Breast Cancer Clinical Trial
Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer
Summary
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.
Full 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.
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
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There are 283 Locations for this study
Mobile Alabama, 36607, United States
Tuscaloosa Alabama, 35401, United States
Gilbert Arizona, 85297, United States
Peoria Arizona, 85381, United States
Scottsdale Arizona, 85258, United States
Surprise Arizona, 85374, United States
Tucson Arizona, 85704, United States
Little Rock Arkansas, 72205, United States
Anaheim California, 92806, United States
Berkeley California, 94704, United States
Carmichael California, 95608, United States
Carmichael California, 95608, United States
Dublin California, 94568, United States
Elk Grove California, 95758, United States
Fresno California, 93720, United States
Greenbrae California, 94904, United States
La Jolla California, 92093, United States
Los Angeles California, 90027, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Modesto California, 95355, United States
Oakland California, 94611, United States
Orange California, 92868, United States
Palo Alto California, 94304, United States
Rancho Cordova California, 95670, United States
Rocklin California, 95765, United States
Rohnert Park California, 94928, United States
Roseville California, 95678, United States
Sacramento California, 95816, United States
Sacramento California, 95816, United States
Sacramento California, 95817, United States
Salinas California, 93901, United States
San Jose California, 95124, United States
Santa Clara California, 95051, United States
South San Francisco California, 94080, United States
Truckee California, 96161, United States
Woodland California, 95695, United States
Aurora Colorado, 80045, United States
Colorado Springs Colorado, 80909, United States
Colorado Springs Colorado, 80920, United States
Denver Colorado, 80210, United States
Fort Collins Colorado, 80524, United States
Glenwood Springs Colorado, 81601, United States
Littleton Colorado, 80122, United States
Parker Colorado, 80138, United States
Guilford Connecticut, 06437, United States
New Haven Connecticut, 06520, United States
Trumbull Connecticut, 06611, United States
Waterford Connecticut, 06385, United States
Frankford Delaware, 19945, United States
Newark Delaware, 19713, United States
Newark Delaware, 19718, United States
Rehoboth Beach Delaware, 19971, United States
Atlantis Florida, 33462, United States
Aventura Florida, 33180, United States
Deerfield Beach Florida, 33064, United States
Fort Lauderdale Florida, 33316, United States
Key West Florida, 33040, United States
Lakewood Ranch Florida, 34202, United States
Miami Beach Florida, 33140, United States
Plantation Florida, 33324, United States
Atlanta Georgia, 30303, United States
Atlanta Georgia, 30308, United States
Atlanta Georgia, 30309, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Fayetteville Georgia, 30214, United States
Savannah Georgia, 31405, United States
Boise Idaho, 83706, United States
Nampa Idaho, 83687, United States
Aurora Illinois, 60504, United States
Decatur Illinois, 62526, United States
Effingham Illinois, 62401, United States
Hines Illinois, 60141, United States
Maywood Illinois, 60153, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Springfield Illinois, 62781, United States
Urbana Illinois, 61801, United States
Zion Illinois, 60099, United States
Fort Wayne Indiana, 46805, United States
Fort Wayne Indiana, 46845, United States
Indianapolis Indiana, 46237, United States
Mooresville Indiana, 46158, United States
Des Moines Iowa, 50314, United States
Kansas City Kansas, 66160, United States
Overland Park Kansas, 66210, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
Metairie Louisiana, 70006, United States
Metairie Louisiana, 70006, United States
New Orleans Louisiana, 70112, United States
Bath Maine, 04530, United States
Portland Maine, 04102, United States
Sanford Maine, 04073, United States
Scarborough Maine, 04074, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21229, United States
Bethesda Maryland, 20889, United States
Columbia Maryland, 21044, United States
Easton Maryland, 21601, United States
Glen Burnie Maryland, 21061, United States
Ocean Pines Maryland, 21811, United States
Salisbury Maryland, 21801, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02118, United States
Danvers Massachusetts, 01923, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Bay City Michigan, 48706, United States
Clarkston Michigan, 48346, United States
Clarkston Michigan, 48346, United States
Dearborn Michigan, 48124, United States
Detroit Michigan, 48201, United States
Farmington Hills Michigan, 48334, United States
Farmington Hills Michigan, 48334, United States
Farmington Hills Michigan, 48336, United States
Flint Michigan, 48503, United States
Flint Michigan, 48532, United States
Grand Rapids Michigan, 49503, United States
Kalamazoo Michigan, 49007, United States
Lansing Michigan, 48910, United States
Lansing Michigan, 48912, United States
Macomb Michigan, 48044, United States
Madison Heights Michigan, 48071, United States
Mount Clemens Michigan, 48043, United States
Petoskey Michigan, 49770, United States
Port Huron Michigan, 48060, United States
Royal Oak Michigan, 48073, United States
Troy Michigan, 48085, United States
Troy Michigan, 48098, United States
Wyoming Michigan, 49519, United States
Bemidji Minnesota, 56601, United States
Maplewood Minnesota, 55109, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Cape Girardeau Missouri, 63703, United States
Cape Girardeau Missouri, 63703, United States
Creve Coeur Missouri, 63141, United States
Rolla Missouri, 65401, United States
Saint Louis Missouri, 63104, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63129, United States
Saint Louis Missouri, 63131, United States
Saint Peters Missouri, 63376, United States
Springfield Missouri, 65804, United States
Billings Montana, 59101, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59804, United States
Omaha Nebraska, 68198, United States
Exeter New Hampshire, 03833, United States
Lebanon New Hampshire, 03756, United States
Paramus New Jersey, 07652, United States
Pennington New Jersey, 08534, United States
Albuquerque New Mexico, 87102, United States
Albuquerque New Mexico, 87109, United States
Albuquerque New Mexico, 87109, United States
Albany New York, 12208, United States
Brooklyn New York, 11215, United States
Canandaigua New York, 14424, United States
Cooperstown New York, 13326, United States
Middletown New York, 10940, United States
New York New York, 10016, United States
Rochester New York, 14620, United States
Rochester New York, 14642, United States
Syracuse New York, 13210, United States
Durham North Carolina, 27705, United States
Durham North Carolina, 27710, United States
Laurinburg North Carolina, 28352, United States
Raleigh North Carolina, 27609, United States
Supply North Carolina, 28462, United States
Wilmington North Carolina, 28401, United States
Bismarck North Dakota, 58501, United States
Fargo North Dakota, 58122, United States
Akron Ohio, 44307, United States
Beachwood Ohio, 44122, United States
Chardon Ohio, 44024, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44111, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43214, United States
Elyria Ohio, 44035, United States
Independence Ohio, 44131, United States
Mansfield Ohio, 44906, United States
Mayfield Heights Ohio, 44124, United States
Mentor Ohio, 44060, United States
Ravenna Ohio, 44266, United States
Sandusky Ohio, 44870, United States
Sylvania Ohio, 43560, United States
Westlake Ohio, 44145, United States
Wooster Ohio, 44691, United States
Oklahoma City Oklahoma, 73104, United States
Gresham Oregon, 97030, United States
Portland Oregon, 97210, United States
Allentown Pennsylvania, 18103, United States
Bryn Mawr Pennsylvania, 19010, United States
Chadds Ford Pennsylvania, 19317, United States
Danville Pennsylvania, 17822, United States
Drexel Hill Pennsylvania, 19026, United States
East Norriton Pennsylvania, 19401, United States
Furlong Pennsylvania, 18925, United States
Gettysburg Pennsylvania, 17325, United States
Hershey Pennsylvania, 17033, United States
Lewisburg Pennsylvania, 17837, United States
Lewistown Pennsylvania, 17044, United States
Paoli Pennsylvania, 19301, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19114, United States
Philadelphia Pennsylvania, 19140, United States
Pottsville Pennsylvania, 17901, United States
West Reading Pennsylvania, 19611, United States
Wilkes-Barre Pennsylvania, 18711, United States
Willow Grove Pennsylvania, 19090, United States
Wynnewood Pennsylvania, 19096, United States
York Pennsylvania, 17403, United States
Boiling Springs South Carolina, 29316, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29607, United States
Greenville South Carolina, 29615, United States
Greenwood South Carolina, 29646, United States
Greer South Carolina, 29650, United States
Hilton Head Island South Carolina, 29926, United States
Myrtle Beach South Carolina, 29577, United States
Seneca South Carolina, 29672, United States
Sioux Falls South Dakota, 57117, United States
Knoxville Tennessee, 37916, United States
Abilene Texas, 79606, United States
McKinney Texas, 75071, United States
Plano Texas, 75093, United States
Sugar Land Texas, 77479, United States
Webster Texas, 77598, United States
Logan Utah, 84321, United States
Murray Utah, 84107, United States
Ogden Utah, 84403, United States
Provo Utah, 84604, United States
Saint George Utah, 84770, United States
Berlin Vermont, 05602, United States
Burlington Vermont, 05401, United States
Saint Johnsbury Vermont, 05819, United States
Hampton Virginia, 23666, United States
Norfolk Virginia, 23505, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23230, United States
Roanoke Virginia, 24014, United States
Suffolk Virginia, 23434, United States
Seattle Washington, 98101, United States
Vancouver Washington, 98686, United States
Walla Walla Washington, 99362, United States
Charleston West Virginia, 25304, United States
Morgantown West Virginia, 26506, United States
Appleton Wisconsin, 54915, United States
Brookfield Wisconsin, 53045, United States
Franklin Wisconsin, 53132, United States
Green Bay Wisconsin, 54311, United States
La Crosse Wisconsin, 54601, United States
Menomonee Falls Wisconsin, 53051, United States
Mequon Wisconsin, 53097, United States
Milwaukee Wisconsin, 53211, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
Oak Creek Wisconsin, 53154, United States
Oshkosh Wisconsin, 54904, United States
Oshkosh Wisconsin, 54904, United States
Racine Wisconsin, 53405, United States
Summit Wisconsin, 53066, United States
Two Rivers Wisconsin, 54241, United States
West Bend Wisconsin, 53095, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Hamilton Ontario, L8V 5, Canada
Ottawa Ontario, K1H 8, Canada
Chicoutimi Quebec, G7H 5, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H2X 3, Canada
Montreal Quebec, H3H 2, Canada
Quebec City Quebec, G1R 2, Canada
Sherbrooke Quebec, J1H 5, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Chai Wan , , Hong Kong
Mumbai , 400 0, India
Dublin Co Dublin, 18, Ireland
Dublin Co Dublin, 6, Ireland
Aarau , 5001, Switzerland
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