AzTrials
AzTrials

Prostate CancerPhase 2NCT01309672

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

A Phase 2 study testing abiraterone acetate and Prednisone in people with Prostate Cancer, run by SWOG Cancer Research Network at 205 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
abiraterone acetate and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
205 sitesUnited States
Study dates
9 Aug 2011to 11 Apr 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

205 sites in 1 country.

205 sites in 1 country

United States205 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Oncare Hawaii, Incorporated - Pali Momi

    ‘Aiea, Hawaii, 96701

  • San Luis Valley Regional Medical Center

    Alamosa, Colorado, 81101

  • Hematology Oncology Associates, PC

    Albuquerque, New Mexico, 87106

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • Tulane Cancer Center Office of Clinical Research

    Alexandria, Louisiana, 71315-3198

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Kaiser Permanente - Deer Valley

    Antioch, California, 94531

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • Hematology-Oncology Clinic

    Baton Rouge, Louisiana, 70809

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Memorial Hospital Cancer Center - Colorado Springs

    Colorado Springs, Colorado, 80909

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Falck Cancer Center at Arnot Ogden Medical Center

    Elmira, New York, 14905

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McLaren Cancer Institute

    Flint, Michigan, 48532

  • Singh and Arora Hematology Oncology, PC

    Flint, Michigan, 48532

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Kaiser Permanente Fresno Medical Center

    Fresno, California, 93720

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • St. Rose Ambulatory and Surgery Center

    Great Bend, Kansas, 67530

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Hays Medical Center

    Hays, Kansas, 67601

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817-3169

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Kaiser Permanente - Moanalua Medical Center and Clinic

    Honolulu, Hawaii, 96819

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • Baylor University Medical Center - Houston

    Houston, Texas, 77030

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Veterans Affairs Medical Center - Houston

    Houston, Texas, 77030

  • Hutchinson Hospital Corporation

    Hutchinson, Kansas, 67502

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • NEA Medical Clinic - East Matthews

    Jonesboro, Arkansas, 72401

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kansas City Cancer Centers - West

    Kansas City, Kansas, 66112

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Kansas City Cancer Centers - South

    Kansas City, Missouri, 64131

  • Kansas City Cancer Centers - North

    Kansas City, Missouri, 64154

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Cancer Center of Acadiana at Lafayette General Medical Center

    Lafayette, Louisiana, 70503

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Great Lakes Cancer Institute - Lapeer Campus

    Lapeer, Michigan, 48446

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Kansas City Cancer Centers - East

    Lee's Summit, Missouri, 64064

  • St. Joseph Regional Medical Center

    Lewiston, Idaho, 83501

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67901

  • Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • UMC Southwest Cancer and Research Center

    Lubbock, Texas, 79415-3364

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP

    Marysville, California, 95901

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Mountain States Tumor Institute - Meridian

    Meridian, Idaho, 83642

  • Caritas Holy Family Hospital

    Methuen, Massachusetts, 01844

  • Tucker Center for Cancer Care at Orange Regional Medical Center

    Middletown, New York, 10940-4199

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Clemens Regional Medical Center

    Mount Clemens, Michigan, 48043

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Mercy General Health Partners

    Muskegon, Michigan, 49444

  • Saint Luke's Mountain States Tumor Institute

    Nampa, Idaho, 83686

  • St. Luke's - Roosevelt Hospital Center - St.Luke's Division

    New York, New York, 10025

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Mid-Illinois Hematology-Oncology Associates at Community Cancer Center

    Normal, Illinois, 61761

  • Kaiser Permanente Medical Center - Oakland

    Oakland, California, 94611

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • M.D. Anderson Cancer Center at Orlando

    Orlando, Florida, 32806

  • Kansas City Cancer Centers - Southwest

    Overland Park, Kansas, 66210

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Mount Carmel Regional Cancer Center

    Pittsburg, Kansas, 66762

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Southern Ohio Medical Center Cancer Center

    Portsmouth, Ohio, 45662

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • Kaiser Permanente Medical Center - Redwood City

    Redwood City, California, 94063

  • Spectrum Health Reed City Hospital

    Reed City, Michigan, 49677

  • Kaiser Permanente Medical Center - Richmond

    Richmond, California, 94801

  • Valley Hospital - Ridgewood

    Ridgewood, New Jersey, 07450

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Highlands Oncology Group - Springdale

    Rogers, Arkansas, 72758

  • Kaiser Permanente Medical Center - Roseville

    Roseville, California, 95661

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • South Sacramento Kaiser-Permanente Medical Center

    Sacramento, California, 95823

  • Kaiser Permanente Medical Center - Sacramento

    Sacramento, California, 95825

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • Kaiser Permanente Medical Center - San Francisco Geary Campus

    San Francisco, California, 94115

  • Kaiser Permanente Medical Center - Santa Teresa

    San Jose, California, 95119

  • Kaiser Foundation Hospital - San Rafael

    San Rafael, California, 94903

  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus

    Santa Clara, California, 95051

  • New Mexico Cancer Care Associates

    Santa Fe, New Mexico, 87505

  • Kaiser Permanente Medical Center - Santa Rosa

    Santa Rosa, California, 95403

  • Kansas City Cancer Center - Shawnee Mission

    Shawnee Mission, Kansas, 66204

  • Highland Clinic

    Shreveport, Louisiana, 71105

  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    Shreveport, Louisiana, 71130-3932

  • Kaiser Permanente Medical Center - South San Francisco

    South San Francisco, California, 94080

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Midwest Hematology Oncology Group, Incorporated

    St Louis, Missouri, 63109

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Kaiser Permanente Medical Facility - Stockton

    Stockton, California, 95210

  • Franciscan Cancer Center at St. Joseph Medical Center

    Tacoma, Washington, 98405-3004

  • Allenmore Hospital

    Tacoma, Washington, 98405

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • St. Clare Hospital

    Tacoma, Washington, 98499

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66606

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Tahoe Forest Cancer Center

    Truckee, California, 96161

  • Mountain States Tumor Institute at St. Luke's

    Twin Falls, Idaho, 83301

  • Kaiser Permanente Medical Center - Vacaville

    Vacaville, California, 95688

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • Kaiser Permanente Medical Center - Walnut Creek

    Walnut Creek, California, 94596

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
abiraterone acetate, Prednisone
Keywords
adenocarcinoma of the prostate, hormone-resistant prostate cancer, stage IV prostate cancer, recurrent prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abiraterone acetateDrug

    1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily

  • PrednisoneDrug

    5 mg, oral, 5 mg twice daily

Study groups in NCT01309672
Study groupRoleWhat they receive
Abiraterone acetate + prednisoneExperimentalAbiraterone, 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
Receives: Drug: abiraterone acetate; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (4)

  1. Number of Patients With PSA Partial Response

    PSA reduction to < 4 ng/ml, but >0.2 ng/ml

    Measured: 12 months

  2. 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.

    Measured: 3 years

  3. Overall Survival

    Measured: 3 years

  4. Number of Patients With Toxicity of Abiraterone Acetate

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2011 (estimated)
  2. Study start9 Aug 2011
  3. Primary completion29 Nov 2016
  4. Study completion11 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01309672
Sponsor's protocol ID
CDR0000696565
Other IDs
S1014, U10CA032102
Status last verified
Feb 2025
First submitted
4 Mar 2011
Last updated
26 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://swog.org/Visitors/Download/Policies/Policy43.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing abiraterone acetate and Prednisone in people with Prostate Cancer, run by SWOG Cancer Research Network at 205 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Undetectable PSA (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01309672.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in