Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score
Purpose
This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading.
Condition
- Prostate Adenocarcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration - Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria: - Has at least one intermediate risk factor (IRF): - PSA 10-20 ng/mL - Clinical stage T2b-c (digital rectal examination [DRE] and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition - Gleason score 7 (Gleason 3+4 or 4+3 [ International Society of Urological Pathology (ISUP) Grade Group 2-3]) - Has ONE or more of the following 'unfavorable' intermediate-risk designators: - > 1 immature reticulocyte fraction (IRF) - Gleason 4+3=7 (ISUP Grade Group 3) - >= 50% of biopsy cores positive - Biopsies may include 'sextant' sampling of right/left regions of the prostate, often labeled base, mid-gland and apex. All such 'sextant' biopsy cores should be counted. Men may also undergo 'targeted' sampling of prostate lesions (guided by MRI, ultrasound or other approaches). A targeted lesion that is biopsied more than once and demonstrates cancer (regardless of number of targeted cores involved) should count as a single additional positive core sampled and positive. In cases of uncertainty, count the biopsy sampling as sextant core(s) - Absence of high-risk features - Appropriate stage for study entry based on the following diagnostic workup: - History/physical examination within 120 days prior to registration; - Negative bone imaging (M0) within 120 days prior to registration; Note: Tc-99m bone scan or sodium fluoride (NaF) positron emission tomography (PET) are allowed. Equivocal bone scan findings are allowed if plain films X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) are negative for metastasis at the concerned site(s). While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for bone imaging, any suspicious findings must be confirmed and correlated with conventional imaging (Tc-99m bone scan, NaF PET, CT, X-ray, or MRI) to determine eligibility based on the latter modalities (e.g. M0 based on conventional imaging modalities) - Clinically negative lymph nodes (N0) as established by conventional imaging (pelvic +/- abdominal CT or MR), within 120 days prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.0 cm in short axis and/or if biopsy is negative. Note: While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for pelvic imaging, any suspicious findings must be confirmed by conventional imaging (CT, MRI or biopsy). If the findings do not meet pathological criteria based on the latter modalities (e.g. node =< 10 mm in short axis, negative biopsy), the patient will still be eligible - Age >= 18 - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration - Non-castrate testosterone level (> 50 ng/dL) within 120 days prior to registration - Absolute neutrophil >= 1,000 cells/mm^3 (within 120 days prior to registration) - Hemoglobin >= 8.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration) - Platelet count >= 100,000 cells/mm^3 independent of transfusion and/or growth factors (within 120 days prior to registration) - Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration) - For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR >= 30 mL/min/1.73m^2 will be considered adequate - Total bilirubin: 1.5 =< institutional upper limit of normal (ULN) (within 120 days prior to registration) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin. If direct bilirubin is less than or equal to 1.5 x ULN, subject is eligible) - Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]): =< 2.5 x institutional ULN (within 120 days prior to registration) - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; Note: HIV testing is not required for eligibility for this protocol - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. - Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B) - For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Exclusion Criteria
- Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, high intensity focused ultrasound [HIFU], laser thermal ablation, etc.) for prostate cancer - Definitive clinical or radiologic evidence of metastatic disease (M1) - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. History of or current diagnosis of hematologic malignancy is not allowed - Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields - Previous bilateral orchiectomy - Previous 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). ADT started prior to study registration is not allowed - Prior use of 5-alpha-reductase inhibitors is allowed, however, it must be stopped prior to enrollment on the study with at least a 30 day washout period before baseline study PSA measure and registration - Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration - Severe, active co-morbidity defined as follows: - Current severe or unstable angina; - New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification) - History of any condition that in the opinion of the investigator, would preclude participation in this study - Inability to swallow oral pills - High risk features, which includes any of the following: - Gleason 8-10 [ISUP Grade Group 4-5] - PSA > 20 - cT3-4 by digital exam OR gross extra-prostatic extension on imaging [indeterminate MRI evidence will not count and the patient will be eligible]
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm I (RT) |
Patients undergo RT using a recognized regimen (2-3 days a week or 5 days a week for 2-11 weeks) in the absence of disease progression or unacceptable toxicity. |
|
|
Experimental Arm II (RT, ADT) |
Patients undergo RT as Arm I. Patients also receive ADT consisting of leuprolide, goserelin, buserelin, histrelin, triptorelin, degarelix, or relugolix at the discretion of the treating physician, for 6 months in the absence of disease progression or unacceptable toxicity. Patients may also receive bicalutamide or flutamide for 0, 30 or 180 days. |
|
|
Experimental Arm III (RT, ADT) |
Patients receive treatment as in Arm II. |
|
|
Experimental Arm IV (RT, ADT, darolutamide) |
Patients receive RT and ADT as in Arm II. Patients also receive darolutamide PO BID on days 1-90. Treatment repeats every 90 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. |
|
Recruiting Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Gilbert, Arizona 85234
Contact:
Site Public Contact
602-747-9738
Site Public Contact
602-747-9738
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California 95603
Auburn, California 95603
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California 93301
Bakersfield, California 93301
Contact:
Site Public Contact
661-323-4673
Site Public Contact
661-323-4673
Tower Cancer Research Foundation
Beverly Hills, California 90211
Beverly Hills, California 90211
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California 95682
Cameron Park, California 95682
City of Hope Corona
Corona, California 92879
Corona, California 92879
City of Hope Comprehensive Cancer Center
Duarte, California 91010
Duarte, California 91010
Kaiser Permanente Dublin
Dublin, California 94568
Dublin, California 94568
Contact:
Site Public Contact
877-642-4691
Site Public Contact
877-642-4691
Kaiser Permanente-Fremont
Fremont, California 94538
Fremont, California 94538
Washington Hospital
Fremont, California 94538
Fremont, California 94538
Contact:
Site Public Contact
510-745-6433
Site Public Contact
510-745-6433
Kaiser Permanente-Fresno
Fresno, California 93720
Fresno, California 93720
Marin General Hospital
Greenbrae, California 94904
Greenbrae, California 94904
Contact:
Site Public Contact
415-925-7325
Site Public Contact
415-925-7325
City of Hope at Irvine Lennar
Irvine, California 92618
Irvine, California 92618
Contact:
Site Public Contact
877-467-3411
Site Public Contact
877-467-3411
City of Hope Antelope Valley
Lancaster, California 93534
Lancaster, California 93534
Los Angeles General Medical Center
Los Angeles, California 90033
Los Angeles, California 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451
Site Public Contact
323-865-0451
Cedars Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
Contact:
Site Public Contact
310-423-8965
Site Public Contact
310-423-8965
Fremont - Rideout Cancer Center
Marysville, California 95901
Marysville, California 95901
Contact:
Site Public Contact
530-749-4400
Site Public Contact
530-749-4400
Memorial Medical Center
Modesto, California 95355
Modesto, California 95355
Kaiser Permanente-Modesto
Modesto, California 95356
Modesto, California 95356
Providence Queen of The Valley
Napa, California 94558
Napa, California 94558
Contact:
Site Public Contact
707-521-3830
Site Public Contact
707-521-3830
Kaiser Permanente-Oakland
Oakland, California 94611
Oakland, California 94611
Saint Joseph Hospital - Orange
Orange, California 92868
Orange, California 92868
Contact:
Site Public Contact
714-734-6220
Site Public Contact
714-734-6220
Kaiser Permanente-Roseville
Roseville, California 95661
Roseville, California 95661
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California 95661
Roseville, California 95661
Kaiser Permanente Downtown Commons
Sacramento, California 95814
Sacramento, California 95814
Sutter Medical Center Sacramento
Sacramento, California 95816
Sacramento, California 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089
Site Public Contact
916-734-3089
Kaiser Permanente-South Sacramento
Sacramento, California 95823
Sacramento, California 95823
Kaiser Permanente-San Francisco
San Francisco, California 94115
San Francisco, California 94115
UCSF Medical Center-Mission Bay
San Francisco, California 94158
San Francisco, California 94158
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
San Jose, California 95119
Kaiser Permanente San Leandro
San Leandro, California 94577
San Leandro, California 94577
Ridley-Tree Cancer Center
Santa Barbara, California 93105
Santa Barbara, California 93105
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Santa Clara, California 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
Santa Rosa, California 95403
City of Hope South Pasadena
South Pasadena, California 91030
South Pasadena, California 91030
Kaiser Permanente-South San Francisco
South San Francisco, California 94080
South San Francisco, California 94080
Cedars-Sinai Cancer - Tarzana
Tarzana, California 91356
Tarzana, California 91356
Contact:
Site Public Contact
818-981-3818
Site Public Contact
818-981-3818
City of Hope South Bay
Torrance, California 90503
Torrance, California 90503
Contact:
Site Public Contact
877-467-3411
Site Public Contact
877-467-3411
Torrance Memorial Physician Network - Cancer Care
Torrance, California 90505
Torrance, California 90505
Torrance Memorial Medical Center
Torrance, California 90509
Torrance, California 90509
Contact:
Site Public Contact
310-517-4665
Site Public Contact
310-517-4665
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California 96161
Truckee, California 96161
Contact:
Site Public Contact
530-582-6450
Site Public Contact
530-582-6450
City of Hope Upland
Upland, California 91786
Upland, California 91786
Kaiser Permanente-Vallejo
Vallejo, California 94589
Vallejo, California 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Walnut Creek, California 94596
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650
Site Public Contact
720-848-0650
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
Boulder, Colorado 80304
UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
Contact:
Site Public Contact
719-365-2406
Site Public Contact
719-365-2406
Memorial Hospital North
Colorado Springs, Colorado 80920
Colorado Springs, Colorado 80920
Contact:
Site Public Contact
719-364-6700
Site Public Contact
719-364-6700
Shaw Cancer Center
Edwards, Colorado 81632
Edwards, Colorado 81632
Contact:
Site Public Contact
970-569-7429
Site Public Contact
970-569-7429
Poudre Valley Hospital
Fort Collins, Colorado 80524
Fort Collins, Colorado 80524
Contact:
Site Public Contact
970-297-6150
Site Public Contact
970-297-6150
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
Fort Collins, Colorado 80528
North Colorado Medical Center
Greeley, Colorado 80631
Greeley, Colorado 80631
UCHealth Greeley Hospital
Greeley, Colorado 80631
Greeley, Colorado 80631
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129
Highlands Ranch, Colorado 80129
Contact:
Site Public Contact
720-848-0650
Site Public Contact
720-848-0650
Medical Center of the Rockies
Loveland, Colorado 80538
Loveland, Colorado 80538
Contact:
Site Public Contact
970-203-7083
Site Public Contact
970-203-7083
McKee Medical Center
Loveland, Colorado 80539
Loveland, Colorado 80539
Hartford HealthCare - Saint Vincent's Medical Center
Bridgeport, Connecticut 06606
Bridgeport, Connecticut 06606
Contact:
Site Public Contact
860-972-4700
Site Public Contact
860-972-4700
Hartford Hospital
Hartford, Connecticut 06102
Hartford, Connecticut 06102
Contact:
Site Public Contact
860-545-5363
Site Public Contact
860-545-5363
Midstate Medical Center
Meriden, Connecticut 06451
Meriden, Connecticut 06451
Contact:
Site Public Contact
866-662-5678
Site Public Contact
866-662-5678
The Hospital of Central Connecticut
New Britain, Connecticut 06050
New Britain, Connecticut 06050
Contact:
Site Public Contact
860-224-5660
Site Public Contact
860-224-5660
Norwalk Hospital
Norwalk, Connecticut 06856
Norwalk, Connecticut 06856
Beebe South Coastal Health Campus
Frankford, Delaware 19945
Frankford, Delaware 19945
Helen F Graham Cancer Center
Newark, Delaware 19713
Newark, Delaware 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Newark, Delaware 19713
Beebe Health Campus
Rehoboth Beach, Delaware 19971
Rehoboth Beach, Delaware 19971
University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
Gainesville, Florida 32610
GenesisCare USA - Plantation
Plantation, Florida 33324
Plantation, Florida 33324
Cleveland Clinic-Weston
Weston, Florida 33331
Weston, Florida 33331
Grady Health System
Atlanta, Georgia 30303
Atlanta, Georgia 30303
Contact:
Site Public Contact
404-489-9164
Site Public Contact
404-489-9164
Emory Proton Therapy Center
Atlanta, Georgia 30308
Atlanta, Georgia 30308
Emory University Hospital Midtown
Atlanta, Georgia 30308
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447
Site Public Contact
888-946-7447
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868
Site Public Contact
404-778-1868
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Contact:
Site Public Contact
404-851-7115
Site Public Contact
404-851-7115
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia 30501
Gainesville, Georgia 30501
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Savannah, Georgia 31405
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Boise, Idaho 83712
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Fruitland, Idaho 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686
Nampa, Idaho 83686
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Twin Falls, Idaho 83301
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
Illinois CancerCare-Carthage
Carthage, Illinois 62321
Carthage, Illinois 62321
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
University of Illinois
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Site Public Contact
312-355-3046
Site Public Contact
312-355-3046
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
DeKalb, Illinois 60115
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Elmhurst Memorial Hospital
Elmhurst, Illinois 60126
Elmhurst, Illinois 60126
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Eureka, Illinois 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Geneva, Illinois 60134
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Kewanee, Illinois 61443
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
Lake Forest, Illinois 60045
Illinois CancerCare-Macomb
Macomb, Illinois 61455
Macomb, Illinois 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Mattoon, Illinois 61938
Loyola University Medical Center
Maywood, Illinois 60153
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357
Site Public Contact
708-226-4357
Edward Hospital/Cancer Center
Naperville, Illinois 60540
Naperville, Illinois 60540
Contact:
Site Public Contact
630-646-6075
Site Public Contact
630-646-6075
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
Methodist Medical Center of Illinois
Peoria, Illinois 61636
Peoria, Illinois 61636
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Princeton, Illinois 61356
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois 61114
Rockford, Illinois 61114
Memorial Hospital East
Shiloh, Illinois 62269
Shiloh, Illinois 62269
Memorial Medical Center
Springfield, Illinois 62781
Springfield, Illinois 62781
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Warrenville, Illinois 60555
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
Saint Luke's Hospital
Cedar Rapids, Iowa 52402
Cedar Rapids, Iowa 52402
Iowa Methodist Medical Center
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727
Site Public Contact
515-241-6727
University of Kansas Cancer Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Olathe Health Cancer Center
Olathe, Kansas 66061
Olathe, Kansas 66061
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Overland Park, Kansas 66210
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
Overland Park, Kansas 66211
Salina Regional Health Center
Salina, Kansas 67401
Salina, Kansas 67401
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas 66606
Topeka, Kansas 66606
Contact:
Site Public Contact
785-270-4939
Site Public Contact
785-270-4939
University of Kansas Health System Saint Francis Campus
Topeka, Kansas 66606
Topeka, Kansas 66606
Contact:
Site Public Contact
785-295-8000
Site Public Contact
785-295-8000
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Westwood, Kansas 66205
Ascension Via Christi Hospitals Wichita
Wichita, Kansas 67214
Wichita, Kansas 67214
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
Lexington, Kentucky 40504
East Jefferson General Hospital
Metairie, Louisiana 70006
Metairie, Louisiana 70006
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Maine Medical Center-Bramhall Campus
Portland, Maine 04102
Portland, Maine 04102
Contact:
Site Public Contact
207-885-7565
Site Public Contact
207-885-7565
Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
Scarborough, Maine 04074
Maine Medical Partners - South Portland
South Portland, Maine 04106
South Portland, Maine 04106
Anne Arundel Medical Center
Annapolis, Maryland 21401
Annapolis, Maryland 21401
Maryland Proton Treatment Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823
Site Public Contact
800-888-8823
UM Upper Chesapeake Medical Center
Bel Air, Maryland 21014
Bel Air, Maryland 21014
Contact:
Site Public Contact
443-643-3010
Site Public Contact
443-643-3010
University of Maryland Shore Medical Center at Easton
Easton, Maryland 21601
Easton, Maryland 21601
Beverly Hospital
Beverly, Massachusetts 01915
Beverly, Massachusetts 01915
Contact:
Site Public Contact
978-922-3000
Site Public Contact
978-922-3000
Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
Burlington, Massachusetts 01805
Addison Gilbert Hospital
Gloucester, Massachusetts 01930
Gloucester, Massachusetts 01930
Contact:
Site Public Contact
978-283-4000
Site Public Contact
978-283-4000
Lahey Medical Center-Peabody
Peabody, Massachusetts 01960
Peabody, Massachusetts 01960
Winchester Hospital
Winchester, Massachusetts 01890
Winchester, Massachusetts 01890
Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125
Site Public Contact
800-865-1125
McLaren Cancer Institute-Bay City
Bay City, Michigan 48706
Bay City, Michigan 48706
Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Saint Joseph Mercy Canton
Canton, Michigan 48188
Canton, Michigan 48188
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
McLaren Cancer Institute-Clarkston
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Michigan Healthcare Professionals Clarkston
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Detroit, Michigan 48201
Henry Ford Hospital
Detroit, Michigan 48202
Detroit, Michigan 48202
Michigan Healthcare Professionals Farmington
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
McLaren Cancer Institute-Flint
Flint, Michigan 48532
Flint, Michigan 48532
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
West Michigan Cancer Center
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Sparrow Hospital
Lansing, Michigan 48912
Lansing, Michigan 48912
Contact:
Site Public Contact
517-364-9400
Site Public Contact
517-364-9400
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan 48446
Lapeer, Michigan 48446
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Livonia, Michigan 48154
Michigan Healthcare Professionals Macomb
Macomb, Michigan 48044
Macomb, Michigan 48044
Michigan Healthcare Professionals Madison Heights
Madison Heights, Michigan 48071
Madison Heights, Michigan 48071
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan 48043
Mount Clemens, Michigan 48043
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan 49770
Petoskey, Michigan 49770
Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
Pontiac, Michigan 48341
McLaren-Port Huron
Port Huron, Michigan 48060
Port Huron, Michigan 48060
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan 48073
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
Saginaw, Michigan 48601
Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Ascension Saint Joseph Hospital
Tawas City, Michigan 48764
Tawas City, Michigan 48764
Munson Medical Center
Traverse City, Michigan 49684
Traverse City, Michigan 49684
William Beaumont Hospital - Troy
Troy, Michigan 48085
Troy, Michigan 48085
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
GenesisCare USA - Troy
Troy, Michigan 48098
Troy, Michigan 48098
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
West Bloomfield, Michigan 48322
University of Michigan Health - West
Wyoming, Michigan 49519
Wyoming, Michigan 49519
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Miller-Dwan Hospital
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Saint Luke's Hospital of Duluth
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Hennepin County Medical Center
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri 65212
Columbia, Missouri 65212
Contact:
Site Public Contact
573-882-7440
Site Public Contact
573-882-7440
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Creve Coeur, Missouri 63141
University of Kansas Cancer Center - North
Kansas City, Missouri 64154
Kansas City, Missouri 64154
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
Lee's Summit, Missouri 64064
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri 64116
North Kansas City, Missouri 64116
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Rolla, Missouri 65401
SSM Health Saint Louis University Hospital
Saint Louis, Missouri 63104
Saint Louis, Missouri 63104
Contact:
Site Public Contact
314-977-4440
Site Public Contact
314-977-4440
Washington University School of Medicine
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Siteman Cancer Center-South County
Saint Louis, Missouri 63129
Saint Louis, Missouri 63129
Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
Saint Louis, Missouri 63136
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Saint Peters, Missouri 63376
Mercy Hospital Springfield
Springfield, Missouri 65804
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Billings Clinic Cancer Center
Billings, Montana 59101
Billings, Montana 59101
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana 59701
Butte, Montana 59701
Contact:
Site Public Contact
406-723-2621
Site Public Contact
406-723-2621
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Great Falls, Montana 59405
Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
Bellevue, Nebraska 68123
Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
Omaha, Nebraska 68118
Contact:
Site Public Contact
402-559-5600
Site Public Contact
402-559-5600
University of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire 03301
Concord, New Hampshire 03301
Contact:
Site Public Contact
603-224-2556
Site Public Contact
603-224-2556
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
Solinsky Center for Cancer Care
Manchester, New Hampshire 03103
Manchester, New Hampshire 03103
Contact:
Site Public Contact
800-339-6484
Site Public Contact
800-339-6484
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Cooper Hospital University Medical Center
Camden, New Jersey 08103
Camden, New Jersey 08103
Contact:
Site Public Contact
856-325-6757
Site Public Contact
856-325-6757
AtlantiCare Surgery Center
Egg Harbor Township, New Jersey 08234
Egg Harbor Township, New Jersey 08234
Contact:
Site Public Contact
609-748-7200
Site Public Contact
609-748-7200
Saint Barnabas Medical Center
Livingston, New Jersey 07039
Livingston, New Jersey 07039
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356
Site Public Contact
732-235-7356
Rutgers New Jersey Medical School
Newark, New Jersey 07101
Newark, New Jersey 07101
Contact:
Site Public Contact
732-235-7356
Site Public Contact
732-235-7356
The Valley Hospital-Luckow Pavilion
Paramus, New Jersey 07652
Paramus, New Jersey 07652
Contact:
Site Public Contact
201-634-5792
Site Public Contact
201-634-5792
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey 08080
Sewell, New Jersey 08080
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
Somerville, New Jersey 08876
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
Contact:
Site Public Contact
856-325-6757
Site Public Contact
856-325-6757
University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
Presbyterian Kaseman Hospital
Albuquerque, New Mexico 87110
Albuquerque, New Mexico 87110
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico 87124
Rio Rancho, New Mexico 87124
Northwell Health Imbert Cancer Center
Bay Shore, New York 11706
Bay Shore, New York 11706
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York 11215
Brooklyn, New York 11215
Roswell Park Cancer Institute
Buffalo, New York 14263
Buffalo, New York 14263
Memorial Sloan Kettering Commack
Commack, New York 11725
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York 14437
Dansville, New York 14437
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York 14905
Elmira, New York 14905
Contact:
Site Public Contact
607-271-7000
Site Public Contact
607-271-7000
The New York Hospital Medical Center of Queens
Flushing, New York 11355
Flushing, New York 11355
Glens Falls Hospital
Glens Falls, New York 12801
Glens Falls, New York 12801
Contact:
Site Public Contact
518-926-6700
Site Public Contact
518-926-6700
Memorial Sloan Kettering Westchester
Harrison, New York 10604
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
Lake Success, New York 11042
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
Lenox Hill Hospital
New York, New York 10021
New York, New York 10021
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
Manhattan Eye Ear and Throat Hospital
New York, New York 10065
New York, New York 10065
Contact:
Site Public Contact
212-434-4460
Site Public Contact
212-434-4460
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Highland Hospital
Rochester, New York 14620
Rochester, New York 14620
Contact:
Site Public Contact
585-341-8113
Site Public Contact
585-341-8113
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830
Site Public Contact
585-275-5830
Phelps Memorial Hospital Center
Sleepy Hollow, New York 10591
Sleepy Hollow, New York 10591
Contact:
Site Public Contact
914-366-1600
Site Public Contact
914-366-1600
Stony Brook University Medical Center
Stony Brook, New York 11794
Stony Brook, New York 11794
Contact:
Site Public Contact
800-862-2215
Site Public Contact
800-862-2215
State University of New York Upstate Medical University
Syracuse, New York 13210
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476
Site Public Contact
315-464-5476
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Westchester Medical Center
Valhalla, New York 10595
Valhalla, New York 10595
Wilmot Cancer Institute at Webster
Webster, New York 14580
Webster, New York 14580
Duke Cancer Institute Cary
Cary, North Carolina 27518
Cary, North Carolina 27518
Contact:
Site Public Contact
919-781-7070
Site Public Contact
919-781-7070
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Durham VA Medical Center
Durham, North Carolina 27705
Durham, North Carolina 27705
Duke University Medical Center
Durham, North Carolina 27710
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853
Site Public Contact
888-275-3853
Duke Raleigh Hospital
Raleigh, North Carolina 27609
Raleigh, North Carolina 27609
Contact:
Site Public Contact
919-862-5400
Site Public Contact
919-862-5400
Novant Cancer Institute Radiation Oncology - Supply
Supply, North Carolina 28462
Supply, North Carolina 28462
Contact:
Site Public Contact
910-754-4716
Site Public Contact
910-754-4716
Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-251-1839
Site Public Contact
910-251-1839
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-342-3000
Site Public Contact
910-342-3000
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
Sanford Broadway Medical Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Altru Cancer Center
Grand Forks, North Dakota 58201
Grand Forks, North Dakota 58201
Contact:
Site Public Contact
701-780-6520
Site Public Contact
701-780-6520
Summa Health System - Akron Campus
Akron, Ohio 44304
Akron, Ohio 44304
Cleveland Clinic Akron General
Akron, Ohio 44307
Akron, Ohio 44307
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio 44011
Avon, Ohio 44011
Contact:
Site Public Contact
800-641-2422
Site Public Contact
800-641-2422
Summa Health System - Barberton Campus
Barberton, Ohio 44203
Barberton, Ohio 44203
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
Beachwood, Ohio 44122
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Case Western Reserve University
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Cleveland, Ohio 44111
Cleveland Clinic Foundation
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio 44906
Mansfield, Ohio 44906
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Mayfield Heights, Ohio 44124
Summa Health Medina Medical Center
Medina, Ohio 44256
Medina, Ohio 44256
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
Mentor, Ohio 44060
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio 44130
Middleburg Heights, Ohio 44130
University Hospitals Parma Medical Center
Parma, Ohio 44129
Parma, Ohio 44129
University Hospitals Portage Medical Center
Ravenna, Ohio 44266
Ravenna, Ohio 44266
North Coast Cancer Care
Sandusky, Ohio 44870
Sandusky, Ohio 44870
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio 44870
Sandusky, Ohio 44870
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio 44136
Strongsville, Ohio 44136
ProMedica Flower Hospital
Sylvania, Ohio 43560
Sylvania, Ohio 43560
South Pointe Hospital
Warrensville Heights, Ohio 44122
Warrensville Heights, Ohio 44122
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
West Chester, Ohio 45069
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio 44691
Wooster, Ohio 44691
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Legacy Mount Hood Medical Center
Gresham, Oregon 97030
Gresham, Oregon 97030
Contact:
Site Public Contact
503-413-2150
Site Public Contact
503-413-2150
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
Portland, Oregon 97210
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Oregon Health and Science University
Portland, Oregon 97239
Portland, Oregon 97239
Legacy Meridian Park Hospital
Tualatin, Oregon 97062
Tualatin, Oregon 97062
Contact:
Site Public Contact
503-413-1742
Site Public Contact
503-413-1742
Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania 18104
Allentown, Pennsylvania 18104
Contact:
Site Public Contact
610-776-4714
Site Public Contact
610-776-4714
UPMC Altoona
Altoona, Pennsylvania 16601
Altoona, Pennsylvania 16601
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania 15009
Beaver, Pennsylvania 15009
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania 18015
Bethlehem, Pennsylvania 18015
Contact:
Site Public Contact
484-503-4151
Site Public Contact
484-503-4151
Crozer-Keystone Regional Cancer Center at Broomall
Broomall, Pennsylvania 19008
Broomall, Pennsylvania 19008
Carlisle Regional Cancer Center
Carlisle, Pennsylvania 17015
Carlisle, Pennsylvania 17015
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
Chadds Ford, Pennsylvania 19317
Chambersburg Hospital
Chambersburg, Pennsylvania 17201
Chambersburg, Pennsylvania 17201
Geisinger Medical Center
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania 19026
Drexel Hill, Pennsylvania 19026
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania 18045
Easton, Pennsylvania 18045
Ephrata Cancer Center
Ephrata, Pennsylvania 17522
Ephrata, Pennsylvania 17522
Contact:
Site Public Contact
717-721-4840
Site Public Contact
717-721-4840
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Erie, Pennsylvania 16505
Saint Vincent Hospital
Erie, Pennsylvania 16544
Erie, Pennsylvania 16544
Contact:
Site Public Contact
814-452-5000
Site Public Contact
814-452-5000
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania 16121
Farrell, Pennsylvania 16121
Adams Cancer Center
Gettysburg, Pennsylvania 17325
Gettysburg, Pennsylvania 17325
Contact:
Site Public Contact
877-441-7957
Site Public Contact
877-441-7957
Crozer Regional Cancer Center at Brinton Lake
Glen Mills, Pennsylvania 19342
Glen Mills, Pennsylvania 19342
Contact:
Site Public Contact
610-284-8237
Site Public Contact
610-284-8237
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
Greensburg, Pennsylvania 15601
Contact:
Site Public Contact
724-838-1900
Site Public Contact
724-838-1900
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
Harrisburg, Pennsylvania 17109
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
Hershey, Pennsylvania 17033-0850
IRMC Cancer Center
Indiana, Pennsylvania 15701
Indiana, Pennsylvania 15701
Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
Jefferson Hills, Pennsylvania 15025
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania 15901
Johnstown, Pennsylvania 15901
Contact:
Site Public Contact
814-534-4724
Site Public Contact
814-534-4724
Sechler Family Cancer Center
Lebanon, Pennsylvania 17042
Lebanon, Pennsylvania 17042
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Lewisburg, Pennsylvania 17837
Yolanda G Barco Oncology Institute
Meadville, Pennsylvania 16335
Meadville, Pennsylvania 16335
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania 17050
Mechanicsburg, Pennsylvania 17050
Forbes Hospital
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
Contact:
Site Public Contact
412-858-7746
Site Public Contact
412-858-7746
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
UPMC Hillman Cancer Center in Coraopolis
Moon, Pennsylvania 15108
Moon, Pennsylvania 15108
Allegheny Valley Hospital
Natrona Heights, Pennsylvania 15065
Natrona Heights, Pennsylvania 15065
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania 19114
Philadelphia, Pennsylvania 19114
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
Contact:
Site Public Contact
877-284-2000
Site Public Contact
877-284-2000
UPMC-Saint Margaret
Pittsburgh, Pennsylvania 15215
Pittsburgh, Pennsylvania 15215
Contact:
Site Public Contact
412-784-4900
Site Public Contact
412-784-4900
West Penn Hospital
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
Contact:
Site Public Contact
412-578-5000
Site Public Contact
412-578-5000
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073
Site Public Contact
412-647-8073
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-621-2334
Site Public Contact
412-621-2334
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
Pittsburgh, Pennsylvania 15237
Contact:
Site Public Contact
412-367-6454
Site Public Contact
412-367-6454
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania 15243
Pittsburgh, Pennsylvania 15243
Contact:
Site Public Contact
412-502-3920
Site Public Contact
412-502-3920
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania 17901
Pottsville, Pennsylvania 17901
Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania 18951
Quakertown, Pennsylvania 18951
Contact:
Site Public Contact
610-776-4714
Site Public Contact
610-776-4714
Saint Luke's Hospital-Quakertown Campus
Quakertown, Pennsylvania 18951
Quakertown, Pennsylvania 18951
Contact:
Site Public Contact
610-776-4714
Site Public Contact
610-776-4714
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania 16346
Seneca, Pennsylvania 16346
Contact:
Site Public Contact
814-676-7900
Site Public Contact
814-676-7900
Saint Luke's Hospital - Monroe Campus
Stroudsburg, Pennsylvania 18360
Stroudsburg, Pennsylvania 18360
Chester County Hospital
West Chester, Pennsylvania 19380
West Chester, Pennsylvania 19380
Contact:
Site Public Contact
610-431-5297
Site Public Contact
610-431-5297
Reading Hospital
West Reading, Pennsylvania 19611
West Reading, Pennsylvania 19611
Contact:
Site Public Contact
610-988-9323
Site Public Contact
610-988-9323
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
Wexford, Pennsylvania 15090
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
Divine Providence Hospital
Williamsport, Pennsylvania 17754
Williamsport, Pennsylvania 17754
WellSpan Health-York Cancer Center
York, Pennsylvania 17403
York, Pennsylvania 17403
Contact:
Site Public Contact
877-441-7957
Site Public Contact
877-441-7957
UPMC Memorial
York, Pennsylvania 17408
York, Pennsylvania 17408
Contact:
Site Public Contact
717-724-6760
Site Public Contact
717-724-6760
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina 29910
Bluffton, South Carolina 29910
Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Saint Francis Hospital
Greenville, South Carolina 29601
Greenville, South Carolina 29601
Saint Francis Cancer Center
Greenville, South Carolina 29607
Greenville, South Carolina 29607
Self Regional Healthcare
Greenwood, South Carolina 29646
Greenwood, South Carolina 29646
Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
Greer, South Carolina 29651
Spartanburg Medical Center
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480
Site Public Contact
800-811-8480
MD Anderson in The Woodlands
Conroe, Texas 77384
Conroe, Texas 77384
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Dallas, Texas 75390
Brooke Army Medical Center
Fort Sam Houston, Texas 78234
Fort Sam Houston, Texas 78234
Contact:
Site Public Contact
210-916-4837
Site Public Contact
210-916-4837
MD Anderson West Houston
Houston, Texas 77079
Houston, Texas 77079
MD Anderson League City
League City, Texas 77573
League City, Texas 77573
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
Richardson, Texas 75080
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
MD Anderson in Sugar Land
Sugar Land, Texas 77478
Sugar Land, Texas 77478
Sandra L Maxwell Cancer Center
Cedar City, Utah 84720
Cedar City, Utah 84720
Farmington Health Center
Farmington, Utah 84025
Farmington, Utah 84025
Intermountain Medical Center
Murray, Utah 84107
Murray, Utah 84107
McKay-Dee Hospital Center
Ogden, Utah 84403
Ogden, Utah 84403
Utah Valley Regional Medical Center
Provo, Utah 84604
Provo, Utah 84604
Saint George Regional Medical Center
Saint George, Utah 84770
Saint George, Utah 84770
University of Utah Sugarhouse Health Center
Salt Lake City, Utah 84106
Salt Lake City, Utah 84106
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont 05602
Berlin, Vermont 05602
Contact:
Site Public Contact
802-225-5400
Site Public Contact
802-225-5400
University of Vermont Medical Center
Burlington, Vermont 05401
Burlington, Vermont 05401
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont 05819
Saint Johnsbury, Vermont 05819
Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
Midlothian, Virginia 23114
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia 23230
Richmond, Virginia 23230
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Richmond, Virginia 23298
Virginia Mason Medical Center
Seattle, Washington 98101
Seattle, Washington 98101
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington 98684
Vancouver, Washington 98684
Legacy Salmon Creek Hospital
Vancouver, Washington 98686
Vancouver, Washington 98686
Contact:
Site Public Contact
503-413-2150
Site Public Contact
503-413-2150
Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Antigo, Wisconsin 54409
ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
Appleton, Wisconsin 54911
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin 54915
Appleton, Wisconsin 54915
Northwest Wisconsin Cancer Center
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin 53045
Brookfield, Wisconsin 53045
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Burlington, Wisconsin 53105
Ascension Calumet Hospital
Chilton, Wisconsin 53014
Chilton, Wisconsin 53014
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin 53132
Franklin, Wisconsin 53132
Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Germantown, Wisconsin 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Grafton, Wisconsin 53024
Bellin Memorial Hospital
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Contact:
Site Public Contact
920-435-8326
Site Public Contact
920-435-8326
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Green Bay, Wisconsin 54311
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin 53038
Johnson Creek, Wisconsin 53038
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Kenosha, Wisconsin 53142
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Contact:
Site Public Contact
800-622-8922
Site Public Contact
800-622-8922
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Marinette, Wisconsin 54143
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Marshfield, Wisconsin 54449
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
Menomonee Falls, Wisconsin 53051
Contact:
Site Public Contact
262-257-5100
Site Public Contact
262-257-5100
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin 53097
Mequon, Wisconsin 53097
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53209
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin 53211
Milwaukee, Wisconsin 53211
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666
Site Public Contact
414-805-3666
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Milwaukee, Wisconsin 53233
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin 53295
Milwaukee, Wisconsin 53295
Contact:
Site Public Contact
888-469-6614
Site Public Contact
888-469-6614
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
Minocqua, Wisconsin 54548
ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
Mukwonago, Wisconsin 53149
Drexel Town Square Health Center
Oak Creek, Wisconsin 53154
Oak Creek, Wisconsin 53154
Contact:
Site Public Contact
414-805-0505
Site Public Contact
414-805-0505
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
Oconomowoc, Wisconsin 53066
Contact:
Site Public Contact
262-928-7878
Site Public Contact
262-928-7878
Ascension Mercy Hospital
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Ascension All Saints Hospital
Racine, Wisconsin 53405
Racine, Wisconsin 53405
Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Racine, Wisconsin 53406
Ascension Saint Mary's Hospital
Rhinelander, Wisconsin 54501
Rhinelander, Wisconsin 54501
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Rice Lake, Wisconsin 54868
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin 54481
Stevens Point, Wisconsin 54481
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Stevens Point, Wisconsin 54482
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
Sturgeon Bay, Wisconsin 54235-1495
Aurora Medical Center in Summit
Summit, Wisconsin 53066
Summit, Wisconsin 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
Two Rivers, Wisconsin 54241
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
Waukesha, Wisconsin 53188
Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Wausau, Wisconsin 54401
Contact:
Site Public Contact
877-405-6866
Site Public Contact
877-405-6866
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
Aurora West Allis Medical Center
West Allis, Wisconsin 53227
West Allis, Wisconsin 53227
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin 53095
West Bend, Wisconsin 53095
Contact:
Site Public Contact
414-805-0505
Site Public Contact
414-805-0505
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Weston, Wisconsin 54476
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
Wisconsin Rapids, Wisconsin 54494
Contact:
Site Public Contact
715-422-7718
Site Public Contact
715-422-7718
More Details
- NCT ID
- NCT05050084
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed Description
PRIMARY OBJECTIVES: I. To determine whether men with National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk (UIR) prostate cancer and lower Decipher genomic risk (Decipher score < 0.40) treated with radiation therapy (RT) alone instead of 6 months androgen deprivation therapy (ADT) + RT experience non-inferior rate of distant metastasis. (De-intensification study) II. To determine whether men with NCCN UIR prostate cancer who are in the higher genomic risk (Decipher score >= 0.40) will have a superior metastasis-free survival through treatment intensification with darolutamide added to the standard of RT plus 6 months ADT. (Intensification study) SECONDARY OBJECTIVES: I. To compare overall survival (OS) between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. II. To compare time to prostate specific antigen (PSA) failure between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. III. To compare metastasis free survival (MFS) based on conventional imaging between the standard of care (RT plus 6 months of ADT) and de-intensification intervention (RT alone). IV. To compare MFS based on either conventional and/or molecular imaging between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. V. To compare cumulative incidence of locoregional failure based upon conventional imaging and/ or biopsy between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months ADT plus darolutamide) interventions. VI. To compare cumulative incidence of distant metastasis based upon conventional imaging between standard of care (RT plus 6 months of ADT) and intensification intervention (RT plus 6 months ADT plus darolutamide). VII. To compare cumulative incidence of distant metastasis based upon either conventional and/or molecular imaging between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. VIII. To compare prostate cancer-specific mortality between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. IX. To compare sexual and hormonal related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. X. To compare fatigue, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue instrument, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. XI. To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. EXPLORATORY OBJECTIVES: I. To compare changes in cardio-metabolic markers, including body mass index, lipids, blood glucose, complete blood count (CBC), comprehensive metabolic panel (CMP), and hemoglobin (Hgb) A1c, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. II. To compare PSA failure-free survival with non-castrate testosterone and no additional therapies between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. III. To compare cumulative incidence of locoregional failure based upon either conventional and/or molecular imaging between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. IV. To compare castrate-resistant prostate cancer (CRPC) between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. V. To compare bowel and urinary function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. VI. To compare time to testosterone recovery (defined as a T > 200ng/dL) between the standard of care (RT plus 6 months of ADT) and intensification (RT plus 6 months of ADT plus darolutamide) interventions. VII. To compare health utilities, as measured by the European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. VIII. To develop and assess a machine learning/artificial intelligence algorithm for radiotherapy planning and/or quality assurance. IX. To perform future translational correlative studies using biological data, Decipher results, and clinical outcomes. OUTLINE: DE-INTENSIFICATION STUDY: Patients with Decipher score < 0.40 are randomized to 1 of 2 arms. ARM I: Patients undergo RT using a recognized regimen (2-3 days a week or 5 days a week for 2-11 weeks) in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo RT as Arm I. Patients also receive ADT consisting of leuprolide, goserelin, buserelin, histrelin, triptorelin, degarelix, or relugolix at the discretion of the treating physician, for 6 months in the absence of disease progression or unacceptable toxicity. Patients may also receive bicalutamide or flutamide for 0, 30 or 180 days. INTENSIFICATION STUDY: Patients with Decipher score >= 0.40 are randomized to 1 of 2 arms. ARM III: Patients receive treatment as in Arm II. ARM IV: Patients receive RT and ADT as in Arm II. Patients also receive darolutamide orally (PO) twice daily (BID). Treatment repeats every 90 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3, 6, 12, 24, 36, 48 and 60 months.