Purpose

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

Condition

Eligibility

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

Criteria


DISEASE CHARACTERISTICS:

- Pathologically (histologically or cytologically) proven diagnosis of prostatic
adenocarcinoma within 180 days of registration at moderate- to high-risk for
recurrence as determined by one of the following combinations:

- Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50
ng/mL (includes intermediate- and high-risk patients)

- Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/mL OR

- Gleason score 6 + >= 50% (positive) biopsies + PSA < 50 ng/ml

- Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL Patients previously
diagnosed with low risk prostate cancer undergoing active surveillance who are
re-biopsied and found to have unfavorable intermediate risk disease or favorable
high risk disease according to the protocol criteria are eligible for enrollment
within 180 days of the repeat biopsy procedure.

- History and/or physical examination (to include at a minimum digital rectal
examination of the prostate and examination of the skeletal system and abdomen) within
90 days prior to registration

- Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT
or MR), (but not by nodal sampling, or dissection) within 90 days prior to
registration

- Patients with lymph nodes equivocal or questionable by imaging are eligible if
the nodes are ≤ 1.5 cm

- Patients status post a negative lymph node dissection are not eligible

- No evidence of bone metastases (M0) on bone scan within 120 days prior to registration
(Na F PET/CT is an acceptable substitute)

- Equivocal bone scan findings are allowed if plain films (or CT or MRI) are
negative for metastasis

- Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott,
Hybritech) within 120 days prior to registration

- Study entry PSA should not be obtained during the following time frames:

- Ten-day period following prostate biopsy

- Following initiation of hormonal therapy

- Within 30 days after discontinuation of finasteride

- Within 90 days after discontinuation of dutasteride

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Absolute neutrophil count (ANC) ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0
g/dL is acceptable)

- No prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for
a minimum of 3 years (1,095 days) and not in the pelvis

- E.g., carcinoma in situ of the oral cavity is permissible; however, patients with
prior history of bladder cancer are not allowed

- No prior hematological (e.g., leukemia, lymphoma, or myeloma) malignancy

- No previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

- No previous pelvic irradiation, prostate brachytherapy or bilateral orchiectomy

- No previous hormonal therapy, such as LHRH agonists (e.g., leuprolide, goserelin,
buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens
(e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., DES), or
surgical castration (orchiectomy)

- Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset
of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 45 days prior to
the date of registration.

- No severe, active co-morbidity, defined as any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
or severe liver dysfunction

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
Control (CDC) definition

- Protocol-specific requirements may also exclude immuno-compromised patients

- HIV testing is not required for entry into this protocol

- No patients who are sexually active and not willing/able to use medically acceptable
forms of contraception

- No prior allergic reaction to the hormones involved in this protocol

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer

- No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

- No prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH)
agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist
(e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone
acetate), estrogens (e.g., diethylstilbestrol (DES) ), or surgical castration
(orchiectomy)

- No prior pharmacologic androgen ablation for prostate cancer unless the onset of
androgen ablation is ≤ 45 days prior to the date of registration

- No finasteride within 30 days prior to registration

- No dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration

- No prior or concurrent cytotoxic chemotherapy for prostate cancer

- Prior chemotherapy for a different cancer is allowable

- No prior radiotherapy, including brachytherapy, to the region of the study cancer that
would result in overlap of radiation therapy fields

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
Arm I
Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using intensity-modulated radiotherapy (IMRT)* or 3D-conformal radiation therapy (3D-CRT)* once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo permanent prostate implant (PPI) brachytherapy or high-dose rate brachytherapy (I 125 or Pd 103 may be used as the radioisotope).
  • Radiation: radiation therapy
    Undergo RT using IMRT or 3D-CRT
  • Radiation: Whole-pelvic radiotherapy (WPRT)
    Undergo whole-pelvic radiotherapy (WPRT)
Experimental
Arm II
Patients undergo whole-pelvic radiotherapy (WPRT)* (3D-CRT or IMRT) once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in arm I.
  • Radiation: Whole-pelvic radiotherapy (WPRT)
    Undergo whole-pelvic radiotherapy (WPRT)

Recruiting Locations

University of South Alabama Mitchell Cancer Institute
Mobile, Alabama 36688
Contact:
Site Public Contact
251-445-9870
pfrancisco@usouthal.edu

Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Fairbanks Memorial Hospital
Fairbanks, Alaska 99701
Contact:
Site Public Contact
907-458-3043
cancerresearch@foundationhealth.org

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-Phoenix
Phoenix, Arizona 85027
Contact:
Site Public Contact
480-922-4600
renee.schein@arizonaccc.com

21st Century Oncology-Scottsdale
Scottsdale, Arizona 85251
Contact:
Site Public Contact
480-945-6896

Arizona Breast Cancer Specialists
Scottsdale, Arizona 85251
Contact:
Site Public Contact
480-922-4600

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 Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona 85704
Contact:
Site Public Contact
520-694-8900

The University of Arizona Medical Center-University Campus
Tucson, Arizona 85724
Contact:
Site Public Contact
520-626-9008

CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas 71913
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

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

Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California 95603
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California 93301
Contact:
Site Public Contact
661-323-4673

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

Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505
Contact:
Site Public Contact
818-847-4793
Madonna.Johnson@providence.org

Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California 95682
Contact:
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415-209-2686
bernicl@sutterhealth.org

Mercy San Juan Medical Center
Carmichael, California 95608
Contact:
Site Public Contact
916-537-5237

Fresno Cancer Center
Fresno, California 93720
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.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

Veterans Administration Long Beach Medical Center
Long Beach, California 90822
Contact:
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562-826-8000

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

Cedars Sinai Medical Center
Los Angeles, California 90048
Contact:
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310-423-8965

Fremont - Rideout Cancer Center
Marysville, California 95901
Contact:
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530-749-4400

Mercy UC Davis Cancer Center
Merced, California 95340
Contact:
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209-564-3600

Memorial Medical Center
Modesto, California 95355
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415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente Oakland-Broadway
Oakland, California 94611
Contact:
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877-642-4691
Kpoct@kp.org

Desert Regional Medical Center
Palm Springs, California 92262
Contact:
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760-416-4730

Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
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415-209-2686
bernicl@sutterhealth.org

Pomona Valley Hospital Medical Center
Pomona, California 91767
Contact:
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909-865-9555

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

Rohnert Park Cancer Center
Rohnert Park, California 94928
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California 95661
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

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

Mercy Cancer Center - Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
916-863-8731
OncologyResearch@DignityHealth.org

Sutter Medical Center Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

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

South Sacramento Cancer Center
Sacramento, California 95823
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

University of California San Diego
San Diego, California 92103
Contact:
Loren K. Mell
858-822-5354
cancercto@ucsd.edu

UCSF Medical Center-Mount Zion
San Francisco, California 94115
Contact:
Site Public Contact
877-827-3222

UCSF Medical Center-Mission Bay
San Francisco, California 94158
Contact:
Site Public Contact
877-827-3222

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

Saint Joseph's Medical Center
Stockton, California 95204
Contact:
Site Public Contact
888-823-5923
ctsucontact@westat.com

Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

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

Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California 95687
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

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

Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

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

Porter Adventist Hospital
Denver, Colorado 80210
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

The Shaw Regional Cancer Center
Edwards, Colorado 81632
Contact:
Site Public Contact
970-569-7429

North Colorado Medical Center
Greeley, Colorado 80631
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Longmont United Hospital
Longmont, Colorado 80501
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

McKee Medical Center
Loveland, Colorado 80539
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Parker Adventist Hospital
Parker, Colorado 80138
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Middlesex Hospital
Middletown, Connecticut 06457
Contact:
Site Public Contact
860-358-2058
beth_slifer@midhosp.org

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

Nanticoke Memorial Hospital
Seaford, Delaware 19973
Contact:
Site Public Contact
302-645-3100
Dmiskin@Beebehealthcare.org

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Site Public Contact
202-877-8839

Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
Contact:
Site Public Contact
904-202-7051

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647

Cleveland Clinic-Weston
Weston, Florida 33331
Contact:
Site Public Contact
954-659-5705
CancerAnswer@ccf.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

John B Amos Cancer Center
Columbus, Georgia 31904
Contact:
Site Public Contact
706-478-7968
cdean@iacthealth.com

Atlanta VA Medical Center
Decatur, Georgia 30033
Contact:
Site Public Contact
404-321-6111

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

The Cancer Center of Hawaii-Pali Momi
'Aiea, Hawaii 96701
Contact:
Site Public Contact
808-678-9000

Queen's Medical Center
Honolulu, Hawaii 96813
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii 96817
Contact:
Site Public Contact
808-547-6881

Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Kootenai Medical Center
Coeur d'Alene, Idaho 83814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Kootenai Cancer Center
Post Falls, Idaho 83854
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kootenai Cancer Clinic
Sandpoint, Idaho 83864
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Northwest Community Hospital
Arlington Heights, Illinois 60005
Contact:
Site Public Contact
847-618-4968

Rush - Copley Medical Center
Aurora, Illinois 60504
Contact:
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

John H Stroger Jr Hospital of Cook County
Chicago, Illinois 60612
Contact:
Site Public Contact
312-864-5204

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Site Public Contact
312-942-5498
clinical_trials@rush.edu

Weiss Memorial Hospital
Chicago, Illinois 60640
Contact:
Site Public Contact
773-564-5032

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

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

OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

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

SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois 61114
Contact:
Site Public Contact
779-696-9400
cancercare@swedishamerican.org

Saint John's Hospital
Springfield, Illinois 62702
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Site Public Contact
217-788-3528

Southwest Illinois Health Services LLP
Swansea, Illinois 62226
Contact:
Site Public Contact
618-236-1000
lynns@thecancercenter.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

Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

IU Health Methodist Hospital
Indianapolis, Indiana 46202
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

Memorial Hospital of South Bend
South Bend, Indiana 46601
Contact:
Site Public Contact
800-284-7370

McFarland Clinic PC - Ames
Ames, Iowa 50010
Contact:
Site Public Contact
515-239-2621

Saint Luke's Hospital
Cedar Rapids, Iowa 52402
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Mercy Hospital
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-365-4673

Central Care Cancer Center - Garden City
Garden City, Kansas 67846
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

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

Lawrence Memorial Hospital
Lawrence, Kansas 66044
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Olathe Medical Center
Olathe, Kansas 66061
Contact:
Site Public Contact
913-791-3500
Jeni.wakefield@olathehealth.org

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

Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas 66606
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

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

Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky 42303
Contact:
Site Public Contact
270-688-3691
shawns@omhs.org

Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
Contact:
Site Public Contact
225-215-1353
clinicalresearch@marybird.com

Mary Bird Cancer Center/Saint Tammany Parish
Covington, Louisiana 70433
Contact:
Site Public Contact
225-215-1353
clinicalresearch@marybird.com

Mary Bird Perkins Cancer Center/Terrebonne General Medical Center
Houma, Louisiana 70360
Contact:
Site Public Contact
225-215-1353
clinicalresearch@marybird.com

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

Tulane University Health Sciences Center
New Orleans, Louisiana 70112
Contact:
Site Public Contact
504-988-6121

Touro Infirmary
New Orleans, Louisiana 70115
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
Contact:
Site Public Contact
504-703-8712
Gregory.Johnstone@ochsner.org

Anne Arundel Medical Center
Annapolis, Maryland 21401
Contact:
Site Public Contact
443-481-1320
kbodenhorn@aahs.org

University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823

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

Upper Chesapeake Medical Center
Bel Air, Maryland 21014
Contact:
Site Public Contact
443-643-3010

Central Maryland Radiation Oncology in Howard County
Columbia, Maryland 21044
Contact:
Site Public Contact
443-546-1300

University of Maryland Radiation Oncology Center at Union Hospital
Elkton, Maryland 21921
Contact:
Site Public Contact
410-328-7501
sgrim@umm.edu

Tate Cancer Center
Glen Burnie, Maryland 21061
Contact:
Site Public Contact
410-553-8100

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

Saint Anne's Hospital
Fall River, Massachusetts 02721
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Lowell General Hospital
Lowell, Massachusetts 01854
Contact:
Site Public Contact
978-788-7084
ghincks@lowellgeneral.org

Beth Israel Deaconess Hospital-Plymouth
Plymouth, Massachusetts 02360
Contact:
Site Public Contact
508-830-2390
cancerinfo@jordanhospital.org

Veteran's Administration Medical Center - Ann Arbor
Ann Arbor, Michigan 48105
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

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

Bronson Battle Creek
Battle Creek, Michigan 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

McLaren Cancer Institute-Bay City
Bay City, Michigan 48706
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Henry Ford Cancer Institute?Downriver
Brownstown, Michigan 48183
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

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

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
Contact:
Site Public Contact
313-916-1784

Beaumont Hospital-Dearborn
Dearborn, Michigan 48124
Contact:
Site Public Contact
248-551-7695

Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Site Public Contact
313-916-1784

Saint John Hospital and Medical Center
Detroit, Michigan 48236
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

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

Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Beaumont Hospital - Farmington Hills
Farmington Hills, Michigan 48336
Contact:
Site Public Contact
248-551-7695

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

Mercy Health Saint Mary's
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

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

West Michigan Cancer Center
Kalamazoo, Michigan 49007
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

Sparrow Hospital
Lansing, Michigan 48912
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan 48446
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Saint Mary Mercy Hospital
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

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

McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan 48858
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Mercy Health Mercy Campus
Muskegon, Michigan 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

McLaren Cancer Institute-Owosso
Owosso, Michigan 48867
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

21st Century Oncology-Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

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

William Beaumont Hospital-Royal Oak
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Saint Mary's of Michigan
Saginaw, Michigan 48601
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

William Beaumont Hospital - Troy
Troy, Michigan 48085
Contact:
Site Public Contact
248-551-7695

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

Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
Contact:
Site Public Contact
888-734-5322

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

Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota 56303
Contact:
Site Public Contact
877-229-4907
coborncancercenter@centracare.com

Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

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

Rice Memorial Hospital
Willmar, Minnesota 56201
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

University of Mississippi Medical Center
Jackson, Mississippi 39216
Contact:
Site Public Contact
601-815-6700

Singing River Hospital
Pascagoula, Mississippi 39581
Contact:
Site Public Contact
228-809-5292

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

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

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Freeman Health System
Joplin, Missouri 64804
Contact:
Site Public Contact
417-347-4030
LJCrockett@freemanhealth.com

North Kansas City Hospital
Kansas City, Missouri 64116
Contact:
Site Public Contact
816-691-1599

Kansas City Veterans Affairs Medical Center
Kansas City, Missouri 64128
Contact:
Site Public Contact
800-525-1483

The University of Kansas Cancer Center-South
Kansas City, Missouri 64131
Contact:
Site Public Contact
913-945-7552
ctnursenav@kumc.edu

The University of Kansas Cancer Center-North
Kansas City, Missouri 64154
Contact:
Site Public Contact
913-945-7552
ctnursenav@kumc.edu

The University of Kansas Cancer Center-Lee's Summit
Lee's Summit, Missouri 64064
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
jrichards@research.pcrmc.com

Heartland Regional Medical Center
Saint Joseph, Missouri 64507
Contact:
Site Public Contact
816-271-7937
linda.schumacher@mymlc.com

Washington University School of Medicine
Saint Louis, Missouri 63110
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

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-6770

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

CoxHealth South Hospital
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520

Billings Clinic Cancer Center
Billings, Montana 59101
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

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

Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

University of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
Site Public Contact
402-559-6941
unmcrsa@unmc.edu

Exeter Hospital
Exeter, New Hampshire 03833
Contact:
Site Public Contact
800-439-3837

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

Virtua Memorial
Mount Holly, New Jersey 08060
Contact:
Site Public Contact
609-914-6762

Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
Contact:
Site Public Contact
908-685-2481

Sparta Cancer Treatment Center
Sparta, New Jersey 07871
Contact:
Site Public Contact
973-729-7001

Inspira Medical Center Vineland
Vineland, New Jersey 08360
Contact:
Site Public Contact
856-641-7933

Virtua Voorhees
Voorhees, New Jersey 08043
Contact:
Site Public Contact
856-247-7395

Inspira Medical Center Woodbury
Woodbury, New Jersey 08096
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Memorial Medical Center - Las Cruces
Las Cruces, New Mexico 88011
Contact:
Site Public Contact
575-556-6545
Kim.Hoffman@lpnt.net

Southside Hospital
Bay Shore, New York 11706
Contact:
Site Public Contact
516-734-8896

Bronx Veterans Administration Medical Center
Bronx, New York 10468
Contact:
Site Public Contact
718-584-9000
kl2965@cumc.columbia.edu

New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York 11215
Contact:
Site Public Contact
718-780-3677
Adg9003@nyp.org

Mary Imogene Bassett Hospital
Cooperstown, New York 13326
Contact:
Site Public Contact
607-547-3073
diana.crean@bassett.org

Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York 14905
Contact:
Site Public Contact
607-271-7000

Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
Contact:
Site Public Contact
516-734-8896

Long Island Jewish Medical Center
New Hyde Park, New York 11040
Contact:
Site Public Contact
516-734-8896

Columbia University/Herbert Irving Cancer Center
New York, New York 10032
Contact:
Site Public Contact
212-305-6361
nr2616@cumc.columbia.edu

Highland Hospital
Rochester, New York 14620
Contact:
Site Public Contact
585-341-8113

University of Rochester
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830

Stony Brook University Medical Center
Stony Brook, New York 11794
Contact:
Site Public Contact
800-862-2215

Durham Veterans Affairs Medical Center
Durham, North Carolina 27705
Contact:
Site Public Contact
919-286-0411
Nicole.Roberge@VA.gov

The Coleman Radiation Center-Carteret General Hospital
Morehead City, North Carolina 28557
Contact:
Site Public Contact
252-808-6177

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

Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103
Contact:
Site Public Contact
336-718-8335
asmarrs@novanthealth.org

Sanford Broadway Medical Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
800-437-4010

Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio 44304
Contact:
Site Public Contact
330-375-6101

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

Summa Barberton Hospital
Barberton, Ohio 44203
Contact:
Site Public Contact
330-615-4132

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

Mercy Medical Center
Canton, Ohio 44708
Contact:
Site Public Contact
888-293-4673

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

Adena Regional Medical Center
Chillicothe, Ohio 45601
Contact:
Site Public Contact
877-779-7585
sheree@columbusccop.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

Cleveland Clinic Foundation
Cleveland, Ohio 44195
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

The Mark H Zangmeister Center
Columbus, Ohio 43219
Contact:
Site Public Contact
614-488-2118
sheree@columbusccop.org

Mount Carmel Health Center West
Columbus, Ohio 43222
Contact:
Site Public Contact
614-234-5433
sheree@columbusccop.org

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

Cleveland Clinic Cancer Center Independence
Independence, Ohio 44131
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

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

Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio 43537
Contact:
Site Public Contact
888-823-5923
ctsucontact@westat.com

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

Summa Health Center at Lake Medina
Medina, Ohio 44256
Contact:
Site Public Contact
330-375-4045

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

Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio 44130
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

University Hospitals Parma Medical Center
Parma, Ohio 44129
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Southern Ohio Medical Center
Portsmouth, Ohio 45662
Contact:
Site Public Contact
614-488-2118
sheree@columbusccop.org

University Hospitals Portage Medical Center
Ravenna, Ohio 44266
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Ireland Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio 44870
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

Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio 44136
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

Flower Hospital
Sylvania, Ohio 43560
Contact:
Site Public Contact
419-824-1842

University of Toledo
Toledo, Ohio 43614
Contact:
Site Public Contact
419-383-6583

Mercy Saint Anne Hospital
Toledo, Ohio 43623
Contact:
Site Public Contact
419-407-1160

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

Genesis Healthcare System Cancer Care Center
Zanesville, Ohio 43701
Contact:
Site Public Contact
740-454-5232
sheree@columbusccop.org

Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Portland Medical Center
Portland, Oregon 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland, Oregon 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Abington Memorial Hospital
Abington, Pennsylvania 19001
Contact:
Site Public Contact
215-481-2402

Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Northeast Radiation Oncology Center
Dunmore, Pennsylvania 18512
Contact:
Site Public Contact
888-808-6762

Ephrata Cancer Center
Ephrata, Pennsylvania 17522
Contact:
Site Public Contact
717-721-4840

Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania 18925
Contact:
Site Public Contact
215-794-2700

Adams Cancer Center
Gettysburg, Pennsylvania 17325
Contact:
Site Public Contact
877-441-7957

Cherry Tree Cancer Center
Hanover, Pennsylvania 17331
Contact:
Site Public Contact
877-441-7957

Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
Contact:
Site Public Contact
717-531-3779
CTO@hmc.psu.edu

Sechler Family Cancer Center
Lebanon, Pennsylvania 17042
Contact:
Site Public Contact
717-741-8303
doxenberg@wellspan.org

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Contact:
Site Public Contact
215-728-4790

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

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

WellSpan Health-York Hospital
York, Pennsylvania 17403
Contact:
Site Public Contact
877-441-7957

AnMed Health Cancer Center
Anderson, South Carolina 29621
Contact:
Site Public Contact
864-512-4651
rhonda.ballew@anmedhealth.org

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

Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina 29440
Contact:
Site Public Contact
843-545-5600
broe@tidelandshealth.org

Saint Francis Cancer Center
Greenville, South Carolina 29607
Contact:
Site Public Contact
864-603-6213
meissa_beckman@bshsi.org

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

Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

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

Spartanburg Medical Center
Spartanburg, South Carolina 29303
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

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

Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee 37660
Contact:
Site Public Contact
423-578-8538
justin.reynolds@wellmont.org

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480

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

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

Brooke Army Medical Center
Fort Sam Houston, Texas 78234
Contact:
Site Public Contact
210-916-4837

The Klabzuba Cancer Center
Fort Worth, Texas 76104
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

University of Texas Medical Branch
Galveston, Texas 77555-0565
Contact:
Site Public Contact
409-772-1950
clinical.research@utmb.edu

UTMB Cancer Center at Victory Lakes
League City, Texas 77573
Contact:
Site Public Contact
800-917-8906

Texas Oncology-McAllen
McAllen, Texas 78503
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

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Site Public Contact
210-450-3800
phoresearchoffice@uthscsa.edu

Texas Cancer Center-Sherman
Sherman, Texas 75090
Contact:
Site Public Contact
903-868-4700

Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas 77479
Contact:
Site Public Contact
281-277-5200

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

American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah 84003
Contact:
Site Public Contact
801-855-4100
officeofresearch@imail.org

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

Ogden Regional Medical Center
Ogden, Utah 84405
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

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

Dixie Medical Center Regional Cancer Center
Saint George, Utah 84770
Contact:
Site Public Contact
435-688-4167
officeofresearch@imail.org

Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah 84106
Contact:
Site Public Contact
801-933-6070
officeofresearch@imail.org

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

Southwestern Vermont Medical Center
Bennington, Vermont 05201
Contact:
Site Public Contact
802-447-1836

Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont 05602
Contact:
Site Public Contact
802-225-5400

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

University of Virginia Cancer Center
Charlottesville, Virginia 22908
Contact:
Site Public Contact
434-243-6303
PAS9E@virginia.edu

Augusta Health Cancer Center
Fishersville, Virginia 22939
Contact:
Site Public Contact
540-245-7106

Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton, Virginia 23666
Contact:
Site Public Contact
888-823-5923
ctsucontact@westat.com

Bon Secours DePaul Medical Center
Norfolk, Virginia 23505
Contact:
Site Public Contact
804-893-8611
Melissa_Godsey@bshsi.org

Sentara Norfolk General Hospital
Norfolk, Virginia 23507
Contact:
Site Public Contact
757-388-2406

Naval Medical Center - Portsmouth
Portsmouth, Virginia 23708-2197
Contact:
Site Public Contact
757-953-5939

Hunter Holmes McGuire Veterans Administration Medical Center
Richmond, Virginia 23249
Contact:
Site Public Contact
804-675-5646
Regina.McClung@va.gov

Oncology and Hematology Associates of Southwest Virginia
Roanoke, Virginia 24014
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Sentara Obici Hospital
Suffolk, Virginia 23434
Contact:
Site Public Contact
757-388-5109
djoverto@sentara.com

Sentara Virginia Beach General Hospital
Virginia Beach, Virginia 23454
Contact:
Site Public Contact
888-823-5923
ctsucontact@westat.com

Saint Francis Hospital
Federal Way, Washington 98003
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Virginia Mason Medical Center
Seattle, Washington 98101
Contact:
Site Public Contact
206-342-6954
vmmc.cancer_clinical_research@VirginiaMason.org

Madigan Army Medical Center
Tacoma, Washington 98431
Contact:
Site Public Contact
253-968-0129
mamcdci@amedd.army.mil

PeaceHealth Southwest Medical Center
Vancouver, Washington 98664
Contact:
Site Public Contact
360-514-3940
kmakin-bond@peacehealth.org

United Hospital Center
Bridgeport, West Virginia 26330
Contact:
Site Public Contact
304-293-7374
cancertrialsinfo@hsc.wvu.edu

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

Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Contact:
Site Public Contact
715-623-9869
Juli.Alford@aspirus.org

Radiology Associates of Appleton/ThedaCare Regional Medical Center
Appleton, Wisconsin 54911
Contact:
Site Public Contact
920-380-1500

ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
Contact:
Site Public Contact
844-510-3600

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

Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Contact:
Site Public Contact
920-433-8889
Christy.Gilchrist@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

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

UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin 53038
Contact:
Site Public Contact
920-699-3500
lynda.persico@uwmf.wisc.edu

Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
Contact:
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608-775-2385
cancerctr@gundersenhealth.org

University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53792
Contact:
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800-622-8922

Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
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414-302-2304
ncorp@aurora.org

Community Memorial Hospital
Menomonee Falls, Wisconsin 53051
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262-257-5100

Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin 53097
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412-339-5294
Roster@nrgoncology.org

Wheaton Franciscan Healthcare - Saint Joseph
Milwaukee, Wisconsin 53210
Contact:
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262-785-2273

Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin 53211
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412-339-5294
Roster@nrgoncology.org

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

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

Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin 53295
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888-469-6614

Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
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414-302-2304
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Wheaton Franciscan Cancer Care - All Saints
Racine, Wisconsin 53405
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262-785-2273

HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin 53081
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920-433-8889
Christy.Gilchrist@hshs.org

Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
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414-302-2304
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Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
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920-433-8889
Christy.Gilchrist@hshs.org

Aurora Medical Center in Summit
Summit, Wisconsin 53066
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414-302-2304
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Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
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414-302-2304
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Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
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877-405-6866

Aurora West Allis Medical Center
West Allis, Wisconsin 53227
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414-302-2304
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The Alyce and Elmore Kraemer Cancer Care Center
West Bend, Wisconsin 53095
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866-680-0505

Aspirus UW Cancer Center
Wisconsin Rapids, Wisconsin 54494
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715-422-7718

Billings Clinic-Cody
Cody, Wyoming 82414
Contact:
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800-996-2663
research@billingsclinic.org

More Details

NCT ID
NCT01368588
Status
Recruiting
Sponsor
Radiation Therapy Oncology Group

Detailed Description

OBJECTIVES:

Primary

- Demonstrate that prophylactic, neoadjuvant, androgen-deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) will result in improvement in overall survival (OS) of patients with "unfavorable" intermediate-risk or "favorable" high-risk prostate cancer compared to NADT and high-dose prostate (P) and seminal vesicle (SV) radiation therapy (RT) using intensity-modulated RT (IMRT) or external-beam RT (EBRT) with a high-dose rate (HDR) or a permanent prostate (radioactive seed) implant (PPI) boost.

Secondary

- Demonstrate that prophylactic WPRT improves biochemical control.

- Determine the distant metastasis (DM)-free survival.

- Determine the cause-specific survival (CSS).

- Compare acute and late treatment-adverse events between patients receiving NADT and WPRT versus NADT, P, and SV RT.

- Determine whether health-related quality of life (HRQOL), as measured by the Expanded Prostate Cancer Index Composite (EPIC), significantly worsens with increasing aggressiveness of treatment (i.e., Arm 2, NADT + WPRT).

- Determine whether more aggressive treatment (Arm 2, NADT + WPRT) is associated with a greater increase in fatigue (PROMIS Fatigue Short Form) from baseline to last week of treatment, and a greater increase in circulating inflammatory markers (IL-1, IL-1ra, IL-6, tumor necrosis factor (TNF)-alpha, and C-reactive protein).

- Demonstrate an incremental gain in OS and CSS with more aggressive therapy that outweighs any detriments in the primary generic domains of HRQOL (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).

- Determine whether changes in fatigue from baseline to the next three time points (week prior to RT, last week of treatment, and 3 months after treatment) are associated with changes in circulating cytokines, mood, sleep, and daily activities across the same time points.

- Collect paraffin-embedded tissue blocks, plasma, whole blood, and urine for planned and future translational research analyses.

OUTLINE: This is a multicenter study. Patients are stratified according to moderate- to high-risk groups as listed in the Disease Characteristics of this abstract, type of radiotherapy boost (IMRT vs brachytherapy [Low-dose rate (LDR) using PPI or HDR]), and duration of androgen-deprivation therapy (short-term [6 months] vs long-term [32 months]). Patients are randomized to 1 of 2 treatment arms.

All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally (PO) once daily or flutamide PO thrice daily for 6 months, and luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy comprising leuprolide acetate, goserelin acetate, buserelin, triptorelin, or degarelix subcutaneously (SC) or intramuscularly (IM) every 1 to 3 months beginning 2 months prior to radiotherapy and continuing for 6 or 32 months.

Radiotherapy begins within 8 weeks after beginning LHRH agonist/antagonist injection.

- Arm I: Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using intensity-modulated radiotherapy (IMRT)* or 3D-conformal radiation therapy (3D-CRT)* once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo permanent prostate implant (PPI) brachytherapy or high-dose rate brachytherapy (iodine I 125 or palladium Pd 103 may be used as the radioisotope).

- Arm II: Patients undergo whole-pelvic radiotherapy (WPRT)* (3D-CRT or IMRT) once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in arm I.

NOTE: * Patients undergoing brachytherapy implant receive 5 weeks of IMRT, 3D-CRT, or WPRT.

Patients may undergo blood and urine sample collection for correlative studies. Primary tumor tissue samples may also be collected.

Patients may complete the Expanded Prostate Cancer Index Composite (EPIC), the PROMIS-Fatigue Short Form, and the EuroQol (EQ-5D) quality-of-life (QOL) questionnaires at baseline and periodically during treatment. Patients who participate in the QOL portion of the study must also agree to periodic blood collection.

After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then yearly thereafter.

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.