S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage T1-T3 adenocarcinoma of the prostate before radical prostatectomy and lymph node dissection Must have undergone prostatectomy within the past 120 days Must meet at least 1 of the following pathologic criteria: Gleason sum at least 8 pT3b (seminal vesicle), pT4, or N1 Gleason sum of 7 and positive margin Preoperative PSA greater than 15 ng/mL, Gleason score greater than 7, or PSA level greater than 10 ng/mL and Gleason score greater than 6 Must have an undetectable PSA (no greater than 0.2 ng/mL) documented after surgery or prior to adjuvant hormonal therapy (for patients initiating adjuvant hormonal therapy prior to study) No evidence of metastatic disease on bone scan if PSA is 20 ng/mL or greater at clinical diagnosis No distant metastatic disease PATIENT CHARACTERISTICS: Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled congestive heart failure If history of cardiac disease, LVEF at least 50% by MUGA scan or 2-D echocardiogram Other: No HIV positivity No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer that is currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Prior neoadjuvant hormonal therapy of no more than 4 months duration before radical prostatectomy allowed Other concurrent adjuvant hormonal therapy allowed if initiated prior to study Concurrent low-dose megestrol (less than 40 mg/day) for hot flashes allowed Radiotherapy: No prior radiotherapy No concurrent whole pelvis irradiation Concurrent radiotherapy allowed at the discretion of the physician Surgery: See Disease Characteristics See Endocrine therapy Recovered from prior surgery Other: No other prior or concurrent therapy for adenocarcinoma of the prostate
Sites / Locations
- Alaska Regional Hospital Cancer Center
- Providence Cancer Center
- Banner Thunderbird Medical Center
- Banner Good Samaritan Medical Center
- CCOP - Western Regional, Arizona
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Highlands Oncology Group - Springdale
- Alta Bates Comprehensive Cancer Center
- Peninsula Medical Center
- California Cancer Care, Incorporated
- Marin Cancer Institute at Marin General Hospital
- Sutter Health - Western Division Cancer Research Group
- Naval Medical Center - San Diego
- San Francisco General Hospital Medical Center
- UCSF Comprehensive Cancer Center
- California Pacific Medical Center - California Campus
- Veterans Affairs Medical Center - San Francisco
- Cancer Center of Santa Barbara
- Sansum Medical Clinic
- Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara
- Santa Barbara Hematology Oncology - Solvang
- Sutter Solano Medical Center
- Memorial Hospital
- North Colorado Medical Center
- McKee Medical Center
- Eastern Connecticut Hematology and Oncology Associates
- Carl and Dorothy Bennett Cancer Center at Stamford Hospital
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- MBCCOP - Medical College of Georgia Cancer Center
- Northeast Georgia Medical Center
- Tripler Army Medical Center
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Rush-Copley Cancer Care Center
- Good Shepherd Hospital
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- Veterans Affairs Medical Center - Lakeside Chicago
- University of Illinois Cancer Center
- Veterans Affairs Medical Center - Chicago Westside Hospital
- Mercy Hospital and Medical Center
- Swedish Covenant Hospital
- University of Chicago Cancer Research Center
- Creticos Cancer Center at Advocate Illinois Masonic Medical Center
- Advocate Good Samaritan Hospital
- Evanston Northwestern Healthcare - Evanston Hospital
- Veterans Affairs Medical Center - Hines
- Midwest Center for Hematology/Oncology
- Joliet Oncology-Hematology Associates, Limited - West
- La Grange Memorial Hospital
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Good Samaritan Regional Health Center
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
- Cancer Care Center at Advocate Lutheran Hospital
- Hematology Oncology Associates - Skokie
- Hematology/Oncology of the North Shore at Gross Point Medical Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Oncology/Hematology Associates of Southwest Indiana at St. Mary's Cancer Center
- Indiana University Cancer Center
- Saint Anthony Memorial Health Centers
- McFarland Clinic, PC
- St. Luke's Hospital
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
- Covenant Cancer Treatment Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Veterans Affairs Medical Center - Kansas City
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Wesley Medical Center
- Cancer Center of Kansas, PA - Winfield
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Louisiana State University Health Sciences Center - Monroe
- Veterans Affairs Medical Center - Shreveport
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Cancer Research Center at Boston Medical Center
- Lahey Clinic Medical Center - Burlington
- Commonwealth Hematology-Oncology P.C. - Worcester
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Mecosta County Medical Center
- Barbara Ann Karmanos Cancer Institute
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Spectrum Health Hospital - Butterworth Campus
- Metro Health Hospital
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Holland Community Hospital
- Green Bay Oncology, Limited - Iron Mountain
- Foote Hospital
- Sparrow Regional Cancer Center
- Hackley Hospital
- Northern Michigan Hospital
- Mercy Regional Cancer Center at Mercy Hospital
- William Beaumont Hospital - Royal Oak Campus
- Seton Cancer Institute - Saginaw
- Munson Medical Center
- St. John Macomb Hospital
- Brainerd Medical Center
- St. Joseph's Medical Center
- Chippewa County - Montevideo Hospital
- CentraCare Clinic - River Campus
- Coborn Cancer Center
- Adult and Pediatric Urology, P.L.L.P.
- Saint Francis Medical Center
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
- Saint Luke's Hospital
- CCOP - Kansas City
- Siteman Cancer Center at Barnes-Jewish Hospital
- Missouri Baptist Cancer Center
- Arch Medical Services, Incorporated at Center for Cancer Care Research
- CCOP - St. Louis-Cape Girardeau
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- St. Vincent Healthcare
- Billings Clinic Cancer Center
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Hospital
- St. James Community Hospital
- Great Falls Clinic
- Sletten Regional Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- Kingsbury Center for Cancer Care at Cheshire Medical Center
- Lakes Region General Hospital
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Elliot Regional Cancer Center at Elliot Hospital
- Frisbie Memorial Hospital
- Cancer Institute of New Jersey at Hamilton
- Mountainside Hospital Cancer Center
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- University of New Mexico Cancer Research and Treatment Center
- Veterans Affairs Medical Center - Brooklyn
- Veterans Affairs Medical Center - Buffalo
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Duke Comprehensive Cancer Center
- Wayne Memorial Hospital, Incorporated
- Pardee Memorial Hospital
- Lenoir Memorial Cancer Center
- Rutherford Hospital
- Bismarck Cancer Center
- Cancer Care Center at Medcenter One Hospital
- Mid Dakota Clinic, PC
- St. Alexius Medical Center
- Akron City Hospital
- Community Hospitals and Wellness Centers - Bryan
- Cleveland Clinic Taussig Cancer Center
- Community Oncology Group at Cleveland Clinic Cancer Center
- St. Rita's Medical Center
- Cleveland Clinic - Wooster
- Tod Children's Hospital - Forum Health
- OU Cancer Institute
- St. Charles Medical Center - Bend
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center & Children's Hospital
- Legacy Meridian Park Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
- Cancer Care Institute of Carolina at Aiken Regional Medical Centers
- AnMed Health Cancer Center
- Roper St. Francis Cancer Center at Roper Hospital
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Mountainview Medical
- Fletcher Allen Health Care - University Health Center Campus
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Skagit Valley Hospital Cancer Care Center
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Rockwood Clinic Cancer Treatment Center
- Madigan Army Medical Center - Tacoma
- Southwest Washington Medical Center Cancer Center
- Wenatchee Valley Medical Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Fox Valley Hematology and Oncology - East Grant Street
- Green Bay Oncology, Limited at St. Vincent Hospital
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Dean Medical Center - Madison
- University of Wisconsin Comprehensive Cancer Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
bicalutamide, goserelin
bicalutamide, goserelin, mitoxantrone, prednisone
androgen deprivation
androgen deprivation plus mitoxantrone, prednisone