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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 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