Trial record 45 of 108 for:    johnstown

Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00288080
First received: February 6, 2006
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: buserelin
Drug: docetaxel
Drug: flutamide
Drug: goserelin acetate
Drug: leuprolide acetate
Drug: prednisone
Drug: triptorelin
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Protocol of Androgen Suppression (AS) and 3DCTR/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical Control [ Time Frame: From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. ] [ Designated as safety issue: No ]
  • Local Control [ Time Frame: From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. ] [ Designated as safety issue: No ]
  • Distant Metastasis [ Time Frame: From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. ] [ Designated as safety issue: No ]
  • Disease-free Survival [ Time Frame: From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: From start of treatment until the end of follow-up ] [ Designated as safety issue: Yes ]
  • The time interval between biochemical failure and distant metastases with respect to testosterone level [ Time Frame: From date of biochemical failure to development of distant failure. Analysis occurs after all patients have been potentially followed for 4 years. ] [ Designated as safety issue: No ]
  • Validity of PSA-defined endpoints as a surrogate for overall survival [ Time Frame: From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. ] [ Designated as safety issue: No ]

Enrollment: 612
Study Start Date: December 2005
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive androgen suppression therapy comprising luteinizing hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin, buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months). Beginning at week 8, patients undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen therapy is discontinued at completion of radiotherapy, but LHRH agonist therapy continues for 20 months.
Drug: bicalutamide
Given orally
Drug: buserelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therapy
Drug: flutamide
Given orally
Drug: goserelin acetate
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therapy
Drug: leuprolide acetate
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therapy
Drug: triptorelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therapy
Radiation: radiation therapy
Patients undergo radiotherapy 5 days a week for approximately 8 weeks.
Experimental: Arm II
Patients receive androgen suppression therapy and undergo radiotherapy as in arm I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients continue LHRH agonist therapy as in arm I.
Drug: bicalutamide
Given orally
Drug: buserelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therapy
Drug: docetaxel
Given IV
Drug: flutamide
Given orally
Drug: goserelin acetate
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therapy
Drug: leuprolide acetate
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therapy
Drug: prednisone
Given orally
Drug: triptorelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therapy
Radiation: radiation therapy
Patients undergo radiotherapy 5 days a week for approximately 8 weeks.

Detailed Description:

OBJECTIVES:

Primary

  • Compare the relative efficacy, in terms of overall survival, of the combination of androgen suppression and radiotherapy versus androgen suppression and radiotherapy followed by docetaxel and prednisone in patients with localized, high-risk prostate cancer.

Secondary

  • Compare the disease-free survival and incidence of adverse events in patients treated with these regimens.
  • Compare the biochemical control, local control, and freedom from distant metastases in patients treated with these regimens.
  • Determine the validity of prostate-specific antigen (PSA)-defined endpoints as a surrogate for overall survival of patients treated with these regimens.
  • Compare the time interval between biochemical failure and distant metastases with respect to testosterone level in patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to risk group.

  • Arm I: Patients receive androgen suppression therapy comprising luteinizing hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin, buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months). Beginning at week 8, patients undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen therapy is discontinued at completion of radiotherapy, but LHRH agonist therapy continues for 20 months.
  • Arm II: Patients receive androgen suppression therapy and undergo radiotherapy as in arm I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients continue LHRH agonist therapy as in arm I.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer at high-risk for recurrence within the past 180 days as determined by 1 of the following combinations (risk groups):

    • Gleason score ≥ 9, prostate-specific antigen (PSA) ≤ 150 ng/mL, and any T stage
    • Gleason score 8, PSA < 20 ng/mL, and stage ≥ T2
    • Gleason score 8, PSA 20-150 ng/mL, and any T stage
    • Gleason score 7, PSA 20-150 ng/mL, and any T stage
  • Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal sampling, or dissection within 90 days prior to study entry

    • Equivocal or questionable lymph nodes ≤ 1.5 cm by imaging allowed
    • Positive lymph nodes by capromab pendetide (ProstaScint^®) scan with a corresponding lymph node ≤ 1.5 cm by CT scan or MRI allowed
  • PSA ≤ 150 ng/mL

    • Cannot have been obtained during any of the following time points:

      • 10-day period after prostate biopsy
      • After initiation of hormonal therapy
      • Within 30 days after discontinuation of finasteride
      • Within 90 days after discontinuation of dutasteride
  • No distant metastases by physical exam and bone scan

    • Equivocal bone scan findings allowed if plain films are negative

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,800/mm^3
  • Hemoglobin ≥ 8 g/dL (transfusion or other intervention allowed)
  • ALT and AST ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
  • No prior invasive malignancy, except nonmelanomatous skin cancer or other malignancy, unless disease-free for ≥ 3 years (e.g., carcinoma in situ of the oral cavity or bladder are allowed)
  • No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • No transmural myocardial infarction within the past 6 months
  • No acute bacterial or fungal infection requiring intravenous antibiotics
  • No AIDS
  • No prior allergic reaction to any study drugs or other drugs formulated with polysorbate 80
  • No existing peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

  • At least 60 days since prior 5-alpha reductase inhibitor (e.g., finasteride) for prostatic hypertrophy
  • At least 90 days since prior testosterone
  • Prior pharmacologic androgen ablation for prostate cancer allowed provided androgen ablation was initiated no more than 50 days prior to study entry
  • No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy
  • No prior systemic chemotherapy for prostate cancer

    • Prior chemotherapy for a different cancer is allowed
  • No prior radiotherapy, including brachytherapy, to the region of prostate cancer that would result in overlap of radiotherapy fields
  • Intensity modulated radiotherapy allowed
  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: NCT00288080

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Alaska
Providence Cancer Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
Arizona Oncology - Tucson
Tucson, Arizona, United States, 85704
United States, California
Auburn Radiation Oncology
Auburn, California, United States, 95603
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States, 95682
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States, 95608
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States, 95926
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States, 94524-4110
Washington Township Hospital
Fremont, California, United States, 94538
Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital
Grass Valley, California, United States, 95945
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Memorial Medical Center
Modesto, California, United States, 95355
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center
Rancho Mirage, California, United States, 92270
Radiation Oncology Center - Roseville
Roseville, California, United States, 95661
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
Mercy General Hospital
Sacramento, California, United States, 95819
University of California Davis Cancer Center
Sacramento, California, United States, 95817
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118
Torrance Memorial Medical Center
Torrance, California, United States, 90509
Solano Radiation Oncology Center
Vacaville, California, United States, 95687
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States, 80012
Swedish Medical Center
Englewood, Colorado, United States, 80110
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States, 80528
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
McKee Medical Center
Loveland, Colorado, United States, 80539
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
St. Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606
Hospital of Saint Raphael
New Haven, Connecticut, United States, 06511
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
William W. Backus Hospital
Norwich, Connecticut, United States, 06360
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Bay Medical
Panama City, Florida, United States, 32401
United States, Georgia
Winship Cancer Institute of Emory University
Altanta, Georgia, United States, 30322
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60126
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States, 46016
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States, 46805
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, United States, 46804
Central Indiana Cancer Centers - East
Indianapolis, Indiana, United States, 46219
Veterans Affairs Medical Center - Indianapolis
Indianapolis, Indiana, United States, 46202
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States, 66210
United States, Kentucky
Norton Suburban Hospital
Louisville, Kentucky, United States, 40207
United States, Louisiana
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States, 71315-3198
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
United States, Maryland
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States, 21229
Suburban Hospital
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States, 02721
Shields Radiation Oncology Center - Mansfield
Mansfield, Massachusetts, United States, 02048
NSMC Cancer Center - Peabody
Peabody, Massachusetts, United States, 01960
South Suburban Oncology Center
Quincy, Massachusetts, United States, 02169
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
St. Luke's Hospital Cancer Care Center
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United States, Mississippi
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States, 63703
St. John's Regional Medical Center
Joplin, Missouri, United States, 64804
Kansas City Cancer Centers - South
Kansas City, Missouri, United States, 64131
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
United States, Nebraska
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New Hampshire
Dartmouth - Hitchcock Concord
Concord, New Hampshire, United States, 03301
Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover, New Hampshire, United States, 03820
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States, 03833
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States, 03431
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Cancer Institute of New Jersey at Cooper University Hospital - Camden
Camden, New Jersey, United States, 08103
CentraState Medical Center
Freehold, New Jersey, United States, 07728
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87109
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, United States, 87102
Radiation Oncology Associates, PA
Albuquerque, New Mexico, United States, 87109
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
Cancer Institute of New Mexico
Santa Fe, New Mexico, United States, 87505
United States, New York
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, United States, 12206
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
CaroMont Cancer Center at Gaston Memorial Hospital
Gastonia, North Carolina, United States, 28053
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States, 27834
High Point Regional Hospital
High Point, North Carolina, United States, 27261
New Hanover Radiation Oncology, PA
Wilmington, North Carolina, United States, 28401
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Grandview Hospital
Dayton, Ohio, United States, 45405
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Cancer Care Center, Incorporated
Salem, Ohio, United States, 44460
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
Cancer Treatment Center
Wooster, Ohio, United States, 44691
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, United States, 97401
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Salem Hospital Regional Cancer Care Services
Salem, Oregon, United States, 97309-5014
Celilo Cancer Center at Mid-Columbia Medical Center
The Dalles, Oregon, United States, 97058
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
UPMC Cancer Center at Beaver Medical Center
Beaver, Pennsylvania, United States, 15009
UPMC Cancer Center at Jefferson Regional Medical Center
Clairton, Pennsylvania, United States, 15025
Cancer Center at Clarion Hospital
Clarion, Pennsylvania, United States, 16214
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
UPMC Cancer Center - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
UPMC Cancer Center at the John P. Murtha Pavilion
Johnstown, Pennsylvania, United States, 15901
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
UPMC - Moon
Moon Township, Pennsylvania, United States, 15108
UPMC Cancer Center - Natrona Heights
Natrona Heights, Pennsylvania, United States, 15065
Jameson Memorial Hospital - North Campus
New Castle, Pennsylvania, United States, 16105
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC Cancer Center at UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
UPMC Cancer Center - Upper St. Clair
Pittsburgh, Pennsylvania, United States, 15243
UPMC - Shadyside
Pittsburgh, Pennsylvania, United States, 15213-2582
UPMC Cancer Center at UPMC Passavant
Pittsburgh, Pennsylvania, United States, 15237
UPMC Cancer Center at UPMC St. Margaret
Pittsburgh, Pennsylvania, United States, 15215
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, United States, 18840
Grand View Hospital
Sellersville, Pennsylvania, United States, 18960
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
UPMC Cancer Center - Uniontown
Uniontown, Pennsylvania, United States, 15401
Washington Hospital Cancer Center
Washington, Pennsylvania, United States, 15301
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States, 19096
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States, 17405
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
United States, Texas
Texas Oncology, PA at Harris Center HEB
Bedford, Texas, United States, 76022
St. Joseph Regional Cancer Center
Bryan, Texas, United States, 77802
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Texas Oncology, PA at Texas Cancer Center Dallas Southwest
Dallas, Texas, United States, 75237
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States, 76104
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, United States, 75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States, 77479
United States, Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, United States, 05701
United States, Virginia
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States, 23249
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99204
CCOP - Northwest
Tacoma, Washington, United States, 98405
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States, 98431
United States, West Virginia
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Theda Care Cancer Institute
Appleton, Wisconsin, United States, 54911
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States, 53051
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States, 53097
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States, 53211
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States, 53295
Vince Lombardi Cancer Clinic - Sheboygan
Sheboygan, Wisconsin, United States, 53081
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1Y 4K7
Canada, Quebec
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Howard M. Sandler, MD University of Michigan Cancer Center
Study Chair: Seth Rosenthal, MD Radiological Associates of Sacramento Medical Group at Sutter Cancer Center
Study Chair: Kenneth J. Pienta, MD, FACP University of Michigan Cancer Center
Study Chair: Leonard G. Gomella, MD Kimmel Cancer Center (KCC)
  More Information

Additional Information:
Publications:
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00288080     History of Changes
Other Study ID Numbers: RTOG-0521, CDR0000462375, NCI-2009-00728
Study First Received: February 6, 2006
Last Updated: May 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage III prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Bicalutamide
Prednisone
Leuprolide
Goserelin
Triptorelin Pamoate
Flutamide
Hormones
Androgens
Buserelin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal
Fertility Agents, Female

ClinicalTrials.gov processed this record on October 01, 2014