S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy

Prostate Cancer Clinical Trial

Official title:

Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01309672
• Other study ID #: CDR0000696565
• Secondary ID: S1014U10CA032102
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 9, 2011
• Est. completion date: October 2024

Study information

• Verified date: December 2023
• Source: SWOG Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: October 2024
• Est. primary completion date: November 29, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate

• Metastatic (M1) disease as evidenced by soft tissue and/or bony metastases at the time of initiation of androgen-deprivation therapy (ADT)

• Must have at least one of the following:

• Visceral disease (liver, lung, other viscera)

• Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton

• Distant lymph node disease (e.g., above the aortic bifurcation, etc.)

• No small cell or neuroendocrine prostate cancer

• Patients must be receiving ADT (e.g., gonadotropin-releasing hormone [GNRH] antagonist, with or without antiandrogen) prior to entering this study

• Degarelix, a FDA-approved GNRH antagonist, is an acceptable form of ADT

• Bilateral surgical orchiectomy is also acceptable

• Suboptimal response to ADT induction as defined by the following criteria:

• Declining PSA (current PSA is less than the PSA prior to starting ADT) that fails to reach 4 ng/mL or below despite continuous ADT

• PSA of > 4 ng/mL must be observed between 6-12 months after the initiation of ADT

• Documentation of failure to achieve this PSA of = 4 ng/mL must be within 28 days of registration

• The PSA must be obtained after any applicable antiandrogen washout period

• If the PSA is declining or stable (defined as a PSA rise = 0.1 ng/mL from nadir) and the patient is on an antiandrogen, they must remain on the antiandrogen

• Patients with stable or declining PSA who have had previous antiandrogen exposure, but are not taking an antiandrogen at the time of registration, must wait at least 6 weeks from the last antiandrogen dose before registration and still demonstrate a stable or falling PSA which is > 4 ng/mL by month 12, in order to be eligible

• If the PSA is rising and they are on an antiandrogen, formal antiandrogen washout must be performed (4 weeks for flutamide and 6 weeks for bicalutamide and nilutamide with no evidence of a falling PSA after washout)

• No patients with radiographic progression when compared to available imaging studies performed prior to starting the GNRH agonist/antagonist therapy

• Patients who have measurable disease must have radiographic assessment (at least an abdominal/pelvic CT scan) within 28 days prior to registration

• Non-measurable disease must be assessed (i.e., bone scan) within 42 days prior to registration

• No patients with a history of brain metastases or who currently have treated or untreated brain metastases

• Patients with clinical evidence of brain metastases must have a brain CT scan or MRI negative for metastatic disease within 56 days prior to registration

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-2

• ANC = 1,500/µL

• Platelet count = 100,000/µL

• Hemoglobin = 10 g/dL

• Serum creatinine = 1.5 times the upper limit of normal (ULN) OR creatinine clearance = 60 mL/min

• Bilirubin = 1.5 times ULN (unless documented Gilbert disease)

• AST and ALT < 1.5 times ULN

• Potassium = 3.5 mmol/L

• Patient must have a testosterone value of < 50 ng/dL obtained within 28 days prior to registration

• Patients must have controlled blood pressure defined as systolic blood pressure < 160 mm Hg and diastolic blood pressure < 95 mm Hg

• Patients with a history of hypertension are eligible provided blood pressure is controlled by anti-hypertensive treatment

• Patients who have partners of child-bearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for 1 week after the last study drug administration

• Must be able to take oral medication without crushing, dissolving, or chewing tablets

• Patients must not have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of abiraterone acetate

• No other prior malignancy is allowed except for any of the following:

• Adequately treated basal cell or squamous cell skin cancer

• Adequately treated stage I or II cancer from which the patient is currently in complete remission

• Any other cancer from which the patient has been disease-free for 5 years

• No patients with active or symptomatic viral hepatitis or chronic liver disease

• No moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment

• No history of NYHA class III or IV heart failure

• Patients must have LVEF = 50%

• No known allergies, hypersensitivity, or intolerance to abiraterone acetate, prednisone, or their excipients

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Patients with a history of prior neoadjuvant or adjuvant GNRH agonist/antagonist therapy (related to previous surgery or radiation) are eligible provided they finished this therapy at least two years prior to registration

• Prior enrollment to SWOG-S0925 (either arm) is not exclusionary

• At least 6 weeks since prior and no concurrent finasteride or dutasteride

• At least 28 days since prior radiotherapy or surgery and recovered

• At least 4 weeks since prior investigational products

• At least 4 weeks since prior flutamide (6 weeks for bicalutamide and nilutamide) with no evidence of a falling PSA

• No other concurrent oral antiandrogen

• No prior or concurrent cytotoxic chemotherapy or radiopharmaceuticals for prostate cancer

• No prior or concurrent ketoconazole for the treatment of prostate cancer

• Not requiring more than 10 mg a day of prednisone for another medical indication

• Not planning to receive any concurrent cytotoxic chemotherapy, immunotherapy, surgery, or radiotherapy during protocol treatment

• No concurrent hormonal-acting agents, including diethylstilbestrol/DES, aldosterone, PC-SPES, or spironolactone

• No concurrent antifungal medication (e.g., fluconazole or itraconazole)

• No medications that alter cardiac conduction

• No prior Provenge (sipuleucel-T)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• abiraterone acetate
1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily
• Prednisone
5 mg, oral, 5 mg twice daily

Locations

Country	Name	City	State
United States	Kapiolani Medical Center at Pali Momi	'Aiea	Hawaii
United States	Oncare Hawaii, Incorporated - Pali Momi	'Aiea	Hawaii
United States	San Luis Valley Regional Medical Center	Alamosa	Colorado
United States	Hematology Oncology Associates, PC	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Tulane Cancer Center Office of Clinical Research	Alexandria	Louisiana
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Kaiser Permanente - Deer Valley	Antioch	California
United States	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado
United States	Hematology-Oncology Clinic	Baton Rouge	Louisiana
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	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho
United States	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	Saint Francis Medical Center	Cape Girardeau	Missouri
United States	Rocky Mountain Oncology	Casper	Wyoming
United States	Providence Centralia Hospital	Centralia	Washington
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Memorial Hospital Cancer Center - Colorado Springs	Colorado Springs	Colorado
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Medical Center Cancer Care	Columbus	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	Shaw Regional Cancer Center	Edwards	Colorado
United States	Falck Cancer Center at Arnot Ogden Medical Center	Elmira	New York
United States	Providence Regional Cancer Partnership	Everett	Washington
United States	St. Francis Hospital	Federal Way	Washington
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	McLaren Cancer Institute	Flint	Michigan
United States	Singh and Arora Hematology Oncology, PC	Flint	Michigan
United States	McLeod Regional Medical Center	Florence	South Carolina
United States	Front Range Cancer Specialists	Fort Collins	Colorado
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas
United States	Kaiser Permanente - Fremont	Fremont	California
United States	Kaiser Permanente Fresno Medical Center	Fresno	California
United States	Saint Luke's Mountain States Tumor Institute - Fruitland	Fruitland	Idaho
United States	Valley View Hospital Cancer Center	Glenwood Springs	Colorado
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	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	St. Rose Ambulatory and Surgery Center	Great Bend	Kansas
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut
United States	Hays Medical Center	Hays	Kansas
United States	Kaiser Permanente Medical Center - Hayward	Hayward	California
United States	St. Peter's Hospital	Helena	Montana
United States	Cancer Research Center of Hawaii	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	Kuakini Medical Center	Honolulu	Hawaii
United States	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii
United States	OnCare Hawaii, Incorporated - Lusitana	Honolulu	Hawaii
United States	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	Baylor University Medical Center - Houston	Houston	Texas
United States	Ben Taub General Hospital	Houston	Texas
United States	St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital	Houston	Texas
United States	Veterans Affairs Medical Center - Houston	Houston	Texas
United States	Hutchinson Hospital Corporation	Hutchinson	Kansas
United States	Cancer Center of Kansas-Independence	Independence	Kansas
United States	Foote Memorial Hospital	Jackson	Michigan
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	NEA Medical Clinic - East Matthews	Jonesboro	Arkansas
United States	Castle Medical Center	Kailua	Hawaii
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Kansas City Cancer Centers - North	Kansas City	Missouri
United States	Kansas City Cancer Centers - South	Kansas City	Missouri
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	Truman Medical Center - Hospital Hill	Kansas City	Missouri
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Cancer Center of Acadiana at Lafayette General Medical Center	Lafayette	Louisiana
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Great Lakes Cancer Institute - Lapeer Campus	Lapeer	Michigan
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	Kansas City Cancer Centers - East	Lee's Summit	Missouri
United States	St. Joseph Regional Medical Center	Lewiston	Idaho
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas
United States	Kauai Medical Clinic	Lihue	Hawaii
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	St. Mary Mercy Hospital	Livonia	Michigan
United States	UMC Southwest Cancer and Research Center	Lubbock	Texas
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Tibotec Therapeutics - Division of Ortho Biotech Products, LP	Marysville	California
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Mountain States Tumor Institute - Meridian	Meridian	Idaho
United States	Caritas Holy Family Hospital	Methuen	Massachusetts
United States	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York
United States	Winthrop University Hospital	Mineola	New York
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Montrose Memorial Hospital Cancer Center	Montrose	Colorado
United States	Clemens Regional Medical Center	Mount Clemens	Michigan
United States	Good Samaritan Regional Health Center	Mount Vernon	Illinois
United States	Knox Community Hospital	Mount Vernon	Ohio
United States	Mercy General Health Partners	Muskegon	Michigan
United States	Saint Luke's Mountain States Tumor Institute	Nampa	Idaho
United States	St. Luke's - Roosevelt Hospital Center - St.Luke's Division	New York	New York
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Mid-Illinois Hematology-Oncology Associates at Community Cancer Center	Normal	Illinois
United States	Kaiser Permanente Medical Center - Oakland	Oakland	California
United States	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington
United States	M.D. Anderson Cancer Center at Orlando	Orlando	Florida
United States	Kansas City Cancer Centers - Southwest	Overland Park	Kansas
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Mount Carmel Regional Cancer Center	Pittsburg	Kansas
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan
United States	Southern Ohio Medical Center Cancer Center	Portsmouth	Ohio
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Good Samaritan Cancer Center	Puyallup	Washington
United States	Kaiser Permanente Medical Center - Redwood City	Redwood City	California
United States	Spectrum Health Reed City Hospital	Reed City	Michigan
United States	Kaiser Permanente Medical Center - Richmond	Richmond	California
United States	Valley Hospital - Ridgewood	Ridgewood	New Jersey
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Highlands Oncology Group - Springdale	Rogers	Arkansas
United States	Kaiser Permanente Medical Center - Roseville	Roseville	California
United States	Kaiser Permanente Medical Center - Sacramento	Sacramento	California
United States	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California
United States	University of California Davis Cancer Center	Sacramento	California
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri
United States	Midwest Hematology Oncology Group, Incorporated	Saint Louis	Missouri
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California
United States	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California
United States	Kaiser Foundation Hospital - San Rafael	San Rafael	California
United States	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California
United States	Kansas City Cancer Center - Shawnee Mission	Shawnee Mission	Kansas
United States	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana
United States	Highland Clinic	Shreveport	Louisiana
United States	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Iredell Memorial Hospital	Statesville	North Carolina
United States	Kaiser Permanente Medical Facility - Stockton	Stockton	California
United States	Allenmore Hospital	Tacoma	Washington
United States	CCOP - Northwest	Tacoma	Washington
United States	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington
United States	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington
United States	St. Clare Hospital	Tacoma	Washington
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Cotton-O'Neil Cancer Center	Topeka	Kansas
United States	St. Francis Comprehensive Cancer Center	Topeka	Kansas
United States	Munson Medical Center	Traverse City	Michigan
United States	Tahoe Forest Cancer Center	Truckee	California
United States	Mountain States Tumor Institute at St. Luke's	Twin Falls	Idaho
United States	Kaiser Permanente Medical Center - Vacaville	Vacaville	California
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California
United States	St. John Macomb Hospital	Warren	Michigan
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
SWOG Cancer Research Network	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Undetectable PSA	undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.	12 months
Secondary	Number of Patients With PSA Partial Response	PSA reduction to < 4 ng/ml, but >0.2 ng/ml	12 months
Secondary	Objective Progression-free Survival	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.	3 years
Secondary	Overall Survival		3 years
Secondary	Number of Patients With Toxicity of Abiraterone Acetate	Only adverse events that are possibly, probably or definitely related to study drug are reported.	Up to 3 years