Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer
Purpose
This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.
Conditions
- Prostate Adenocarcinoma
- Stage I Prostate Cancer AJCC v8
- Stage II Prostate Cancer AJCC v8
- Stage IIA Prostate Cancer AJCC v8
- Stage IIB Prostate Cancer AJCC v8
- Stage IIC Prostate Cancer AJCC v8
- Stage III Prostate Cancer AJCC v8
- Stage IIIA Prostate Cancer AJCC v8
- Stage IIIB Prostate Cancer AJCC v8
- Stage IIIC Prostate Cancer AJCC v8
- Stage IVA Prostate Cancer AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Pathologically (histologically) proven diagnosis of prostate adenocarcinoma. Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted - Any T-stage is eligible (American Joint Committee on Cancer [AJCC] 8th edition [ed]) - Appropriate stage for study entry based on fluciclovine F-18 positron emission tomography (PET) scan (FACBC, Axumin) within 90 days prior to registration that is negative for distant metastatic (M1a, M1b, M1c) disease; Note that though every effort should be made to obtain a fluciclovine F-18 PET (FACBC, Axumin) scan; however, if the patient has already had a recent F-18 PSMA PET (PyLarify) scan or gallium Ga 68-labeled PSMA-11 (Ga-68 PSMA) PET scan or C-11 or F-18 choline PET scan within 90 days prior to registration (to include scan report) then repeat molecular imaging with a fluciclovine F-18 PET (FACBC, Axumin) scan will not be required. - Pathologically node positive disease with nodal involvement only in the pelvis in the prostatectomy specimen (including external iliacs, internal iliacs, and/or obturator nodes); peri-prostatic and peri-rectal nodes can also be considered regional lymphadenopathy and are allowed - History/physical examination within 90 days prior to registration - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 90 days prior to registration - Detectable PSA after radical prostatectomy. Detectable PSA is defined as serum PSA > 0 ng/mL at least 30 days after prostatectomy and within 180 days of registration and before start of GnRH agonist/antagonist - Patients who have already started on post-prostatectomy GnRH agonist/antagonist for =< 180 days prior to registration are eligible (Note: patients who started on an oral antiandrogen are eligible if started =< 180 days and stopped prior to registration) - Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors (within 90 days prior to registration) - Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors (within 90 days prior to registration) - Serum potassium >= 3.5 mmol/L within 90 days prior to registration - Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault (please use actual weight for calculation unless greater than 30% above ideal body weight then use the adjusted body weight) (within 90 days prior to registration) - Total bilirubin =< 1.5 x institutional 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 registration) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (within 90 days prior to registration) - Serum albumin >= 3.0 g/dL (within 90 days prior to registration) - Discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to 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 - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count >= 200 cells/microliter within 30 days prior to registration. 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 within 30 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol - 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 within 30 days prior to registration - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ) who has no evidence of disease for < 3 years must contact the principal investigator, Ronald Chen, Doctor of Medicine (MD) - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria
- Definitive radiologic evidence of metastatic disease (M1a, M1b or M1c) on molecular imaging (e.g. fluciclovine F-18 PET, F-18 PSMA, PSMA, F-18 choline 11) - Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration) - Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields - Androgen deprivation therapy (ADT) prior to radical prostatectomy - Prior treatment with androgen receptor signaling inhibitor (including but not exclusive to a growing list of: abiraterone acetate, enzalutamide, apalutamide, darolutamide), unless started =< 180 days and stopped prior to registration, which is allowed - Current use of 5-alpha reductase inhibitor. NOTE: if the alpha reductase inhibitor is stopped prior to randomization the patient is eligible - 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 registration, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy) - Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 12 months prior to registration - 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 - Current evidence of any of the following: - Known gastrointestinal disorder affecting absorption of oral medications - Active uncontrolled infection - Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment - Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily - Baseline moderate and severe hepatic impairment (Child-Pugh Class B & C) - Inability to swallow oral pills - Any current condition that in the opinion of the investigator, would preclude participation in this study - Patients must not plan to participate in any other therapeutic clinical trials while receiving treatment on this study - Patients with inflammatory bowel disease
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 |
|---|---|---|
|
Active Comparator Arm I (hormone therapy, radiation therapy) |
Patients receive standard of care hormone therapy per physician discretion for 24 months. Patients also undergo standard of care pelvis and prostate bed radiation therapy 5 days per week over 5-6 or 7-8 weeks beginning within 90 days of randomization in the absence of disease progression or unacceptable toxicity. |
|
|
Experimental Arm II (hormone therapy, radiation therapy, apalutamide) |
Patients undergo standard of care hormone therapy and radiation therapy as in Arm I. Patients also receive apalutamide PO QD on days 1-90. Cycles repeat every 90 days for 8 cycles in the absence of disease progression or unacceptable toxicity. |
|
Recruiting Locations
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
Kaiser Permanente-Anaheim
Anaheim, California 92806
Anaheim, California 92806
Kaiser Permanente-Baldwin Park
Baldwin Park, California 91706
Baldwin Park, California 91706
Kaiser Permanente-Bellflower
Bellflower, California 90706
Bellflower, California 90706
Kaiser Permanente-Fontana
Fontana, California 92335
Fontana, California 92335
Marin General Hospital
Greenbrae, California 94904
Greenbrae, California 94904
Contact:
Site Public Contact
415-925-7325
Site Public Contact
415-925-7325
Kaiser Permanente - Harbor City
Harbor City, California 90710
Harbor City, California 90710
Kaiser Permanente-Irvine
Irvine, California 92618
Irvine, California 92618
Tibor Rubin VA Medical Center
Long Beach, California 90822
Long Beach, California 90822
Contact:
Site Public Contact
562-826-8000
Site Public Contact
562-826-8000
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Los Angeles, California 90027
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
Kaiser Permanente West Los Angeles
Los Angeles, California 90034
Los Angeles, California 90034
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California 90095
Los Angeles, California 90095
Contact:
Site Public Contact
888-798-0719
Site Public Contact
888-798-0719
Kaiser Permanente-Ontario
Ontario, California 91761
Ontario, California 91761
Kaiser Permanente - Panorama City
Panorama City, California 91402
Panorama City, California 91402
Kaiser Permanente-Riverside
Riverside, California 92505
Riverside, California 92505
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-San Diego Zion
San Diego, California 92120
San Diego, California 92120
UCSF Medical Center-Mount Zion
San Francisco, California 94115
San Francisco, California 94115
Contact:
Site Public Contact
877-827-3222
Site Public Contact
877-827-3222
UCSF Medical Center-Parnassus
San Francisco, California 94143
San Francisco, California 94143
Contact:
Site Public Contact
877-827-3222
Site Public Contact
877-827-3222
UCSF Medical Center-Mission Bay
San Francisco, California 94158
San Francisco, California 94158
Kaiser Permanente-San Marcos
San Marcos, California 92078
San Marcos, California 92078
Kaiser Permanente-Woodland Hills
Woodland Hills, California 91367
Woodland Hills, California 91367
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
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
Newark, Delaware 19718
Beebe Health Campus
Rehoboth Beach, Delaware 19971
Rehoboth Beach, Delaware 19971
George Washington University Medical Center
Washington, District of Columbia 20037
Washington, District of Columbia 20037
Contact:
Site Public Contact
202-741-2981
Site Public Contact
202-741-2981
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
Alton Memorial Hospital
Alton, Illinois 62002
Alton, Illinois 62002
Contact:
Site Public Contact
618-463-7323
Site Public Contact
618-463-7323
Rush - Copley Medical Center
Aurora, Illinois 60504
Aurora, Illinois 60504
Advocate Good Shepherd Hospital
Barrington, Illinois 60010
Barrington, Illinois 60010
Contact:
Site Public Contact
847-842-4847
Site Public Contact
847-842-4847
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
University of Illinois
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Site Public Contact
312-355-3046
Site Public Contact
312-355-3046
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Chicago, Illinois 60637
Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
Chicago, Illinois 60657
Contact:
Site Public Contact
773-296-5360
Site Public Contact
773-296-5360
AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
Crystal Lake, Illinois 60014
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Illinois CancerCare-Dixon
Dixon, Illinois 61021
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800
Site Public Contact
815-285-7800
Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
Downers Grove, Illinois 60515
Carle Physician Group-Effingham
Effingham, Illinois 62401
Effingham, Illinois 62401
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Advocate Sherman Hospital
Elgin, Illinois 60123
Elgin, Illinois 60123
Contact:
Site Public Contact
847-429-2907
Site Public Contact
847-429-2907
Elmhurst Memorial Hospital
Elmhurst, Illinois 60126
Elmhurst, Illinois 60126
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Eureka, Illinois 61530
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Evanston, Illinois 60201
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-344-2831
Site Public Contact
309-344-2831
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Glenview, Illinois 60026
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
Hazel Crest, Illinois 60429
Contact:
Site Public Contact
708-799-9995
Site Public Contact
708-799-9995
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Highland Park, Illinois 60035
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Kewanee, Illinois 61443
AMG Libertyville - Oncology
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Condell Memorial Hospital
Libertyville, Illinois 60048
Libertyville, Illinois 60048
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
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
New Lenox, Illinois 60451
Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
Oak Lawn, Illinois 60453-2699
Contact:
Site Public Contact
800-323-8622
Site Public Contact
800-323-8622
University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
Orland Park, Illinois 60462
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Park Ridge, Illinois 60068
Contact:
Site Public Contact
847-384-3621
Site Public Contact
847-384-3621
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois 61615
Peoria, Illinois 61615
Methodist Medical Center of Illinois
Peoria, Illinois 61636
Peoria, Illinois 61636
OSF Saint Francis Medical Center
Peoria, Illinois 61637
Peoria, Illinois 61637
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Valley Radiation Oncology
Peru, Illinois 61354
Peru, Illinois 61354
Contact:
Site Public Contact
815-664-4141
Site Public Contact
815-664-4141
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Princeton, Illinois 61356
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Memorial Medical Center
Springfield, Illinois 62781
Springfield, Illinois 62781
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
McFarland Clinic - Ames
Ames, Iowa 50010
Ames, Iowa 50010
Saint Luke's Hospital
Cedar Rapids, Iowa 52402
Cedar Rapids, Iowa 52402
Mercy Hospital
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-365-4673
Site Public Contact
319-365-4673
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-363-2690
Site Public Contact
319-363-2690
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
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Iowa Lutheran Hospital
Des Moines, Iowa 50316
Des Moines, Iowa 50316
Contact:
Site Public Contact
515-241-8704
Site Public Contact
515-241-8704
Methodist West Hospital
West Des Moines, Iowa 50266-7700
West Des Moines, Iowa 50266-7700
Contact:
Site Public Contact
515-343-1000
Site Public Contact
515-343-1000
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
Salina Regional Health Center
Salina, Kansas 67401
Salina, Kansas 67401
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
East Jefferson General Hospital
Metairie, Louisiana 70006
Metairie, Louisiana 70006
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Tulane University School of Medicine
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
Lafayette Family Cancer Center-EMMC
Brewer, Maine 04412
Brewer, Maine 04412
Contact:
Site Public Contact
800-987-3005
Site Public Contact
800-987-3005
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Contact:
Site Public Contact
877-726-5130
Site Public Contact
877-726-5130
Brigham and Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Contact:
Site Public Contact
617-724-5200
Site Public Contact
617-724-5200
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Contact:
Site Public Contact
877-442-3324
Site Public Contact
877-442-3324
Henry Ford Hospital
Detroit, Michigan 48202
Detroit, Michigan 48202
McLaren Cancer Institute-Flint
Flint, Michigan 48532
Flint, Michigan 48532
Singh and Arora Hematology Oncology PC
Flint, Michigan 48532
Flint, Michigan 48532
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan 48910
Lansing, Michigan 48910
Mid-Michigan Physicians-Lansing
Lansing, Michigan 48912
Lansing, Michigan 48912
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan 48043
Mount Clemens, Michigan 48043
McLaren Cancer Institute-Owosso
Owosso, Michigan 48867
Owosso, Michigan 48867
Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
Maple Grove, Minnesota 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Hennepin County Medical Center
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
Monticello Cancer Center
Monticello, Minnesota 55362
Monticello, Minnesota 55362
North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Robbinsdale, Minnesota 55422
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota 56303
Saint Cloud, Minnesota 56303
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
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Shakopee, Minnesota 55379
Lakeview Hospital
Stillwater, Minnesota 55082
Stillwater, Minnesota 55082
Ridgeview Medical Center
Waconia, Minnesota 55387
Waconia, Minnesota 55387
Rice Memorial Hospital
Willmar, Minnesota 56201
Willmar, Minnesota 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Woodbury, Minnesota 55125
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
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
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
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Saint Peters, Missouri 63376
Billings Clinic Cancer Center
Billings, Montana 59101
Billings, Montana 59101
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Great Falls, Montana 59405
Cancer Partners of Nebraska - Pine Lake
Lincoln, Nebraska 68516
Lincoln, Nebraska 68516
Southeast Nebraska Cancer Center - 68th Street Place
Lincoln, Nebraska 68516
Lincoln, Nebraska 68516
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
Henderson, Nevada 89052
OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
Henderson, Nevada 89052
OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
GenesisCare USA - Las Vegas
Las Vegas, Nevada 89109
Las Vegas, Nevada 89109
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada 89119
Las Vegas, Nevada 89119
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
OptumCare Cancer Care at MountainView
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
GenesisCare USA - Fort Apache
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
Renown Regional Medical Center
Reno, Nevada 89502
Reno, Nevada 89502
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
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
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
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
Sands Cancer Center
Canandaigua, New York 14424
Canandaigua, New York 14424
Contact:
Site Public Contact
585-396-6161
Site Public Contact
585-396-6161
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
Northwell Health Physicians Partners Radiation Medicine at Queens
Forest Hills, New York 11375
Forest Hills, New York 11375
Contact:
Site Public Contact
718-520-6620
Site Public Contact
718-520-6620
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
Garnet Health Medical Center
Middletown, New York 10940
Middletown, New York 10940
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
Queens Cancer Center
Rego Park, New York 11374
Rego Park, New York 11374
Contact:
Site Public Contact
718-312-3446
Site Public Contact
718-312-3446
Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York 14606
Rochester, New York 14606
Contact:
Site Public Contact
585-758-7877
Site Public Contact
585-758-7877
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
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
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
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
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771
Site Public Contact
336-713-6771
Cleveland Clinic Akron General
Akron, Ohio 44307
Akron, Ohio 44307
Miami Valley Hospital South
Centerville, Ohio 45459
Centerville, Ohio 45459
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
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
Dayton Blood and Cancer Center
Dayton, Ohio 45409
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320
Site Public Contact
937-276-8320
Miami Valley Hospital
Dayton, Ohio 45409
Dayton, Ohio 45409
Miami Valley Hospital North
Dayton, Ohio 45415
Dayton, Ohio 45415
Armes Family Cancer Center
Findlay, Ohio 45840
Findlay, Ohio 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Franklin, Ohio 45005-1066
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio 44906
Mansfield, Ohio 44906
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Mayfield Heights, Ohio 44124
North Coast Cancer Care
Sandusky, Ohio 44870
Sandusky, Ohio 44870
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio 44136
Strongsville, Ohio 44136
Upper Valley Medical Center
Troy, Ohio 45373
Troy, Ohio 45373
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
UPMC Altoona
Altoona, Pennsylvania 16601
Altoona, Pennsylvania 16601
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania 15009
Beaver, Pennsylvania 15009
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
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania 19026
Drexel Hill, Pennsylvania 19026
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Erie, Pennsylvania 16505
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania 16121
Farrell, Pennsylvania 16121
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
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
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania 17050
Mechanicsburg, Pennsylvania 17050
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
UPMC Hillman Cancer Center in Coraopolis
Moon, Pennsylvania 15108
Moon, Pennsylvania 15108
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Contact:
Site Public Contact
412-647-2811
Site Public Contact
412-647-2811
UPMC-Saint Margaret
Pittsburgh, Pennsylvania 15215
Pittsburgh, Pennsylvania 15215
Contact:
Site Public Contact
412-784-4900
Site Public Contact
412-784-4900
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
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
UPMC Uniontown Hospital Radiation Oncology
Uniontown, Pennsylvania 15401
Uniontown, Pennsylvania 15401
Contact:
Site Public Contact
724-437-2503
Site Public Contact
724-437-2503
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania 15301
Washington, Pennsylvania 15301
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
UPMC Memorial
York, Pennsylvania 17408
York, Pennsylvania 17408
Contact:
Site Public Contact
717-724-6760
Site Public Contact
717-724-6760
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Dallas, Texas 75390
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
Fort Worth, Texas 76104
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
Richardson, Texas 75080
VCU Massey Cancer Center at Hanover Medical Park
Mechanicsville, Virginia 23116
Mechanicsville, Virginia 23116
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Richmond, Virginia 23235
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Richmond, Virginia 23298
West Virginia University Charleston Division
Charleston, West Virginia 25304
Charleston, West Virginia 25304
Contact:
Site Public Contact
304-388-9944
Site Public Contact
304-388-9944
Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Antigo, Wisconsin 54409
ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
Appleton, Wisconsin 54911
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Burlington, Wisconsin 53105
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
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
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Green Bay, Wisconsin 54311
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Kenosha, Wisconsin 53142
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
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53209
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
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
Minocqua, Wisconsin 54548
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
New Richmond, Wisconsin 54017
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
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
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
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
Aurora Medical Center in Summit
Summit, Wisconsin 53066
Summit, Wisconsin 53066
Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Wausau, Wisconsin 54401
Contact:
Site Public Contact
877-405-6866
Site Public Contact
877-405-6866
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
Diagnostic and Treatment Center
Weston, Wisconsin 54476
Weston, Wisconsin 54476
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
- NCT04134260
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed Description
PRIMARY OBJECTIVE: I. Compare metastasis-free survival (MFS) of salvage radiation therapy (RT) and gonadotropin releasing hormone (GnRH) agonist/antagonist versus (vs.) RT/GnRH agonist/antagonist with apalutamide for patients with pathologic node-positive prostate cancer after radical prostatectomy with detectable prostate-specific antigen (PSA). SECONDARY OBJECTIVES: I. Compare health-related quality of life (Expanded Prostate Cancer Index Composite [EPIC]-26, EuroQol [EQ]-5 Dimension [D]-5 Level [L]), Brief Pain Inventory, Patient Reported Outcome Measurement Information System [PROMIS]-Fatigue) among the treatment arms. II. Compare overall survival, biochemical progression-free survival, time to local-regional progression, time to castrate resistance, and cancer-specific survival among the treatment arms. III. Compare the short-term and long-term treatment-related adverse events among the treatment arms. EXPLORATORY OBJECTIVES: I. Validate Decipher score for an exclusively node-positive population and use additional genomic information from Affymetrix Human Exon 1.0st array to develop and validate novel prognostic and predictive biomarkers. II. Validate the PAM50-based classification of prostate cancer into luminal A, luminal B, and basal subtypes as prognostic markers and determine whether the luminal B subtype is a predictive marker for having a larger improvement in outcome from the addition of apalutamide. III. To optimize quality assurance methodologies and processes for radiotherapy and imaging with machine learning strategies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard of care hormone therapy per physician discretion for 24 months. Patients also undergo standard of care pelvis and prostate bed radiation therapy 5 days per week over 5-6 or 7-8 weeks beginning within 90 days of randomization in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo standard of care hormone therapy and radiation therapy as in Arm I. Patients also receive apalutamide orally (PO) once daily (QD) on days 1-90. Cycles repeat every 90 days for 8 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 3 years, then annually thereafter.