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

ArmDescriptionAssigned 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.
  • Drug: Hormone Therapy
    Receive hormone therapy
    Other names:
    • Chemotherapy-Hormones/Steroids
    • Endocrine Therapy
    • Hormonal Therapy
    • hormone treatment
    • Hormones
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Radiation: Radiation Therapy
    Undergo pelvis and prostate bed radiation therapy
    Other names:
    • Cancer Radiotherapy
    • ENERGY_TYPE
    • Irradiate
    • Irradiated
    • Irradiation
    • Radiation
    • Radiation Therapy, NOS
    • Radiotherapeutics
    • Radiotherapy
    • RT
    • Therapy, Radiation
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.
  • Drug: Apalutamide
    Given PO
    Other names:
    • ARN 509
    • ARN-509
    • ARN509
    • Erleada
    • JNJ 56021927
    • JNJ-56021927
  • Drug: Hormone Therapy
    Receive hormone therapy
    Other names:
    • Chemotherapy-Hormones/Steroids
    • Endocrine Therapy
    • Hormonal Therapy
    • hormone treatment
    • Hormones
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Radiation: Radiation Therapy
    Undergo pelvis and prostate bed radiation therapy
    Other names:
    • Cancer Radiotherapy
    • ENERGY_TYPE
    • Irradiate
    • Irradiated
    • Irradiation
    • Radiation
    • Radiation Therapy, NOS
    • Radiotherapeutics
    • Radiotherapy
    • RT
    • Therapy, Radiation

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313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Owosso
Owosso, Michigan 48867
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Mercy Hospital
Coon Rapids, Minnesota 55433
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Fairview Southdale Hospital
Edina, Minnesota 55435
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Hennepin County Medical Center
Minneapolis, Minnesota 55415
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Monticello Cancer Center
Monticello, Minnesota 55362
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

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

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

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

United Hospital
Saint Paul, Minnesota 55102
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Lakeview Hospital
Stillwater, Minnesota 55082
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Ridgeview Medical Center
Waconia, Minnesota 55387
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

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

Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

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

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

University of Kansas Cancer Center - North
Kansas City, Missouri 64154
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri 64116
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center-South County
Saint Louis, Missouri 63129
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

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

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

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

Cancer Partners of Nebraska - Pine Lake
Lincoln, Nebraska 68516
Contact:
Site Public Contact
402-327-7363
research@cancerpartners.com

Cancer Partners of Nebraska
Lincoln, Nebraska 68516
Contact:
Site Public Contact
402-327-7363
research@cancerpartners.com

Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada 89106
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

GenesisCare USA - Las Vegas
Las Vegas, Nevada 89109
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada 89119
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at MountainView
Las Vegas, Nevada 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

GenesisCare USA - Fort Apache
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Renown Regional Medical Center
Reno, Nevada 89502
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire 03301
Contact:
Site Public Contact
603-224-2556

Solinsky Center for Cancer Care
Manchester, New Hampshire 03103
Contact:
Site Public Contact
800-339-6484

Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592

Cooper Hospital University Medical Center
Camden, New Jersey 08103
Contact:
Site Public Contact
856-325-6757

Saint Barnabas Medical Center
Livingston, New Jersey 07039
Contact:
Site Public Contact
973-322-2934
joanne.loeb@rwjbh.org

Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356

Rutgers New Jersey Medical School
Newark, New Jersey 07101
Contact:
Site Public Contact
732-235-7356

Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
Contact:
Site Public Contact
908-685-2481
Siby.Varughese@rwjbh.org

MD Anderson Cancer Center at Cooper-Voorhees
Voorhees, New Jersey 08043
Contact:
Site Public Contact
856-325-6757

Sands Cancer Center
Canandaigua, New York 14424
Contact:
Site Public Contact
585-396-6161

Memorial Sloan Kettering Commack
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592

Northwell Health Physicians Partners Radiation Medicine at Queens
Forest Hills, New York 11375
Contact:
Site Public Contact
718-520-6620

Memorial Sloan Kettering Westchester
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592

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

Garnet Health Medical Center
Middletown, New York 10940
Contact:
Site Public Contact
845-333-1133
jgerlach@garnethealth.org

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Site Public Contact
212-639-7592

Queens Cancer Center
Rego Park, New York 11374
Contact:
Site Public Contact
718-312-3446

Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York 14606
Contact:
Site Public Contact
585-758-7877

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

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

Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592

Duke Cancer Institute Cary
Cary, North Carolina 27518
Contact:
Site Public Contact
919-781-7070

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853

Duke Raleigh Hospital
Raleigh, North Carolina 27609
Contact:
Site Public Contact
919-862-5400

Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771

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

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

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

Miami Valley Hospital
Dayton, Ohio 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Premier Blood and Cancer Center
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320

Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Armes Family Cancer Center
Findlay, Ohio 45840
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

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

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

North Coast Cancer Care
Sandusky, Ohio 44870
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

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

Upper Valley Medical Center
Troy, Ohio 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio 44691
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

UPMC Altoona
Altoona, Pennsylvania 16601
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania 15009
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Crozer-Keystone Regional Cancer Center at Broomall
Broomall, Pennsylvania 19008
Contact:
Site Public Contact
610-284-8237
Jolene.garney@crozer.org

Carlisle Regional Cancer Center
Carlisle, Pennsylvania 17015
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania 16121
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Crozer Regional Cancer Center at Brinton Lake
Glen Mills, Pennsylvania 19342
Contact:
Site Public Contact
610-284-8237

UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
Contact:
Site Public Contact
724-838-1900

UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
Contact:
Site Public Contact
717-724-6765
klitchfield@PINNACLEHEALTH.org

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

IRMC Cancer Center
Indiana, Pennsylvania 15701
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania 15901
Contact:
Site Public Contact
814-534-4724

UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania 15132
Contact:
Site Public Contact
412-647-8073

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania 17050
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

UPMC Hillman Cancer Center in Coraopolis
Moon, Pennsylvania 15108
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania 15213
Contact:
Site Public Contact
412-647-2811

UPMC-Saint Margaret
Pittsburgh, Pennsylvania 15215
Contact:
Site Public Contact
412-784-4900

UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-621-2334

UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
Contact:
Site Public Contact
412-367-6454

UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania 15243
Contact:
Site Public Contact
412-502-3920

UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania 16346
Contact:
Site Public Contact
814-676-7900

UPMC Uniontown Hospital Radiation Oncology
Uniontown, Pennsylvania 15401
Contact:
Site Public Contact
724-437-2503

UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania 15301
Contact:
Site Public Contact
724-223-3788
cancer@washingtonhospital.org

Chester County Hospital
West Chester, Pennsylvania 19380
Contact:
Site Public Contact
610-431-5044
carolann.hoppes@pennmedicine.upenn.edu

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

UPMC Memorial
York, Pennsylvania 17408
Contact:
Site Public Contact
717-724-6760

Avera Cancer Institute
Sioux Falls, South Dakota 57105
Contact:
Site Public Contact
605-322-3095
OncRegulatory@avera.org

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

Tarrant County Hospital District/JPS Health Network
Fort Worth, Texas 76104
Contact:
Site Public Contact
817-702-5913
macosta02@jpshealth.org

UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
Contact:
Site Public Contact
972-669-7044
Suzanne.cole@utsouthwestern.edu

VCU Massey Cancer Center at Hanover Medical Park
Mechanicsville, Virginia 23116
Contact:
Site Public Contact
CTOclinops@vcu.edu

Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
Contact:
Site Public Contact
804-893-8978
anne_carmellat@bshsi.org

Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia 23230
Contact:
Site Public Contact
804-893-8978
Anne_caramella@bshsi.org

VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Contact:
Site Public Contact
ctoclinops@vcu.edu

Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Contact:
Site Public Contact
CTOclinops@vcu.edu

West Virginia University Charleston Division
Charleston, West Virginia 25304
Contact:
Site Public Contact
304-388-9944

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

ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
Contact:
Site Public Contact
920-364-3604
ResearchDept@thedacare.org

Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Bellin Memorial Hospital
Green Bay, Wisconsin 54301
Contact:
Site Public Contact
920-435-8326

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

Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

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

Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
Contact:
Site Public Contact
262-257-5100

Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666

Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center - Minocqua
Minocqua, Wisconsin 54548
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Drexel Town Square Health Center
Oak Creek, Wisconsin 53154
Contact:
Site Public Contact
414-805-0505

Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin 54501
Contact:
Site Public Contact
715-847-2353
Beth.Knetter@aspirus.org

Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin 54481
Contact:
Site Public Contact
715-847-2353
Beth.Knetter@aspirus.org

Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

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

Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Contact:
Site Public Contact
877-405-6866

Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora West Allis Medical Center
West Allis, Wisconsin 53227
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin 53095
Contact:
Site Public Contact
414-805-0505

Diagnostic and Treatment Center
Weston, Wisconsin 54476
Contact:
Site Public Contact
888-799-3989
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
Contact:
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.