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A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer


OBJECTIVES:

- Compare the efficacy of moderate-duration (28 weeks) neoadjuvant total androgen
suppression (TAS) and radiotherapy (RT) with short-duration (8 weeks) neoadjuvant TAS
and RT, as related to disease-specific survival, in patients with intermediate-risk
adenocarcinoma of the prostate.

- Compare these regimens, in terms of overall survival, disease-free survival, time to
local tumor progression or distant failure, time to first biochemical failure,
hormone-refractory state, and treatment-induced morbidity, in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
prostate-specific antigen level (no greater than 10 ng/mL vs greater than 10 but no greater
than 20 ng/mL vs greater than 20 ng/mL), tumor stage (T1b-2 vs T3-4), Gleason score (2-4 vs
5-6 vs 7-10), and prior hormonal therapy (yes vs no). Patients are randomized to one of two
treatment arms.

- Arm I: Patients receive total androgen suppression for 8 weeks prior to the initiation
of radiotherapy and throughout radiotherapy. A luteinizing hormone-releasing hormone
(LHRH) agonist is administered every 1-3 months AND bicalutamide OR flutamide is given
orally daily for a total duration of 16 weeks. Beginning with week 9, patients undergo
radiotherapy 5 days a week for 8 weeks.

- Arm II: Patients receive total androgen suppression for 28 weeks prior to the
initiation of radiotherapy and throughout radiotherapy. An LHRH agonist AND
bicalutamide OR flutamide are administered as in arm I for a total duration of 36
weeks. Beginning with week 29, patients undergo radiotherapy as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 1,540 patients (770 per treatment arm) will be accrued for
this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Intermediate risk for disease relapse as determined by any of the following
combination of factors:

- T1b-4, Gleason score 2-6, and prostate-specific antigen (PSA) greater than 10
but no greater than 100 ng/mL

- T1b-4, Gleason score 7, and PSA less than 20 ng/mL

- T1b-1c, Gleason score 8-10, and PSA less than 20 ng/mL

- Must have disease confirmation within 180 days of study randomization

- Clinically negative lymph nodes (N0) as established by imaging or negative lymph
nodes by nodal sampling or dissection

- Radiologic or radioimmunoscintigraphy findings suggestive of regional nodal
involvement allowed provided cytologic or histologic evaluation shows no
evidence of a neoplastic process

- Equivocal radiologic findings (i.e., maximum nodal size no greater than 1.5 cm)
allowed

- No distant metastases (M0)

- Radionuclide imaging findings suggestive but not diagnostic of metastatic
disease allowed provided radiologic imaging does not confirm metastatic disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0 or 1

Life expectancy:

- At least 10 years

Hematopoietic:

- Not specified

Hepatic:

- ALT no greater than 2 times upper limit of normal

Renal:

- Not specified

Other:

- Fertile patients must use effective contraception

- No other concurrent medical illness that would result in a life expectancy of less
than 10 years

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

- No other concurrent major medical or psychiatric illness that would preclude study
treatment or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for prostate cancer

Endocrine therapy:

- No prior androgen-deprivation therapy except luteinizing hormone-releasing hormone
(LHRH) agonist AND bicalutamide OR flutamide provided:

- LHRH agonist was initiated no more than 30 days before study randomization and
bicalutamide OR flutamide was initiated no more than 14 days before or after
LHRH agonist administration

- No concurrent finasteride for prostatic hypertrophy

Radiotherapy:

- No prior pelvic external beam radiotherapy

- No prior radionuclide prostate brachytherapy

- No concurrent intensity-modulated radiotherapy

Surgery:

- No prior prostatectomy

- No prior prostatic cryosurgery

- No prior bilateral orchiectomy

Other:

- No other concurrent medical research study involving prostate cancer treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Michael G. Haddock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000067635

NCT ID:

NCT00005044

Start Date:

February 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

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
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
MBCCOP - Hawaii Honolulu, Hawaii  96813
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
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Abington Memorial Hospital Abington, Pennsylvania  19001
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
St. Luke's Medical Center Milwaukee, Wisconsin  53215
Hurley Medical Center Flint, Michigan  48503
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
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
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Sinai Hospital of Baltimore Baltimore, Maryland  21225
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
Bloomington Hospital Bloomington, Indiana  47402
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
Methodist Cancer Center at Methodist Hospital Indianapolis, Indiana  46202
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
MD Anderson Cancer Center Orlando Orlando, Florida  32806
CCOP - Ochsner New Orleans, Louisiana  70121
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
Marshfield Clinic Marshfield, Wisconsin  54449
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
Mount Diablo Medical Center Concord, California  94524-4110
California Cancer Center Fresno, California  93720
Saint Agnes Cancer Center Fresno, California  93720
Sutter Health Western Division Cancer Research Group Greenbrae, California  94904
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
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
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
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
Wendt Regional Cancer Center of Finley Hospital Dubuque, Iowa  52001
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
Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
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
New York Methodist Hospital Brooklyn, New York  11215-3609
Champlain Valley Physicians Hospital Medical Center Plattsburgh, New York  12901
Akron General Medical Center Akron, Ohio  44302
University Hospitals of Cleveland Cleveland, Ohio  44106
CCOP - Columbus Columbus, Ohio  43206
CCOP - Dayton Kettering, Ohio  45429
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
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
CCOP - Greenville Greenville, South Carolina  29615
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
LDS Hospital Salt Lake City, Utah  84143
Green Mountain Oncology Group Rutland, Vermont  05701
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Deaconess Medical Center Spokane, Washington  99210-0248
Yakima Valley Memorial Hospital Yakima, Washington  98902
St. Vincent Hospital Green Bay, Wisconsin  54307-3508
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
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology Program Portland, Oregon  97225
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
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
Naval Medical Center - San Diego San Diego, California  92134-3202
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
CCOP - Oklahoma Tulsa, Oklahoma  74136
Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Foundation for Cancer Research and Education Phoenix, Arizona  85013
Bay Medical Center Panama City, Florida  32401
Peninsula Regional Medical Center Salisbury, Maryland  21801
MidMichigan Medical Center - Midland Midland, Michigan  48670
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
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. 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
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
City of Hope Comprehensive Cancer Center Duarte, California  91010
UCSF Comprehensive Cancer Center San Francisco, California  94115
Cooper Cancer Institute Camden, New Jersey  08103
CCOP - Beaumont Royal Oak, Michigan  48073-6769
CCOP - Colorado Cancer Research Program, Incorporated Denver, Colorado  80224
Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15236
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
Cancer Research Center at Boston Medical Center Boston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
St. Louis University Hospital Cancer Center Saint Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia University New York, New York  10032
James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky  40202
Roger Williams Medical Center Providence, Rhode Island  02908-4735
Fairview University Medical Center - University Campus Minneapolis, Minnesota  55455
DCH Cancer Treatment Center Tuscaloosa, Alabama  35401
Robert and Beverly Lewis Family Cancer Care Center Pomona, California  91767
Radiation Medical Group, Incorporated San Diego, California  92101
Hospital of St. Raphael New Haven, Connecticut  06511
Holmes Regional Medical Center Melbourne, Florida  32901-3276
Regional Radiation Oncology Center at Rome Rome, Georgia  30165
Community Regional Cancer Care Indianapolis, Indiana  46219
Central Baptist Hospital Lexington, Kentucky  40503
William Beaumont Hospital - Troy Troy, Michigan  48098
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Mount Holly, New Jersey  08060
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
Riverhill Radiation Oncology Yonkers, New York  10701
Trinity Cancer Care Center Minot, North Dakota  58701
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
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
RMH Regional Cancer Center Harrisonburg, Virginia  22801
Bon Secours - St. Mary's Hospital Richmond, Virginia  23226
Waukesha Memorial Hospital Regional Cancer Center Waukesha, Wisconsin  53188
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Massey Cancer Center at Virginia Commonwealth University Richmond, Virginia  23298-0037
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha Omaha, Nebraska  68114-4199
Wellspan Health - York Cancer Center York, Pennsylvania  17403
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Comprehensive Cancer Institute Huntsville, Alabama  35801
Torrance Memorial Medical Center Torrance, California  90505
Sibley Memorial Hospital Washington, District of Columbia  20016
21st Century Oncology - Fort Myers Fort Myers, Florida  33901-8082
Tallahassee Memorial Hospital Tallahassee, Florida  32308
CCOP - Scott and White Hospital Peoria, Illinois  61602
St. Elizabeth Medical Center Edgewood, Kentucky  41017
St. Agnes Cancer Center Baltimore, Maryland  21229
NSMC Cancer Center Peabody, Massachusetts  01960
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Medical Center of Princeton Princeton, New Jersey  08540
Somerset Medical Center Somerville, New Jersey  08876
Batte Cancer Center at Northeast Medical Center Concord, North Carolina  28025
Cancer Center at Christ Hospital Cincinnati, Ohio  45219
Parma Community General Hospital Parma, Ohio  44129
Arlington Cancer Center Arlington, Texas  76012
Vermont Cancer Center at University of Vermont Burlington, Vermont  05405-0075
Cancer Institute at Virginia Mason Medical Center Seattle, Washington  98111
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
Shands Cancer Center at the University of Florida Health Science Center Gainesville, Florida  32610-0296
William Beaumont Hospital - Royal Oak Royal Oak, Michigan  48073-6769
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina Greenville, North Carolina  27858-4354
Norris Cotton Cancer Center at Dartmouth Medical School Lebanon, New Hampshire  03756-0002
Abramson Cancer Center at University of Pennsylvania Medical Center Philadelphia, Pennsylvania  19104
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Fox Chase Cancer Center at St. Francis Medical Center Trenton, New Jersey  08629
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital Allentown, Pennsylvania  18105
All Saints Cancer Center at All Saints Healthcare Racine, Wisconsin  53405
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73126
University of Miami Sylvester Cancer Center Miami, Florida  33136
Huntington Cancer Center at Huntington Hospital Pasadena, California  91105
Ball Memorial Hospital Cancer Center Muncie, Indiana  47303-3499
Frank C. Love Cancer Institute at St. Anthony Hospital Oklahoma City, Oklahoma  73101
Huntsville Hospital Huntsville, Alabama  35807
Montgomery Cancer Center Montgomery, Alabama  36106-3657
Louisville Radiation Oncology Center at Caritas Regional Cancer Center Louisville, Kentucky  40215
Beth Israel Medical Center - Philipps Ambulatory Care Center New York, New York  10003
Wilkes-Barre General Hospital Wilkes-Barre, Pennsylvania  18764-0001
West Tennessee Cancer Center at Jackson-Madison County General Hospital Jackson, Tennessee  38301