Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer

Phase III IGRT and SBRT vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer

This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage II Prostate Adenocarcinoma
• Intervention / Treatment: Radiation: Intensity-Modulated Radiation Therapy (IMRT); Radiation: Stereotactic Body Radiation Therapy (SBRT)

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether stereotactic body radiation therapy (SBRT) can be shown to be superior to hypofractionated intensity-modulated radiation therapy (IMRT) in terms of genitourinary (GU) and gastrointestinal (GI) toxicity by having fewer patients that experience a minimal important decline (MID) in urinary irritation/obstructive and bowel Health Related Quality of Life (HRQOL) as measured by Expanded Prostate Cancer Index Composite (EPIC)-26 at 24 months post completion of therapy.

SECONDARY OBJECTIVES:

I. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy) as measured by disease free survival (DFS).

II. To determine whether SBRT can be shown to be superior to hypofractionated IMRT at 12 and 24 months post completion of therapy in terms of HRQOL by having fewer patients that experience a minimal important decline (MID) bowel (12 months only) sexual, hormonal, urinary irritation/obstructive (12 months only) and in urinary incontinence HRQOL as measured by EPIC-26.

III. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy) as measured by biochemical failure, overall survival, local failure, prostate cancer specific survival, and distant metastases.

IV. To determine if prostate imaging-reporting and data system (PIRADS)version (v)2 = 4/5 disease is predictive for biochemical failure.

TERTIARY OBJECTIVES:

I. To determine whether a potentially more expensive therapy, SBRT, would be cost-effective than standard hypofractionated IMRT as measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).

II. To determine if disease characteristics captured on MRI can be used to predict which patients will respond to SBRT versus hypofractionated IMRT.

III. Collect specimens for future translational research analyses.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients undergo IMRT once daily for 5 fractions per week for 28 fractions over less than 32 business days.

ARM II: Patients undergo SBRT at least every other day for 2-3 fractions per week for 5 fractions over less than 12 business days.

After completion of study treatment, patients are followed up every 6-12 months until death or study termination.

• Study Type: Interventional
• Enrollment (Actual): 698
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre at Hamilton Health Sciences
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital and Cancer Center-General Campus
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Centre de sante et de services sociaux de Chicoutimi
    • Montreal, Quebec, Canada, H3H 2R9
      • The Research Institute of the McGill University Health Centre (MUHC)
    • Montreal, Quebec, Canada, H2X 3E4
      • CHUM - Centre Hospitalier de l'Universite de Montreal
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSSEMTL-Hopital Maisonneuve-Rosemont
    • Quebec City, Quebec, Canada, G1R 2J6
      • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• Hong Kong
  • Chai Wan, Hong Kong
    • Pamela Youde Nethersole Eastern Hospital
• India
  • Mumbai, India, 400 012
    • Tata Memorial Hospital
• Ireland
  • Co Dublin
    • Dublin, Co Dublin, Ireland, 18
      • Beacon Hospital
    • Dublin, Co Dublin, Ireland, 6
      • Saint Lukes Hospital
• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonsspital Aarau
• United States
  • Alabama
    • Mobile, Alabama, United States, 36607
      • Mobile Infirmary Medical Center
    • Tuscaloosa, Alabama, United States, 35401
      • Lewis and Faye Manderson Cancer Center
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Arizona Breast Cancer Specialists-Gilbert
    • Peoria, Arizona, United States, 85381
      • Arizona Center for Cancer Care-Peoria
    • Scottsdale, Arizona, United States, 85258
      • Arizona Breast Cancer Specialists-Scottsdale
    • Surprise, Arizona, United States, 85374
      • Arizona Center for Cancer Care-Surprise
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates-West Orange Grove
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Anaheim, California, United States, 92806
      • Kaiser Permanente-Anaheim
    • Berkeley, California, United States, 94704
      • Alta Bates Summit Medical Center-Herrick Campus
    • Carmichael, California, United States, 95608
      • Mercy San Juan Medical Center
    • Carmichael, California, United States, 95608
      • Mercy Cancer Center �� Carmichael
    • Dublin, California, United States, 94568
      • Kaiser Permanente Dublin
    • Elk Grove, California, United States, 95758
      • Mercy Cancer Center - Elk Grove
    • Fresno, California, United States, 93720
      • Fresno Cancer Center
    • Greenbrae, California, United States, 94904
      • Marin General Hospital
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Los Angeles, California, United States, 90033
      • Los Angeles General Medical Center
    • Modesto, California, United States, 95355
      • Memorial Medical Center
    • Oakland, California, United States, 94611
      • Kaiser Permanente Oakland-Broadway
    • Orange, California, United States, 92868
      • Saint Joseph Hospital - Orange
    • Palo Alto, California, United States, 94304
      • Stanford Cancer Institute Palo Alto
    • Rancho Cordova, California, United States, 95670
      • Kaiser Permanente-Rancho Cordova Cancer Center
    • Rocklin, California, United States, 95765
      • Mercy Cancer Center - Rocklin
    • Rohnert Park, California, United States, 94928
      • Rohnert Park Cancer Center
    • Roseville, California, United States, 95678
      • The Permanente Medical Group-Roseville Radiation Oncology
    • Sacramento, California, United States, 95816
      • Sutter Medical Center Sacramento
    • Sacramento, California, United States, 95817
      • University of California Davis Comprehensive Cancer Center
    • Sacramento, California, United States, 95816
      • Mercy Cancer Center - Sacramento
    • Salinas, California, United States, 93901
      • Salinas Valley Memorial
    • San Jose, California, United States, 95124
      • Stanford Cancer Center South Bay
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Medical Center - Santa Clara
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente Cancer Treatment Center
    • Truckee, California, United States, 96161
      • Gene Upshaw Memorial Tahoe Forest Cancer Center
    • Woodland, California, United States, 95695
      • Woodland Memorial Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCHealth University of Colorado Hospital
    • Colorado Springs, Colorado, United States, 80909
      • UCHealth Memorial Hospital Central
    • Colorado Springs, Colorado, United States, 80920
      • Memorial Hospital North
    • Denver, Colorado, United States, 80210
      • Porter Adventist Hospital
    • Fort Collins, Colorado, United States, 80524
      • Poudre Valley Hospital
    • Glenwood Springs, Colorado, United States, 81601
      • Valley View Hospital Cancer Center
    • Littleton, Colorado, United States, 80122
      • Littleton Adventist Hospital
    • Parker, Colorado, United States, 80138
      • Parker Adventist Hospital
  • Connecticut
    • Guilford, Connecticut, United States, 06437
      • Smilow Cancer Hospital Care Center - Guilford
    • New Haven, Connecticut, United States, 06520
      • Yale University
    • Trumbull, Connecticut, United States, 06611
      • Smilow Cancer Hospital Care Center-Trumbull
    • Waterford, Connecticut, United States, 06385
      • Smilow Cancer Hospital Care Center - Waterford
  • 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
    • Atlantis, Florida, United States, 33462
      • John Fitzgerald Kennedy Medical Center
    • Aventura, Florida, United States, 33180
      • Mount Sinai Comprehensive Cancer Center at Aventura
    • Deerfield Beach, Florida, United States, 33064
      • Broward Health North
    • Fort Lauderdale, Florida, United States, 33316
      • Broward Health Medical Center
    • Key West, Florida, United States, 33040
      • GenesisCare USA - Key West
    • Lakewood Ranch, Florida, United States, 34202
      • GenesisCare USA - Lakewood Ranch
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • 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
    • Nampa, Idaho, United States, 83687
      • Saint Alphonsus Cancer Care Center-Nampa
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Rush - Copley Medical Center
    • Decatur, Illinois, United States, 62526
      • Decatur Memorial Hospital
    • Effingham, Illinois, United States, 62401
      • Crossroads Cancer Center
    • Hines, Illinois, United States, 60141
      • Edward Hines Jr VA Hospital
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61637
      • OSF Saint Francis Medical Center
    • Springfield, Illinois, United States, 62781
      • Memorial Medical Center
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
    • Zion, Illinois, United States, 60099
      • Midwestern Regional Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46805
      • Parkview Hospital Randallia
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Regional Medical Center
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Health Indianapolis
    • Mooresville, Indiana, United States, 46158
      • Franciscan Health Mooresville
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Mercy Medical Center - Des Moines
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Cancer Center
    • Overland Park, Kansas, United States, 66210
      • University of Kansas Cancer Center-Overland Park
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi Hospitals Wichita
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky/Markey Cancer Center
    • Louisville, Kentucky, United States, 40202
      • The James Graham Brown Cancer Center at University of Louisville
  • 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, 70112
      • Tulane University School of Medicine
  • Maine
    • Bath, Maine, United States, 04530
      • MaineHealth Coastal Cancer Treatment Center
    • Portland, Maine, United States, 04102
      • Maine Medical Center-Bramhall Campus
    • Sanford, Maine, United States, 04073
      • MaineHealth Cancer Care Center of York County
    • Scarborough, Maine, United States, 04074
      • Maine Medical Center- Scarborough Campus
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21201
      • University of Maryland/Greenebaum Cancer Center
    • Baltimore, Maryland, United States, 21229
      • Saint Agnes Hospital
    • Bethesda, Maryland, United States, 20889-5600
      • Walter Reed National Military Medical Center
    • Columbia, Maryland, United States, 21044
      • Central Maryland Radiation Oncology in Howard County
    • Easton, Maryland, United States, 21601
      • University of Maryland Shore Medical Center at Easton
    • 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
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
    • Danvers, Massachusetts, United States, 01923
      • Mass General/North Shore Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center
    • Ann Arbor, Michigan, United States, 48106
      • Saint Joseph Mercy Hospital
    • Bay City, Michigan, United States, 48706
      • McLaren Cancer Institute-Bay City
    • Clarkston, Michigan, United States, 48346
      • McLaren Cancer Institute-Clarkston
    • Clarkston, Michigan, United States, 48346
      • Michigan Healthcare Professionals Clarkston
    • Dearborn, Michigan, United States, 48124
      • Beaumont Hospital - Dearborn
    • Detroit, Michigan, United States, 48201
      • Wayne State University/Karmanos Cancer Institute
    • Farmington Hills, Michigan, United States, 48334
      • Weisberg Cancer Treatment Center
    • Farmington Hills, Michigan, United States, 48336
      • Beaumont Hospital - Farmington Hills
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Healthcare Professionals Farmington
    • Flint, Michigan, United States, 48532
      • McLaren Cancer Institute-Flint
    • Flint, Michigan, United States, 48503
      • Genesys Hurley Cancer Institute
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health at Butterworth Campus
    • Kalamazoo, Michigan, United States, 49007
      • West Michigan Cancer Center
    • Lansing, Michigan, United States, 48912
      • Sparrow Hospital
    • Lansing, Michigan, United States, 48910
      • Karmanos Cancer Institute at McLaren Greater Lansing
    • Macomb, Michigan, United States, 48044
      • Michigan Healthcare Professionals Macomb
    • Madison Heights, Michigan, United States, 48071
      • Michigan Healthcare Professionals Madison Heights
    • Mount Clemens, Michigan, United States, 48043
      • McLaren Cancer Institute-Macomb
    • Petoskey, Michigan, United States, 49770
      • McLaren Cancer Institute-Northern Michigan
    • Port Huron, Michigan, United States, 48060
      • McLaren-Port Huron
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital-Royal Oak
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital - Troy
    • Troy, Michigan, United States, 48098
      • GenesisCare USA - Troy
    • Wyoming, Michigan, United States, 49519
      • University of Michigan Health - West
  • Minnesota
    • Bemidji, Minnesota, United States, 56601
      • Sanford Joe Lueken Cancer Center
    • Maplewood, Minnesota, United States, 55109
      • Saint John's Hospital - Healtheast
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Clinic - Saint Louis Park
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
  • Missouri
    • Cape Girardeau, Missouri, United States, 63703
      • Saint Francis Medical Center
    • Cape Girardeau, Missouri, United States, 63703
      • Southeast Cancer Center
    • Creve Coeur, Missouri, United States, 63141
      • Siteman Cancer Center at West County Hospital
    • Rolla, Missouri, United States, 65401
      • Delbert Day Cancer Institute at PCRMC
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
    • Saint Louis, Missouri, United States, 63129
      • Siteman Cancer Center-South County
    • Saint Louis, Missouri, United States, 63104
      • SSM Health Saint Louis University 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
    • Butte, Montana, United States, 59701
      • Saint James Community Hospital and Cancer Treatment Center
    • Great Falls, Montana, United States, 59405
      • Benefis Healthcare- Sletten Cancer Institute
    • Kalispell, Montana, United States, 59901
      • Kalispell Regional Medical Center
    • Missoula, Montana, United States, 59804
      • Community Medical Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University Of Nebraska Medical Center
  • New Hampshire
    • Exeter, New Hampshire, United States, 03833
      • Exeter Hospital
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • The Valley Hospital-Luckow Pavilion
    • Pennington, New Jersey, United States, 08534
      • Capital Health Medical Center-Hopewell
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico Cancer Center
    • Albuquerque, New Mexico, United States, 87109
      • Lovelace Radiation Oncology
    • Albuquerque, New Mexico, United States, 87109
      • New Mexico Oncology Hematology Consultants
  • New York
    • Albany, New York, United States, 12208
      • Saint Peter's Health Partners
    • Brooklyn, New York, United States, 11215
      • New York-Presbyterian/Brooklyn Methodist Hospital
    • Canandaigua, New York, United States, 14424
      • Sands Cancer Center
    • Cooperstown, New York, United States, 13326
      • Mary Imogene Bassett Hospital
    • Middletown, New York, United States, 10940
      • Garnet Health Medical Center
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Rochester, New York, United States, 14620
      • Highland Hospital
    • Syracuse, New York, United States, 13210
      • State University of New York Upstate Medical University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27705
      • Durham VA Medical Center
    • Laurinburg, North Carolina, United States, 28352
      • Scotland Memorial Hospital-Laurinburg Cancer Center
    • Raleigh, North Carolina, United States, 27609
      • Duke Raleigh Hospital
    • Supply, North Carolina, United States, 28462
      • Novant Cancer Institute Radiation Oncology - Supply
    • Wilmington, North Carolina, United States, 28401
      • Novant Health Cancer Institute Radiation Oncology - Wilmington
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Sanford Bismarck Medical Center
    • Fargo, North Dakota, United States, 58122
      • Sanford Roger Maris Cancer Center
  • Ohio
    • Akron, Ohio, United States, 44307
      • Cleveland Clinic Akron General
    • Beachwood, Ohio, United States, 44122
      • UHHS-Chagrin Highlands Medical Center
    • Chardon, Ohio, United States, 44024
      • Geauga Hospital
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
    • Cleveland, Ohio, United States, 44111
      • Cleveland Clinic Cancer Center/Fairview Hospital
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
    • Elyria, Ohio, United States, 44035
      • Mercy Cancer Center-Elyria
    • Independence, Ohio, United States, 44131
      • Cleveland Clinic Cancer Center Independence
    • Mansfield, Ohio, United States, 44906
      • Cleveland Clinic Cancer Center Mansfield
    • Mayfield Heights, Ohio, United States, 44124
      • Hillcrest Hospital Cancer Center
    • Mentor, Ohio, United States, 44060
      • UH Seidman Cancer Center at Lake Health Mentor Campus
    • Ravenna, Ohio, United States, 44266
      • University Hospitals Portage Medical Center
    • Sandusky, Ohio, United States, 44870
      • North Coast Cancer Care
    • Sylvania, Ohio, United States, 43560
      • ProMedica Flower Hospital
    • Westlake, Ohio, United States, 44145
      • UHHS-Westlake Medical Center
    • Wooster, Ohio, United States, 44691
      • Cleveland Clinic Wooster Family Health and Surgery Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Legacy Mount Hood Medical Center
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan Hospital and Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital-Cedar Crest
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Hospital
    • Chadds Ford, Pennsylvania, United States, 19317
      • Christiana Care Health System-Concord Health Center
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Drexel Hill, Pennsylvania, United States, 19026
      • Delaware County Memorial Hospital
    • East Norriton, Pennsylvania, United States, 19401
      • Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
    • Furlong, Pennsylvania, United States, 18925
      • Fox Chase Cancer Center Buckingham
    • Gettysburg, Pennsylvania, United States, 17325
      • Adams Cancer Center
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Milton S Hershey Medical Center
    • Lewisburg, Pennsylvania, United States, 17837
      • Geisinger Medical Oncology-Lewisburg
    • Lewistown, Pennsylvania, United States, 17044
      • Lewistown Hospital
    • Paoli, Pennsylvania, United States, 19301
      • Paoli Memorial 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
    • Pottsville, Pennsylvania, United States, 17901
      • Geisinger Cancer Services-Pottsville
    • West Reading, Pennsylvania, United States, 19611
      • Reading Hospital
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley/Henry Cancer Center
    • Willow Grove, Pennsylvania, United States, 19090
      • Asplundh Cancer Pavilion
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
    • York, Pennsylvania, United States, 17403
      • WellSpan Health-York Cancer Center
  • 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
    • 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
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117-5134
      • Sanford USD Medical Center - Sioux Falls
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Center
  • Texas
    • Abilene, Texas, United States, 79606
      • Texas Cancer Center
    • McKinney, Texas, United States, 75071
      • Texas Oncology-McKinney
    • Plano, Texas, United States, 75093
      • Texas Oncology-Plano West
    • Sugar Land, Texas, United States, 77479
      • Texas Oncology Cancer Center Sugar Land
    • Webster, Texas, United States, 77598
      • Deke Slayton Cancer Center
  • Utah
    • 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
    • Provo, Utah, United States, 84604
      • Utah Valley Regional Medical Center
    • Saint George, Utah, United States, 84770
      • Saint George Regional Medical Center
  • Vermont
    • Berlin, Vermont, United States, 05602
      • Central Vermont Medical Center/National Life Cancer Treatment
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center
    • Saint Johnsbury, Vermont, United States, 05819
      • Norris Cotton Cancer Center-North
  • Virginia
    • Hampton, Virginia, United States, 23666
      • Sentara Cancer Institute at Sentara CarePlex Hospital
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Norfolk, Virginia, United States, 23505
      • Bon Secours DePaul Medical Center
    • Richmond, Virginia, United States, 23230
      • Bon Secours Cancer Institute at Reynolds Crossing
    • Roanoke, Virginia, United States, 24014
      • Oncology and Hematology Associates of Southwest Virginia
    • Suffolk, Virginia, United States, 23434
      • Sentara Obici Hospital
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Vancouver, Washington, United States, 98686
      • Legacy Salmon Creek Hospital
    • Walla Walla, Washington, United States, 99362
      • Providence Saint Mary Regional Cancer Center
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • West Virginia University Charleston Division
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Healthcare
  • Wisconsin
    • Appleton, Wisconsin, United States, 54915
      • Ascension Saint Elizabeth Hospital
    • Brookfield, Wisconsin, United States, 53045
      • Ascension Southeast Wisconsin Hospital - Elmbrook Campus
    • Franklin, Wisconsin, United States, 53132
      • Ascension Saint Francis - Reiman Cancer Center
    • Green Bay, Wisconsin, United States, 54311
      • Aurora BayCare Medical Center
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Center
    • 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, 53211
      • Ascension Columbia Saint Mary's Hospital - Milwaukee
    • Milwaukee, Wisconsin, United States, 53295
      • Zablocki Veterans Administration Medical Center
    • Oak Creek, Wisconsin, United States, 53154
      • Drexel Town Square Health Center
    • Oshkosh, Wisconsin, United States, 54904
      • Ascension Mercy Hospital
    • Oshkosh, Wisconsin, United States, 54904
      • Vince Lombardi Cancer Clinic - Oshkosh
    • Racine, Wisconsin, United States, 53405
      • Ascension All Saints Hospital
    • Summit, Wisconsin, United States, 53066
      • Aurora Medical Center in Summit
    • Two Rivers, Wisconsin, United States, 54241
      • Vince Lombardi Cancer Clinic-Two Rivers
    • West Bend, Wisconsin, United States, 53095
      • Froedtert West Bend Hospital/Kraemer Cancer Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Previously untreated (no local therapy such as surgery, radiation cryotherapy, HIFU, etc.) localized adenocarcinoma of the prostate with the following clinical findings:

  • Clinical stage by digital rectal exam of either T1c or T2a/b (limited to one side of the gland); (American Joint Committee on Cancer [AJCC], version 7) or cT1a-c or 2a or 2b,
  • Stages T1a-T1b are eligible if patient underwent transurethral prostatic resection (TURP),

  • The patient must meet one of the following 3 criteria: 1) Gleason score must be Gleason 7(3+4) with a PSA < 20 ng/mL, or 2) Gleason 6(3+3) with a PSA > 10 ng/mL and < 20 ng/mL which is considered intermediate risk and eligible for the study. (AJCC, version 7) or 3) Group Grade 1 with a PSA > 10 ng/mL and < 20 ng/mL or 2 with a PSA < 20 ng/mL.

    • If patient is receiving a 5-alpha reductase inhibitor at the time of enrollment the baseline PSA value may be double the initial value and the medication should be discontinued but a washout period is not required to eligible, a PSA drawn while still on the medicine must be:

      • < 10 ng/mL if Gleason 7(3+4) (Note: This patient would be on stratification level 1 if PSA < 5 ng/mL and stratification level 2 if less than 10 ng/mL).
      • > 5 ng/mL and less than 10 ng/mL for Gleason 6(3+3) (Note: This patients would be on stratification level 3).
  • The prostate volume must be < 70 cc as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including magnetic resonance imaging (MRI) or computed tomography (CT) scan
  • Patients in active surveillance who elect to be treated are eligible if they meet protocol requirements
• History and physical including a digital rectal exam 60 days prior to registration
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 60 days prior to registration
• MRI of the prostate and pelvis (per institutional SOC - should be compliant with PIRADSv2.1 guidelines) within 1 year prior to registration
• Bone scan or sodium fluoride positron emission tomography (PET) scan within 120 days prior to registration
• Charlson modified co-morbidity score =< 4 for patients under 60 and =< 5 for patients 60 and over 21 days prior to registration
• International prostate symptom score (IPSS) of < 15 21 days prior to registration
• The patient must provide study-specific informed consent prior to study entry
• Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire
• Completion of all items of the EPIC-26 which will be data entered at registration 60 days prior to registration
• Only English, Spanish, and French-speaking patients are eligible to participate

Exclusion Criteria:

• Definitive clinical or radiologic evidence of metastatic disease; no nodal involvement or evidence of metastatic disease allowed as defined by screening of the pelvis and a bone scan or sodium fluoride PET scan
• Definitive T3 disease on MRI

• Prior or current invasive malignancy with current evidence of active disease within the past 2 years

  • Exceptions: Non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma.
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment for at least 3 years
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• The use of hormonal therapy is not allowed; if the patient in on a 5-alpha reductase inhibitor, then they should be stopped prior to treatment once enrolled onto the study; no washout period is required for this study to participate

• Severe, active co-morbidity defined as follows:

  • Human immunodeficiency virus (HIV) positive with 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 registration; Note also that HIV testing is not required for eligibility for this protocol
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on Coumadin or other blood thinning agents are eligible for this study)

• Contraindication to MRI

  • Cardiac pacemaker or defibrillator
  • Surgically implanted electrical devices such as spinal stimulation devices or intracranial stimulation devices, cochlear implants, the presence of metallic foreign bodies in the orbits, and incompatible old mechanical heart valves and aneurysm clips

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: Intensity-Modulated Radiation Therapy (IMRT); Patients undergo Intensity-Modulated Radiation Therapy (IMRT) once daily 5 fractions per week for 28 fractions over less than 32 business days.	Radiation: Intensity-Modulated Radiation Therapy (IMRT); Undergo IMRT; Other Names: IMRT; Intensity Modulated RT; Intensity-Modulated Radiotherapy; intensity-modulated radiation therapy
Experimental: Stereotactic Body Radiation Therapy (SBRT); Patients undergo Stereotactic Body Radiation Therapy (SBRT) at least every other day for 2-3 fractions per week for 5 fractions over less than 12 business days.	Radiation: Stereotactic Body Radiation Therapy (SBRT); Undergo SBRT; Other Names: SBRT; stereotactic body radiation therapy; SABR; Stereotactic Ablative Body Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Patients-Reported Gastrointestinal and Genitourinary Toxicity	Will be measured by Expanded Prostate Cancer Index Composite-(EPIC) 26 bowel and urinary irritation domains. Will be compared between treatment arms using a test of proportions with two-sided significance level of 0.05.	Up to 2 years
Disease Free Survival	Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test.	Time to biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical Failure	Will be assessed by Phoenix definition.	yearsFrom the date of randomization to the date of biochemical failure, date of precluding death, or last known follow-up, assessed up to 5 years.
Distant Metastasis	Will be assessed.	From the time of randomization to the date of distant metastasis, date of precluding death, or last known follow-up date , assessed for up to 5 years
Health Related Quality of Life	Will be measured by EPIC-26 urinary incontinence, sexual, and hormonal domains.	Up to 2 years
Incidence of adverse events (AEs)	Will be assessed by Common Terminology Criteria for Adverse Events version 4. Counts of all AEs by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm. The number of patients with at least 1 grade 3 or higher AE will be compared between the treatment arms. A comparison between treatment arms of grade 3 and higher genitourinary (GU) and gastrointestinal (GI) events related to treatment (separately) will also be tested. There are 5 pre-specified AEs, dysuria, hematuria, incontinence, rectal bleeding,	Up to 2 years
Local Failure	Will be assessed.	From the time of randomization to the date of local failure, date of precluding death, or last known follow-up date, assessed for up to 5 years
Overall Survival	Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test.	From the date of randomization to the date of death or last known follow-up date, assessed up to 5 years
Presence of Prostate Imaging-Reporting and Data System version (PIRADSv) 2 = 4/5 disease	Will be assessed by magnetic resonance imaging (MRI).	Baseline
Prostate Cancer Specific Survival	Will be assessed.	yearsFrom the date of randomization to the date of prostate cancer death, date of precluding death, or last known follow-up date, assessed up to 5 years
Regional Failure	Will be assessed.	From the time of randomization to the date of local failure, date of precluding death, or last known follow-up date, assessed for up to 5 years

Collaborators and Investigators

• Sponsor: NRG Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Rodney Ellis, NRG Oncology

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: NRG-GU005 (Other Identifier: CTEP); U10CA180868 (U.S. NIH Grant/Contract); NCI-2017-01398 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No