Purpose

This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with stage III-IV prostate cancer. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer than radiation alone.

Conditions

Eligibility

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

Inclusion Criteria

  • Pathologically (histologically) proven diagnosis of prostate adenocarcinoma; prostatectomy must have been performed within 10 years prior to Step 1 registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
  • Post-prostatectomy patients with a detectable serum PSA (≥ 0.1, but ≤ 1.0 ng/mL) at study entry (within 90 days of Step 1 registration) and at least one of the following:
  • Gleason score 7-10 (International Society of Urological Pathology [ISUP] grade group 2 to 5)
  • ISUP grade group:
  • Grade Group 1: Gleason score ≤ 6,
  • Grade Group 2: Gleason score 3 + 4 = 7,
  • Grade Group 3: Gleason score 4 + 3 = 7,
  • Grade Group 4: Gleason score 8,
  • Grade Group 5: Gleason scores 9 and 10
  • >= T3a disease
  • Persistent elevation of PSA after prostatectomy measured within 90 days after surgery (PSA never became undetectable) of > 0.04 but < 0.2 ng/mL (PSA nadir)
  • pN0 or pNx
  • History/physical examination within 90 days prior to Step 1 registration
  • Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
  • Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on Decipher GRID platform; Note: if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation
  • Prior androgen deprivation therapy (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to Step 1 registration and given for ≤ 90 days duration
  • For example: patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug; for instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date; for a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date
  • Please note: finasteride or dutasteride must be stopped before treatment starts but prior usage will not affect eligibility
  • Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to Step 1 registration
  • Platelet count ≥ 100,000 x 10^9/uL independent of transfusion and/or growth factors within 90 days prior to step 1 registration
  • Serum albumin ≥ 3.0 g/dL within 90 days prior to Step 1 registration
  • Glomerular filtration rate (GFR) ≥ 35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to Step 1 registration
  • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Note: in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject is eligible) within 90 days prior to Step 1 registration
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x ULN within 90 days prior to Step 1 registration
  • Testosterone > 50 ng/dL within 90 days prior to Step 1 registration
  • Concomitant medications known to lower the seizure threshold discontinued or substituted at least 4 weeks (30 days) prior to Step 1 registration.
  • The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
  • The patient must agree not to donate sperm during the study treatment and for 3 months after receiving the last dose of study drug
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Exclusion Criteria

  • Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or lymph node involvement (N1)
  • Prior invasive malignancy (except 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) unless disease free for a minimum of 2 years
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • History of any of the following:
  • Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to Step 1 registration)
  • History of documented inflammatory bowel disease
  • Transmural myocardial infarction within the last 4 months prior to Step 1 registration.
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to Step 1 registration
  • History of any condition that in the opinion of the investigator, would preclude participation in this study
  • Current evidence of any of the following:
  • Known gastrointestinal disorder affecting absorption of oral medications
  • Active uncontrolled infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)
  • Uncontrolled hypertension
  • Any current condition that in the opinion of the investigator, would preclude participation in this study
  • Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is not allowed
  • HIV positive with CD4 count < 200 cells/microliter within 30 days prior to registration
  • HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count. (Note: HIV testing is not required for eligibility for this protocol as it is self-reported.)
  • For patients who have not undergone prior Decipher analysis, submission of the specimen to GenomeDx should be as soon as possible after study registration (Step 1) as these results can take up 21 days after the specimen is received at GenomeDx; Step 2 registration must occur within 6 weeks (42 days) of Step 1 registration; if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Arm 1 (Radiation Therapy + Placebo)
Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive placebo PO QD on Days 1-30. Treatment repeats every 30 days for up to 6 courses (6 months) in the absence of disease progression or unacceptable toxicity.
  • Radiation: External Beam Radiation Therapy
    Undergo external beam radiation therapy
    Other names:
    • Definitive Radiation Therapy
    • EBRT
    • External Beam Radiotherapy
    • External Beam RT
    • external radiation
    • External Radiation Therapy
    • external-beam radiation
  • Other: Placebo
    Given PO
    Other names:
    • placebo therapy
    • PLCB
    • sham therapy
Experimental
Arm 2 (Radiation Therapy + Apalutamide)
Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive apalutamide PO QD on Days 1-30. Treatment repeats every 30 days for up to 6 courses (6 months)in the absence of disease progression or unacceptable toxicity.
  • Drug: Apalutamide
    Given PO
    Other names:
    • ARN 509
    • ARN-509
    • ARN509
    • JNJ 56021927
    • JNJ-56021927
  • Radiation: External Beam Radiation Therapy
    Undergo external beam radiation therapy
    Other names:
    • Definitive Radiation Therapy
    • EBRT
    • External Beam Radiotherapy
    • External Beam RT
    • external radiation
    • External Radiation Therapy
    • external-beam radiation

Recruiting Locations

Arizona Breast Cancer Specialists-Gilbert
Gilbert, Arizona 85297
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480-922-4600

Arizona Center for Cancer Care-Peoria
Peoria, Arizona 85381
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Arizona Breast Cancer Specialists-Scottsdale
Scottsdale, Arizona 85258
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480-922-4600

Arizona Center for Cancer Care-Surprise
Surprise, Arizona 85374
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412-339-5294
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University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
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501-686-8274

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
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415-209-2686
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Marin General Hospital
Greenbrae, California 94904
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415-925-7325

Los Angeles County-USC Medical Center
Los Angeles, California 90033
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323-865-0451

USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
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323-865-0451

Sutter Medical Center Sacramento
Sacramento, California 95816
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916-454-6500
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University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
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Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
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UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
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Poudre Valley Hospital
Fort Collins, Colorado 80524
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Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
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Valley View Hospital Cancer Center
Glenwood Springs, Colorado 81601
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UCHealth Greeley Hospital
Greeley, Colorado 80631
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Medical Center of the Rockies
Loveland, Colorado 80538
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Helen F Graham Cancer Center
Newark, Delaware 19713
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Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
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Beebe Health Campus
Rehoboth Beach, Delaware 19971
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Florida Hospital Orlando
Orlando, Florida 32803
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Grady Health System
Atlanta, Georgia 30303
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Emory University Hospital Midtown
Atlanta, Georgia 30308
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
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Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
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Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
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Rush University Medical Center
Chicago, Illinois 60612
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University of Illinois
Chicago, Illinois 60612
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312-355-3046

Decatur Memorial Hospital
Decatur, Illinois 62526
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Crossroads Cancer Center
Effingham, Illinois 62401
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Illinois CancerCare-Peoria
Peoria, Illinois 61615
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OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois 61615
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OSF Saint Francis Medical Center
Peoria, Illinois 61637
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Carle Cancer Center
Urbana, Illinois 61801
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Parkview Regional Medical Center
Fort Wayne, Indiana 46845
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Goshen Center for Cancer Care
Goshen, Indiana 46526
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Reid Health
Richmond, Indiana 47374
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Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
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Mercy Cancer Center-West Lakes
Clive, Iowa 50325
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Greater Regional Medical Center
Creston, Iowa 50801
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Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa 50314
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Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
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Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
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University of Kansas Cancer Center
Kansas City, Kansas 66160
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Olathe Medical Center
Olathe, Kansas 66061
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University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
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University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
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University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
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East Jefferson General Hospital
Metairie, Louisiana 70006
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Saint Agnes Hospital
Baltimore, Maryland 21229
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Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
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University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
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Bronson Battle Creek
Battle Creek, Michigan 49017
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Saint Joseph Mercy Chelsea
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Michigan State University Clinical Center
East Lansing, Michigan 48824-7016
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Mercy Health Saint Mary's
Grand Rapids, Michigan 49503
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Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
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West Michigan Cancer Center
Kalamazoo, Michigan 49007
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Sparrow Hospital
Lansing, Michigan 48912
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Lakeland Hospital Niles
Niles, Michigan 49120
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Spectrum Health Reed City Hospital
Reed City, Michigan 49677
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Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan 49085
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Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
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Munson Medical Center
Traverse City, Michigan 49684
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Metro Health Hospital
Wyoming, Michigan 49519
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Fairview Ridges Hospital
Burnsville, Minnesota 55337
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952-993-1517
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Mercy Hospital
Coon Rapids, Minnesota 55433
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Fairview-Southdale Hospital
Edina, Minnesota 55435
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Unity Hospital
Fridley, Minnesota 55432
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Fairview Maple Grove Medical Center
Maple Grove, Minnesota 55369
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Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
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952-993-1517
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Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
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412-339-5294
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Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
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Hennepin County Medical Center
Minneapolis, Minnesota 55415
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Health Partners Inc
Minneapolis, Minnesota 55454
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Monticello Cancer Center
Monticello, Minnesota 55362
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952-993-1517
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North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
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Mayo Clinic
Rochester, Minnesota 55905
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855-776-0015

Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
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Regions Hospital
Saint Paul, Minnesota 55101
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United Hospital
Saint Paul, Minnesota 55102
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Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
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952-993-1517
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Lakeview Hospital
Stillwater, Minnesota 55082
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952-993-1517
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Ridgeview Medical Center
Waconia, Minnesota 55387
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952-993-1517
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Rice Memorial Hospital
Willmar, Minnesota 56201
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952-993-1517
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Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
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952-993-1517
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Fairview Lakes Medical Center
Wyoming, Minnesota 55092
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952-993-1517
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Southeast Cancer Center
Cape Girardeau, Missouri 63703
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573-651-5550

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
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800-600-3606
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Capital Region Southwest Campus
Jefferson City, Missouri 65109
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573-632-4814
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The University of Kansas Cancer Center-North
Kansas City, Missouri 64154
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913-945-7552
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The University of Kansas Cancer Center-Lee's Summit
Lee's Summit, Missouri 64064
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412-339-5294
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Washington University School of Medicine
Saint Louis, Missouri 63110
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800-600-3606
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Siteman Cancer Center-South County
Saint Louis, Missouri 63129
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Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
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800-600-3606
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Billings Clinic Cancer Center
Billings, Montana 59101
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800-996-2663
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Bozeman Deaconess Hospital
Bozeman, Montana 59715
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406-969-6060
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Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
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406-969-6060
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Nebraska Methodist Hospital
Omaha, Nebraska 68114
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402-354-5144

Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
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702-384-0013
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Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada 89052
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702-384-0013
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Las Vegas Cancer Center-Henderson
Henderson, Nevada 89052
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702-384-0013
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OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
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702-384-0013
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21st Century Oncology-Henderson
Henderson, Nevada 89074
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702-384-0013
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Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada 89074
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702-384-0013
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Desert West Surgery
Las Vegas, Nevada 89102
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702-384-0013
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OptumCare Cancer Care at Oakey
Las Vegas, Nevada 89102
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702-384-0013
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University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
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702-384-0013
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Hope Cancer Care of Nevada
Las Vegas, Nevada 89103
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702-384-0013
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Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada 89106
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702-384-0013
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21st Century Oncology
Las Vegas, Nevada 89109
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702-384-0013
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HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada 89109
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702-384-0013
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HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada 89113
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702-384-0013
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Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada 89119
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702-384-0013
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21st Century Oncology-Vegas Tenaya
Las Vegas, Nevada 89128
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702-384-0013
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Ann M Wierman MD LTD
Las Vegas, Nevada 89128
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702-384-0013
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Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
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702-384-0013
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HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada 89128
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702-384-0013
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OptumCare Cancer Care at MountainView
Las Vegas, Nevada 89128
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702-384-0013
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Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
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702-384-0013
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Summerlin Hospital Medical Center
Las Vegas, Nevada 89144
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702-384-0013
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Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada 89148-2405
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702-384-0013
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21st Century Oncology-Fort Apache
Las Vegas, Nevada 89148
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702-384-0013
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Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
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702-384-0013
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OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
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702-384-0013
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HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada 89149
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702-384-0013
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Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
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702-384-0013
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University Cancer Center
Las Vegas, Nevada 89169
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702-384-0013
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Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada 89048
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702-384-0013
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Radiation Oncology Associates
Reno, Nevada 89509
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702-384-0013
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Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
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800-639-6918
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Virtua Memorial
Mount Holly, New Jersey 08060
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609-914-6762

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
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732-235-8675

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

Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
Contact:
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212-263-4434
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Stony Brook University Medical Center
Stony Brook, New York 11794
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State University of New York Upstate Medical University
Syracuse, New York 13210
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315-464-5476

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
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877-668-0683
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Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio 44304
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330-375-6101

Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
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937-775-1350
som_dcop@wright.edu

Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
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937-775-1350
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Miami Valley Hospital South
Centerville, Ohio 45459
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University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio 45219
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513-558-4553
uchealthnews@uc.edu

Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio 45236
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937-775-1350
som_dcop@wright.edu

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

Good Samaritan Hospital - Dayton
Dayton, Ohio 45406
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Miami Valley Hospital
Dayton, Ohio 45409
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Dayton Physicians LLC-Samaritan North
Dayton, Ohio 45415
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Miami Valley Hospital North
Dayton, Ohio 45415
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937-832-1093
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Armes Family Cancer Center
Findlay, Ohio 45840
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Blanchard Valley Hospital
Findlay, Ohio 45840
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Orion Cancer Care
Findlay, Ohio 45840
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Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
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Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
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Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
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Wayne Hospital
Greenville, Ohio 45331
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Greater Dayton Cancer Center
Kettering, Ohio 45409
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First Dayton Cancer Care
Kettering, Ohio 45420
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Kettering Medical Center
Kettering, Ohio 45429
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Springfield Regional Cancer Center
Springfield, Ohio 45504
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Springfield Regional Medical Center
Springfield, Ohio 45505
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Dayton Physicians LLC-Upper Valley
Troy, Ohio 45373
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Upper Valley Medical Center
Troy, Ohio 45373
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University Pointe
West Chester, Ohio 45069
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
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405-271-8777
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Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania 18015
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Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
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302-623-4450
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
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215-955-6084

Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania 18840
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800-836-0388

Reading Hospital
West Reading, Pennsylvania 19611
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610-988-9323

Abington Memorial Hospital-Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
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215-481-2402

Greenville Health System Cancer Institute-Faris
Greenville, South Carolina 29605
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864-241-6251
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Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina 29615
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Self Regional Healthcare
Greenwood, South Carolina 29646
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864-725-4771
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Greenville Health System Cancer Institute-Greer
Greer, South Carolina 29650
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Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina 29672
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Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina 29307
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University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
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210-450-3800
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American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah 84003
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801-855-4100
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Sandra L Maxwell Cancer Center
Cedar City, Utah 84720
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435-868-5680
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Logan Regional Hospital
Logan, Utah 84321
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435-716-6400
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Intermountain Medical Center
Murray, Utah 84107
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801-507-3950
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McKay-Dee Hospital Center
Ogden, Utah 84403
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801-387-7426
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Utah Valley Regional Medical Center
Provo, Utah 84604
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801-357-7965
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Riverton Hospital
Riverton, Utah 84065
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801-507-3950
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Dixie Medical Center Regional Cancer Center
Saint George, Utah 84770
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435-688-4167
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Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah 84106
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801-933-6070
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LDS Hospital
Salt Lake City, Utah 84143
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801-408-1347
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Southwestern Vermont Medical Center
Bennington, Vermont 05201
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802-447-1836

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

University of Vermont Medical Center
Burlington, Vermont 05401
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802-656-4101

University of Vermont College of Medicine
Burlington, Vermont 05405
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802-656-8990

Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont 05819
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802-473-4100

PeaceHealth Saint Joseph Medical Center
Bellingham, Washington 98225
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360-715-4133
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West Virginia University Healthcare
Morgantown, West Virginia 26506
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304-293-7374
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Camden Clark Medical Center
Parkersburg, West Virginia 26101
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304-424-2585
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Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
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414-302-2304
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Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
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414-302-2304
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Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
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414-302-2304
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Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
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412-339-5294
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Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin 53295
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888-469-6614

Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
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952-993-1517
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Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
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414-302-2304
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Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
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414-302-2304
ncorp@aurora.org

Aurora Medical Center in Summit
Summit, Wisconsin 53066
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414-302-2304
ncorp@aurora.org

Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
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414-302-2304
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Aurora West Allis Medical Center
West Allis, Wisconsin 53227
Contact:
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414-302-2304
ncorp@aurora.org

More Details

NCT ID
NCT03371719
Status
Recruiting
Sponsor
NRG Oncology

Study Contact

Daniel Spratt, MD
734-232-5244
sprattda@med.umich.edu

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.

SECONDARY OBJECTIVES:

I. To assess whether molecular stratification by the PAM50 gene expression clustering will identify subsets of prostate cancer (luminal A or basal, luminal B) which derive the greatest benefit from anti-androgen therapy.

II. To assess overall survival. III. To assess cancer-specific mortality. IV. To assess metastasis-free survival. V. To assess distant metastasis. VI. To assess local-regional progression. VII. To assess PSA nadir during first year of treatment and prior to initiation of any hormonal salvage therapy.

VIII. To assess initiation of salvage hormonal therapy. IX. To assess PSA with a non-castrate testosterone at 1 and 3 years post randomization: PSA < 0.1 ng/ml and testosterone >= 50 ng/dl.

X. To assess acute and late physician-reported morbidity (per the Common Terminology Criteria for Adverse Events [CTCAE] version 5) after SRT +/- apalutamide.

XI. To assess acute and late patient-reported morbidity (per the patient reported outcomes [PRO]-CTCAE) after SRT +/- apalutamide.

XII. To assess testosterone levels at 3, 6, 9, 12, and 36 months post randomization.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive placebo orally (PO) once daily (QD) on days 1-30. Treatment repeats every 30 days for up to 6 courses (6 months) in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive apalutamide PO QD on Days 1-30. Treatment repeats every 30 days for up to 6 courses (6 months) in the absence of disease progression or unacceptable toxicity.

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