S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy
- Registration Number
- NCT01309672
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. It may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate works in treating patients with prostate cancer who have undergone initial hormone therapy.
- Detailed Description
OBJECTIVES:
Primary
* To assess the rate of achieving a prostate-specific antigen (PSA) of ≤ 0.2 ng/mL with abiraterone acetate therapy in men with metastatic prostate cancer with a sub-optimal response to androgen-deprivation therapy (ADT).
Secondary
* To assess the overall survival and objective progression-free survival of this group of patients.
* To assess PSA partial response.
* To evaluate the qualitative and quantitative toxicity of abiraterone acetate.
OUTLINE: This is a multicenter study.
Patients receive abiraterone acetate orally daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive androgen blockade with GNRH agonist (goserelin acetate or leuprolide acetate) or a GNRH antagonist (degarelix) per the treating physician and this will be given continuously until evidence of disease progression. Bilateral surgical orchiectomy is also acceptable.
After completion of study therapy, patients are followed up every 3 months for 1 year and then every 6 months for up to 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Abiraterone acetate + prednisone abiraterone acetate Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily Abiraterone acetate + prednisone Prednisone Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily
- Primary Outcome Measures
Name Time Method Number of Patients With Undetectable PSA 12 months undetectable PSA defined as \<= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.
- Secondary Outcome Measures
Name Time Method Number of Patients With Toxicity of Abiraterone Acetate Up to 3 years Only adverse events that are possibly, probably or definitely related to study drug are reported.
Objective Progression-free Survival 3 years Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease.
Number of Patients With PSA Partial Response 12 months PSA reduction to \< 4 ng/ml, but \>0.2 ng/ml
Overall Survival 3 years
Trial Locations
- Locations (205)
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Kaiser Permanente Medical Center - Richmond
🇺🇸Richmond, California, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Oakland, California, United States
Kaiser Permanente Medical Center - Roseville
🇺🇸Roseville, California, United States
Kaiser Permanente Medical Center - Santa Rosa
🇺🇸Santa Rosa, California, United States
Kaiser Permanente Medical Center - South San Francisco
🇺🇸South San Francisco, California, United States
Tahoe Forest Cancer Center
🇺🇸Truckee, California, United States
Kaiser Permanente Medical Center - Vacaville
🇺🇸Vacaville, California, United States
Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
Valley View Hospital Cancer Center
🇺🇸Glenwood Springs, Colorado, United States
Kaiser Permanente Medical Center - Santa Teresa
🇺🇸San Jose, California, United States
Kaiser Permanente Medical Center - Walnut Creek
🇺🇸Walnut Creek, California, United States
Mountain States Tumor Institute - Meridian
🇺🇸Meridian, Idaho, United States
Shaw Regional Cancer Center
🇺🇸Edwards, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Hematology Oncology Associates, PC
🇺🇸Albuquerque, New Mexico, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Southern Ohio Medical Center Cancer Center
🇺🇸Portsmouth, Ohio, United States
Midwest Hematology Oncology Group, Incorporated
🇺🇸Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Knox Community Hospital
🇺🇸Mount Vernon, Ohio, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Falck Cancer Center at Arnot Ogden Medical Center
🇺🇸Elmira, New York, United States
Valley Hospital - Ridgewood
🇺🇸Ridgewood, New Jersey, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
🇺🇸Middletown, New York, United States
UMC Southwest Cancer and Research Center
🇺🇸Lubbock, Texas, United States
New Mexico Cancer Care Associates
🇺🇸Santa Fe, New Mexico, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Good Samaritan Cancer Center
🇺🇸Puyallup, Washington, United States
Ben Taub General Hospital
🇺🇸Houston, Texas, United States
St. Francis Hospital
🇺🇸Federal Way, Washington, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
🇺🇸San Francisco, California, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
Kansas City Cancer Centers - Southwest
🇺🇸Overland Park, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Hays Medical Center
🇺🇸Hays, Kansas, United States
Mount Carmel Regional Cancer Center
🇺🇸Pittsburg, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
St. Francis Comprehensive Cancer Center
🇺🇸Topeka, Kansas, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Liberal
🇺🇸Liberal, Kansas, United States
St. Rose Ambulatory and Surgery Center
🇺🇸Great Bend, Kansas, United States
Hutchinson Hospital Corporation
🇺🇸Hutchinson, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Kansas City Cancer Centers - West
🇺🇸Kansas City, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
🇺🇸New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Kapiolani Medical Center at Pali Momi
🇺🇸'Aiea, Hawaii, United States
Castle Medical Center
🇺🇸Kailua, Hawaii, United States
Franciscan Cancer Center at St. Joseph Medical Center
🇺🇸Tacoma, Washington, United States
Kaiser Permanente - Fremont
🇺🇸Fremont, California, United States
Kaiser Permanente - Deer Valley
🇺🇸Antioch, California, United States
NEA Medical Clinic - East Matthews
🇺🇸Jonesboro, Arkansas, United States
Kaiser Permanente Medical Center - Hayward
🇺🇸Hayward, California, United States
Kaiser Permanente Fresno Medical Center
🇺🇸Fresno, California, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
🇺🇸Marysville, California, United States
Kaiser Permanente Medical Center - Redwood City
🇺🇸Redwood City, California, United States
Kaiser Foundation Hospital - San Rafael
🇺🇸San Rafael, California, United States
Kaiser Permanente Medical Facility - Stockton
🇺🇸Stockton, California, United States
San Luis Valley Regional Medical Center
🇺🇸Alamosa, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Montrose Memorial Hospital Cancer Center
🇺🇸Montrose, Colorado, United States
Oncare Hawaii, Incorporated - Pali Momi
🇺🇸'Aiea, Hawaii, United States
Kauai Medical Clinic
🇺🇸Lihue, Hawaii, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Fruitland
🇺🇸Fruitland, Idaho, United States
St. Joseph Regional Medical Center
🇺🇸Lewiston, Idaho, United States
Saint Luke's Mountain States Tumor Institute
🇺🇸Nampa, Idaho, United States
Mountain States Tumor Institute at St. Luke's
🇺🇸Twin Falls, Idaho, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Kansas City Cancer Center - Shawnee Mission
🇺🇸Shawnee Mission, Kansas, United States
Cotton-O'Neil Cancer Center
🇺🇸Topeka, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Hematology-Oncology Clinic
🇺🇸Baton Rouge, Louisiana, United States
Tulane Cancer Center Office of Clinical Research
🇺🇸Alexandria, Louisiana, United States
Highland Clinic
🇺🇸Shreveport, Louisiana, United States
Caritas Holy Family Hospital
🇺🇸Methuen, Massachusetts, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Bay Regional Medical Center
🇺🇸Bay City, Michigan, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
McLaren Cancer Institute
🇺🇸Flint, Michigan, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Singh and Arora Hematology Oncology, PC
🇺🇸Flint, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Great Lakes Cancer Institute - Lapeer Campus
🇺🇸Lapeer, Michigan, United States
Clemens Regional Medical Center
🇺🇸Mount Clemens, Michigan, United States
Mercy General Health Partners
🇺🇸Muskegon, Michigan, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Iredell Memorial Hospital
🇺🇸Statesville, North Carolina, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Providence Centralia Hospital
🇺🇸Centralia, Washington, United States
Allenmore Hospital
🇺🇸Tacoma, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
🇺🇸Santa Clara, California, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Highlands Oncology Group - Springdale
🇺🇸Rogers, Arkansas, United States
Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
🇺🇸Normal, Illinois, United States
Genesis Regional Cancer Center at Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Memorial Hospital Cancer Center - Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
🇺🇸Boise, Idaho, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
🇺🇸Shreveport, Louisiana, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Kansas City Cancer Centers - East
🇺🇸Lee's Summit, Missouri, United States
Cancer Center of Acadiana at Lafayette General Medical Center
🇺🇸Lafayette, Louisiana, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Spectrum Health Reed City Hospital
🇺🇸Reed City, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Providence St. Peter Hospital Regional Cancer Center
🇺🇸Olympia, Washington, United States
McLeod Regional Medical Center
🇺🇸Florence, South Carolina, United States
Veterans Affairs Medical Center - Houston
🇺🇸Houston, Texas, United States
Providence Regional Cancer Partnership
🇺🇸Everett, Washington, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
St. Clare Hospital
🇺🇸Tacoma, Washington, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento
🇺🇸Sacramento, California, United States
South Sacramento Kaiser-Permanente Medical Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸Aurora, Colorado, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
M.D. Anderson Cancer Center at Orlando
🇺🇸Orlando, Florida, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Queen's Cancer Institute at Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Kaiser Permanente - Moanalua Medical Center and Clinic
🇺🇸Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana
🇺🇸Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
🇺🇸Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini
🇺🇸Honolulu, Hawaii, United States
Kuakini Medical Center
🇺🇸Honolulu, Hawaii, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Truman Medical Center - Hospital Hill
🇺🇸Kansas City, Missouri, United States
Kansas City Cancer Centers - South
🇺🇸Kansas City, Missouri, United States
Kansas City Cancer Centers - North
🇺🇸Kansas City, Missouri, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Front Range Cancer Specialists
🇺🇸Fort Collins, Colorado, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States