Last updated on May 2020

Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Docetaxel


Brief description of study

This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with castration-resistant prostate cancer previously treated with docetaxel that has spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using abiraterone acetate and antiandrogen therapy may fight prostate cancer by lowering and/or blocking the use of androgens by the tumor cells. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving abiraterone acetate and antiandrogen therapy with or without cabazitaxel and prednisone may help kill more tumor cells.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with castration-resistant prostate cancer (CRPC) that have previously received docetaxel and androgen deprivation therapy (ADT) for hormone-sensitive prostate cancer (HSPC) can improve progression-free survival (PFS) compared to abiraterone acetate alone.

SECONDARY OBJECTIVES:

I. To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can increase the percentage of change in prostate-specific antigen (PSA) from baseline to week 12 of treatment as well as the maximum decline in PSA that occurs at any point after treatment compared to abiraterone acetate alone.

II. To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel for HSPC can prolong time to PSA progression compared to abiraterone acetate alone.

III. To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel for HSPC can improve radiographic response (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) compared to abiraterone acetate alone.

IV. To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can prolong the overall survival (OS) compared to abiraterone acetate alone.

V. To assess safety and tolerability of the combination of 6 cycles of cabazitaxel and abiraterone acetate.

TERTIARY OBJECTIVES:

I. To examine whether patients with circulating tumor cells (CTCs) positive for AR-V7 at baseline have a longer radiographic or clinical PFS to the combination of cabazitaxel and abiraterone acetate vs. abiraterone acetate alone.

II. To examine whether the addition of cabazitaxel to abiraterone acetate can change the AR-V7 status of patients who are positive at study entry.

III. To examine whether the addition of cabazitaxel to abiraterone acetate has any impact on future development of AR-V7 positivity at the time of disease progression.

IV. To assess if the changes in total tumor burden from baseline to week 12 as assessed with sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT) will differ between two arms.

V. To correlate total tumor burden at the baseline as assessed with NaF PET/CT with the PFS.

VI. To correlate heterogeneity of response from baseline to week 12 as assessed with NaF PET/CT with the PFS.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive abiraterone acetate orally (PO) once daily (QD) on days 1-21, prednisone PO twice daily (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 intravenously (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 luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, or surgical castration with bilateral orchiectomy.

ARM B: 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.

After completion of study treatment, patients are followed up every 3 or 6 months and then annually for up to 5 years.

Clinical Study Identifier: NCT03419234

Find a site near you

Start Over

Kootenai Cancer Center

Post Falls, ID United States
  Connect »

Boulder Community Hospital

Boulder, CO United States
  Connect »

Heartland Regional Medical Center

Saint Joseph, MO United States
  Connect »

Freeman Health System

Joplin, MO United States
  Connect »

ECOG-ACRIN Cancer Research Group

Philadelphia, PA United States
  Connect »

SIH Cancer Institute

Carterville, IL United States
  Connect »

Feather River Cancer Center

Paradise, CA United States
  Connect »

Carle Cancer Center

Urbana, IL United States
  Connect »

Saint Francis Medical Center

Cape Girardeau, MO United States
  Connect »

Mills-Peninsula Medical Center

Burlingame, CA United States
  Connect »

Mercy Hospital Joplin

Joplin, MO United States
  Connect »

Mercy Hospital

Coon Rapids, MN United States
  Connect »

PCR Oncology

Arroyo Grande, CA United States
  Connect »

Sibley Memorial Hospital

Washington, WA United States
  Connect »

Middlesex Hospital

Middletown, CT United States
  Connect »

Decatur Memorial Hospital

Decatur, IL United States
  Connect »

Farmington Health Center

Farmington, UT United States
  Connect »

Island Urology

Honolulu, HI United States
  Connect »

Illinois CancerCare-Bloomington

Bloomington, IL United States
  Connect »

Fairbanks Memorial Hospital

Fairbanks, AK United States
  Connect »

Eden Hospital Medical Center

Castro Valley, CA United States
  Connect »

Sutter Davis Hospital

Davis, CA United States
  Connect »

Memorial Medical Center

Modesto, CA United States
  Connect »

Bay Area Tumor Institute

Oakland, CA United States
  Connect »

Kaiser Permanente-Redwood City

Redwood City, CA United States
  Connect »

Kaiser Permanente-Richmond

Richmond, CA United States
  Connect »

Kaiser Permanente-Roseville

Roseville, CA United States
  Connect »

Kaiser Permanente - Sacramento

Sacramento, CA United States
  Connect »

Kaiser Permanente-San Francisco

San Francisco, CA United States
  Connect »

Kaiser Permanente-San Rafael

San Rafael, CA United States
  Connect »

Kaiser San Rafael-Gallinas

San Rafael, CA United States
  Connect »

Kaiser Permanente-Santa Rosa

Santa Rosa, CA United States
  Connect »

Kaiser Permanente-South San Francisco

South San Francisco, CA United States
  Connect »

Kaiser Permanente-Stockton

Stockton, CA United States
  Connect »

Kaiser Permanente-Vallejo

Vallejo, CA United States
  Connect »

Kaiser Permanente-Walnut Creek

Walnut Creek, CA United States
  Connect »

Epic Care Cyberknife Center

Walnut Creek, CA United States
  Connect »

Penrose-Saint Francis Healthcare

Colorado Springs, CO United States
  Connect »

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, CO United States
  Connect »

Porter Adventist Hospital

Denver, CO United States
  Connect »

Rose Medical Center

Denver, CO United States
  Connect »

Mercy Medical Center

Durango, CO United States
  Connect »

Southwest Oncology PC

Durango, CO United States
  Connect »

Swedish Medical Center

Englewood, CO United States
  Connect »

Saint Anthony Hospital

Lakewood, CO United States
  Connect »

Littleton Adventist Hospital

Littleton, CO United States
  Connect »

Sky Ridge Medical Center

Lone Tree, CO United States
  Connect »

Longmont United Hospital

Longmont, CO United States
  Connect »

McKee Medical Center

Loveland, CO United States
  Connect »

Parker Adventist Hospital

Parker, CO United States
  Connect »

Yale University

New Haven, CT United States
  Connect »

Beebe Medical Center

Lewes, DE United States
  Connect »

Beebe Health Campus

Rehoboth Beach, DE United States
  Connect »

Nanticoke Memorial Hospital

Seaford, DE United States
  Connect »

John B Amos Cancer Center

Columbus, GA United States
  Connect »

Kootenai Medical Center

Coeur d'Alene, ID United States
  Connect »

Kootenai Cancer Clinic

Sandpoint, ID United States
  Connect »

Memorial Hospital of Carbondale

Carbondale, IL United States
  Connect »

Illinois CancerCare-Carthage

Carthage, IL United States
  Connect »

Centralia Oncology Clinic

Centralia, IL United States
  Connect »

Northwestern University

Chicago, IL United States
  Connect »

Carle on Vermilion

Danville, IL United States
  Connect »

Crossroads Cancer Center

Effingham, IL United States
  Connect »

Illinois CancerCare-Galesburg

Galesburg, IL United States
  Connect »

Illinois CancerCare-Princeton

Princeton, IL United States
  Connect »

Rush-Copley Healthcare Center

Yorkville, IL United States
  Connect »

Deaconess Clinic Downtown

Evansville, IN United States
  Connect »

Sidney and Lois Eskenazi Hospital

Indianapolis, IN United States
  Connect »

Reid Health

Richmond, IN United States
  Connect »

Alegent Health Mercy Hospital

Council Bluffs, IA United States
  Connect »

Mercy Medical Center-West Lakes

West Des Moines, IA United States
  Connect »

Lawrence Memorial Hospital

Lawrence, KS United States
  Connect »

Flaget Memorial Hospital

Bardstown, KY United States
  Connect »

Saint Joseph Hospital East

Lexington, KY United States
  Connect »

Saint Joseph London

London, KY United States
  Connect »

Jewish Hospital

Louisville, KY United States
  Connect »

Jewish Hospital Medical Center South

Shepherdsville, KY United States
  Connect »

Penobscot Bay Medical Center

Rockport, ME United States
  Connect »

Anne Arundel Medical Center

Annapolis, MD United States
  Connect »

Baystate Medical Center

Springfield, MA United States
  Connect »

Bronson Battle Creek

Battle Creek, MI United States
  Connect »

Weisberg Cancer Treatment Center

Farmington Hills, MI United States
  Connect »

Mercy Health Saint Mary's

Grand Rapids, MI United States
  Connect »

Bronson Methodist Hospital

Kalamazoo, MI United States
  Connect »

West Michigan Cancer Center

Kalamazoo, MI United States
  Connect »

Borgess Medical Center

Kalamazoo, MI United States
  Connect »

McLaren-Greater Lansing

Lansing, MI United States
  Connect »

McLaren Cancer Institute-Macomb

Mount Clemens, MI United States
  Connect »

Mercy Health Mercy Campus

Muskegon, MI United States
  Connect »

Marie Yeager Cancer Center

Saint Joseph, MI United States
  Connect »

Munson Medical Center

Traverse City, MI United States
  Connect »

Metro Health Hospital

Wyoming, MI United States
  Connect »

Fairview Ridges Hospital

Burnsville, MN United States
  Connect »

Cambridge Medical Center

Cambridge, MN United States
  Connect »

Miller-Dwan Hospital

Duluth, MN United States
  Connect »

Essentia Health - Fosston

Fosston, MN United States
  Connect »

Unity Hospital

Fridley, MN United States
  Connect »

Abbott-Northwestern Hospital

Minneapolis, MN United States
  Connect »

Hennepin County Medical Center

Minneapolis, MN United States
  Connect »

Health Partners Inc

Minneapolis, MN United States
  Connect »

Monticello Cancer Center

Monticello, MN United States
  Connect »

New Ulm Medical Center

New Ulm, MN United States
  Connect »

Essentia Health - Park Rapids

Park Rapids, MN United States
  Connect »

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, MN United States
  Connect »

Regions Hospital

Saint Paul, MN United States
  Connect »

United Hospital

Saint Paul, MN United States
  Connect »

Essentia Health Sandstone

Sandstone, MN United States
  Connect »

Lakeview Hospital

Stillwater, MN United States
  Connect »

Ridgeview Medical Center

Waconia, MN United States
  Connect »

Rice Memorial Hospital

Willmar, MN United States
  Connect »

Capital Region Southwest Campus

Jefferson City, MO United States
  Connect »

Mercy Hospital South

Saint Louis, MO United States
  Connect »

Saint Vincent Healthcare

Billings, MT United States
  Connect »

Bozeman Deaconess Hospital

Bozeman, MT United States
  Connect »

Great Falls Clinic

Great Falls, MT United States
  Connect »

Community Medical Hospital

Missoula, MT United States
  Connect »

CHI Health Saint Francis

Grand Island, NE United States
  Connect »

CHI Health Good Samaritan

Kearney, NE United States
  Connect »

Midlands Community Hospital

Papillion, NE United States
  Connect »

Las Vegas Urology - Pebble

Henderson, NV United States
  Connect »

Las Vegas Urology - Pecos

Las Vegas, NV United States
  Connect »

Desert West Surgery

Las Vegas, NV United States
  Connect »

OptumCare Cancer Care at Oakey

Las Vegas, NV United States
  Connect »

Hope Cancer Care of Nevada

Las Vegas, NV United States
  Connect »

21st Century Oncology

Las Vegas, NV United States
  Connect »

Las Vegas Urology - Sunset

Las Vegas, NV United States
  Connect »

Ann M Wierman MD LTD

Las Vegas, NV United States
  Connect »

University Cancer Center

Las Vegas, NV United States
  Connect »

East Carolina University

Greenville, NC United States
  Connect »

Vidant Oncology-Kenansville

Kenansville, NC United States
  Connect »

Vidant Oncology-Kinston

Kinston, NC United States
  Connect »

Vidant Oncology-Richlands

Richlands, NC United States
  Connect »

Indu and Raj Soin Medical Center

Beavercreek, OH United States
  Connect »

Miami Valley Hospital South

Centerville, OH United States
  Connect »

Geauga Hospital

Chardon, OH United States
  Connect »

Bethesda North Hospital

Cincinnati, OH United States
  Connect »

Miami Valley Hospital

Dayton, OH United States
  Connect »

Armes Family Cancer Center

Findlay, OH United States
  Connect »

Blanchard Valley Hospital

Findlay, OH United States
  Connect »

Orion Cancer Care

Findlay, OH United States
  Connect »

Dayton Physicians LLC-Atrium

Franklin, OH United States
  Connect »

Dayton Physicians LLC-Wayne

Greenville, OH United States
  Connect »

Wayne Hospital

Greenville, OH United States
  Connect »

Greater Dayton Cancer Center

Kettering, OH United States
  Connect »

First Dayton Cancer Care

Kettering, OH United States
  Connect »

Kettering Medical Center

Kettering, OH United States
  Connect »

UHHS-Westlake Medical Center

Westlake, OH United States
  Connect »

Geisinger Medical Center

Danville, PA United States
  Connect »

Lewistown Hospital

Lewistown, PA United States
  Connect »

Community Medical Center

Scranton, PA United States
  Connect »

Geisinger Medical Group

State College, PA United States
  Connect »

M D Anderson Cancer Center

Houston, TX United States
  Connect »

MD Anderson West Houston

Houston, TX United States
  Connect »

MD Anderson League City

League City, TX United States
  Connect »

MD Anderson in Sugar Land

Sugar Land, TX United States
  Connect »

South Jordan Health Center

South Jordan, UT United States
  Connect »

University of Virginia Cancer Center

Charlottesville, VA United States
  Connect »

Harrison Medical Center

Bremerton, WA United States
  Connect »

Saint Elizabeth Hospital

Enumclaw, WA United States
  Connect »

Saint Francis Hospital

Federal Way, WA United States
  Connect »

Saint Clare Hospital

Lakewood, WA United States
  Connect »

Valley Medical Center

Renton, WA United States
  Connect »

Duluth Clinic Ashland

Ashland, WI United States
  Connect »

Marshfield Clinic-Chippewa Center

Chippewa Falls, WI United States
  Connect »

UW Cancer Center Johnson Creek

Johnson Creek, WI United States
  Connect »

Cancer Center of Western Wisconsin

New Richmond, WI United States
  Connect »

Billings Clinic-Cody

Cody, WY United States
  Connect »

Welch Cancer Center

Sheridan, WY United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.