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

About this trial
This is an interventional treatment trial for Stage II Prostate Adenocarcinoma
Eligibility Criteria
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
Sites / Locations
- Mobile Infirmary Medical Center
- Lewis and Faye Manderson Cancer Center
- Arizona Breast Cancer Specialists-Gilbert
- Arizona Center for Cancer Care-Peoria
- Arizona Breast Cancer Specialists-Scottsdale
- Arizona Center for Cancer Care-Surprise
- Arizona Oncology Associates-West Orange Grove
- University of Arkansas for Medical Sciences
- Kaiser Permanente-Anaheim
- Alta Bates Summit Medical Center-Herrick Campus
- Mercy Cancer Center �� Carmichael
- Mercy San Juan Medical Center
- Kaiser Permanente Dublin
- Mercy Cancer Center - Elk Grove
- Fresno Cancer Center
- Marin General Hospital
- UC San Diego Moores Cancer Center
- Kaiser Permanente Los Angeles Medical Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Memorial Medical Center
- Kaiser Permanente Oakland-Broadway
- Saint Joseph Hospital - Orange
- Stanford Cancer Institute Palo Alto
- Kaiser Permanente-Rancho Cordova Cancer Center
- Mercy Cancer Center - Rocklin
- Rohnert Park Cancer Center
- The Permanente Medical Group-Roseville Radiation Oncology
- Mercy Cancer Center - Sacramento
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Salinas Valley Memorial
- Stanford Cancer Center South Bay
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente Cancer Treatment Center
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Woodland Memorial Hospital
- UCHealth University of Colorado Hospital
- UCHealth Memorial Hospital Central
- Memorial Hospital North
- Porter Adventist Hospital
- Poudre Valley Hospital
- Valley View Hospital Cancer Center
- Littleton Adventist Hospital
- Parker Adventist Hospital
- Smilow Cancer Hospital Care Center - Guilford
- Yale University
- Smilow Cancer Hospital Care Center-Trumbull
- Smilow Cancer Hospital Care Center - Waterford
- Beebe South Coastal Health Campus
- Helen F Graham Cancer Center
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- John Fitzgerald Kennedy Medical Center
- Mount Sinai Comprehensive Cancer Center at Aventura
- Broward Health North
- Broward Health Medical Center
- GenesisCare USA - Key West
- GenesisCare USA - Lakewood Ranch
- Mount Sinai Medical Center
- GenesisCare USA - Plantation
- Grady Health System
- Emory University Hospital Midtown
- Piedmont Hospital
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Piedmont Fayette Hospital
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Saint Alphonsus Cancer Care Center-Boise
- Saint Alphonsus Cancer Care Center-Nampa
- Rush - Copley Medical Center
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Edward Hines Jr VA Hospital
- Loyola University Medical Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Memorial Medical Center
- Carle Cancer Center
- Midwestern Regional Medical Center
- Parkview Hospital Randallia
- Parkview Regional Medical Center
- Franciscan Health Indianapolis
- Franciscan Health Mooresville
- Mercy Medical Center - Des Moines
- University of Kansas Cancer Center
- University of Kansas Cancer Center-Overland Park
- Ascension Via Christi Hospitals Wichita
- University of Kentucky/Markey Cancer Center
- The James Graham Brown Cancer Center at University of Louisville
- East Jefferson General Hospital
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
- Tulane University Health Sciences Center
- MaineHealth Coastal Cancer Treatment Center
- Maine Medical Center-Bramhall Campus
- MaineHealth Cancer Care Center of York County
- Maine Medical Center- Scarborough Campus
- Anne Arundel Medical Center
- University of Maryland/Greenebaum Cancer Center
- Saint Agnes Hospital
- Walter Reed National Military Medical Center
- Central Maryland Radiation Oncology in Howard County
- University of Maryland Shore Medical Center at Easton
- UM Baltimore Washington Medical Center/Tate Cancer Center
- TidalHealth Richard A Henson Cancer Institute
- TidalHealth Peninsula Regional
- Massachusetts General Hospital Cancer Center
- Boston Medical Center
- Mass General/North Shore Cancer Center
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- McLaren Cancer Institute-Bay City
- GenesisCare USA - Clarkston
- McLaren Cancer Institute-Clarkston
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- GenesisCare USA - Farmington Hills
- Weisberg Cancer Treatment Center
- Beaumont Hospital - Farmington Hills
- Genesys Hurley Cancer Institute
- McLaren Cancer Institute-Flint
- Spectrum Health at Butterworth Campus
- West Michigan Cancer Center
- Karmanos Cancer Institute at McLaren Greater Lansing
- Sparrow Hospital
- GenesisCare USA - Macomb
- GenesisCare USA - Madison Heights
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Northern Michigan
- McLaren-Port Huron
- William Beaumont Hospital-Royal Oak
- William Beaumont Hospital - Troy
- GenesisCare USA - Troy
- University of Michigan Health - West
- Sanford Joe Lueken Cancer Center
- Saint John's Hospital - Healtheast
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- Saint Francis Medical Center
- Southeast Cancer Center
- Siteman Cancer Center at West County Hospital
- Delbert Day Cancer Institute at PCRMC
- SSM Health Saint Louis University Hospital
- Washington University School of Medicine
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Saint Peters Hospital
- Mercy Hospital Springfield
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Kalispell Regional Medical Center
- Community Medical Hospital
- University of Nebraska Medical Center
- Exeter Hospital
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- The Valley Hospital-Luckow Pavilion
- Capital Health Medical Center-Hopewell
- University of New Mexico Cancer Center
- Lovelace Radiation Oncology
- New Mexico Oncology Hematology Consultants
- Saint Peter's Health Partners
- New York-Presbyterian/Brooklyn Methodist Hospital
- Sands Cancer Center
- Mary Imogene Bassett Hospital
- Garnet Health Medical Center
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Highland Hospital
- University of Rochester
- State University of New York Upstate Medical University
- Durham VA Medical Center
- Duke University Medical Center
- Scotland Memorial Hospital-Laurinburg Cancer Center
- Duke Raleigh Hospital
- Novant Cancer Institute Radiation Oncology - Supply
- Novant Health Cancer Institute Radiation Oncology - Wilmington
- Sanford Bismarck Medical Center
- Sanford Roger Maris Cancer Center
- Cleveland Clinic Akron General
- UHHS-Chagrin Highlands Medical Center
- Geauga Hospital
- The Christ Hospital
- Case Western Reserve University
- Cleveland Clinic Cancer Center/Fairview Hospital
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Mercy Cancer Center-Elyria
- Cleveland Clinic Cancer Center Independence
- Cleveland Clinic Cancer Center Mansfield
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- University Hospitals Portage Medical Center
- North Coast Cancer Care
- ProMedica Flower Hospital
- UHHS-Westlake Medical Center
- Cleveland Clinic Wooster Family Health and Surgery Center
- University of Oklahoma Health Sciences Center
- Legacy Mount Hood Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Lehigh Valley Hospital-Cedar Crest
- Bryn Mawr Hospital
- Christiana Care Health System-Concord Health Center
- Geisinger Medical Center
- Delaware County Memorial Hospital
- Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
- Fox Chase Cancer Center Buckingham
- Adams Cancer Center
- Penn State Milton S Hershey Medical Center
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- Paoli Memorial Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Jefferson Torresdale Hospital
- Temple University Hospital
- Geisinger Cancer Services-Pottsville
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Asplundh Cancer Pavilion
- Lankenau Medical Center
- WellSpan Health-York Cancer Center
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Prisma Health Cancer Institute - Faris
- Saint Francis Cancer Center
- Prisma Health Cancer Institute - Eastside
- Self Regional Healthcare
- Prisma Health Cancer Institute - Greer
- The Radiation Oncology Center-Hilton Head/Bluffton
- Carolina Regional Cancer Center
- Prisma Health Cancer Institute - Seneca
- Sanford USD Medical Center - Sioux Falls
- Thompson Cancer Survival Center
- Texas Cancer Center
- Texas Oncology-McKinney
- Texas Oncology-Plano West
- Texas Oncology Cancer Center Sugar Land
- Deke Slayton Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Saint George Regional Medical Center
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont Medical Center
- Norris Cotton Cancer Center-North
- Sentara Cancer Institute at Sentara CarePlex Hospital
- Bon Secours DePaul Medical Center
- Sentara Norfolk General Hospital
- Bon Secours Cancer Institute at Reynolds Crossing
- Oncology and Hematology Associates of Southwest Virginia
- Sentara Obici Hospital
- Virginia Mason Medical Center
- Legacy Salmon Creek Hospital
- Providence Saint Mary Regional Cancer Center
- West Virginia University Charleston Division
- West Virginia University Healthcare
- Ascension Saint Elizabeth Hospital
- Ascension Southeast Wisconsin Hospital - Elmbrook Campus
- Ascension Saint Francis - Reiman Cancer Center
- Aurora BayCare Medical Center
- Gundersen Lutheran Medical Center
- Froedtert Menomonee Falls Hospital
- Ascension Columbia Saint Mary's Hospital Ozaukee
- Ascension Columbia Saint Mary's Hospital - Milwaukee
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Zablocki Veterans Administration Medical Center
- Drexel Town Square Health Center
- Ascension Mercy Hospital
- Vince Lombardi Cancer Clinic - Oshkosh
- Ascension All Saints Hospital
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Froedtert West Bend Hospital/Kraemer Cancer Center
- Tom Baker Cancer Centre
- Cross Cancer Institute
- Juravinski Cancer Centre at Hamilton Health Sciences
- Ottawa Hospital and Cancer Center-General Campus
- Centre De Sante Et De Services Sociaux De Chicoutimi
- CIUSSSEMTL-Hopital Maisonneuve-Rosemont
- CHUM - Centre Hospitalier de l'Universite de Montreal
- The Research Institute of the McGill University Health Centre (MUHC)
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Pamela Youde Nethersole Eastern Hospital
- Tata Memorial Hospital
- Beacon Hospital
- Saint Lukes Hospital
- Kantonsspital Aarau
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Intensity-Modulated Radiation Therapy (IMRT)
Stereotactic Body Radiation Therapy (SBRT)
Patients undergo Intensity-Modulated Radiation Therapy (IMRT) once daily 5 fractions per week for 28 fractions over less than 32 business days.
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.