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Phase 3
Open (Enrolling)
Prostate Cancer

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Trial Information



- Compare overall survival following radiotherapy with or without bicalutamide in
patients with an elevated prostate-specific antigen (PSA) and no evidence of metastatic
disease following radical prostatectomy for pathologic T3 N0 prostate cancer.

- Compare each regimen with respect to time to second PSA-based progression, time to
distant failure, disease-specific survival, and non-disease-specific survival in this
patient population.

- Compare each regimen with respect to time to third PSA failure (or PSA progression on
hormone therapy for second PSA failure) as a potential predictor for impending cancer
death in these patients.

- Compare each regimen with respect to 5-year and 10-year freedom from progression rates.

- Compare each regimen with respect to unintended adverse effects on treatment.

- Allow for subsequent analysis of emerging molecular pathologic predictors of outcome
with the prospective collection of paraffin blocks from the radical prostatectomy

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified by
neoadjuvant hormone therapy, surgical (inked) margin status, PSA nadir after surgery, PSA
level at entry, and participating center.

All patients undergo radiotherapy to the original prostate volume, tumor resection bed, and
proximal membranous urethra over 7.2 weeks. Beginning immediately upon or just prior to the
initiation of radiotherapy, patients are randomized to receive either bicalutamide or
placebo daily for 2 years.

Recommended treatment for patients with increasing PSA and bone metastases consists of
maximal androgen blockage with a combination of orchiectomy or LHRH analogues plus
bicalutamide or flutamide.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 810 patients will be accrued for this study within
approximately 3 years.

Inclusion Criteria


- Carcinoma of the prostate with pathologic stage T3 N0 or pT2 pN0 with positive inked
resection margin at least 12 weeks prior to study entry

- Radical prostatectomy (retropubic or perineal) and pelvic lymphadenectomy (open or
laparoscopic) required at least 16 weeks prior to entry

- No persistent urinary extravasation after surgery

- Suitable for radiotherapy and hormonal therapy as determined by the radiation
oncologist and urologist

- No metastasis by post-prostatectomy radioisotope bone scan within 16 weeks prior to

- Pathologic stage T2 without positive margins and pathologic N0 with prostatic
fossa/anastamosis biopsy at the time of rising PSA documenting recurrent cancer

- PSA 0.2-4.0 ng/mL at study entry

- No distant metastases



- Any age

Performance status:

- Karnofsky 80-100%

Life expectancy:

- More than 10 years


- White blood cell count (WBC) at least 4,000/mm^3

- Platelet count at least 100,000/mm^3

- Hematocrit at least 36%

- Hemoglobin at least 10 g/dL


- Bilirubin normal

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) no greater than
2.5 times normal


- Creatinine no greater than 2 times normal


- No other malignancy within the past 5 years except basal or squamous cell skin cancer
or adequately treated invasive cancers


Biologic therapy:

- No prior biologic therapy for prostate cancer


- No prior chemotherapy for prostate cancer

Endocrine therapy:

- No prior adjuvant hormonal therapy

- Prior neoadjuvant hormonal therapy allowed


- No prior radiotherapy for prostate cancer


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

From date of randomization to date of death.

Safety Issue:


Principal Investigator

William U. Shipley, MD, FACR

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital


United States: Federal Government

Study ID:




Start Date:

February 1998

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Akron City Hospital Akron, Ohio  44304
Roswell Park Cancer Institute Buffalo, New York  14263
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
University of Colorado Cancer Center Denver, Colorado  80262
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
St. Luke's Medical Center Milwaukee, Wisconsin  53215
Sylvester Cancer Center, University of Miami Miami, Florida  33136
Hurley Medical Center Flint, Michigan  48503
East Carolina University School of Medicine Greenville, North Carolina  27858-4354
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Bloomington Hospital Bloomington, Indiana  47402
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Loyola University Medical Center Maywood, Illinois  60153
CCOP - Ochsner New Orleans, Louisiana  70121
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Rapid City Regional Hospital Rapid City, South Dakota  57709
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Henry Ford Hospital Detroit, Michigan  48202
Marshfield Clinic Marshfield, Wisconsin  54449
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Huntsville Hospital System Huntsville, Alabama  35801
Alabama Oncology, LLC Montgomery, Alabama  36106-2801
Radiation Oncology Associates of West Alabama Tuscallosa, Alabama  35401
Mount Diablo Medical Center Concord, California  94524-4110
California Cancer Center Fresno, California  93720
Saint Agnes Cancer Center Fresno, California  93720
Loma Linda University Medical Center Loma Linda, California  92354
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
Cancer Care Center Pomona, California  91767
Radiation Oncology Center - Sacramento Sacramento, California  95816
O'Connor Hospital San Jose, California  95128
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
Memorial Hospital Cancer Center Colorado Springs, Colorado  80909
University of Florida Health Science Center Gainesville, Florida  32610-0296
Health First Holmes Regional Medical Center Melbourne, Florida  32901
Baptist Hospital of Miami Miami, Florida  33176-2197
Florida Radiation Oncology Group Orange Park, Florida  32073
Gulf Coast Cancer Treatment Center Panama City, Florida  32405-4587
Sarasota Radiation and Medical Oncology Center Sarasota, Florida  34233
Medical Center/John B. Amos Community Cancer Center Columbus, Georgia  31902
Northwest Community Hospital Arlington Heights, Illinois  60005
Northwestern Memorial Hospital Chicago, Illinois  60611
Ingalls Memorial Hospital Harvey, Illinois  60426
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Methodist Medical Center of Illinois Peoria, Illinois  61636
CCOP - Central Illinois Springfield, Illinois  62526
St. John's Medical Center Anderson, Indiana  46016
Ball Memorial Hospital Muncie, Indiana  47303-3499
Wendt Regional Cancer Center of Finley Hospital Dubuque, Iowa  52001
James Graham Brown Cancer Center Louisville, Kentucky  40202
Louisville Radiation Oncology Louisville, Kentucky  40215
Merle M. Mahr Cancer Center Madisonville, Kentucky  42431
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
Tulane University School of Medicine New Orleans, Louisiana  70112
Maine Medical Center Portland, Maine  04102
Anne Arundel Oncology Center Annapolis, Maryland  21401
Greater Baltimore Medical Center and Cancer Center Baltimore, Maryland  21204
Harbor Hospital Center Baltimore, Maryland  21225
Cape Cod Hospital Hyannis, Massachusetts  02601
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
McLaren Regional Cancer Center Flint, Michigan  48432
Marquette General Hospital Marquette, Michigan  49855
Mallinckrodt Institute of Radiology Saint Louis, Missouri  63110
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Methodist Cancer Center - Omaha Omaha, Nebraska  68114
Elliot Regional Cancer Center Manchester, New Hampshire  03103
John F. Kennedy Medical Center Edison, New Jersey  08818
Newark Beth Israel Medical Center Newark, New Jersey  07112
Community Medical Center Toms River, New Jersey  08755
St. Francis Medical Center Trenton, New Jersey  08629
New York Methodist Hospital Brooklyn, New York  11215-3609
Champlain Valley Physicians Hospital Medical Center Plattsburgh, New York  12901
Northeast Medical Center Concord, North Carolina  28025
Akron General Medical Center Akron, Ohio  44302
Christ Hospital Cincinnati, Ohio  45219
University Hospitals of Cleveland Cleveland, Ohio  44106
CCOP - Columbus Columbus, Ohio  43206
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
Lehigh Valley Hospital Allentown, Pennsylvania  18103
Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
Veterans Affairs Medical Center - Philadelphia Philadelphia, Pennsylvania  19104
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Mercy Hospital of Pittsburgh Pittsburgh, Pennsylvania  15219
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - Scranton Scranton, Pennsylvania  18501
Wilkes Barre General Hospital Wilkes-Barre, Pennsylvania  18764
York Hospital York, Pennsylvania  17315
Roger Williams Medical Center/BUSM Providence, Rhode Island  02908-4735
CCOP - Greenville Greenville, South Carolina  29615
Jackson-Madison County General Hospital Jackson, Tennessee  38301
Harrington Cancer Center Amarillo, Texas  79106
University of Texas Medical Branch Galveston, Texas  77555-1329
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
Bayshore Medical Center Pasadena, Texas  77504
Dixie Regional Medical Center Saint George, Utah  84770
Green Mountain Oncology Group Rutland, Vermont  05701
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Massey Cancer Center Richmond, Virginia  23298-0037
Virginia Mason Medical Center Seattle, Washington  98111
Deaconess Medical Center Spokane, Washington  99210-0248
Yakima Valley Memorial Hospital Yakima, Washington  98902
St. Vincent Hospital Green Bay, Wisconsin  54307-3508
Gundersen Lutheran Medical Foundation La Crosse, Wisconsin  54601
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Southern Wisconsin Radiotherapy Center Madison, Wisconsin  53713
Community Memorial Hospital Menomonee Falls, Wisconsin  53051
Columbia Hospital Milwaukee, Wisconsin  53211
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
Waukesha Memorial Hospital Waukesha, Wisconsin  53188
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Dana-Farber Cancer Institute Boston, Massachusetts  02115
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - Gulf Coast Mobile, Alabama  36688
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Regional Cancer Center Indianapolis, Indiana  46219
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
CCOP - Oklahoma Tulsa, Oklahoma  74136
Comprehensive Cancer Institute of Huntsville Huntsville, Alabama  35801
Foundation for Cancer Research and Education Phoenix, Arizona  85013
Radiation Medical Group, Inc. San Diego, California  92101-1492
Veterans Affairs Medical Center - Miami Miami, Florida  33125
Bay Medical Center Panama City, Florida  32401
Tallahassee Memorial Healthcare Tallahassee, Florida  32308
Peninsula Regional Medical Center Salisbury, Maryland  21801
MidMichigan Medical Center - Midland Midland, Michigan  48670
William Beaumont Hospital Royal Oak, Michigan  48073
Nebraska Health System Omaha, Nebraska  68105-1018
Trinitas Hospital - Jersey Street Campus Elizabeth, New Jersey  07201
Monmouth Medical Center Long Branch, New Jersey  07740-6395
South Jersey Regional Cancer Center Millville, New Jersey  08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County Mount Holly, New Jersey  08060
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Atlantic City Medical Center Pomona, New Jersey  08240
Associated Radiologists, P.A. Warren, New Jersey  07059
St. Anthony Hospital Oklahoma City, Oklahoma  73101
St. John Health System Tulsa, Oklahoma  74104
University of Utah Health Sciences Center Salt Lake City, Utah  84132
Schiffler Cancer Center Wheeling, West Virginia  26003
Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201-1595
James P. Wilmot Cancer Center Rochester, New York  14642
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
City of Hope Comprehensive Cancer Center Duarte, California  91010
University of Tennessee Cancer Institute Memphis, Tennessee  38103
Cooper Cancer Institute Camden, New Jersey  08103
Capital Health System at Mercer Trenton, New Jersey  08607
CCOP - Beaumont Royal Oak, Michigan  48073-6769
Sutter Health West Cancer Research Group Greenbrae, California  94904
Huntington Cancer Center Pasadena, California  91105
Saint Mary's Hospital and Medical Center Grand Junction, Colorado  81502-1628
Hospital of St. Raphael New Haven, Connecticut  06511
Regional Radiation Oncology Center at Rome Rome, Georgia  30165
Clarian Health Partners Inc. Indianapolis, Indiana  46206-1367
Central Baptist Hospital Lexington, Kentucky  40503
William Beaumont Hospital - Troy Troy, Michigan  48098
Valley Hospital Ridgewood, New Jersey  07450
Radiation Oncology Associates of Albuquerque Albuquerque, New Mexico  87109
Finger Lakes Radiation Oncology Center Clifton Springs, New York  14432
Vassar Brothers Medical Center Poughkeepsie, New York  12601
Riverhill Radiation Oncology Yonkers, New York  10701
Trinity Cancer Care Center Minot, North Dakota  58701
Barrett Cancer Center Cincinnati, Ohio  45267-0502
St. Luke's Hospital Cancer Center Bethlehem, Pennsylvania  18015
Mercy Fitzgerald Hospital Darby, Pennsylvania  19023
Pocono Cancer Center East Stroudsburg, Pennsylvania  18301
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
Latter Day Saints Hospital Salt Lake City, Utah  84143
RMH Regional Cancer Center Harrisonburg, Virginia  22801
All Saints Cancer Center Racine, Wisconsin  53405
Cancer Center at Lexington Clinic Lexington, Kentucky  40504
Somerset Medical Center Somerville, New Jersey  08876
Bon-Secours - St. Mary's Hospital Richmond, Virginia  23226