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Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

at month 4 and every 3 months for 2 years

Safety Issue:

No

Principal Investigator

L. Michael Glode, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Federal Government

Study ID:

CDR0000067352

NCT ID:

NCT00004124

Start Date:

October 1999

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Evanston Northwestern Healthcare - Evanston HospitalEvanston, Illinois  60201-1781
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Foote HospitalJackson, Michigan  49201
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
St. Rita's Medical CenterLima, Ohio  45801
Dean Medical Center - MadisonMadison, Wisconsin  53717
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Wesley Medical CenterWichita, Kansas  67214
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Great Falls ClinicGreat Falls, Montana  59405
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Tod Children's Hospital - Forum HealthYoungstown, Ohio  44501
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Lahey Clinic Medical Center - BurlingtonBurlington, Massachusetts  01805
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
Banner Good Samaritan Medical CenterPhoenix, Arizona  85006
Banner Thunderbird Medical CenterPhoenix, Arizona  85306
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Veterans Affairs Medical Center - Kansas CityKansas City, Kansas  64128
Southwest Medical CenterLiberal, Kansas  67901
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Northern Michigan HospitalPetoskey, Michigan  49770
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Munson Medical CenterTraverse City, Michigan  49684
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Lenoir Memorial Cancer CenterKinston, North Carolina  28503-1678
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
University of Illinois Cancer CenterChicago, Illinois  60612-7243
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Madigan Army Medical Center - TacomaTacoma, Washington  98431
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Cancer Center of Santa BarbaraSanta Barbara, California  93105
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Veterans Affairs Medical Center - Chicago Westside HospitalChicago, Illinois  60612
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Fox Valley Hematology and Oncology - East Grant StreetAppleton, Wisconsin  54911-3496
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Peninsula Medical CenterBurlingame, California  94010
Sutter Health - Western Division Cancer Research GroupGreenbrae, California  94904
Marin Cancer Institute at Marin General HospitalGreenbrae, California  94904
California Pacific Medical Center - California CampusSan Francisco, California  94118
Sutter Solano Medical CenterVallejo, California  94589
Memorial HospitalColorado Springs, Colorado  80909
Swedish Covenant HospitalChicago, Illinois  60625
Mercy Hospital and Medical CenterChicago, Illinois  60616
Hematology and Oncology AssociatesChicago, Illinois  60611
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
Hematology/Oncology of the North Shore at Gross Point Medical CenterSkokie, Illinois  60076
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Louisiana State University Health Sciences Center - MonroeMonroe, Louisiana  71210
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Mecosta County Medical CenterBig Rapids, Michigan  49307
Green Bay Oncology, Limited - Iron MountainIron Mountain, Michigan  49801
Alexandria, Minnesota  56308
Brainerd Medical CenterBrainerd, Minnesota  56401
St. Joseph's Medical CenterBrainerd, Minnesota  56401
Chippewa County - Montevideo HospitalMontevideo, Minnesota  56265
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Kingsbury Center for Cancer Care at Cheshire Medical CenterKeene, New Hampshire  03431
Frisbie Memorial HospitalRochester, New Hampshire  03867
Mountainside Hospital Cancer CenterMontclair, New Jersey  07042
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Cleveland Clinic - WoosterWooster, Ohio  44691
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer CenterPortland, Oregon  97210
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Mountainview MedicalBerlin, Vermont  05602
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, Washington  98902
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
San Francisco General Hospital Medical CenterSan Francisco, California  94110
Northeast Georgia Medical CenterGainesville, Georgia  30501
Good Shepherd HospitalBarrington, Illinois  60010
Creticos Cancer Center at Advocate Illinois Masonic Medical CenterChicago, Illinois  60657
Adult and Pediatric Urology, P.L.L.P.St. Cloud, Minnesota  56303
Saint Luke's HospitalChesterfield, Missouri  63017
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Carl and Dorothy Bennett Cancer Center at Stamford HospitalStamford, Connecticut  06904
Cancer Care and Hematology Specialists of Chicagoland - NilesNiles, Illinois  60714
McFarland Clinic, PCAmes, Iowa  50010
Covenant Cancer Treatment CenterWaterloo, Iowa  50702
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
St. Joseph Cancer CenterBellingham, Washington  98225
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Mid Dakota Clinic, PCBismarck, North Dakota  58501
OU Cancer InstituteOklahoma City, Oklahoma  73104
Sansum Medical ClinicSanta Barbara, California  93105
Advocate Good Samaritan HospitalDowners Grove, Illinois  60515
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Elliot Regional Cancer Center at Elliot HospitalManchester, New Hampshire  03103
Pardee Memorial HospitalHendersonville, North Carolina  28791
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Cancer Care Center at Advocate Lutheran HospitalPark Ridge, Illinois  60068-1174
Providence Cancer CenterAnchorage, Alaska  99508
Highlands Oncology Group - SpringdaleSpringdale, Arkansas  72764
California Cancer Care, IncorporatedGreenbrae, California  94904
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa BarbaraSanta Barbara, California  93105
Santa Barbara Hematology Oncology - SolvangSolvang, California  93463
La Grange Memorial HospitalLa Grange, Illinois  60525
Mid-Illinois Hematology-Oncology Associates at Community Cancer CenterNormal, Illinois  61761
Oncology/Hematology Associates of Southwest Indiana at St. Mary's Cancer CenterEvansville, Indiana  47714
Cedar Valley Medical Specialists, PC - West Ridgeway AvenueWaterloo, Iowa  50702
Commonwealth Hematology-Oncology P.C. - WorcesterWorcester, Massachusetts  01605
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Arch Medical Services, Incorporated at Center for Cancer Care ResearchSaint Louis, Missouri  63141
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Great Falls, Montana  59405
Sletten Regional Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Lakes Region General HospitalLaconia, New Hampshire  03246
Community Hospitals and Wellness Centers - BryanBryan, Ohio  43506
St. Charles Medical Center - BendBend, Oregon  97701
PinnacleHealth Regional Cancer Center at Polyclinic HospitalHarrisburg, Pennsylvania  17105
Cancer Care Institute of Carolina at Aiken Regional Medical CentersAiken, South Carolina  29801
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401
Rockwood Clinic Cancer Treatment CenterSpokane, Washington  99204-2967
University of Wisconcin Cancer Center at Aspirus Wausau HospitalWausau, Wisconsin  54401