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

Trial Status: Active

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 uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.

Inclusion Criteria

  • Previously untreated (no local therapy such as surgery, radiation cryotherapy, high-intensity focused ultrasound [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; (AJCC, version 7), or 3) group grade 1 or 2 ** 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 be 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) **** 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 patient 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 (compliant with PIRADSv2.1 guidelines) within 1 year prior to registration
  • Bone scan as clinically indicated 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 as these are the only languages EPIC-26 has been validated in

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
  • 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 is 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; this exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive * 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

Alabama

Mobile
Mobile Infirmary Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 251-435-3942
Tuscaloosa
Lewis and Faye Manderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-338-2948

Arizona

Gilbert
Arizona Breast Cancer Specialists-Gilbert
Status: ACTIVE
Contact: Site Public Contact
Phone: 480-922-4600
Peoria
Arizona Center for Cancer Care-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 623-773-2873
Scottsdale
Arizona Breast Cancer Specialists-Scottsdale
Status: ACTIVE
Contact: Site Public Contact
Phone: 480-922-4600
Surprise
Arizona Center for Cancer Care-Surprise
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Tucson
Arizona Oncology Associates-West Orange Grove
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 520-544-2919

Arkansas

Little Rock
University of Arkansas for Medical Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 501-686-8274

California

Anaheim
Kaiser Permanente-Anaheim
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Carmichael
Mercy San Juan Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-556-3301
Dublin
Kaiser Permanente Dublin
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Fresno
Fresno Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Greenbrae
Marin General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-925-7325
La Jolla
UC San Diego Moores Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 858-822-5354
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
Modesto
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Oakland
Kaiser Permanente Oakland-Broadway
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
Saint Joseph Hospital - Orange
Status: ACTIVE
Contact: Site Public Contact
Phone: 714-734-6220
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
Contact: Site Public Contact
Phone: 650-498-7061
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Rohnert Park
Rohnert Park Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
Mercy Cancer Center - Sacramento
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-556-3301
Sutter Medical Center Sacramento
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 916-734-3089
San Jose
Stanford Cancer Center South Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 650-498-7061
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 530-582-6450

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 720-848-0650
Colorado Springs
Memorial Hospital North
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-364-6700
UCHealth Memorial Hospital Central
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-365-2406
Denver
Porter Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Fort Collins
Poudre Valley Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 970-297-6150
Glenwood Springs
Valley View Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 970-384-7570

Connecticut

Guilford
Smilow Cancer Hospital Care Center - Guiford
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702
New Haven
Yale University
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702
Waterford
Smilow Cancer Hospital Care Center - Waterford
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Helen F Graham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Rehoboth Beach
Beebe Health Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100

Florida

Deerfield Beach
Broward Health North
Status: ACTIVE
Contact: Site Public Contact
Phone: 954-941-8300
Fort Lauderdale
Broward Health Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 954-355-5346
Key West
GenesisCare USA - Key West
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Plantation
GenesisCare USA - Plantation
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-946-7447
Grady Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-489-9164
Piedmont Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 404-425-7943
Fayetteville
Piedmont Fayette Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-339-5294
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704

Illinois

Decatur
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Effingham
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Hines
Edward Hines Jr VA Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-202-8387
Maywood
Loyola University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-226-4357
Peoria
Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-788-3528
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Zion
Midwestern Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294

Indiana

Fort Wayne
Parkview Hospital Randallia
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 260-373-8888
Parkview Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-784-4673
Indianapolis
Franciscan Health Indianapolis
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-528-7060

Iowa

Des Moines
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Overland Park
University of Kansas Cancer Center-Overland Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Wichita
Ascension Via Christi Hospitals Wichita
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-362-0070

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: ACTIVE
Contact: Site Public Contact
Phone: 502-562-3429

Louisiana

Metairie
East Jefferson General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539

Maine

Bath
MaineHealth Coastal Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-339-5294
Portland
Maine Medical Center-Bramhall Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 207-885-7565
Sanford
MaineHealth Cancer Care Center of York County
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 207-459-1600
Scarborough
Maine Medical Center- Scarborough Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 207-396-8090

Maryland

Baltimore
Saint Agnes Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-368-2910
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-888-8823
Bethesda
Walter Reed National Military Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 301-319-2100
Columbia
Central Maryland Radiation Oncology in Howard County
Status: ACTIVE
Contact: Site Public Contact
Phone: 443-546-1300
Glen Burnie
UM Baltimore Washington Medical Center / Tate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-553-8100
Ocean Pines
TidalHealth Richard A Henson Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-543-7067
Salisbury
TidalHealth Peninsula Regional
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-543-7032

Massachusetts

Boston
Boston Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 617-638-8265

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Bay City
McLaren Cancer Institute-Bay City
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Clarkston
GenesisCare USA - Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
McLaren Cancer Institute-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Dearborn
Beaumont Hospital - Dearborn
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Farmington Hills
Beaumont Hospital - Farmington Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
GenesisCare USA - Farmington Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Weisberg Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Flint
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
McLaren Cancer Institute-Flint
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Grand Rapids
Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Kalamazoo
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Lansing
McLaren-Greater Lansing
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Sparrow Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Macomb
GenesisCare USA - Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Madison Heights
GenesisCare USA - Madison Heights
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Mount Clemens
McLaren Cancer Institute-Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Petoskey
McLaren Cancer Institute-Northern Michigan
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Port Huron
McLaren-Port Huron
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Royal Oak
William Beaumont Hospital-Royal Oak
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
Troy
21st Century Oncology MHP - Troy
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
William Beaumont Hospital - Troy
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-333-5000
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-651-5550
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-8776
Saint Louis
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Saint Louis University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-977-4440
Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Springfield
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520

Montana

Butte
Saint James Community Hospital and Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

Nebraska

Omaha
University of Nebraska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-6941

New Hampshire

Exeter
Exeter Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-439-3837
Lebanon
Dartmouth Hitchcock Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-639-6918

New Jersey

Paramus
The Valley Hospital-Luckow Pavilion
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 201-634-5792

New Mexico

Albuquerque
Lovelace Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-272-0530
New Mexico Oncology Hematology Consultants
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-272-0530
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

New York

Albany
Saint Peter's Health Partners
Status: ACTIVE
Contact: Site Public Contact
Phone: 518-525-6739
Brooklyn
New York-Presbyterian / Brooklyn Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 718-780-3677
Cooperstown
Mary Imogene Bassett Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-547-1750
Middletown
Garnet Health Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 845-333-1133
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-263-4434
Rochester
Highland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-341-8113
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830
Syracuse
State University of New York Upstate Medical University
Status: ACTIVE
Contact: Site Public Contact
Phone: 315-464-5476

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-275-3853
Durham VA Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-286-0411
Laurinburg
Scotland Memorial Hospital-Laurinburg Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-762-2735
Raleigh
Duke Raleigh Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-862-5400
Supply
NHRMC Radiation Oncology - Supply
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-754-4716
Wilmington
NHRMC Radiation Oncology - 16th Street
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-251-1839

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Akron
Cleveland Clinic Akron General
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Beachwood
UHHS-Chagrin Highlands Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Chardon
Geauga Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Cleveland
Case Western Reserve University
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Cleveland Clinic Cancer Center / Fairview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-293-5066
Riverside Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
Elyria
Mercy Cancer Center-Elyria
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Independence
Cleveland Clinic Cancer Center Independence
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-223-8100
Mansfield
Cleveland Clinic Cancer Center Mansfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Sandusky
North Coast Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Sylvania
ProMedica Flower Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-824-1842
Westlake
UHHS-Westlake Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2150
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-220-4937

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Bryn Mawr
Bryn Mawr Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649
Chadds Ford
Christiana Care Health System-Concord Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Drexel Hill
Delaware County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-284-8237
East Norriton
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Furlong
Fox Chase Cancer Center Buckingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-794-2700
Gettysburg
Adams Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-441-7957
Hershey
Penn State Milton S Hershey Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-531-3779
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
Lewistown
Lewistown Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-242-7703
Paoli
Paoli Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649
Philadelphia
Aria Health-Torresdale Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-612-5296
Fox Chase Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-728-4790
Temple University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-728-2983
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-955-6084
Pottsville
Geisinger Cancer Services-Pottsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-275-6401
West Reading
Reading Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-988-9323
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Willow Grove
Abington Memorial Hospital-Asplundh Cancer Pavilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-481-2402
Wynnewood
Lankenau Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649
York
WellSpan Health-York Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-441-7957

South Carolina

Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-792-9321
Greenville
Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213
Greenwood
Self Regional Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-725-4771
Greer
Prisma Health Cancer Institute - Greer
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Hilton Head Island
The Radiation Oncology Center-Hilton Head / Bluffton
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704
Seneca
Prisma Health Cancer Institute - Seneca
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Knoxville
Thompson Cancer Survival Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 865-331-1812

Texas

Abilene
Texas Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
McKinney
Texas Oncology-McKinney
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 972-542-8609
Plano
Texas Oncology-Plano West
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
Sugar Land
Texas Oncology Cancer Center Sugar Land
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 281-277-5200
Webster
Deke Slayton Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923

Utah

Murray
Intermountain Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-507-3950
Provo
Utah Valley Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-357-7965
Saint George
Dixie Medical Center Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 435-688-4167

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-225-5400
Burlington
University of Vermont Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-656-4101
Email: rpo@uvm.edu
Saint Johnsbury
Norris Cotton Cancer Center-North
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-473-4100

Virginia

Hampton
Sentara Cancer Institute at Sentara CarePlex Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 757-388-2840
Norfolk
Bon Secours DePaul Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8663
Sentara Norfolk General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 757-388-2406
Richmond
Bon Secours Cancer Institute at Reynolds Crossing
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8663
Roanoke
Oncology and Hematology Associates of Southwest Virginia
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
Suffolk
Sentara Obici Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 757-388-5109

Washington

Seattle
Virginia Mason Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-342-6954
Vancouver
Legacy Salmon Creek Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2150

West Virginia

Charleston
West Virginia University Charleston Division
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 304-388-9944
Morgantown
West Virginia University Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374

Wisconsin

Appleton
Ascension Saint Elizabeth Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-635-6420
Brookfield
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-635-6420
Franklin
Ascension Saint Francis - Reiman Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-635-6420
Green Bay
Aurora BayCare Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 608-775-2385
Menomonee Falls
Froedtert Menomonee Falls Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-257-5100
Mequon
Ascension Columbia Saint Mary's Hospital Ozaukee
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-635-6420
Milwaukee
Ascension Columbia Saint Mary's Hospital - Milwaukee
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-635-6420
Aurora Saint Luke's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-3666
Zablocki Veterans Administration Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-469-6614
Oshkosh
Ascension Mercy Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-831-8900
Racine
Ascension All Saints Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-635-6420
West Bend
Froedtert West Bend Hospital / Kraemer Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-0505

Alberta

Calgary
Tom Baker Cancer Centre
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 403-521-3433
Edmonton
Cross Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 780-432-8500

Ontario

Ottawa
Ottawa Hospital and Cancer Center-General Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 613-761-4395

Quebec

Chicoutimi
Centre De Sante Et De Services Sociaux De Chicoutimi
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 418-541-1234
Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 514-890-8000ext12725
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 514-252-3400ext3329
The Research Institute of the McGill University Health Centre (MUHC)
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 514-934-1934ext48354
Quebec City
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Sherbrooke
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 819-820-6480

Saskatchewan

Regina
Allan Blair Cancer Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 306-766-2213
Saskatoon
Saskatoon Cancer Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 306-655-2914

India

Mumbai
Tata Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294

Ireland

Dublin
Beacon Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 353 1 2936691
Saint Lukes Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 353 1 4065000

Switzerland

Aarau
Kantonsspital Aarau
Status: ACTIVE
Contact: Site Public Contact
Phone: 41 62 838 60 50

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.

II. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy or 20 fractions of 3 Gy) as measured by disease free survival (DFS).

SECONDARY OBJECTIVES:

I. 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.

II. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy or 20 fractions of 3 Gy) as measured by biochemical failure, overall survival, local failure, prostate cancer specific survival, and distant metastases.

III. To determine the correspondence between the diagnostic magnetic resonance imaging (MRI) and biopsy.

IV. To determine if prostate imaging-reporting and data system (PIRADS)version (v)2.1 = 4/5 disease is prognostic for biochemical failure.

EXPLORATORY 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 baseline and follow-up MRI can be used to predict which patients will respond to SBRT versus hypofractionated IMRT.

III. To validate autosegmentation tools for the prostate and tumors.

IV. 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 20 or 28 fractions over less than 32 business days.

ARM II: Patients undergo SBRT at least every other day for 2-3 fractions per week over less than 17 business days.

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

Trial Phase Phase III

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Rodney J. Ellis

  • Primary ID NRG-GU005
  • Secondary IDs NCI-2017-01398
  • Clinicaltrials.gov ID NCT03367702