Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging Into Salvage Treatment for Patients With Node-Positive Prostate Cancer After Radical Prostatectomy (INNOVATE*) *INtensifying Treatment for NOde Positive Prostate Cancer by VArying the Hormonal ThErapy

Who is this study for? Adult patients with positive lymph node prostate cancer
Status: Recruiting
Location: See all (338) locations...
Intervention Type: Other, Procedure, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 PET scan (FACBC, Axumin) F-18 prostate-specific membrane antigen (PSMA) PET (PyLarify) scan, Gallium-68 PSMA PET scan, flotufolastat F-18 PSMA PET scan (Posluma), or C-11 or F-18 Choline PET within 90 days prior to registration that is negative for distant metastatic (M1a, M1b, M1c) disease. For patients with PSA \< 0.20 ng/mL at time of registration, PET scan is recommended but not required

• Pathologically node positive disease with nodal involvement only in the pelvis in the prostatectomy specimen or nodal disease on imaging at time of recurrence (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

• Age \>= 18

• 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

• 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

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Arizona
Cancer Center at Saint Joseph's
RECRUITING
Phoenix
California
Kaiser Permanente-Anaheim
RECRUITING
Anaheim
Kaiser Permanente-Baldwin Park
RECRUITING
Baldwin Park
Kaiser Permanente-Bellflower
RECRUITING
Bellflower
Mercy Cancer Center - Carmichael
RECRUITING
Carmichael
Mercy San Juan Medical Center
RECRUITING
Carmichael
Mercy Cancer Center - Elk Grove
RECRUITING
Elk Grove
Kaiser Permanente-Fontana
RECRUITING
Fontana
Marin General Hospital
RECRUITING
Greenbrae
Kaiser Permanente South Bay
RECRUITING
Harbor City
Kaiser Permanente-Irvine
RECRUITING
Irvine
Tibor Rubin VA Medical Center
RECRUITING
Long Beach
Kaiser Permanente Los Angeles Medical Center
RECRUITING
Los Angeles
Kaiser Permanente West Los Angeles
RECRUITING
Los Angeles
Los Angeles General Medical Center
ACTIVE_NOT_RECRUITING
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
RECRUITING
Los Angeles
USC / Norris Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Los Angeles
Kaiser Permanente-Ontario
RECRUITING
Ontario
Kaiser Permanente - Panorama City
RECRUITING
Panorama City
Kaiser Permanente-Riverside
RECRUITING
Riverside
Mercy Cancer Center - Rocklin
RECRUITING
Rocklin
Mercy Cancer Center - Sacramento
RECRUITING
Sacramento
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Kaiser Permanente-San Diego Zion
RECRUITING
San Diego
UCSF Medical Center-Mission Bay
RECRUITING
San Francisco
UCSF Medical Center-Mount Zion
RECRUITING
San Francisco
UCSF Medical Center-Parnassus
RECRUITING
San Francisco
Kaiser Permanente-San Marcos
RECRUITING
San Marcos
Ridley-Tree Cancer Center
ACTIVE_NOT_RECRUITING
Santa Barbara
Woodland Memorial Hospital
RECRUITING
Woodland
Kaiser Permanente-Woodland Hills
RECRUITING
Woodland Hills
Washington, D.c.
George Washington University Medical Center
RECRUITING
Washington D.c.
Delaware
Beebe South Coastal Health Campus
RECRUITING
Millville
Christiana Care Health System-Christiana Hospital
RECRUITING
Newark
Helen F Graham Cancer Center
RECRUITING
Newark
Medical Oncology Hematology Consultants PA
RECRUITING
Newark
Beebe Health Campus
RECRUITING
Rehoboth Beach
Florida
UM Sylvester Comprehensive Cancer Center at Aventura
RECRUITING
Aventura
UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITING
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITING
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Doral
RECRUITING
Doral
UM Sylvester Comprehensive Cancer Center at Kendall
RECRUITING
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING
Miami
UM Sylvester Comprehensive Cancer Center at Plantation
RECRUITING
Plantation
Tampa General Hospital
RECRUITING
Tampa
Georgia
Emory Proton Therapy Center
RECRUITING
Atlanta
Emory Saint Joseph's Hospital
RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Grady Health System
RECRUITING
Atlanta
Emory Decatur Hospital
RECRUITING
Decatur
Emory Johns Creek Hospital
RECRUITING
Johns Creek
Iowa
McFarland Clinic - Ames
RECRUITING
Ames
UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITING
Ankeny
Saint Anthony Regional Hospital
RECRUITING
Carroll
Mercy Hospital
RECRUITING
Cedar Rapids
Oncology Associates at Mercy Medical Center
RECRUITING
Cedar Rapids
Saint Luke's Hospital
ACTIVE_NOT_RECRUITING
Cedar Rapids
Broadlawns Medical Center
RECRUITING
Des Moines
Iowa Lutheran Hospital
RECRUITING
Des Moines
Iowa Methodist Medical Center
RECRUITING
Des Moines
Mercy Medical Center - Des Moines
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITING
Des Moines
Methodist West Hospital
RECRUITING
West Des Moines
Illinois
Alton Memorial Hospital
RECRUITING
Alton
Advocate Outpatient Center - Aurora
RECRUITING
Aurora
Rush-Copley Medical Center
RECRUITING
Aurora
Advocate Good Shepherd Hospital
RECRUITING
Barrington
Illinois CancerCare-Bloomington
RECRUITING
Bloomington
Illinois CancerCare-Canton
RECRUITING
Canton
Illinois CancerCare-Carthage
RECRUITING
Carthage
Advocate Illinois Masonic Medical Center
RECRUITING
Chicago
Northwestern University
RECRUITING
Chicago
Rush University Medical Center
ACTIVE_NOT_RECRUITING
Chicago
University of Chicago Comprehensive Cancer Center
RECRUITING
Chicago
University of Illinois
RECRUITING
Chicago
AMG Crystal Lake - Oncology
RECRUITING
Crystal Lake
Carle at The Riverfront
RECRUITING
Danville
Decatur Memorial Hospital
RECRUITING
Decatur
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING
Dekalb
Illinois CancerCare-Dixon
RECRUITING
Dixon
Advocate Good Samaritan Hospital
RECRUITING
Downers Grove
Carle Physician Group-Effingham
RECRUITING
Effingham
Crossroads Cancer Center
RECRUITING
Effingham
Advocate Sherman Hospital
RECRUITING
Elgin
Elmhurst Memorial Hospital
RECRUITING
Elmhurst
Illinois CancerCare-Eureka
RECRUITING
Eureka
NorthShore University HealthSystem-Evanston Hospital
RECRUITING
Evanston
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Western Illinois Cancer Treatment Center
SUSPENDED
Galesburg
Northwestern Medicine Cancer Center Delnor
RECRUITING
Geneva
NorthShore University HealthSystem-Glenbrook Hospital
RECRUITING
Glenview
Ingalls Memorial Hospital
RECRUITING
Harvey
Advocate South Suburban Hospital
RECRUITING
Hazel Crest
NorthShore University HealthSystem-Highland Park Hospital
RECRUITING
Highland Park
Illinois CancerCare-Kewanee Clinic
RECRUITING
Kewanee
AMG Libertyville - Oncology
RECRUITING
Libertyville
Condell Memorial Hospital
RECRUITING
Libertyville
Illinois CancerCare-Macomb
RECRUITING
Macomb
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
Loyola University Medical Center
RECRUITING
Maywood
Edward Hospital/Cancer Center
RECRUITING
Naperville
UC Comprehensive Cancer Center at Silver Cross
RECRUITING
New Lenox
HSHS Saint Elizabeth's Hospital
RECRUITING
O'fallon
Northwestern Medicine Oak Brook
RECRUITING
Oak Brook
Advocate Christ Medical Center
RECRUITING
Oak Lawn
Northwestern Medicine Orland Park
RECRUITING
Orland Park
University of Chicago Medicine-Orland Park
RECRUITING
Orland Park
Illinois CancerCare-Ottawa Clinic
RECRUITING
Ottawa
Advocate High Tech Medical Park
RECRUITING
Palos Heights
Advocate Lutheran General Hospital
RECRUITING
Park Ridge
Illinois CancerCare-Pekin
RECRUITING
Pekin
OSF Saint Francis Radiation Oncology at Pekin
RECRUITING
Pekin
Illinois CancerCare-Peoria
RECRUITING
Peoria
Methodist Medical Center of Illinois
RECRUITING
Peoria
OSF Saint Francis Medical Center
RECRUITING
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
RECRUITING
Peoria
Illinois CancerCare-Peru
RECRUITING
Peru
Valley Radiation Oncology
RECRUITING
Peru
Illinois CancerCare-Princeton
RECRUITING
Princeton
Memorial Hospital East
RECRUITING
Shiloh
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Springfield Memorial Hospital
RECRUITING
Springfield
Carle Cancer Center
RECRUITING
Urbana
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Illinois CancerCare - Washington
RECRUITING
Washington
Indiana
Reid Health
RECRUITING
Richmond
Kansas
University of Kansas Cancer Center
RECRUITING
Kansas City
The University of Kansas Cancer Center - Olathe
RECRUITING
Olathe
University of Kansas Cancer Center-Overland Park
RECRUITING
Overland Park
Salina Regional Health Center
RECRUITING
Salina
University of Kansas Health System Saint Francis Campus
RECRUITING
Topeka
University of Kansas Hospital-Westwood Cancer Center
RECRUITING
Westwood
Louisiana
LSU Health Baton Rouge-North Clinic
RECRUITING
Baton Rouge
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Our Lady of the Lake Physician Group
RECRUITING
Baton Rouge
East Jefferson General Hospital
RECRUITING
Metairie
LSU Healthcare Network / Metairie Multi-Specialty Clinic
RECRUITING
Metairie
Mary Bird Perkins Cancer Center - Metairie
RECRUITING
Metairie
Ochsner Medical Center Jefferson
RECRUITING
New Orleans
Tulane University School of Medicine
RECRUITING
New Orleans
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Maine
Lafayette Family Cancer Center-EMMC
RECRUITING
Brewer
Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RECRUITING
Ann Arbor
Trinity Health Medical Center - Brighton
RECRUITING
Brighton
Trinity Health Medical Center - Canton
RECRUITING
Canton
Chelsea Hospital
RECRUITING
Chelsea
Henry Ford Hospital
RECRUITING
Detroit
McLaren Cancer Institute-Flint
RECRUITING
Flint
Singh and Arora Hematology Oncology PC
RECRUITING
Flint
Karmanos Cancer Institute at McLaren Greater Lansing
RECRUITING
Lansing
Mid-Michigan Physicians-Lansing
RECRUITING
Lansing
University of Michigan Health - Sparrow Lansing
RECRUITING
Lansing
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
McLaren Cancer Institute-Macomb
RECRUITING
Mount Clemens
McLaren Cancer Institute-Owosso
RECRUITING
Owosso
Minnesota
Minnesota Oncology - Burnsville
RECRUITING
Burnsville
Mercy Hospital
RECRUITING
Coon Rapids
Fairview Southdale Hospital
RECRUITING
Edina
Unity Hospital
ACTIVE_NOT_RECRUITING
Fridley
Fairview Clinics and Surgery Center Maple Grove
RECRUITING
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
RECRUITING
Maplewood
Saint John's Hospital - Healtheast
RECRUITING
Maplewood
Abbott-Northwestern Hospital
RECRUITING
Minneapolis
Hennepin County Medical Center
RECRUITING
Minneapolis
Monticello Cancer Center
RECRUITING
Monticello
North Memorial Medical Health Center
RECRUITING
Robbinsdale
Coborn Cancer Center at Saint Cloud Hospital
RECRUITING
Saint Cloud
Park Nicollet Clinic - Saint Louis Park
RECRUITING
Saint Louis Park
Regions Hospital
RECRUITING
Saint Paul
United Hospital
RECRUITING
Saint Paul
Saint Francis Regional Medical Center
RECRUITING
Shakopee
Lakeview Hospital
RECRUITING
Stillwater
Ridgeview Medical Center
RECRUITING
Waconia
Rice Memorial Hospital
RECRUITING
Willmar
Minnesota Oncology Hematology PA-Woodbury
RECRUITING
Woodbury
Missouri
Mercy Oncology and Hematology - Clayton-Clarkson
SUSPENDED
Ballwin
Saint Francis Medical Center
RECRUITING
Cape Girardeau
Siteman Cancer Center at Saint Peters Hospital
RECRUITING
City Of Saint Peters
MU Health - University Hospital/Ellis Fischel Cancer Center
RECRUITING
Columbia
Siteman Cancer Center at West County Hospital
RECRUITING
Creve Coeur
University of Kansas Cancer Center - North
RECRUITING
Kansas City
University of Kansas Cancer Center - Lee's Summit
RECRUITING
Lee's Summit
University of Kansas Cancer Center at North Kansas City Hospital
RECRUITING
North Kansas City
Mercy Hospital Saint Louis
RECRUITING
St Louis
Siteman Cancer Center at Christian Hospital
RECRUITING
St Louis
Siteman Cancer Center-South County
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
Montana
Billings Clinic Cancer Center
RECRUITING
Billings
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
North Carolina
Duke Cancer Center Cary
RECRUITING
Cary
Duke University Medical Center
RECRUITING
Durham
Duke Cancer Center Raleigh
RECRUITING
Raleigh
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Nebraska
Cancer Partners of Nebraska
RECRUITING
Lincoln
New Hampshire
New Hampshire Oncology Hematology PA-Concord
RECRUITING
Concord
Solinsky Center for Cancer Care
RECRUITING
Manchester
New Jersey
Memorial Sloan Kettering Basking Ridge
RECRUITING
Basking Ridge
Cooper Hospital University Medical Center
RECRUITING
Camden
Saint Barnabas Medical Center
RECRUITING
Livingston
Memorial Sloan Kettering Monmouth
RECRUITING
Middletown
Memorial Sloan Kettering Bergen
RECRUITING
Montvale
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Rutgers New Jersey Medical School
RECRUITING
Newark
Robert Wood Johnson University Hospital Somerset
RECRUITING
Somerville
MD Anderson Cancer Center at Cooper-Voorhees
RECRUITING
Voorhees Township
Nevada
Comprehensive Cancer Centers of Nevada - Henderson
RECRUITING
Henderson
OptumCare Cancer Care at Seven Hills
RECRUITING
Henderson
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
RECRUITING
Las Vegas
GenesisCare USA - Fort Apache
RECRUITING
Las Vegas
GenesisCare USA - Las Vegas
SUSPENDED
Las Vegas
OptumCare Cancer Care at Charleston
RECRUITING
Las Vegas
OptumCare Cancer Care at Fort Apache
RECRUITING
Las Vegas
OptumCare Cancer Care at MountainView
RECRUITING
Las Vegas
Radiation Oncology Centers of Nevada Central
RECRUITING
Las Vegas
Radiation Oncology Centers of Nevada Southeast
RECRUITING
Las Vegas
Summerlin Hospital Medical Center
RECRUITING
Las Vegas
Renown Regional Medical Center
RECRUITING
Reno
New York
Sands Cancer Center
RECRUITING
Canandaigua
Memorial Sloan Kettering Commack
RECRUITING
Commack
Northwell Health Physicians Partners Radiation Medicine at Queens
RECRUITING
Forest Hills
Memorial Sloan Kettering Westchester
RECRUITING
Harrison
Northwell Health/Center for Advanced Medicine
RECRUITING
Lake Success
Garnet Health Medical Center
RECRUITING
Middletown
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Queens Cancer Center
RECRUITING
Rego Park
Highland Hospital
RECRUITING
Rochester
University of Rochester
RECRUITING
Rochester
Wilmot Cancer Institute Radiation Oncology at Greece
RECRUITING
Rochester
Memorial Sloan Kettering Nassau
RECRUITING
Uniondale
Wilmot Cancer Institute at Webster
RECRUITING
Webster
Ohio
Cleveland Clinic Akron General
RECRUITING
Akron
Miami Valley Hospital South
RECRUITING
Centerville
University of Cincinnati Cancer Center-UC Medical Center
RECRUITING
Cincinnati
Cleveland Clinic Cancer Center/Fairview Hospital
RECRUITING
Cleveland
Cleveland Clinic Foundation
RECRUITING
Cleveland
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Miami Valley Hospital
RECRUITING
Dayton
Miami Valley Hospital North
RECRUITING
Dayton
Premier Blood and Cancer Center
RECRUITING
Dayton
Armes Family Cancer Center
RECRUITING
Findlay
Atrium Medical Center-Middletown Regional Hospital
RECRUITING
Franklin
Cleveland Clinic Cancer Center Mansfield
RECRUITING
Mansfield
Hillcrest Hospital Cancer Center
RECRUITING
Mayfield Heights
North Coast Cancer Care
RECRUITING
Sandusky
Cleveland Clinic Cancer Center Strongsville
RECRUITING
Strongsville
Upper Valley Medical Center
RECRUITING
Troy
University of Cincinnati Cancer Center-West Chester
RECRUITING
West Chester
Cleveland Clinic Wooster Family Health and Surgery Center
RECRUITING
Wooster
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Legacy Mount Hood Medical Center
ACTIVE_NOT_RECRUITING
Gresham
Legacy Good Samaritan Hospital and Medical Center
ACTIVE_NOT_RECRUITING
Portland
Pennsylvania
UPMC Altoona
RECRUITING
Altoona
UPMC-Heritage Valley Health System Beaver
RECRUITING
Beaver
Crozer-Keystone Regional Cancer Center at Broomall
SUSPENDED
Broomall
Carlisle Regional Cancer Center
RECRUITING
Carlisle
Christiana Care Health System-Concord Health Center
RECRUITING
Chadds Ford
Delaware County Memorial Hospital
SUSPENDED
Drexel Hill
UPMC Hillman Cancer Center Erie
RECRUITING
Erie
UPMC Cancer Center at UPMC Horizon
RECRUITING
Farrell
Crozer Regional Cancer Center at Brinton Lake
SUSPENDED
Glen Mills
UPMC Cancer Centers - Arnold Palmer Pavilion
RECRUITING
Greensburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
RECRUITING
Harrisburg
Penn State Milton S Hershey Medical Center
RECRUITING
Hershey
IRMC Cancer Center
RECRUITING
Indiana
UPMC-Johnstown/John P. Murtha Regional Cancer Center
RECRUITING
Johnstown
UPMC Cancer Center at UPMC McKeesport
RECRUITING
Mckeesport
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
RECRUITING
Mechanicsburg
UPMC Cancer Center - Monroeville
RECRUITING
Monroeville
UPMC Hillman Cancer Center in Coraopolis
RECRUITING
Moon Township
UPMC-Magee Womens Hospital
RECRUITING
Pittsburgh
UPMC-Passavant Hospital
RECRUITING
Pittsburgh
UPMC-Saint Clair Hospital Cancer Center
RECRUITING
Pittsburgh
UPMC-Saint Margaret
RECRUITING
Pittsburgh
UPMC-Shadyside Hospital
RECRUITING
Pittsburgh
UPMC Cancer Center at UPMC Northwest
RECRUITING
Seneca
UPMC Uniontown Hospital Radiation Oncology
RECRUITING
Uniontown
Crozer-Chester Medical Center
SUSPENDED
Upland
UPMC Washington Hospital Radiation Oncology
RECRUITING
Washington
Chester County Hospital
RECRUITING
West Chester
Reading Hospital
RECRUITING
West Reading
UPMC Memorial
RECRUITING
York
South Dakota
Avera Cancer Institute - Mitchell
RECRUITING
Mitchell
Avera Cancer Institute
RECRUITING
Sioux Falls
Texas
Parkland Memorial Hospital
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
Tarrant County Hospital District/JPS Health Network
RECRUITING
Fort Worth
UT Southwestern/Simmons Cancer Center-Fort Worth
RECRUITING
Fort Worth
UT Southwestern Clinical Center at Richardson/Plano
RECRUITING
Richardson
Audie L Murphy VA Hospital
ACTIVE_NOT_RECRUITING
San Antonio
Virginia
VCU Massey Cancer Center at Hanover Medical Park
RECRUITING
Mechanicsville
Bon Secours Saint Francis Medical Center
RECRUITING
Midlothian
Bon Secours Cancer Institute at Reynolds Crossing
RECRUITING
Richmond
VCU Massey Cancer Center at Stony Point
RECRUITING
Richmond
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
Washington
Legacy Salmon Creek Hospital
ACTIVE_NOT_RECRUITING
Vancouver
Wisconsin
Langlade Hospital and Cancer Center
RECRUITING
Antigo
ThedaCare Regional Cancer Center
RECRUITING
Appleton
Aurora Cancer Care-Southern Lakes VLCC
RECRUITING
Burlington
Marshfield Medical Center-EC Cancer Center
RECRUITING
Eau Claire
Aurora Health Care Germantown Health Center
RECRUITING
Germantown
Aurora Cancer Care-Grafton
RECRUITING
Grafton
Aurora BayCare Medical Center
RECRUITING
Green Bay
Bellin Memorial Hospital
RECRUITING
Green Bay
Aurora Cancer Care-Kenosha South
RECRUITING
Kenosha
Aurora Bay Area Medical Group-Marinette
RECRUITING
Marinette
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
Froedtert Menomonee Falls Hospital
RECRUITING
Menomonee Falls
Aurora Cancer Care-Milwaukee
RECRUITING
Milwaukee
Aurora Saint Luke's Medical Center
RECRUITING
Milwaukee
Aurora Sinai Medical Center
RECRUITING
Milwaukee
Medical College of Wisconsin
RECRUITING
Milwaukee
Marshfield Medical Center - Minocqua
RECRUITING
Minocqua
Cancer Center of Western Wisconsin
RECRUITING
New Richmond
Drexel Town Square Health Center
RECRUITING
Oak Creek
Vince Lombardi Cancer Clinic - Oshkosh
RECRUITING
Oshkosh
Aurora Cancer Care-Racine
RECRUITING
Racine
Aspirus Cancer Care - James Beck Cancer Center
RECRUITING
Rhinelander
Marshfield Medical Center-Rice Lake
RECRUITING
Rice Lake
Vince Lombardi Cancer Clinic-Sheboygan
RECRUITING
Sheboygan
Aspirus Cancer Care - Stevens Point
RECRUITING
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
RECRUITING
Stevens Point
Aurora Medical Center in Summit
RECRUITING
Summit
Aspirus Regional Cancer Center
RECRUITING
Wausau
Aurora Cancer Care-Milwaukee West
RECRUITING
Wauwatosa
Aurora West Allis Medical Center
RECRUITING
West Allis
Froedtert West Bend Hospital/Kraemer Cancer Center
RECRUITING
West Bend
Marshfield Medical Center - Weston
RECRUITING
Weston
Aspirus Cancer Care - Wisconsin Rapids
RECRUITING
Wisconsin Rapids
West Virginia
West Virginia University Charleston Division
RECRUITING
Charleston
Time Frame
Start Date: 2020-04-16
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 586
Treatments
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. Patients in both arms may undergo CT, MRI, bone scan, and PET as clinically indicated throughout the study. Patients may also undergo blood sample collection throughout the study.
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 of each cycle. Cycles repeat every 90 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients in both arms may undergo CT, MRI, bone scan, and PET as clinically indicated throughout the study. Patients may also undergo blood sample collection throughout the study.
Related Therapeutic Areas
Sponsors
Leads: NRG Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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