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RECRUITING

NCT04134260

PHASE3

Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial

Sponsor: NRG Oncology

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

586

Start Date

2020-04-16

Completion Date

2026-11-01

Last Updated

2026-01-14

Healthy Volunteers

Conditions

Prostate Adenocarcinoma Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8

Interventions

DRUG

Apalutamide

Given PO

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Hormone Therapy

Receive hormone therapy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy

Undergo pelvis and prostate bed radiation therapy

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 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 Exclusion Criteria: * Definitive radiologic evidence of metastatic disease (M1a, M1b or M1c) on molecular imaging (e.g. Fluciclovine F-18 PET, \[FACBC, Axumin\], F-18 PSMA PET \[Pylarify\], flotufolastat F-18 PSMA PET scan \[Posluma\], Gallium-68 PSMA PET scan or C-11 choline PET) * 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

Locations (347)

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Kaiser Permanente-Fontana

Fontana, California, United States

Marin General Hospital

Greenbrae, California, United States

Kaiser Permanente South Bay

Harbor City, California, United States

Kaiser Permanente-Irvine

Irvine, California, United States

Tibor Rubin VA Medical Center

Long Beach, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Kaiser Permanente West Los Angeles

Los Angeles, California, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Kaiser Permanente-Ontario

Ontario, California, United States

Kaiser Permanente - Panorama City

Panorama City, California, United States

Kaiser Permanente-Riverside

Riverside, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Kaiser Permanente-San Diego Zion

San Diego, California, United States

UCSF Medical Center-Mount Zion

San Francisco, California, United States

UCSF Medical Center-Parnassus

San Francisco, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Kaiser Permanente-San Marcos

San Marcos, California, United States

Ridley-Tree Cancer Center

Santa Barbara, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

George Washington University Medical Center

Washington D.C., District of Columbia, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Emory Decatur Hospital

Decatur, Georgia, United States

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

Alton Memorial Hospital

Alton, Illinois, United States

Rush-Copley Medical Center

Aurora, Illinois, United States

Advocate Outpatient Center - Aurora

Aurora, Illinois, United States

Advocate Good Shepherd Hospital

Barrington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Advocate Sherman Hospital

Elgin, Illinois, United States

Elmhurst Memorial Hospital

Elmhurst, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

AMG Libertyville - Oncology

Libertyville, Illinois, United States

Condell Memorial Hospital

Libertyville, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Edward Hospital/Cancer Center

Naperville, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

Northwestern Medicine Oak Brook

Oak Brook, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Advocate High Tech Medical Park

Palos Heights, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Valley Radiation Oncology

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Memorial Hospital East

Shiloh, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Illinois CancerCare - Washington

Washington, Illinois, United States

Reid Health

Richmond, Indiana, United States

McFarland Clinic - Ames

Ames, Iowa, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Saint Anthony Regional Hospital

Carroll, Iowa, United States

Saint Luke's Hospital

Cedar Rapids, Iowa, United States

Mercy Hospital

Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Broadlawns Medical Center

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Methodist West Hospital

West Des Moines, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Salina Regional Health Center

Salina, Kansas, United States

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, United States

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Mary Bird Perkins Cancer Center - Metairie

Metairie, Louisiana, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, United States

Tulane University School of Medicine

New Orleans, Louisiana, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Chelsea Hospital

Chelsea, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Singh and Arora Hematology Oncology PC

Flint, Michigan, United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Mid-Michigan Physicians-Lansing

Lansing, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

McLaren Cancer Institute-Owosso

Owosso, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Monticello Cancer Center

Monticello, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Mercy Oncology and Hematology - Clayton-Clarkson

Ballwin, Missouri, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Freeman Health System

Joplin, Missouri, United States

University of Kansas Cancer Center - Briarcliff

Kansas City, Missouri, United States

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Cancer Partners of Nebraska

Lincoln, Nebraska, United States

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Oncology Las Vegas - Henderson

Henderson, Nevada, United States

OptumCare Cancer Care at Charleston