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
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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Survival at 4 years after registration
No
Howard M. Sandler, MD
Study Chair
University of Michigan Cancer Center
United States: Federal Government
CDR0000462375
NCT00288080
December 2005
Name | Location |
---|---|
Suburban Hospital | Bethesda, Maryland 20814 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
St. Joseph Regional Cancer Center | Bryan, Texas 77802 |
Swedish Medical Center | Englewood, Colorado 80110 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Bridgeport Hospital | Bridgeport, Connecticut 06610 |
Northwest Community Hospital | Arlington Heights, Illinois 60005 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
Grand View Hospital | Sellersville, Pennsylvania 18960 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough, Maine 04074 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Mercy Fitzgerald Hospital | Darby, Pennsylvania 19023 |
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Breslin Cancer Center at Ingham Regional Medical Center | Lansing, Michigan 48910 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Naval Medical Center - Portsmouth | Portsmouth, Virginia 23708-2197 |
Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Saint Peter's University Hospital | New Brunswick, New Jersey 08901-1780 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Torrance Memorial Medical Center | Torrance, California 90505 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Madigan Army Medical Center - Tacoma | Tacoma, Washington 98431 |
West Virginia University Health Sciences Center - Charleston | Charleston, West Virginia 25302 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center | Rancho Mirage, California 92270 |
California Pacific Medical Center - California Campus | San Francisco, California 94118 |
John Muir/Mt. Diablo Comprehensive Cancer Center | Walnut Creek, California 94598 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis, Maryland 21401 |
Poudre Valley Radiation Oncology | Fort Collins, Colorado 80528 |
William W. Backus Hospital | Norwich, Connecticut 06360 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
South Suburban Oncology Center | Quincy, Massachusetts 02169 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Cancer Treatment Center | Wooster, Ohio 44691 |
UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
McFarland Clinic, PC | Ames, Iowa 50010 |
St. Luke's Hospital Cancer Care Center | Duluth, Minnesota 55805 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Leo W. Jenkins Cancer Center at ECU Medical School | Greenville, North Carolina 27834 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
Salem Hospital Regional Cancer Care Services | Salem, Oregon 97309-5014 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Guthrie Cancer Center at Guthrie Clinic Sayre | Sayre, Pennsylvania 18840 |
York Cancer Center at Apple Hill Medical Center | York, Pennsylvania 17405 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
Vince Lombardi Cancer Clinic - Sheboygan | Sheboygan, Wisconsin 53081 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
Enloe Cancer Center at Enloe Medical Center | Chico, California 95926 |
Washington Township Hospital | Fremont, California 94538 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
St. Vincent's Medical Center | Bridgeport, Connecticut 06606 |
Hospital of Saint Raphael | New Haven, Connecticut 06511 |
Parkview Regional Cancer Center at Parkview Health | Fort Wayne, Indiana 46805 |
Dartmouth - Hitchcock Concord | Concord, New Hampshire 03301 |
Elliot Regional Cancer Center at Elliot Hospital | Manchester, New Hampshire 03103 |
Community Cancer Center at Rutland Regional Medical Center | Rutland, Vermont 05701 |
Theda Care Cancer Institute | Appleton, Wisconsin 54911 |
Community Memorial Hospital Cancer Care Center | Menomonee Falls, Wisconsin 53051 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
St. John's Regional Medical Center | Joplin, Missouri 64804 |
Providence Cancer Center | Anchorage, Alaska 99508 |
University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau, Wisconsin 54401 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Center for Cancer Care at OSF Saint Anthony Medical Center | Rockford, Illinois 61108 |
Mercy General Hospital | Sacramento, California 95819 |
Memorial Medical Center | Modesto, California 95355 |
Elmhurst Memorial Hospital | Elmhurst, Illinois 60126 |
Veterans Affairs Medical Center - Indianapolis | Indianapolis, Indiana 46202 |
Center for Cancer Care at Exeter Hospital | Exeter, New Hampshire 03833 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
CCOP - Main Line Health | Wynnewood, Pennsylvania 19096 |
Cancer Care Center, Incorporated | Salem, Ohio 44460 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
UPMC Cancer Center at UPMC Presbyterian | Pittsburgh, Pennsylvania 15213 |
Bay Medical | Panama City, Florida 32401 |
Cancer Institute of Cape Girardeau, LLC | Cape Girardeau, Missouri 63703 |
High Point Regional Hospital | High Point, North Carolina 27261 |
Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
CaroMont Cancer Center at Gaston Memorial Hospital | Gastonia, North Carolina 28053 |
Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden, New Jersey 08103 |
Lovelace Medical Center - Downtown | Albuquerque, New Mexico 87102 |
Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
NSMC Cancer Center - Peabody | Peabody, Massachusetts 01960 |
Columbia Saint Mary's Hospital - Ozaukee | Mequon, Wisconsin 53097 |
Columbia-Saint Mary's Cancer Care Center | Milwaukee, Wisconsin 53211 |
Cancer Care Center at John Muir Health - Concord Campus | Concord, California 94524-4110 |
Georgia Cancer Center for Excellence at Grady Memorial Hospital | Atlanta, Georgia 30303 |
CentraState Medical Center | Freehold, New Jersey 07728 |
UPMC Cancer Center at Beaver Medical Center | Beaver, Pennsylvania 15009 |
UPMC Cancer Center at Jefferson Regional Medical Center | Clairton, Pennsylvania 15025 |
UPMC Cancer Center - Arnold Palmer Pavilion | Greensburg, Pennsylvania 15601 |
UPMC Cancer Center at the John P. Murtha Pavilion | Johnstown, Pennsylvania 15901 |
UPMC - Moon | Moon Township, Pennsylvania 15108 |
UPMC Cancer Center - Natrona Heights | Natrona Heights, Pennsylvania 15065 |
Jameson Memorial Hospital - North Campus | New Castle, Pennsylvania 16105 |
UPMC - Shadyside | Pittsburgh, Pennsylvania 15213-2582 |
UPMC Cancer Center at UPMC St. Margaret | Pittsburgh, Pennsylvania 15215 |
UPMC Cancer Center at UPMC Passavant | Pittsburgh, Pennsylvania 15237 |
UPMC Cancer Center at UPMC Northwest | Seneca, Pennsylvania 16346 |
Washington Hospital Cancer Center | Washington, Pennsylvania 15301 |
Radiation Oncology Associates, PA | Albuquerque, New Mexico 87109 |
New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany, New York 12208 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Saint John's Cancer Center at Saint John's Medical Center | Anderson, Indiana 46016 |
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
Shields Radiation Oncology Center - Mansfield | Mansfield, Massachusetts 02048 |
Nevada Cancer Institute | Las Vegas, Nevada 89135 |
Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital | Grass Valley, California 95945 |
Kansas City Cancer Centers - Southwest | Overland Park, Kansas 66210 |
Northeast Radiation Oncology Center | Dunmore, Pennsylvania 18512 |
New Mexico Cancer Center | Albuquerque, New Mexico 87109 |
Radiation Oncology Associates Southwest | Fort Wayne, Indiana 46804 |
Central Indiana Cancer Centers - East | Indianapolis, Indiana 46219 |
Kansas City Cancer Centers - North | Kansas City, Missouri 64154 |
Seacoast Cancer Center at Wentworth - Douglass Hospital | Dover, New Hampshire 03820 |
Willamette Valley Cancer Center - Eugene | Eugene, Oregon 97401 |
Texas Oncology, PA at Harris Center HEB | Bedford, Texas 76022 |
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital | Fort Worth, Texas 76104 |
Texas Oncology, PA at Texas Cancer Center - Sherman | Sherman, Texas 75090 |
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land | Sugar Land, Texas 77479 |
Arizona Oncology - Tucson | Tucson, Arizona 85704 |
Rocky Mountain Cancer Centers - Aurora | Aurora, Colorado 80012 |
Norton Suburban Hospital | Louisville, Kentucky 40207 |
Kansas City Cancer Centers - South | Kansas City, Missouri 64131 |
Cancer Institute of New Mexico | Santa Fe, New Mexico 87505 |
New Hanover Radiation Oncology, PA | Wilmington, North Carolina 28401 |
Celilo Cancer Center at Mid-Columbia Medical Center | The Dalles, Oregon 97058 |
Cancer Center at Clarion Hospital | Clarion, Pennsylvania 16214 |
UPMC Cancer Center at UPMC McKeesport | McKeesport, Pennsylvania 15132 |
UPMC Cancer Center - Upper St. Clair | Pittsburgh, Pennsylvania 15243 |
UPMC Cancer Center - Uniontown | Uniontown, Pennsylvania 15401 |
Texas Oncology, PA at Texas Cancer Center Dallas Southwest | Dallas, Texas 75237 |