Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Previously untreated 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, stage group IIA or IIB (AJCC, version 8); both versions 7 and 8 staging should be recorded
  • Patients in active surveillance who elect to be treated are eligible if they meet protocol requirements
  • Stages T1a-T1b are eligible if patient underwent transurethral prostatic resection (TURP) previously Gleason score must be Gleason 7(3+4) with a PSA < 20 ng/mL, or Gleason 6(3+3) with a PSA > 10 ng/mL and < 20 ng/mL; (AJCC, version 7) or group grade 1 or 2, stage Group IIA or IIB (AJCC version 8)
  • If patient is receiving a 5-alpha reductase inhibitor at the time of enrollment the baseline PSA value will be assumed to be double the initial value and the medication should be discontinued but does not need to have a washout period to participate, to remain eligible a PSA drawn while still on the medicine must be:
  • < 10 ng/mL to remain eligible if Gleason 7(3+4)
  • Stratification level 1 if PSA < 5 ng/mL and level 2 if less than 10 ng/mL
  • > 5 ng/mL and less than 10 ng/mL for Gleason 6(3+3)
  • Stratification level 3
  • Percent of submitted positive core biopsies must be < 50% of all sextants
  • NOTE: all cores from a targeted lesion will be counted as an N of 1 core for calculating percent positive cores in total
  • The prostate volume must be < 60 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
  • 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 pelvis within 90 days prior to registration
  • Bone scan or sodium fluoride positron emission tomography (PET) scan within 90 days prior to registration
  • Charlson modified co-morbidity score =< 3 for patients under 60 and =< 4 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 3 years
  • 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; [applicable only to studies that incorporate systemic therapy]
  • 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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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 radiation therapy
    • Intensity-Modulated Radiotherapy
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:
    • SABR
    • SBRT
    • Stereotactic Ablative Body Radiation Therapy
    • stereotactic body radiation therapy

Recruiting Locations

Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama 35401
Contact:
Site Public Contact
800-338-2948

Arizona Breast Cancer Specialists-Gilbert
Gilbert, Arizona 85297
Contact:
Site Public Contact
480-922-4600

Arizona Center for Cancer Care-Peoria
Peoria, Arizona 85381
Contact:
Site Public Contact
623-773-2873

Arizona Breast Cancer Specialists-Scottsdale
Scottsdale, Arizona 85258
Contact:
Site Public Contact
480-922-4600

Arizona Center for Cancer Care-Surprise
Surprise, Arizona 85374
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Arizona Oncology Associates-West Orange Grove
Tucson, Arizona 85704
Contact:
Site Public Contact
520-544-2919

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Marin General Hospital
Greenbrae, California 94904
Contact:
Site Public Contact
415-925-7325

UC San Diego Moores Cancer Center
La Jolla, California 92093
Contact:
Site Public Contact
858-822-5354
cancercto@ucsd.edu

Los Angeles County-USC Medical Center
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451

USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451

Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California 95670
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California 95678
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089

Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California 96161
Contact:
Site Public Contact
530-582-6450

University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650

UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
Contact:
Site Public Contact
719-365-2406

Memorial Hospital North
Colorado Springs, Colorado 80920
Contact:
Site Public Contact
719-364-6700

Poudre Valley Hospital
Fort Collins, Colorado 80524
Contact:
Site Public Contact
970-297-6150

Valley View Hospital Cancer Center
Glenwood Springs, Colorado 81601
Contact:
Site Public Contact
970-384-7570

Yale University
New Haven, Connecticut 06520
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Helen F Graham Cancer Center
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
KDempsey@christianacare.org

Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
Contact:
Site Public Contact
302-623-4450
KDempsey@christianacare.org

Beebe Health Campus
Rehoboth Beach, Delaware 19971
Contact:
Site Public Contact
302-645-3100
Dmiskin@Beebehealthcare.org

Grady Health System
Atlanta, Georgia 30303
Contact:
Site Public Contact
404-489-9164

Emory University Hospital Midtown
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447

Piedmont Hospital
Atlanta, Georgia 30309
Contact:
Site Public Contact
404-425-7943
ORS@piedmont.org

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868

Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Hines Veterans Administration Hospital
Hines, Illinois 60141
Contact:
Site Public Contact
708-202-8387

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357

OSF Saint Francis Medical Center
Peoria, Illinois 61637
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Parkview Hospital Randallia
Fort Wayne, Indiana 46805
Contact:
Site Public Contact
260-373-8888
parkviewresearch@parkview.com

Franciscan Health Indianapolis
Indianapolis, Indiana 46237
Contact:
Site Public Contact
317-528-7060

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Site Public Contact
913-945-7552
ctnursenav@kumc.edu

University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Contact:
Site Public Contact
913-945-7552
ctnursenav@kumc.edu

Via Christi Regional Medical Center
Wichita, Kansas 67214
Contact:
Site Public Contact
800-362-0070
Keisha.humphries@ascension.org

East Jefferson General Hospital
Metairie, Louisiana 70006
Contact:
Site Public Contact
504-210-3539
trials@jeffradonc.com

Maine Medical Center-Bramhall Campus
Portland, Maine 04102
Contact:
Site Public Contact
207-885-7565

Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
Contact:
Site Public Contact
207-396-8090
wrighd@mmc.org

Saint Agnes Hospital
Baltimore, Maryland 21229
Contact:
Site Public Contact
410-368-2910

Peninsula Regional Medical Center
Salisbury, Maryland 21801
Contact:
Site Public Contact
866-922-6237

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Site Public Contact
617-638-8265

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125

21st Century Oncology MHP - Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
248-338-0663

McLaren Cancer Institute-Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

21st Century Oncology MHP - Farmington
Farmington Hills, Michigan 48334
Contact:
Site Public Contact
248-338-0663

McLaren Cancer Institute-Flint
Flint, Michigan 48532
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

McLaren-Greater Lansing
Lansing, Michigan 48910
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Macomb
Mount Clemens, Michigan 48043
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan 49770
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren-Port Huron
Port Huron, Michigan 48060
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

21st Century Oncology MHP - Troy
Troy, Michigan 48098
Contact:
Site Public Contact
248-338-0663

Sanford Clinic North-Bemidgi
Bemidji, Minnesota 56601
Contact:
Site Public Contact
218-333-5000

Regions Hospital
Saint Paul, Minnesota 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Southeast Cancer Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-651-5550

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center-South County
Saint Louis, Missouri 63129
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kalispell Regional Medical Center
Kalispell, Montana 59901
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
Contact:
Site Public Contact
800-639-6918
cancer.research.nurse@dartmouth.edu

University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
Contact:
Site Public Contact
505-925-0366
LByatt@nmcca.org

Lovelace Radiation Oncology
Albuquerque, New Mexico 87109
Contact:
Site Public Contact
505-272-0530
AYost@nmcca.org

New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico 87109
Contact:
Site Public Contact
505-272-0530
CLee@nmcca.org

Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
Contact:
Site Public Contact
212-263-4434
prmc.coordinator@nyumc.org

NHRMC Radiation Oncology - Supply
Supply, North Carolina 28462
Contact:
Site Public Contact
910-754-4716

NHRMC Radiation Oncology - 16th Street
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-251-1839

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Contact:
Site Public Contact
701-323-5760
tamara.fischer@sanfordhealth.org

Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-234-6161

Cleveland Clinic Akron General
Akron, Ohio 44307
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Geauga Hospital
Chardon, Ohio 44024
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Case Western Reserve University
Cleveland, Ohio 44106
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

Mercy Cancer Center-Elyria
Elyria, Ohio 44035
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio 44906
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

Lake University Ireland Cancer Center
Mentor, Ohio 44060
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

North Coast Cancer Care
Sandusky, Ohio 44870
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

UHHS-Westlake Medical Center
Westlake, Ohio 44145
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio 44691
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
Contact:
Site Public Contact
302-623-4450
KDempsey@christianacare.org

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Delaware County Memorial Hospital
Drexel Hill, Pennsylvania 19026
Contact:
Site Public Contact
610-284-8237
jolene.garney@crozer.org

Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Contact:
Site Public Contact
570-374-8555
HemonCCTrials@geisinger.edu

Paoli Memorial Hospital
Paoli, Pennsylvania 19301
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
215-955-6084

Reading Hospital
West Reading, Pennsylvania 19611
Contact:
Site Public Contact
610-988-9323

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Abington Memorial Hospital-Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Site Public Contact
843-792-9321
hcc-clinical-trials@musc.edu

Greenville Health System Cancer Institute-Faris
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina 29615
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Self Regional Healthcare
Greenwood, South Carolina 29646
Contact:
Site Public Contact
864-725-4771
nmcgaha@selfregional.org

The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina 29926
Contact:
Site Public Contact
912-819-5704
underberga@sjchs.org

Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina 29672
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina 29307
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Texas Cancer Center
Abilene, Texas 79606
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Texas Oncology-McKinney
McKinney, Texas 75071
Contact:
Site Public Contact
972-542-8609

Texas Oncology-Plano West
Plano, Texas 75093
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Deke Slayton Cancer Center
Webster, Texas 77598
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Intermountain Medical Center
Murray, Utah 84107
Contact:
Site Public Contact
801-507-3950
officeofresearch@imail.org

Utah Valley Regional Medical Center
Provo, Utah 84604
Contact:
Site Public Contact
801-357-7965
officeofresearch@imail.org

University of Vermont Medical Center
Burlington, Vermont 05401
Contact:
Site Public Contact
802-656-4101

Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont 05819
Contact:
Site Public Contact
802-473-4100

West Virginia University Healthcare
Morgantown, West Virginia 26506
Contact:
Site Public Contact
304-293-7374
cancertrialsinfo@hsc.wvu.edu

Wheaton Franciscan Healthcare-Elmbrook Memorial Hospital
Brookfield, Wisconsin 53045
Contact:
Site Public Contact
262-785-2273

Wheaton Franciscan Healthcare-Saint Francis/Reiman Cancer Center
Franklin, Wisconsin 53132
Contact:
Site Public Contact
262-785-2273

Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Community Memorial Hospital
Menomonee Falls, Wisconsin 53051
Contact:
Site Public Contact
262-257-5100

Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-4380

Wheaton Franciscan Cancer Care - All Saints
Racine, Wisconsin 53405
Contact:
Site Public Contact
262-785-2273

The Alyce and Elmore Kraemer Cancer Care Center
West Bend, Wisconsin 53095
Contact:
Site Public Contact
866-680-0505

More Details

NCT ID
NCT03367702
Status
Recruiting
Sponsor
NRG Oncology

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.