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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
abiraterone acetate
Prednisone
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, hormone-resistant prostate cancer, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • NEA Medical Clinic - East Matthews
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Highlands Oncology Group - Springdale
  • Kaiser Permanente - Deer Valley
  • Kaiser Permanente - Fremont
  • Kaiser Permanente Fresno Medical Center
  • Kaiser Permanente Medical Center - Hayward
  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP
  • Kaiser Permanente Medical Center - Oakland
  • Kaiser Permanente Medical Center - Redwood City
  • Kaiser Permanente Medical Center - Richmond
  • Kaiser Permanente Medical Center - Roseville
  • University of California Davis Cancer Center
  • South Sacramento Kaiser-Permanente Medical Center
  • Kaiser Permanente Medical Center - Sacramento
  • Kaiser Permanente Medical Center - San Francisco Geary Campus
  • Kaiser Permanente Medical Center - Santa Teresa
  • Kaiser Foundation Hospital - San Rafael
  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
  • Kaiser Permanente Medical Center - Santa Rosa
  • Kaiser Permanente Medical Center - South San Francisco
  • Kaiser Permanente Medical Facility - Stockton
  • Tahoe Forest Cancer Center
  • Kaiser Permanente Medical Center - Vacaville
  • Kaiser Permanente Medical Center - Vallejo
  • Kaiser Permanente Medical Center - Walnut Creek
  • San Luis Valley Regional Medical Center
  • University of Colorado Cancer Center at UC Health Sciences Center
  • Memorial Hospital Cancer Center - Colorado Springs
  • Shaw Regional Cancer Center
  • Poudre Valley Hospital
  • Front Range Cancer Specialists
  • Valley View Hospital Cancer Center
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  • Montrose Memorial Hospital Cancer Center
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
  • M.D. Anderson Cancer Center at Orlando
  • Kapiolani Medical Center at Pali Momi
  • Oncare Hawaii, Incorporated - Pali Momi
  • Cancer Research Center of Hawaii
  • OnCare Hawaii, Incorporated - Lusitana
  • Queen's Cancer Institute at Queen's Medical Center
  • Straub Clinic and Hospital, Incorporated
  • OnCare Hawaii, Incorporated - Kuakini
  • Kuakini Medical Center
  • Kaiser Permanente - Moanalua Medical Center and Clinic
  • Kapiolani Medical Center for Women and Children
  • Tripler Army Medical Center
  • Castle Medical Center
  • Kauai Medical Clinic
  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
  • Mountain States Tumor Institute at St. Luke's Regional Medical Center
  • Saint Luke's Mountain States Tumor Institute - Fruitland
  • St. Joseph Regional Medical Center
  • Mountain States Tumor Institute - Meridian
  • Saint Luke's Mountain States Tumor Institute
  • Mountain States Tumor Institute at St. Luke's
  • Decatur Memorial Hospital Cancer Care Institute
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center
  • Good Samaritan Regional Health Center
  • Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
  • Regional Cancer Center at Memorial Medical Center
  • Genesis Regional Cancer Center at Genesis Medical Center
  • Cancer Center of Kansas, PA - Chanute
  • Cancer Center of Kansas, PA - Dodge City
  • Cancer Center of Kansas - Fort Scott
  • St. Rose Ambulatory and Surgery Center
  • Hays Medical Center
  • Hutchinson Hospital Corporation
  • Cancer Center of Kansas-Independence
  • Kansas City Cancer Centers - West
  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  • Cancer Center of Kansas, PA - Kingman
  • Lawrence Memorial Hospital
  • Cancer Center of Kansas, PA - Liberal
  • Cancer Center of Kansas, PA - Newton
  • Kansas City Cancer Centers - Southwest
  • Cancer Center of Kansas, PA - Parsons
  • Mount Carmel Regional Cancer Center
  • Cancer Center of Kansas, PA - Pratt
  • Cancer Center of Kansas, PA - Salina
  • Tammy Walker Cancer Center at Salina Regional Health Center
  • Kansas City Cancer Center - Shawnee Mission
  • Cotton-O'Neil Cancer Center
  • St. Francis Comprehensive Cancer Center
  • Cancer Center of Kansas, PA - Wellington
  • Associates in Womens Health, PA - North Review
  • Cancer Center of Kansas, PA - Medical Arts Tower
  • Cancer Center of Kansas, PA - Wichita
  • CCOP - Wichita
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Cancer Center of Kansas, PA - Winfield
  • Central Baptist Hospital
  • Tulane Cancer Center Office of Clinical Research
  • Hematology-Oncology Clinic
  • Cancer Center of Acadiana at Lafayette General Medical Center
  • Highland Clinic
  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
  • Caritas Holy Family Hospital
  • Saint Joseph Mercy Cancer Center
  • CCOP - Michigan Cancer Research Consortium
  • University of Michigan Comprehensive Cancer Center
  • Battle Creek Health System Cancer Care Center
  • Bay Regional Medical Center
  • Mecosta County Medical Center
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
  • Barbara Ann Karmanos Cancer Institute
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • McLaren Cancer Institute
  • Singh and Arora Hematology Oncology, PC
  • Butterworth Hospital at Spectrum Health
  • CCOP - Grand Rapids
  • Lacks Cancer Center at Saint Mary's Health Care
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Foote Memorial Hospital
  • Sparrow Regional Cancer Center
  • Great Lakes Cancer Institute - Lapeer Campus
  • St. Mary Mercy Hospital
  • Clemens Regional Medical Center
  • Mercy General Health Partners
  • Northern Michigan Hospital
  • St. Joseph Mercy Oakland
  • Mercy Regional Cancer Center at Mercy Hospital
  • Spectrum Health Reed City Hospital
  • Seton Cancer Institute at Saint Mary's - Saginaw
  • Munson Medical Center
  • St. John Macomb Hospital
  • University of Mississippi Cancer Clinic
  • Saint Francis Medical Center
  • Truman Medical Center - Hospital Hill
  • Kansas City Cancer Centers - South
  • Kansas City Cancer Centers - North
  • Kansas City Cancer Centers - East
  • Midwest Hematology Oncology Group, Incorporated
  • CCOP - St. Louis-Cape Girardeau
  • David C. Pratt Cancer Center at St. John's Mercy
  • CCOP - Cancer Research for the Ozarks
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • CCOP - Montana Cancer Consortium
  • St. Vincent Healthcare Cancer Care Services
  • Hematology-Oncology Centers of the Northern Rockies - Billings
  • Billings Clinic - Downtown
  • Bozeman Deaconess Cancer Center
  • Great Falls Clinic - Main Facility
  • Sletten Cancer Institute at Benefis Healthcare
  • St. Peter's Hospital
  • Glacier Oncology, PLLC
  • Kalispell Regional Medical Center
  • Montana Cancer Specialists at Montana Cancer Center
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • University Medical Center of Southern Nevada
  • CCOP - Nevada Cancer Research Foundation
  • Valley Hospital - Ridgewood
  • Hematology Oncology Associates, PC
  • University of New Mexico Cancer Center
  • New Mexico Cancer Care Associates
  • Falck Cancer Center at Arnot Ogden Medical Center
  • Tucker Center for Cancer Care at Orange Regional Medical Center
  • Winthrop University Hospital
  • St. Luke's - Roosevelt Hospital Center - St.Luke's Division
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Presbyterian Cancer Center at Presbyterian Hospital
  • Wayne Memorial Hospital, Incorporated
  • Iredell Memorial Hospital
  • Adena Regional Medical Center
  • Charles M. Barrett Cancer Center at University Hospital
  • Riverside Methodist Hospital Cancer Care
  • CCOP - Columbus
  • Grant Medical Center Cancer Care
  • Mount Carmel Health - West Hospital
  • Doctors Hospital at Ohio Health
  • Grady Memorial Hospital
  • Fairfield Medical Center
  • Strecker Cancer Center at Marietta Memorial Hospital
  • Knox Community Hospital
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • Southern Ohio Medical Center Cancer Center
  • Community Hospital of Springfield and Clark County
  • Mount Carmel St. Ann's Cancer Center
  • Genesis - Good Samaritan Hospital
  • Hollings Cancer Center at Medical University of South Carolina
  • McLeod Regional Medical Center
  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
  • Thompson Cancer Survival Center
  • Baylor University Medical Center - Houston
  • Ben Taub General Hospital
  • St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
  • Veterans Affairs Medical Center - Houston
  • UMC Southwest Cancer and Research Center
  • CCOP - Scott and White Hospital
  • Huntsman Cancer Institute at University of Utah
  • Providence Centralia Hospital
  • Providence Regional Cancer Partnership
  • St. Francis Hospital
  • Providence St. Peter Hospital Regional Cancer Center
  • Good Samaritan Cancer Center
  • Franciscan Cancer Center at St. Joseph Medical Center
  • Allenmore Hospital
  • CCOP - Northwest
  • MultiCare Regional Cancer Center at Tacoma General Hospital
  • St. Clare Hospital
  • Rocky Mountain Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abiraterone acetate + prednisone

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Patients With PSA Partial Response
PSA reduction to < 4 ng/ml, but >0.2 ng/ml
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.
Overall Survival
Number of Patients With Toxicity of Abiraterone Acetate
Only adverse events that are possibly, probably or definitely related to study drug are reported.

Full Information

First Posted
March 4, 2011
Last Updated
November 30, 2022
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01309672
Brief Title
S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy
Official Title
Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 9, 2011 (undefined)
Primary Completion Date
November 29, 2016 (Actual)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, hormone-resistant prostate cancer, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abiraterone acetate + prednisone
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
abiraterone acetate
Intervention Description
1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
5 mg, oral, 5 mg twice daily
Primary Outcome Measure Information:
Title
Number of Patients With Undetectable PSA
Description
undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Patients With PSA Partial Response
Description
PSA reduction to < 4 ng/ml, but >0.2 ng/ml
Time Frame
12 months
Title
Objective Progression-free Survival
Description
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.
Time Frame
3 years
Title
Overall Survival
Time Frame
3 years
Title
Number of Patients With Toxicity of Abiraterone Acetate
Description
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame
Up to 3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas W. Flaig, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
NEA Medical Clinic - East Matthews
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Highlands Oncology Group - Springdale
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Kaiser Permanente - Deer Valley
City
Antioch
State/Province
California
ZIP/Postal Code
94531
Country
United States
Facility Name
Kaiser Permanente - Fremont
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Kaiser Permanente Fresno Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Kaiser Permanente Medical Center - Hayward
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
Facility Name
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
City
Marysville
State/Province
California
ZIP/Postal Code
95901
Country
United States
Facility Name
Kaiser Permanente Medical Center - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente Medical Center - Redwood City
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Kaiser Permanente Medical Center - Richmond
City
Richmond
State/Province
California
ZIP/Postal Code
94801
Country
United States
Facility Name
Kaiser Permanente Medical Center - Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
South Sacramento Kaiser-Permanente Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Kaiser Permanente Medical Center - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Kaiser Permanente Medical Center - San Francisco Geary Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Teresa
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Foundation Hospital - San Rafael
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Rosa
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Kaiser Permanente Medical Center - South San Francisco
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
Kaiser Permanente Medical Facility - Stockton
City
Stockton
State/Province
California
ZIP/Postal Code
95210
Country
United States
Facility Name
Tahoe Forest Cancer Center
City
Truckee
State/Province
California
ZIP/Postal Code
96161
Country
United States
Facility Name
Kaiser Permanente Medical Center - Vacaville
City
Vacaville
State/Province
California
ZIP/Postal Code
95688
Country
United States
Facility Name
Kaiser Permanente Medical Center - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Kaiser Permanente Medical Center - Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
San Luis Valley Regional Medical Center
City
Alamosa
State/Province
Colorado
ZIP/Postal Code
81101
Country
United States
Facility Name
University of Colorado Cancer Center at UC Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Memorial Hospital Cancer Center - Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Shaw Regional Cancer Center
City
Edwards
State/Province
Colorado
ZIP/Postal Code
81632
Country
United States
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Front Range Cancer Specialists
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Valley View Hospital Cancer Center
City
Glenwood Springs
State/Province
Colorado
ZIP/Postal Code
81601
Country
United States
Facility Name
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81502
Country
United States
Facility Name
Montrose Memorial Hospital Cancer Center
City
Montrose
State/Province
Colorado
ZIP/Postal Code
81401
Country
United States
Facility Name
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
M.D. Anderson Cancer Center at Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Kapiolani Medical Center at Pali Momi
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Oncare Hawaii, Incorporated - Pali Momi
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
OnCare Hawaii, Incorporated - Lusitana
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Cancer Institute at Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Straub Clinic and Hospital, Incorporated
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
OnCare Hawaii, Incorporated - Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817-3169
Country
United States
Facility Name
Kuakini Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kaiser Permanente - Moanalua Medical Center and Clinic
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Tripler Army Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859
Country
United States
Facility Name
Castle Medical Center
City
Kailua
State/Province
Hawaii
ZIP/Postal Code
96734
Country
United States
Facility Name
Kauai Medical Clinic
City
Lihue
State/Province
Hawaii
ZIP/Postal Code
96766
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Mountain States Tumor Institute at St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Facility Name
St. Joseph Regional Medical Center
City
Lewiston
State/Province
Idaho
ZIP/Postal Code
83501
Country
United States
Facility Name
Mountain States Tumor Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Mountain States Tumor Institute at St. Luke's
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Regional Cancer Center at Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Genesis Regional Cancer Center at Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Cancer Center of Kansas, PA - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas, PA - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas - Fort Scott
City
Fort Scott
State/Province
Kansas
ZIP/Postal Code
66701
Country
United States
Facility Name
St. Rose Ambulatory and Surgery Center
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Facility Name
Hays Medical Center
City
Hays
State/Province
Kansas
ZIP/Postal Code
67601
Country
United States
Facility Name
Hutchinson Hospital Corporation
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Kansas City Cancer Centers - West
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66112
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Cancer Center of Kansas, PA - Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Cancer Center of Kansas, PA - Liberal
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas, PA - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Kansas City Cancer Centers - Southwest
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Cancer Center of Kansas, PA - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Mount Carmel Regional Cancer Center
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Cancer Center of Kansas, PA - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas, PA - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Tammy Walker Cancer Center at Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Kansas City Cancer Center - Shawnee Mission
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Cotton-O'Neil Cancer Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
St. Francis Comprehensive Cancer Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health, PA - North Review
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas, PA - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503-9985
Country
United States
Facility Name
Tulane Cancer Center Office of Clinical Research
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71315-3198
Country
United States
Facility Name
Hematology-Oncology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Cancer Center of Acadiana at Lafayette General Medical Center
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Highland Clinic
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Caritas Holy Family Hospital
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Saint Joseph Mercy Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
Battle Creek Health System Cancer Care Center
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Bay Regional Medical Center
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Facility Name
Mecosta County Medical Center
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Facility Name
Oakwood Cancer Center at Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123-2500
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
McLaren Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Singh and Arora Hematology Oncology, PC
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Butterworth Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Lacks Cancer Center at Saint Mary's Health Care
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Foote Memorial Hospital
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912-1811
Country
United States
Facility Name
Great Lakes Cancer Institute - Lapeer Campus
City
Lapeer
State/Province
Michigan
ZIP/Postal Code
48446
Country
United States
Facility Name
St. Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Clemens Regional Medical Center
City
Mount Clemens
State/Province
Michigan
ZIP/Postal Code
48043
Country
United States
Facility Name
Mercy General Health Partners
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
St. Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341-2985
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Hospital
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Spectrum Health Reed City Hospital
City
Reed City
State/Province
Michigan
ZIP/Postal Code
49677
Country
United States
Facility Name
Seton Cancer Institute at Saint Mary's - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
St. John Macomb Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
University of Mississippi Cancer Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Truman Medical Center - Hospital Hill
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Kansas City Cancer Centers - South
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Kansas City Cancer Centers - North
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Kansas City Cancer Centers - East
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Facility Name
Midwest Hematology Oncology Group, Incorporated
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
David C. Pratt Cancer Center at St. John's Mercy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare Cancer Care Services
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Great Falls Clinic - Main Facility
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Cancer Institute at Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
St. Peter's Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology, PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Valley Hospital - Ridgewood
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Hematology Oncology Associates, PC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
Facility Name
New Mexico Cancer Care Associates
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Falck Cancer Center at Arnot Ogden Medical Center
City
Elmira
State/Province
New York
ZIP/Postal Code
14905
Country
United States
Facility Name
Tucker Center for Cancer Care at Orange Regional Medical Center
City
Middletown
State/Province
New York
ZIP/Postal Code
10940-4199
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Iredell Memorial Hospital
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Medical Center Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel Health - West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital at Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Knox Community Hospital
City
Mount Vernon
State/Province
Ohio
ZIP/Postal Code
43050
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Southern Ohio Medical Center Cancer Center
City
Portsmouth
State/Province
Ohio
ZIP/Postal Code
45662
Country
United States
Facility Name
Community Hospital of Springfield and Clark County
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Mount Carmel St. Ann's Cancer Center
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Genesis - Good Samaritan Hospital
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
McLeod Regional Medical Center
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37662
Country
United States
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Baylor University Medical Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Veterans Affairs Medical Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UMC Southwest Cancer and Research Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415-3364
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Providence Centralia Hospital
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531-9027
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
St. Francis Hospital
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Providence St. Peter Hospital Regional Cancer Center
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506-5166
Country
United States
Facility Name
Good Samaritan Cancer Center
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Franciscan Cancer Center at St. Joseph Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-3004
Country
United States
Facility Name
Allenmore Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
MultiCare Regional Cancer Center at Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
St. Clare Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Rocky Mountain Oncology
City
Casper
State/Province
Wyoming
ZIP/Postal Code
82609
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://swog.org/Visitors/Download/Policies/Policy43.pdf

Learn more about this trial

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

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