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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 HospitalAkron, Ohio  44304
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
MBCCOP - HawaiiHonolulu, Hawaii  96813
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Hurley Medical CenterFlint, Michigan  48503
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Bloomington HospitalBloomington, Indiana  47402
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
Methodist Cancer Center at Methodist HospitalIndianapolis, Indiana  46202
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
CCOP - OchsnerNew Orleans, Louisiana  70121
Rapid City Regional HospitalRapid City, South Dakota  57709
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Marshfield ClinicMarshfield, Wisconsin  54449
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Mount Diablo Medical CenterConcord, California  94524-4110
California Cancer CenterFresno, California  93720
Saint Agnes Cancer CenterFresno, California  93720
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Radiation Oncology Center - SacramentoSacramento, California  95816
O'Connor HospitalSan Jose, California  95128
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
Baptist Hospital of MiamiMiami, Florida  33176-2197
Florida Radiation Oncology GroupOrange Park, Florida  32073
Gulf Coast Cancer Treatment CenterPanama City, Florida  32405-4587
Sarasota Radiation and Medical Oncology CenterSarasota, Florida  34233
Medical Center/John B. Amos Community Cancer CenterColumbus, Georgia  31902
Northwest Community HospitalArlington Heights, Illinois  60005
Ingalls Memorial HospitalHarvey, Illinois  60426
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Central IllinoisSpringfield, Illinois  62526
St. John's Medical CenterAnderson, Indiana  46016
Wendt Regional Cancer Center of Finley HospitalDubuque, Iowa  52001
Merle M. Mahr Cancer CenterMadisonville, Kentucky  42431
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Tulane University School of MedicineNew Orleans, Louisiana  70112
Maine Medical CenterPortland, Maine  04102
Anne Arundel Oncology CenterAnnapolis, Maryland  21401
Greater Baltimore Medical Center and Cancer CenterBaltimore, Maryland  21204
Harbor Hospital CenterBaltimore, Maryland  21225
Cape Cod HospitalHyannis, Massachusetts  02601
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
McLaren Regional Cancer CenterFlint, Michigan  48432
Marquette General HospitalMarquette, Michigan  49855
Mallinckrodt Institute of RadiologySaint Louis, Missouri  63110
Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Elliot Regional Cancer CenterManchester, New Hampshire  03103
John F. Kennedy Medical CenterEdison, New Jersey  08818
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Community Medical CenterToms River, New Jersey  08755
New York Methodist HospitalBrooklyn, New York  11215-3609
Champlain Valley Physicians Hospital Medical CenterPlattsburgh, New York  12901
Akron General Medical CenterAkron, Ohio  44302
University Hospitals of ClevelandCleveland, Ohio  44106
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Veterans Affairs Medical Center - PhiladelphiaPhiladelphia, Pennsylvania  19104
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Mercy Hospital of PittsburghPittsburgh, Pennsylvania  15219
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Bayshore Medical CenterPasadena, Texas  77504
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
Green Mountain Oncology GroupRutland, Vermont  05701
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Deaconess Medical CenterSpokane, Washington  99210-0248
Yakima Valley Memorial HospitalYakima, Washington  98902
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Southern Wisconsin Radiotherapy CenterMadison, Wisconsin  53713
Community Memorial HospitalMenomonee Falls, Wisconsin  53051
Columbia HospitalMilwaukee, Wisconsin  53211
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Naval Medical Center - San DiegoSan Diego, California  92134-3202
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
CCOP - OklahomaTulsa, Oklahoma  74136
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Bay Medical CenterPanama City, Florida  32401
Peninsula Regional Medical CenterSalisbury, Maryland  21801
MidMichigan Medical Center - MidlandMidland, Michigan  48670
Trinitas Hospital - Jersey Street CampusElizabeth, New Jersey  07201
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
South Jersey Regional Cancer CenterMillville, New Jersey  08332
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Atlantic City Medical CenterPomona, New Jersey  08240
Associated Radiologists, P.A.Warren, New Jersey  07059
St. John Health SystemTulsa, Oklahoma  74104
University of Utah Health Sciences CenterSalt Lake City, Utah  84132
Schiffler Cancer CenterWheeling, West Virginia  26003
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
City of Hope Comprehensive Cancer CenterDuarte, California  91010
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Cooper Cancer InstituteCamden, New Jersey  08103
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
St. Louis University Hospital Cancer CenterSaint Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
James Graham Brown Cancer Center at University of LouisvilleLouisville, Kentucky  40202
Roger Williams Medical CenterProvidence, Rhode Island  02908-4735
Fairview University Medical Center - University CampusMinneapolis, Minnesota  55455
DCH Cancer Treatment CenterTuscaloosa, Alabama  35401
Robert and Beverly Lewis Family Cancer Care CenterPomona, California  91767
Radiation Medical Group, IncorporatedSan Diego, California  92101
Hospital of St. RaphaelNew Haven, Connecticut  06511
Holmes Regional Medical CenterMelbourne, Florida  32901-3276
Regional Radiation Oncology Center at RomeRome, Georgia  30165
Community Regional Cancer CareIndianapolis, Indiana  46219
Central Baptist HospitalLexington, Kentucky  40503
William Beaumont Hospital - TroyTroy, Michigan  48098
Fox Chase Virtua Health Cancer Program at Virtua Memorial HospitalMount Holly, New Jersey  08060
Valley HospitalRidgewood, New Jersey  07450
Radiation Oncology Associates of AlbuquerqueAlbuquerque, New Mexico  87109
Finger Lakes Radiation Oncology CenterClifton Springs, New York  14432
Riverhill Radiation OncologyYonkers, New York  10701
Trinity Cancer Care CenterMinot, North Dakota  58701
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
Mercy Fitzgerald HospitalDarby, Pennsylvania  19023
Pocono Cancer CenterEast Stroudsburg, Pennsylvania  18301
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
RMH Regional Cancer CenterHarrisonburg, Virginia  22801
Bon Secours - St. Mary's HospitalRichmond, Virginia  23226
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - OmahaOmaha, Nebraska  68114-4199
Wellspan Health - York Cancer CenterYork, Pennsylvania  17403
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Comprehensive Cancer InstituteHuntsville, Alabama  35801
Torrance Memorial Medical CenterTorrance, California  90505
Sibley Memorial HospitalWashington, District of Columbia  20016
21st Century Oncology - Fort MyersFort Myers, Florida  33901-8082
Tallahassee Memorial HospitalTallahassee, Florida  32308
CCOP - Scott and White HospitalPeoria, Illinois  61602
St. Elizabeth Medical CenterEdgewood, Kentucky  41017
St. Agnes Cancer CenterBaltimore, Maryland  21229
NSMC Cancer CenterPeabody, Massachusetts  01960
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Medical Center of PrincetonPrinceton, New Jersey  08540
Somerset Medical CenterSomerville, New Jersey  08876
Batte Cancer Center at Northeast Medical CenterConcord, North Carolina  28025
Cancer Center at Christ HospitalCincinnati, Ohio  45219
Parma Community General HospitalParma, Ohio  44129
Arlington Cancer CenterArlington, Texas  76012
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
Cancer Institute at Virginia Mason Medical CenterSeattle, Washington  98111
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Shands Cancer Center at the University of Florida Health Science CenterGainesville, Florida  32610-0296
William Beaumont Hospital - Royal OakRoyal Oak, Michigan  48073-6769
Leo W. Jenkins Cancer Center of University Health Systems of Eastern CarolinaGreenville, North Carolina  27858-4354
Norris Cotton Cancer Center at Dartmouth Medical SchoolLebanon, New Hampshire  03756-0002
Abramson Cancer Center at University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Cancer Center at St. Francis Medical CenterTrenton, New Jersey  08629
John and Dorothy Morgan Cancer Center at Lehigh Valley HospitalAllentown, Pennsylvania  18105
All Saints Cancer Center at All Saints HealthcareRacine, Wisconsin  53405
Oklahoma University Medical Center at University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73126
University of Miami Sylvester Cancer CenterMiami, Florida  33136
Huntington Cancer Center at Huntington HospitalPasadena, California  91105
Ball Memorial Hospital Cancer CenterMuncie, Indiana  47303-3499
Frank C. Love Cancer Institute at St. Anthony HospitalOklahoma City, Oklahoma  73101
Huntsville HospitalHuntsville, Alabama  35807
Montgomery Cancer CenterMontgomery, Alabama  36106-3657
Louisville Radiation Oncology Center at Caritas Regional Cancer CenterLouisville, Kentucky  40215
Beth Israel Medical Center - Philipps Ambulatory Care CenterNew York, New York  10003
Wilkes-Barre General HospitalWilkes-Barre, Pennsylvania  18764-0001
West Tennessee Cancer Center at Jackson-Madison County General HospitalJackson, Tennessee  38301