute-Bay City
- McLaren Cancer Institute-Bloomfield
- McLaren Cancer Institute-Clarkston
- Wayne State University/Karmanos Cancer Institute
- Weisberg Cancer Treatment Center
- McLaren Cancer Institute-Flint
- Singh and Arora Hematology Oncology PC
- Helen DeVos Children's Hospital at Spectrum Health
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- McLaren-Greater Lansing
- McLaren Cancer Institute-Lapeer Region
- Toledo Clinic Cancer Centers-Monroe
- McLaren Cancer Institute-Macomb
- Mercy Health Mercy Campus
- Lakeland Hospital Niles
- Cancer and Hematology Centers of Western Michigan - Norton Shores
- McLaren Cancer Institute-Northern Michigan
- Huron Medical Center PC
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Munson Medical Center
- Metro Health Hospital
- Riverwood Healthcare Center
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Cambridge Medical Center
- Mercy Hospital
- Essentia Health - Deer River Clinic
- Essentia Health Saint Mary's - Detroit Lakes Clinic
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Essentia Health - Fosston
- Unity Hospital
- Essentia Health Hibbing Clinic
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- Monticello Cancer Center
- New Ulm Medical Center
- Essentia Health - Park Rapids
- Fairview Northland Medical Center
- North Memorial Medical Health Center
- Coborn Cancer Center at Saint Cloud Hospital
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Essentia Health Sandstone
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Sanford Thief River Falls Medical Center
- Essentia Health Virginia Clinic
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Sanford Cancer Center Worthington
- Fairview Lakes Medical Center
- Baptist Cancer Center-Grenada
- University of Mississippi Medical Center
- Baptist Memorial Hospital and Cancer Center-Union County
- Baptist Memorial Hospital and Cancer Center-Oxford
- Baptist Memorial Hospital and Cancer Center-Desoto
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- University of Missouri - Ellis Fischel
- Siteman Cancer Center at West County Hospital
- Parkland Health Center - Farmington
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Truman Medical Centers
- The University of Kansas Cancer Center-South
- Research Medical Center
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Veteran's Affairs Medical Center - Saint Louis
- Mercy Hospital South
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Community Medical Hospital
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Alegent Health Immanuel Medical Center
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Midlands Community Hospital
- Carson Tahoe Regional Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven Hills
- 21st Century Oncology-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- Las Vegas Urology - Green Valley
- Las Vegas Urology - Pebble
- Urology Specialists of Nevada - Green Valley
- Las Vegas Urology - Pecos
- Desert West Surgery
- OptumCare Cancer Care at Oakey
- University Medical Center of Southern Nevada
- Hope Cancer Care of Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- Urology Specialists of Nevada - Central
- 21st Century Oncology
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- Sunrise Hospital and Medical Center
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Las Vegas Prostate Cancer Center
- Las Vegas Urology - Sunset
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- 21st Century Oncology-Vegas Tenaya
- Ann M Wierman MD LTD
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Las Vegas Urology - Cathedral Rock
- Las Vegas Urology - Smoke Ranch
- OptumCare Cancer Care at MountainView
- Urology Specialists of Nevada - Northwest
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
- Comprehensive Cancer Centers of Nevada - Town Center
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- 21st Century Oncology-Fort Apache
- Comprehensive Cancer Centers of Nevada
- OptumCare Cancer Care at Fort Apache
- Urology Specialists of Nevada - Southwest
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- University Cancer Center
- Hope Cancer Care of Nevada-Pahrump
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- AtlantiCare Health Park-Cape May Court House
- AtlantiCare Surgery Center
- Holy Name Hospital
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Southeastern Medical Oncology Center-Clinton
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- East Carolina University
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kenansville
- Vidant Oncology-Kinston
- Vidant Oncology-Richlands
- Marion L Shepard Cancer Center at Vidant Beaufort Hospital
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford South University Medical Center
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Essentia Health - Jamestown Clinic
- Cleveland Clinic Akron General
- UHHS-Chagrin Highlands Medical Center
- Indu and Raj Soin Medical Center
- Saint Elizabeth Boardman Hospital
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Geauga Hospital
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve University
- Ohio State University Comprehensive Cancer Center
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Mercy Cancer Center-Elyria
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Greater Dayton Cancer Center
- First Dayton Cancer Care
- Kettering Medical Center
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- University Hospitals Parma Medical Center
- Mercy Health Perrysburg Cancer Center
- UH Seidman Cancer Center at Firelands Regional Medical Center
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- ProMedica Flower Hospital
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Dayton Physicians LLC-Upper Valley
- Upper Valley Medical Center
- Saint Joseph Warren Hospital
- UHHS-Westlake Medical Center
- Saint Elizabeth Youngstown Hospital
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Cancer Treatment Centers of America
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Alphonsus Medical Center-Baker City
- Saint Alphonsus Medical Center-Ontario
- Abington Memorial Hospital
- UPMC-Heritage Valley Health System Beaver
- Christiana Care Health System-Concord Health Center
- Geisinger Medical Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Milton S Hershey Medical Center
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- UPMC Cancer Center at UPMC McKeesport
- UPMC-Coraopolis/Heritage Valley Radiation Oncology
- University of Pennsylvania/Abramson Cancer Center
- Temple University Hospital
- UPMC-Magee Womens Hospital
- UPMC-Presbyterian Hospital
- UPMC-Saint Margaret
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Shadyside Hospital
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- Geisinger Cancer Services-Pottsville
- Guthrie Medical Group PC-Robert Packer Hospital
- Community Medical Center
- Geisinger Medical Oncology-Selinsgrove
- UPMC Cancer Center at UPMC Northwest
- Geisinger Medical Group
- UPMC Uniontown Hospital Radiation Oncology
- UPMC Washington Hospital Radiation Oncology
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- UPMC Susquehanna
- Abington Memorial Hospital-Asplundh Cancer Pavilion
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- Wellmont Bristol Regional Medical Center
- Memorial Hospital
- Baptist Memorial Hospital and Cancer Center-Collierville
- Vanderbilt-Ingram Cancer Center Cool Springs
- Pulmonary Medicine Center of Chattanooga-Hixson
- Wellmont Medical Associates Oncology and Hematology-Johnson City
- Regional Cancer Center at Indian Path Community Hospital
- Wellmont Holston Valley Hospital and Medical Center
- Baptist Memorial Hospital and Cancer Center-Memphis
- Vanderbilt Breast Center at One Hundred Oaks
- Vanderbilt University/Ingram Cancer Center
- Memorial GYN Plus
- Saint Joseph Regional Cancer Center
- MD Anderson in The Woodlands
- Lyndon Baines Johnson General Hospital
- M D Anderson Cancer Center
- MD Anderson West Houston
- MD Anderson League City
- University of Texas Health Science Center at San Antonio
- MD Anderson in Sugar Land
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Farmington Health Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Riverton Hospital
- Dixie Medical Center Regional Cancer Center
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- South Jordan Health Center
- Wellmont Medical Associates-Bristol
- University of Virginia Cancer Center
- Sovah Health Martinsville
- Bon Secours Memorial Regional Medical Center
- Bon Secours Saint Francis Medical Center
- Bon Secours DePaul Medical Center
- Southwest VA Regional Cancer Center
- Bon Secours Maryview Medical Center
- Bon Secours Saint Mary's Hospital
- Bon Secours Cancer Institute at Reynolds Crossing
- Bon Secours Health Center at Harbour View
- MultiCare Auburn Medical Center
- Overlake Hospital Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Saint Elizabeth Hospital
- Saint Francis Hospital
- MultiCare Gig Harbor Medical Park
- Saint Clare Hospital
- Jefferson Healthcare
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Valley Medical Center
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- Franciscan Research Center-Northwest Medical Plaza
- Mary Bridge Children's Hospital and Health Center
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- West Virginia University Charleston Division
- Duluth Clinic Ashland
- Northwest Wisconsin Cancer Center
- Marshfield Clinic-Chippewa Center
- Marshfield Medical Center-EC Cancer Center
- Saint Vincent Hospital Cancer Center Green Bay
- Saint Vincent Hospital Cancer Center at Saint Mary's
- UW Cancer Center Johnson Creek
- Marshfield Clinic - Ladysmith Center
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Marshfield Medical Center-Marshfield
- Froedtert Menomonee Falls Hospital
- Medical College of Wisconsin
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Marshfield Medical Center-Rice Lake
- Marshfield Clinic Stevens Point Center
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Marshfield Clinic-Wausau Center
- Froedtert West Bend Hospital/Kraemer Cancer Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Cheyenne Regional Medical Center-West
- Billings Clinic-Cody
- Welch Cancer Center
- Cancer Center-Metro Medical Center Bayamon
- HIMA San Pablo Oncologic Hospital
- Doctors Cancer Center
- Instituto Oncologia Moderna Ponce
- San Juan Community Oncology Group
- Centro Comprensivo de Cancer de UPR
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A (abiraterone acetate, prednisone, cabazitaxel)
Arm B (abiraterone acetate, prednisone)
Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.
Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.