Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy
OBJECTIVES:
- Compare the overall and disease-free survival of patients with high-risk adenocarcinoma
of the prostate treated with adjuvant androgen deprivation therapy with or without
mitoxantrone and prednisone after radical prostatectomy.
- Compare the qualitative and quantitative toxic effects of these regimens in this
patient population.
- Compare the prostate-specific antigen (PSA) progression-free survival rate in patient
treated with these regimens.
- Determine whether PSA progression is a surrogate endpoint for survival or disease-free
survival in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
surgical extent of disease (organ confined vs not organ confined, but N0 vs N1), Gleason's
sum (less than 7 vs 7 vs greater than 7), and planned radiotherapy (yes vs no). Patients are
randomized to one of two treatment arms.
- Arm I:Patients receive goserelin subcutaneously once every 13 weeks (8 injections
total) and oral bicalutamide once daily for 2 years in the absence of disease
progression or unacceptable toxicity.
- Arm II:Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone
twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence
of disease progression or unacceptable toxicity. Patients also receive hormonal therapy
as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
Patients may undergo radiotherapy 5 days a week for 6.5-7.8 weeks beginning anytime (arm I)
or after completion of chemotherapy (arm II), at the discretion of the physician, in the
absence of disease progression or unacceptable toxicity.
Patients are offered the possibility to participate in biomarker research by allowing their
tissue/blood to be studied.
Patients are followed every 6 months for 2 years and then annually for up to 13 years.
PROJECTED ACCRUAL: A total of 1,360 patients (680 per treatment arm) will be accrued for
this study within 9.5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
at month 4 and every 3 months for 2 years
No
L. Michael Glode, MD
Study Chair
University of Colorado, Denver
United States: Federal Government
CDR0000067352
NCT00004124
October 1999
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Evanston Northwestern Healthcare - Evanston Hospital | Evanston, Illinois 60201-1781 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Foote Hospital | Jackson, Michigan 49201 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
St. John Macomb Hospital | Warren, Michigan 48093 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Dean Medical Center - Madison | Madison, Wisconsin 53717 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Naval Medical Center - San Diego | San Diego, California 92134-3202 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Wesley Medical Center | Wichita, Kansas 67214 |
University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
Great Falls Clinic | Great Falls, Montana 59405 |
Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Tod Children's Hospital - Forum Health | Youngstown, Ohio 44501 |
Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Lahey Clinic Medical Center - Burlington | Burlington, Massachusetts 01805 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Alaska Regional Hospital Cancer Center | Anchorage, Alaska 99508 |
Banner Good Samaritan Medical Center | Phoenix, Arizona 85006 |
Banner Thunderbird Medical Center | Phoenix, Arizona 85306 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Kansas 64128 |
Southwest Medical Center | Liberal, Kansas 67901 |
Holland Community Hospital | Holland, Michigan 49423 |
Hackley Hospital | Muskegon, Michigan 49443 |
Northern Michigan Hospital | Petoskey, Michigan 49770 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Munson Medical Center | Traverse City, Michigan 49684 |
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Vincent Healthcare | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
St. James Community Hospital | Butte, Montana 59701 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
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 |
Madigan Army Medical Center - Tacoma | Tacoma, Washington 98431 |
Spectrum Health Hospital - Butterworth Campus | Grand Rapids, Michigan 49503 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Cancer Center of Santa Barbara | Santa Barbara, California 93105 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Veterans Affairs Medical Center - Chicago Westside Hospital | Chicago, Illinois 60612 |
Hematology Oncology Associates - Skokie | Skokie, Illinois 60076 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Fox Valley Hematology and Oncology - East Grant Street | Appleton, Wisconsin 54911-3496 |
Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
Peninsula Medical Center | Burlingame, California 94010 |
Sutter Health - Western Division Cancer Research Group | Greenbrae, California 94904 |
Marin Cancer Institute at Marin General Hospital | Greenbrae, California 94904 |
California Pacific Medical Center - California Campus | San Francisco, California 94118 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Memorial Hospital | Colorado Springs, Colorado 80909 |
Swedish Covenant Hospital | Chicago, Illinois 60625 |
Mercy Hospital and Medical Center | Chicago, Illinois 60616 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Midwest Center for Hematology/Oncology | Joliet, Illinois 60432 |
North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois 60048 |
Hematology/Oncology of the North Shore at Gross Point Medical Center | Skokie, Illinois 60076 |
St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Louisiana State University Health Sciences Center - Monroe | Monroe, Louisiana 71210 |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
Alexandria, Minnesota 56308 | |
Brainerd Medical Center | Brainerd, Minnesota 56401 |
St. Joseph's Medical Center | Brainerd, Minnesota 56401 |
Chippewa County - Montevideo Hospital | Montevideo, Minnesota 56265 |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
Frisbie Memorial Hospital | Rochester, New Hampshire 03867 |
Mountainside Hospital Cancer Center | Montclair, New Jersey 07042 |
Cancer Care Center at Medcenter One Hospital | Bismarck, North Dakota 58501 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center | Bismarck, North Dakota 58502 |
Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio 44131 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland, Oregon 97210 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
Mountainview Medical | Berlin, Vermont 05602 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
San Francisco General Hospital Medical Center | San Francisco, California 94110 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Good Shepherd Hospital | Barrington, Illinois 60010 |
Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago, Illinois 60657 |
Adult and Pediatric Urology, P.L.L.P. | St. Cloud, Minnesota 56303 |
Saint Luke's Hospital | Chesterfield, Missouri 63017 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
Carl and Dorothy Bennett Cancer Center at Stamford Hospital | Stamford, Connecticut 06904 |
Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles, Illinois 60714 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Covenant Cancer Treatment Center | Waterloo, Iowa 50702 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
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 - Winfield | Winfield, Kansas 67156 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
OU Cancer Institute | Oklahoma City, Oklahoma 73104 |
Sansum Medical Clinic | Santa Barbara, California 93105 |
Advocate Good Samaritan Hospital | Downers Grove, Illinois 60515 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Elliot Regional Cancer Center at Elliot Hospital | Manchester, New Hampshire 03103 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Cancer Care Center at Advocate Lutheran Hospital | Park Ridge, Illinois 60068-1174 |
Providence Cancer Center | Anchorage, Alaska 99508 |
Highlands Oncology Group - Springdale | Springdale, Arkansas 72764 |
California Cancer Care, Incorporated | Greenbrae, California 94904 |
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara | Santa Barbara, California 93105 |
Santa Barbara Hematology Oncology - Solvang | Solvang, California 93463 |
La Grange Memorial Hospital | La Grange, Illinois 60525 |
Mid-Illinois Hematology-Oncology Associates at Community Cancer Center | Normal, Illinois 61761 |
Oncology/Hematology Associates of Southwest Indiana at St. Mary's Cancer Center | Evansville, Indiana 47714 |
Cedar Valley Medical Specialists, PC - West Ridgeway Avenue | Waterloo, Iowa 50702 |
Commonwealth Hematology-Oncology P.C. - Worcester | Worcester, Massachusetts 01605 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Arch Medical Services, Incorporated at Center for Cancer Care Research | Saint Louis, Missouri 63141 |
Billings Clinic Cancer Center | Billings, Montana 59107-5100 |
Great Falls, Montana 59405 | |
Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Lakes Region General Hospital | Laconia, New Hampshire 03246 |
Community Hospitals and Wellness Centers - Bryan | Bryan, Ohio 43506 |
St. Charles Medical Center - Bend | Bend, Oregon 97701 |
PinnacleHealth Regional Cancer Center at Polyclinic Hospital | Harrisburg, Pennsylvania 17105 |
Cancer Care Institute of Carolina at Aiken Regional Medical Centers | Aiken, South Carolina 29801 |
Roper St. Francis Cancer Center at Roper Hospital | Charleston, South Carolina 29401 |
Rockwood Clinic Cancer Treatment Center | Spokane, Washington 99204-2967 |
University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau, Wisconsin 54401 |