Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

Phase II-III Trial of Adjuvant Radiotherapy Following Radical Prostatectomy With or Without Adjuvant Docetaxel

This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage II Prostate Adenocarcinoma; Stage III Prostate Adenocarcinoma; Stage I Prostate Adenocarcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Drug: Docetaxel; Radiation: External Beam Radiation Therapy; Drug: Flutamide; Drug: Nilutamide; Drug: Goserelin Acetate; Drug: Bicalutamide; Drug: Leuprolide Acetate

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the benefit of docetaxel as measured by improvement in freedom from progression (phase II) and subsequently metastasis free survival (phase III) when given in combination with radiation and androgen deprivation in treatment of high risk prostate cancer post-radical prostatectomy.

SECONDARY OBJECTIVES:

I. To assess overall survival. II. To assess local time to progression. III. To assess undetectable prostate-specific antigen (PSA) with a non-castrate testosterone at 2.5 years post treatment.

IV. To assess the utility of genomic profiling in making adjuvant therapy decisions post-prostatectomy.

V. To assess toxicity of docetaxel in the post-operative setting when combined with radiation and androgen deprivation therapy.

VI. To assess treatment response by genomically defined sub-groups of prostate cancer patients.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive external beam radiation therapy (EBRT) for 7.5 weeks.

ARM II: Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel intravenously (IV) on day 1 of every 21 days for 6 courses in the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then yearly.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
• Puerto Rico
  • San Juan, Puerto Rico, 00927
    • Centro Comprensivo de Cancer de UPR
• United States
  • Alabama
    • Mobile, Alabama, United States, 36607
      • Mobile Infirmary Medical Center
  • Alaska
    • Fairbanks, Alaska, United States, 99701
      • Fairbanks Memorial Hospital
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Cancer Center at Saint Joseph's
    • Tucson, Arizona, United States, 85704
      • University of Arizona Cancer Center-Orange Grove Campus
    • Tucson, Arizona, United States, 85719
      • Banner University Medical Center - Tucson
    • Tucson, Arizona, United States, 85719
      • University of Arizona Cancer Center-North Campus
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
  • California
    • Antioch, California, United States, 94531
      • Kaiser Permanente-Deer Valley Medical Center
    • Chico, California, United States, 95973
      • Adventist Health Cancer Care Center Chico
    • Dublin, California, United States, 94568
      • Kaiser Permanente Dublin
    • Fremont, California, United States, 94538
      • Kaiser Permanente-Fremont
    • Fresno, California, United States, 93720
      • Kaiser Permanente-Fresno
    • Fresno, California, United States, 93720
      • Fresno Cancer Center
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • Modesto, California, United States, 95356
      • Kaiser Permanente-Modesto
    • Oakland, California, United States, 94611
      • Kaiser Permanente-Oakland
    • Oakland, California, United States, 94611
      • Kaiser Permanente Oakland-Broadway
    • Rancho Cordova, California, United States, 95670
      • Kaiser Permanente-Rancho Cordova Cancer Center
    • Redwood City, California, United States, 94063
      • Kaiser Permanente-Redwood City
    • Richmond, California, United States, 94801
      • Kaiser Permanente-Richmond
    • Rohnert Park, California, United States, 94928
      • Rohnert Park Cancer Center
    • Roseville, California, United States, 95678
      • The Permanente Medical Group-Roseville Radiation Oncology
    • Roseville, California, United States, 95661
      • Kaiser Permanente-Roseville
    • Roseville, California, United States, 95661
      • Sutter Cancer Centers Radiation Oncology Services-Roseville
    • Sacramento, California, United States, 95816
      • Sutter Medical Center Sacramento
    • Sacramento, California, United States, 95823
      • Kaiser Permanente-South Sacramento
    • Sacramento, California, United States, 95823
      • South Sacramento Cancer Center
    • Sacramento, California, United States, 95825
      • Kaiser Permanente - Sacramento
    • San Diego, California, United States, 92134
      • Naval Medical Center -San Diego
    • San Francisco, California, United States, 94115
      • Kaiser Permanente-San Francisco
    • San Jose, California, United States, 95119
      • Kaiser Permanente-Santa Teresa-San Jose
    • San Leandro, California, United States, 94577
      • Kaiser Permanente San Leandro
    • San Rafael, California, United States, 94903
      • Kaiser San Rafael-Gallinas
    • San Rafael, California, United States, 94903
      • Kaiser Permanente-San Rafael
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Medical Center - Santa Clara
    • Santa Rosa, California, United States, 95403
      • Kaiser Permanente-Santa Rosa
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente Cancer Treatment Center
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente-South San Francisco
    • Stockton, California, United States, 95210
      • Kaiser Permanente-Stockton
    • Sunnyvale, California, United States, 94086
      • Palo Alto Medical Foundation-Sunnyvale
    • Truckee, California, United States, 96161
      • Gene Upshaw Memorial Tahoe Forest Cancer Center
    • Vacaville, California, United States, 95688
      • Kaiser Permanente Medical Center-Vacaville
    • Vallejo, California, United States, 94589
      • Kaiser Permanente-Vallejo
    • Vallejo, California, United States, 94589
      • Sutter Solano Medical Center/Cancer Center
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente-Walnut Creek
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Colorado Springs, Colorado, United States, 80907
      • Penrose-Saint Francis Healthcare
    • Colorado Springs, Colorado, United States, 80909
      • UCHealth Memorial Hospital Central
    • Fort Collins, Colorado, United States, 80524
      • Poudre Valley Hospital
  • Delaware
    • Frankford, Delaware, United States, 19945
      • Beebe South Coastal Health Campus
    • Newark, Delaware, United States, 19713
      • Helen F Graham Cancer Center
    • Newark, Delaware, United States, 19718
      • Christiana Care Health System-Christiana Hospital
    • Rehoboth Beach, Delaware, United States, 19971
      • Beebe Health Campus
  • Florida
    • Aventura, Florida, United States, 33180
      • Mount Sinai Comprehensive Cancer Center at Aventura
    • Aventura, Florida, United States, 33180
      • GenesisCare USA - Aventura FP
    • Aventura, Florida, United States, 33180
      • GenesisCare USA - Aventura
    • Celebration, Florida, United States, 34747
      • AdventHealth Celebration
    • Coral Gables, Florida, United States, 33146
      • UM Sylvester Comprehensive Cancer Center at Coral Gables
    • Deerfield Beach, Florida, United States, 33442
      • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
    • Key West, Florida, United States, 33040
      • GenesisCare USA - Key West
    • Kissimmee, Florida, United States, 34744
      • AdventHealth Kissimmee
    • Lakeland, Florida, United States, 33805
      • Lakeland Regional Health Hollis Cancer Center
    • Lakewood Ranch, Florida, United States, 34202
      • GenesisCare USA - Lakewood Ranch
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine-Sylvester Cancer Center
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
    • Plantation, Florida, United States, 33324
      • GenesisCare USA - Plantation
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital/Winship Cancer Institute
    • Atlanta, Georgia, United States, 30342
      • Emory Saint Joseph's Hospital
    • Atlanta, Georgia, United States, 30303
      • Grady Health System
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
    • Fayetteville, Georgia, United States, 30214
      • Piedmont Fayette Hospital
    • Savannah, Georgia, United States, 31405
      • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Idaho
    • Boise, Idaho, United States, 83706
      • Saint Alphonsus Cancer Care Center-Boise
  • Illinois
    • Alton, Illinois, United States, 62002
      • Alton Memorial Hospital
    • Bloomington, Illinois, United States, 61704
      • Illinois CancerCare-Bloomington
    • Canton, Illinois, United States, 61520
      • Illinois CancerCare-Canton
    • Carthage, Illinois, United States, 62321
      • Illinois CancerCare-Carthage
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Decatur, Illinois, United States, 62526
      • Decatur Memorial Hospital
    • Effingham, Illinois, United States, 62401
      • Crossroads Cancer Center
    • Elmhurst, Illinois, United States, 60126
      • Elmhurst Memorial Hospital
    • Eureka, Illinois, United States, 61530
      • Illinois CancerCare-Eureka
    • Galesburg, Illinois, United States, 61401
      • Illinois CancerCare-Galesburg
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Kewanee, Illinois, United States, 61443
      • Illinois CancerCare-Kewanee Clinic
    • Macomb, Illinois, United States, 61455
      • Illinois CancerCare-Macomb
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Naperville, Illinois, United States, 60540
      • Edward Hospital/Cancer Center
    • Ottawa, Illinois, United States, 61350
      • Illinois CancerCare-Ottawa Clinic
    • Pekin, Illinois, United States, 61554
      • Illinois CancerCare-Pekin
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61637
      • OSF Saint Francis Medical Center
    • Peoria, Illinois, United States, 61615
      • Illinois CancerCare-Peoria
    • Peoria, Illinois, United States, 61615
      • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
    • Peru, Illinois, United States, 61354
      • Illinois CancerCare-Peru
    • Plainfield, Illinois, United States, 60585
      • Edward Hospital/Cancer Center?Plainfield
    • Princeton, Illinois, United States, 61356
      • Illinois CancerCare-Princeton
  • Indiana
    • Fort Wayne, Indiana, United States, 46805
      • Parkview Hospital Randallia
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Regional Medical Center
    • Goshen, Indiana, United States, 46526
      • Goshen Center for Cancer Care
    • Indianapolis, Indiana, United States, 46202
      • Indiana University/Melvin and Bren Simon Cancer Center
    • Richmond, Indiana, United States, 47374
      • Reid Health
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic PC - Ames
    • Cedar Rapids, Iowa, United States, 52403
      • Mercy Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Cancer Center
    • Olathe, Kansas, United States, 66061
      • Olathe Health Cancer Center
    • Overland Park, Kansas, United States, 66210
      • University of Kansas Cancer Center-Overland Park
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Cancer Center / Stormont Vail Health
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi Hospitals Wichita
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • East Jefferson General Hospital
    • Metairie, Louisiana, United States, 70006
      • LSU Healthcare Network / Metairie Multi-Specialty Clinic
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center Jefferson
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland/Greenebaum Cancer Center
    • Columbia, Maryland, United States, 21044
      • Central Maryland Radiation Oncology in Howard County
    • Glen Burnie, Maryland, United States, 21061
      • UM Baltimore Washington Medical Center/Tate Cancer Center
    • Ocean Pines, Maryland, United States, 21811
      • TidalHealth Richard A Henson Cancer Institute
    • Salisbury, Maryland, United States, 21801
      • TidalHealth Peninsula Regional
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
    • Peabody, Massachusetts, United States, 01960
      • Lahey Medical Center-Peabody
    • Winchester, Massachusetts, United States, 01890
      • Winchester Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center
    • Ann Arbor, Michigan, United States, 48106
      • Saint Joseph Mercy Hospital
    • Brownstown, Michigan, United States, 48183
      • Henry Ford Cancer Institute-Downriver
    • Clarkston, Michigan, United States, 48346
      • McLaren Cancer Institute-Clarkston
    • Clarkston, Michigan, United States, 48346
      • GenesisCare USA - Clarkston
    • Clinton Township, Michigan, United States, 48038
      • Henry Ford Macomb Hospital-Clinton Township
    • Dearborn, Michigan, United States, 48124
      • Beaumont Hospital - Dearborn
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201
      • Wayne State University/Karmanos Cancer Institute
    • Detroit, Michigan, United States, 48236
      • Ascension Saint John Hospital
    • Farmington Hills, Michigan, United States, 48334
      • Weisberg Cancer Treatment Center
    • Farmington Hills, Michigan, United States, 48334
      • GenesisCare USA - Farmington Hills
    • Flint, Michigan, United States, 48532
      • McLaren Cancer Institute-Flint
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health at Butterworth Campus
    • Jackson, Michigan, United States, 49201
      • Allegiance Health
    • Kalamazoo, Michigan, United States, 49007
      • West Michigan Cancer Center
    • Lansing, Michigan, United States, 48912
      • Sparrow Hospital
    • Lansing, Michigan, United States, 48912
      • Mid-Michigan Physicians-Lansing
    • Lansing, Michigan, United States, 48910
      • Karmanos Cancer Institute at McLaren Greater Lansing
    • Lapeer, Michigan, United States, 48446
      • McLaren Cancer Institute-Lapeer Region
    • Livonia, Michigan, United States, 48154
      • Trinity Health Saint Mary Mercy Livonia Hospital
    • Macomb, Michigan, United States, 48044
      • GenesisCare USA - Macomb
    • Madison Heights, Michigan, United States, 48071
      • GenesisCare USA - Madison Heights
    • Mount Clemens, Michigan, United States, 48043
      • McLaren Cancer Institute-Macomb
    • Mount Pleasant, Michigan, United States, 48858
      • McLaren Cancer Institute-Central Michigan
    • Petoskey, Michigan, United States, 49770
      • McLaren Cancer Institute-Northern Michigan
    • Pontiac, Michigan, United States, 48341
      • Saint Joseph Mercy Oakland
    • Pontiac, Michigan, United States, 48341
      • 21st Century Oncology-Pontiac
    • Port Huron, Michigan, United States, 48060
      • McLaren-Port Huron
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital-Royal Oak
    • Saginaw, Michigan, United States, 48601
      • Ascension Saint Mary's Hospital
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital - Troy
    • Troy, Michigan, United States, 48098
      • GenesisCare USA - Troy
    • Warren, Michigan, United States, 48093
      • Saint John Macomb-Oakland Hospital
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford West Bloomfield Hospital
    • Wyoming, Michigan, United States, 49519
      • Metro Health Hospital
  • Minnesota
    • Albert Lea, Minnesota, United States, 56007
      • Mayo Clinic Health System in Albert Lea
    • Bemidji, Minnesota, United States, 56601
      • Sanford Joe Lueken Cancer Center
    • Duluth, Minnesota, United States, 55805
      • Saint Luke's Hospital of Duluth
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital
    • Mankato, Minnesota, United States, 56001
      • Mayo Clinic Health Systems-Mankato
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
    • Saint Cloud, Minnesota, United States, 56303
      • Coborn Cancer Center at Saint Cloud Hospital
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Clinic - Saint Louis Park
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Cape Girardeau, Missouri, United States, 63703
      • Saint Francis Medical Center
    • Kansas City, Missouri, United States, 64154
      • University of Kansas Cancer Center - North
    • Kansas City, Missouri, United States, 64131
      • The University of Kansas Cancer Center-South
    • Lee's Summit, Missouri, United States, 64064
      • University of Kansas Cancer Center - Lee's Summit
    • Rolla, Missouri, United States, 65401
      • Delbert Day Cancer Institute at PCRMC
    • Saint Joseph, Missouri, United States, 64506
      • Heartland Regional Medical Center
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital Saint Louis
    • Saint Louis, Missouri, United States, 63129
      • Siteman Cancer Center-South County
    • Saint Louis, Missouri, United States, 63136
      • Siteman Cancer Center at Christian Hospital
    • Saint Peters, Missouri, United States, 63376
      • Siteman Cancer Center at Saint Peters Hospital
    • Springfield, Missouri, United States, 65804
      • Mercy Hospital Springfield
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic Cancer Center
    • Bozeman, Montana, United States, 59715
      • Bozeman Deaconess Hospital
    • Great Falls, Montana, United States, 59405
      • Benefis Healthcare- Sletten Cancer Institute
    • Kalispell, Montana, United States, 59901
      • Kalispell Regional Medical Center
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Radiation Oncology Centers of Nevada Central
    • Las Vegas, Nevada, United States, 89119
      • Radiation Oncology Centers of Nevada Southeast
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
  • New Jersey
    • Cape May Court House, New Jersey, United States, 08210
      • AtlantiCare Health Park-Cape May Court House
    • Egg Harbor Township, New Jersey, United States, 08234
      • AtlantiCare Surgery Center
    • Somerville, New Jersey, United States, 08876
      • Robert Wood Johnson University Hospital Somerset
  • New York
    • Brooklyn, New York, United States, 11215
      • New York-Presbyterian/Brooklyn Methodist Hospital
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Rochester, New York, United States, 14620
      • Highland Hospital
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
    • White Plains, New York, United States, 10601
      • Dickstein Cancer Treatment Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Greensboro, North Carolina, United States, 27403
      • Cone Health Cancer Center
    • Hendersonville, North Carolina, United States, 28791
      • Margaret R Pardee Memorial Hospital
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Sanford Bismarck Medical Center
    • Fargo, North Dakota, United States, 58122
      • Sanford Roger Maris Cancer Center
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • UHHS-Chagrin Highlands Medical Center
    • Chardon, Ohio, United States, 44024
      • Geauga Hospital
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
    • Dayton, Ohio, United States, 45415
      • Miami Valley Hospital North
    • Elyria, Ohio, United States, 44035
      • Mercy Cancer Center-Elyria
    • Franklin, Ohio, United States, 45005-1066
      • Atrium Medical Center-Middletown Regional Hospital
    • Mentor, Ohio, United States, 44060
      • UH Seidman Cancer Center at Lake Health Mentor Campus
    • Middleburg Heights, Ohio, United States, 44130
      • UH Seidman Cancer Center at Southwest General Hospital
    • Parma, Ohio, United States, 44129
      • University Hospitals Parma Medical Center
    • Ravenna, Ohio, United States, 44266
      • University Hospitals Portage Medical Center
    • Sandusky, Ohio, United States, 44870
      • UH Seidman Cancer Center at Firelands Regional Medical Center
    • Springfield, Ohio, United States, 45504
      • Springfield Regional Cancer Center
    • Sylvania, Ohio, United States, 43560
      • ProMedica Flower Hospital
    • Toledo, Ohio, United States, 43614
      • University of Toledo
    • Westlake, Ohio, United States, 44145
      • UHHS-Westlake Medical Center
  • Oklahoma
    • Lawton, Oklahoma, United States, 73505
      • Cancer Centers of Southwest Oklahoma Research
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Clackamas Radiation Oncology Center
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
    • Portland, Oregon, United States, 97225
      • Providence Saint Vincent Medical Center
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Jefferson Abington Hospital
    • Broomall, Pennsylvania, United States, 19008
      • Crozer-Keystone Regional Cancer Center at Broomall
    • Chadds Ford, Pennsylvania, United States, 19317
      • Christiana Care Health System-Concord Health Center
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Dunmore, Pennsylvania, United States, 18512
      • Northeast Radiation Oncology Center
    • Erie, Pennsylvania, United States, 16544
      • Saint Vincent Hospital
    • Glen Mills, Pennsylvania, United States, 19342
      • Crozer Regional Cancer Center at Brinton Lake
    • Harrisburg, Pennsylvania, United States, 17109
      • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
    • Jefferson Hills, Pennsylvania, United States, 15025
      • Jefferson Hospital
    • Langhorne, Pennsylvania, United States, 19047
      • Saint Mary Medical and Regional Cancer Center
    • Lewisburg, Pennsylvania, United States, 17837
      • Geisinger Medical Oncology-Lewisburg
    • Lewistown, Pennsylvania, United States, 17044
      • Lewistown Hospital
    • Monroeville, Pennsylvania, United States, 15146
      • Forbes Hospital
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Philadelphia, Pennsylvania, United States, 19114
      • Jefferson Torresdale Hospital
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Reading, Pennsylvania, United States, 19605
      • Penn State Health Saint Joseph Medical Center
    • West Reading, Pennsylvania, United States, 19611
      • Reading Hospital
    • Wexford, Pennsylvania, United States, 15090
      • Wexford Health and Wellness Pavilion
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley/Henry Cancer Center
    • Willow Grove, Pennsylvania, United States, 19090
      • Asplundh Cancer Pavilion
  • South Carolina
    • Boiling Springs, South Carolina, United States, 29316
      • Prisma Health Cancer Institute - Spartanburg
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Cancer Institute - Faris
    • Greenville, South Carolina, United States, 29607
      • Saint Francis Cancer Center
    • Greenville, South Carolina, United States, 29615
      • Prisma Health Cancer Institute - Eastside
    • Greenwood, South Carolina, United States, 29646
      • Self Regional Healthcare
    • Greer, South Carolina, United States, 29650
      • Prisma Health Cancer Institute - Greer
    • Greer, South Carolina, United States, 29651
      • Gibbs Cancer Center-Pelham
    • Hilton Head Island, South Carolina, United States, 29926
      • The Radiation Oncology Center-Hilton Head/Bluffton
    • Myrtle Beach, South Carolina, United States, 29577
      • Carolina Regional Cancer Center
    • Seneca, South Carolina, United States, 29672
      • Prisma Health Cancer Institute - Seneca
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
    • Sioux Falls, South Dakota, United States, 57117-5134
      • Sanford USD Medical Center - Sioux Falls
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern/Simmons Cancer Center-Dallas
    • Galveston, Texas, United States, 77555-0565
      • University of Texas Medical Branch
    • League City, Texas, United States, 77573
      • UTMB Cancer Center at Victory Lakes
  • Utah
    • Cedar City, Utah, United States, 84720
      • Sandra L Maxwell Cancer Center
    • Logan, Utah, United States, 84321
      • Logan Regional Hospital
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Ogden, Utah, United States, 84403
      • McKay-Dee Hospital Center
    • Saint George, Utah, United States, 84770
      • Saint George Regional Medical Center
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists-Salt Lake City
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Southwestern Vermont Medical Center
    • Saint Johnsbury, Vermont, United States, 05819
      • Norris Cotton Cancer Center-North
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Cancer Center
  • Washington
    • Auburn, Washington, United States, 98001
      • MultiCare Auburn Medical Center
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • West Virginia University Charleston Division
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Healthcare
    • Parkersburg, West Virginia, United States, 26101
      • Camden Clark Medical Center
  • Wisconsin
    • Antigo, Wisconsin, United States, 54409
      • Langlade Hospital and Cancer Center
    • Appleton, Wisconsin, United States, 54911
      • ThedaCare Regional Cancer Center
    • Eau Claire, Wisconsin, United States, 54701
      • Marshfield Medical Center-EC Cancer Center
    • Grafton, Wisconsin, United States, 53024
      • Aurora Cancer Care-Grafton
    • Green Bay, Wisconsin, United States, 54311
      • Aurora BayCare Medical Center
    • Johnson Creek, Wisconsin, United States, 53038
      • UW Cancer Center Johnson Creek
    • Kenosha, Wisconsin, United States, 53142
      • Aurora Cancer Care-Kenosha South
    • Marinette, Wisconsin, United States, 54143
      • Aurora Bay Area Medical Group-Marinette
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Medical Center-Marshfield
    • Menomonee Falls, Wisconsin, United States, 53051
      • Froedtert Menomonee Falls Hospital
    • Mequon, Wisconsin, United States, 53097
      • Ascension Columbia Saint Mary's Hospital Ozaukee
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53233
      • Aurora Sinai Medical Center
    • Milwaukee, Wisconsin, United States, 53211
      • Ascension Columbia Saint Mary's Hospital - Milwaukee
    • Milwaukee, Wisconsin, United States, 53295
      • Zablocki Veterans Administration Medical Center
    • Minocqua, Wisconsin, United States, 54548
      • Marshfield Clinic-Minocqua Center
    • Oak Creek, Wisconsin, United States, 53154
      • Drexel Town Square Health Center
    • Oshkosh, Wisconsin, United States, 54904
      • Vince Lombardi Cancer Clinic - Oshkosh
    • Rice Lake, Wisconsin, United States, 54868
      • Marshfield Medical Center-Rice Lake
    • Sheboygan, Wisconsin, United States, 53081
      • Vince Lombardi Cancer Clinic-Sheboygan
    • Stevens Point, Wisconsin, United States, 54482
      • Marshfield Medical Center-River Region at Stevens Point
    • Summit, Wisconsin, United States, 53066
      • Aurora Medical Center in Summit
    • Two Rivers, Wisconsin, United States, 54241
      • Vince Lombardi Cancer Clinic-Two Rivers
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Regional Cancer Center
    • Wauwatosa, Wisconsin, United States, 53226
      • Aurora Cancer Care-Milwaukee West
    • West Allis, Wisconsin, United States, 53227
      • Aurora West Allis Medical Center
    • West Bend, Wisconsin, United States, 53095
      • Froedtert West Bend Hospital/Kraemer Cancer Center
    • Weston, Wisconsin, United States, 54476
      • Marshfield Medical Center - Weston
    • Weston, Wisconsin, United States, 54476
      • Diagnostic and Treatment Center
    • Wisconsin Rapids, Wisconsin, United States, 54494
      • Aspirus Cancer Care - Wisconsin Rapids

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patients post-prostatectomy with baseline Gleason >= 7 (per prostatectomy pathology) and baseline PSA prior to the start of androgen deprivation therapy nadir >= 0.2 ng/ml (post-operative value is never undetectable) obtained prior to step 1 registration
• Baseline testosterone level obtained post prostatectomy prior to the start of androgen deprivation therapy and prior to step 1 registration
• Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy; prostatectomy must have been performed =< 365 days (1 year) prior to step 1 registration
• Primary treatment with radical prostatectomy
• Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
• Prior ablative treatment for treatment of benign prostatic hypertrophy or focal high-intensity focused ultrasound therapy (HIFU) prior to prostatectomy is allowed
• Prior androgen deprivation (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to study enrollment and given for =< 90 days duration prior to radical prostatectomy; finasteride or dutasteride must be stopped before treatment but should not determine eligibility; for patients on prior LHRH analogs, the discontinuation date should be calculated based the expected duration of the sustained release injection, not simply the injection date of the drug
• Pathologically proven to be lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [pNx])

• Any pT-stage based on American Joint Committee on Cancer 7th edition is acceptable for study entry based on the following diagnostic workup:

  • History/physical examination within 60 days prior to step 1 registration
  • No distant metastases, based upon the following minimum diagnostic workup:
  • A computed tomography (CT) scan of the abdomen and/or pelvis (with contrast if renal function is acceptable; a CT without contrast is permitted if the patient is not a candidate for contrast) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to step 1 registration; lymph nodes will be non-metastatic unless they measure more than 1.5 cm short axis;
  • Bone scan within 120 days prior to step 1 registration (a sodium fluoride [NaF] positron emission tomography/computed tomography [PET/CT] is an acceptable substitute); if the bone scan is suspicious, a plain x-ray, CT scan, NaF PET/CT and/or MRI must be obtained to rule out metastasis
• Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 90 days prior to step 1 registration
• Platelets >= 1 X 10^6 cells/mm^3 (100,000) based upon complete blood count (CBC)
• Hemoglobin >= 10.0 g/dl based upon CBC (Note: The use of transfusion or other intervention to achieve Hgb >= 10.0 g/dl is not allowed)
• Absolute neutrophil count greater than 1.5 x 10^9/L (1500)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 1.5 x the upper limit of normal
• Total bilirubin normal unless history of Gilbert's syndrome
• The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration
• Available surgical formalin-fixed paraffin-embedded (FFPE) specimen for genomic analysis on DECIPHER Genomic Resource Information Database (GRID) platform

Exclusion Criteria:

• Definitive clinical or radiologic evidence of metastatic disease
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years) Ta bladder cancer is not considered invasive
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if completed more than two years prior to step 1 registration; prior androgen deprivation is allowed
• Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is allowed; prior focal HIFU or treatment for benign prostatic hypertrophy is allowed
• Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration

• Severe and/or active co-morbidity defined as follows:

  • History of inflammatory bowel disease
  • History of active hepatitis B or C; blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 15 days of step 1 registration or precluding study therapy at the time of step 1 registration
  • Uncontrolled severe illness or medical condition (including uncontrolled diabetes), which in the judgment of the treating physician would make the administration of chemotherapy inadvisable
  • Concurrent or planned treatment with strong inhibitors (e.g. ketoconazole, clarithromycin, etcetera [etc]) or strong inducers (e.g. carbamazepine, phenytoin, rifampin, phenobarbital, efavirenz, tipranavir, St. John's wort) of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
• Human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (CD4) count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to step 1 registration; note also that HIV testing is not required for eligibility for this protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (androgen deprivation therapy, EBRT); Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive EBRT for 7.5 weeks.	Other: Laboratory Biomarker Analysis; Correlative studies; Radiation: External Beam Radiation Therapy; Undergo external beam radiation therapy; Other Names: EBRT; Definitive Radiation Therapy; External Beam Radiotherapy; External Beam RT; external radiation; External Radiation Therapy; external-beam radiation; Drug: Flutamide; Other Names: Apimid; Cebatrol; Chimax; Cytomid; Drogenil; Euflex; Eulexine; Flucinom; Flucinome; Flugerel; Fluken; Flulem; FLUT; Fluta-Gry; Flutabene; Flutacan; Flutamex; Flutamin; Flutan; Flutaplex; Fugerel; Grisetin; Niftolide; Oncosal; Profamid; Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-; Prostacur; Prostadirex; Prostica; Prostogenat; Tafenil; Tecnoflut; Testotard; 4'-Nitro-3'-trifluoromethylisobutyranilide; SCH 13521; Drug: Nilutamide; Other Names: Anandron; Nilandron; RU-23908; Drug: Goserelin Acetate; Other Names: ZDX; Zoladex; Drug: Bicalutamide; Given orally; Other Names: Casodex; Cosudex; ICI 176,334; ICI 176334; Drug: Leuprolide Acetate; Other Names: Enantone; LEUP; Lupron; Lupron Depot; Leuprorelin Acetate; A-43818; Abbott 43818; Abbott-43818; Carcinil; Depo-Eligard; Eligard; Enanton; Enantone-Gyn; Ginecrin; Leuplin; Lucrin; Lucrin Depot; Lupron Depot-3 Month; Lupron Depot-4 Month; Lupron Depot-Ped; Procren; Procrin; Prostap; TAP-144; Trenantone; Uno-Enantone; Viadur
Experimental: Arm II (androgen deprivation therapy, EBRT, docetaxel); Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel IV on day 1 of every 21 days for 6 courses in the absence of disease progression or unexpected toxicity.	Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Docetaxel; Given IV; Other Names: Taxotere; Docecad; RP56976; Taxotere Injection Concentrate; Radiation: External Beam Radiation Therapy; Undergo external beam radiation therapy; Other Names: EBRT; Definitive Radiation Therapy; External Beam Radiotherapy; External Beam RT; external radiation; External Radiation Therapy; external-beam radiation; Drug: Flutamide; Other Names: Apimid; Cebatrol; Chimax; Cytomid; Drogenil; Euflex; Eulexine; Flucinom; Flucinome; Flugerel; Fluken; Flulem; FLUT; Fluta-Gry; Flutabene; Flutacan; Flutamex; Flutamin; Flutan; Flutaplex; Fugerel; Grisetin; Niftolide; Oncosal; Profamid; Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-; Prostacur; Prostadirex; Prostica; Prostogenat; Tafenil; Tecnoflut; Testotard; 4'-Nitro-3'-trifluoromethylisobutyranilide; SCH 13521; Drug: Nilutamide; Other Names: Anandron; Nilandron; RU-23908; Drug: Goserelin Acetate; Other Names: ZDX; Zoladex; Drug: Bicalutamide; Given orally; Other Names: Casodex; Cosudex; ICI 176,334; ICI 176334; Drug: Leuprolide Acetate; Other Names: Enantone; LEUP; Lupron; Lupron Depot; Leuprorelin Acetate; A-43818; Abbott 43818; Abbott-43818; Carcinil; Depo-Eligard; Eligard; Enanton; Enantone-Gyn; Ginecrin; Leuplin; Lucrin; Lucrin Depot; Lupron Depot-3 Month; Lupron Depot-4 Month; Lupron Depot-Ped; Procren; Procrin; Prostap; TAP-144; Trenantone; Uno-Enantone; Viadur

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from progression (FFP) (Phase II)	Will be determined with a one-sided stratified log-rank test when 89 FFP events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed. Events for FFP will be the first occurrence of biochemical failure by PSA >= 0.4 ng/ml over the nadir PSA confirmed by a second PSA higher than the first by any amount, recurrence (local, regional or distant), institution of secondary androgen deprivation therapy and death from any cause.	From time of randomization to first event, assessed up to 43 months
Metastasis free survival (MFS) (Phase III)	Will be measured with a one-sided stratified log-rank test when 282 MFS events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.	From time of randomization to first occurrence of distant metastasis or death from any cause, assessed up to 9.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Will be analyzed using log-rank methodology and Cox proportional models. Tests for violations of proportionality will performed for the survival models. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.	Time to death from any cause assessed up to 9.5 years
Time to local progression	Data will be summarized by cumulative incidence curves. Fine and Gray models will be used to adjust inference for competing risks. Both unadjusted and adjusted hazard ratios and the respective 95% confidence intervals will be computed.	Baseline to local or regional recurrence ignoring biochemical failure and distant recurrence and censoring for death, assessed up to 2.5 years
Proportions of patients with Grade 3 through Grade 5 adverse events that are either related to study drug or not graded according to NCI CTCAE version 3.0	Frequencies, proportions and severity of acute adverse events by treatment arm will be presented. Specifically, Grade 3 - 5 adverse events will be tallied. Adverse events related to study drug will also be tallied.	Up to 30 days post radiation therapy
Proportion of undetectable PSA with a non-castrate testosterone	Both unadjusted and adjusted odds ratios and the respective 95% confidence interval will be computed.	At 2.5 years post treatment

Collaborators and Investigators

• Sponsor: NRG Oncology
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2017
• Primary Completion (Anticipated): May 1, 2026
• Study Completion (Anticipated): May 1, 2031

Study Registration Dates

• First Submitted: December 30, 2016
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (Actual): March 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Adenocarcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Androgen Antagonists; Docetaxel; Leuprolide; Goserelin; Bicalutamide; Flutamide; Nilutamide
• Other Study ID Numbers: NRG-GU002 (Other Identifier: NRG Oncology); U10CA180868 (U.S. NIH Grant/Contract); NCI-2016-00963 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No