Trial record 1 of 5 for:    SWOG 1014
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S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01309672
First received: March 4, 2011
Last updated: December 2, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: abiraterone acetate
Drug: degarelix
Drug: leuprolide acetate
Procedure: orchiectomy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Rates of undetectable PSA [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival and objective progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Toxicity of abiraterone acetate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: September 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abiraterone acetate + prednisone

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

Prednisone, 5 mg, oral, 5 mg twice daily

Drug: abiraterone acetate Drug: degarelix Drug: leuprolide acetate Procedure: orchiectomy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309672

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

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01309672     History of Changes
Other Study ID Numbers: CDR0000696565, S1014, U10CA032102
Study First Received: March 4, 2011
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
adenocarcinoma of the prostate
hormone-resistant prostate cancer
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Leuprolide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014