Randomized Phase III Trial Testing Apalutamide with Hormone and Radiation Therapy After Surgery for Node-Positive Prostate Cancer (INNOVATE)
Led by NRG Oncology · Updated on 2026-05-07
586
Participants Needed
347
Research Sites
N/A
Total Duration
On this page
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
How is the study designed?
Similar Trials
Frequently Asked Questions
Research Publications
Sponsors
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NRG Oncology
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding the drug apalutamide to the usual hormone therapy and radiation therapy after surgery improves outcomes for men with prostate cancer that has spread to lymph nodes. This phase III trial focuses on patients who have undergone radical prostatectomy and have detectable prostate-specific antigen (PSA), aiming to see if apalutamide can help prevent the cancer from spreading further and extend the time without metastasis.
Participants are randomly assigned to one of two groups. One group receives standard hormone therapy and radiation to the pelvis and prostate bed for 5 to 8 weeks. The other group receives the same treatment plus daily oral apalutamide for 90 days per cycle, repeated for up to eight cycles, unless disease progression or unacceptable side effects occur. Both groups may undergo imaging tests like CT, MRI, bone scans, and PET scans as needed, along with blood sample collections.
Throughout the study, participants are closely monitored with scans and blood tests to assess cancer progression and treatment effects. Researchers will measure metastasis-free survival as the primary outcome, along with quality of life, overall survival, biochemical progression, time to local progression, castrate resistance, cancer-specific survival, and adverse events. After treatment, participants will have follow-up visits every six months for three years, then yearly thereafter to track long-term outcomes.
CONDITIONS
Brief Title
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
Pathologically confirmed prostate adenocarcinoma
Any type of radical prostatectomy completed
Any T-stage according to AJCC 8th edition
Appropriate stage based on recent PET scans showing no distant metastases
Node-positive disease limited to pelvic lymph nodes or regional lymphadenopathy
History and physical exam within 90 days
Age 18 years or older
ECOG performance status 0-1 within 90 days
Detectable PSA (>0 ng/mL) at least 30 days after prostatectomy
Started post-prostatectomy GnRH agonist/antagonist therapy ≤180 days prior or stopped oral antiandrogens ≤180 days before registration
Hemoglobin ≥9.0 g/dL within 90 days
Platelet count ≥100,000 x10^9/uL within 90 days
Serum potassium ≥3.5 mmol/L within 90 days
Creatinine clearance ≥30 mL/min within 90 days
Total bilirubin ≤1.5 times institutional upper limit or appropriately evaluated in Gilbert's syndrome within 90 days
AST/ALT ≤2.5 times institutional upper limit within 90 days
Serum albumin ≥3.0 g/dL within 90 days
Discontinued medications lowering seizure threshold at least 30 days prior
Agrees to use condoms and effective birth control during and for 3 months after treatment if sexually active with women of childbearing potential
HIV patients on effective therapy with undetectable viral load and CD4 ≥200 cells/microliter eligible
HBV patients with undetectable viral load on therapy eligible
Treated and cured HCV patients or those with undetectable viral load on treatment eligible
Prior or concurrent malignancies allowed if not interfering with study
Provides informed consent prior to study entry
You will not qualify if you...
Evidence of distant metastatic disease on advanced molecular imaging
Prior systemic chemotherapy for prostate cancer
Prior radiotherapy overlapping study fields
Androgen deprivation therapy before prostatectomy
Prior androgen receptor signaling inhibitors unless stopped ≤180 days before registration
Current use of 5-alpha reductase inhibitors unless stopped before randomization
History of seizures or conditions increasing seizure risk
Recent severe cardiac events or significant heart disease
New York Heart Association class III/IV heart failure
Any condition that investigator deems unsuitable for participation
Gastrointestinal disorders affecting oral drug absorption
Active uncontrolled infections
Uncontrolled hypertension (BP ≥160/100 mmHg)
Chronic medical conditions requiring >10 mg daily corticosteroids
Moderate or severe liver impairment (Child-Pugh B or C)
Inability to swallow oral pills
Participation in other therapeutic clinical trials during this study
Inflammatory bowel disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 months
Participants receive hormone therapy for up to 24 months and undergo pelvis and prostate bed radiation therapy 5 days per week over 5-8 weeks. Participants in the experimental arm also take apalutamide orally once daily for 90 days per cycle, repeating up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Radiation therapy 5 days per week for 5-8 weeks; apalutamide cycles every 90 days for up to 8 cycles; hormone therapy per physician discretion
Follow-up
Duration - Up to 7.5 years
After completion of study treatment, participants are followed every 6 months for 3 years, then annually thereafter to monitor health outcomes and adverse events.
Visits every 6 months for 3 years, then annual visits
Trial Site Locations
Total: 347 locations
1
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States, 85004
Actively Recruiting
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Kaiser Permanente-Anaheim
Anaheim, California, United States, 92806
Actively Recruiting
4
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States, 91706
Actively Recruiting
5
Kaiser Permanente-Bellflower
Bellflower, California, United States, 90706
Actively Recruiting
6
Mercy Cancer Center - Carmichael
Carmichael, California, United States, 95608
Actively Recruiting
7
Mercy San Juan Medical Center
Carmichael, California, United States, 95608
Actively Recruiting
8
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States, 95758
Actively Recruiting
9
Kaiser Permanente-Fontana
Fontana, California, United States, 92335
Actively Recruiting
10
Marin General Hospital
Greenbrae, California, United States, 94904
Actively Recruiting
11
Kaiser Permanente South Bay
Harbor City, California, United States, 90710
Actively Recruiting
12
Kaiser Permanente-Irvine
Irvine, California, United States, 92618
Actively Recruiting
13
Tibor Rubin VA Medical Center
Long Beach, California, United States, 90822
Actively Recruiting
14
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Actively Recruiting
15
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Active, Not Recruiting
16
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Active, Not Recruiting
17
Kaiser Permanente West Los Angeles
Los Angeles, California, United States, 90034
Actively Recruiting
18
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
19
Kaiser Permanente-Ontario
Ontario, California, United States, 91761
Actively Recruiting
20
Kaiser Permanente - Panorama City
Panorama City, California, United States, 91402
Actively Recruiting
21
Kaiser Permanente-Riverside
Riverside, California, United States, 92505
Actively Recruiting
22
Mercy Cancer Center - Rocklin
Rocklin, California, United States, 95765
Actively Recruiting
23
Mercy Cancer Center - Sacramento
Sacramento, California, United States, 95816
Actively Recruiting
24
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
25
Kaiser Permanente-San Diego Zion
San Diego, California, United States, 92120
Actively Recruiting
26
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
Actively Recruiting
27
UCSF Medical Center-Parnassus
San Francisco, California, United States, 94143
Actively Recruiting
28
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
29
Kaiser Permanente-San Marcos
San Marcos, California, United States, 92078
Actively Recruiting
30
Ridley-Tree Cancer Center
Santa Barbara, California, United States, 93105
Active, Not Recruiting
31
Woodland Memorial Hospital
Woodland, California, United States, 95695
Actively Recruiting
32
Kaiser Permanente-Woodland Hills
Woodland Hills, California, United States, 91367
Actively Recruiting
33
Beebe South Coastal Health Campus
Millville, Delaware, United States, 19967
Actively Recruiting
34
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Actively Recruiting
35
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Actively Recruiting
36
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Actively Recruiting
37
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
Actively Recruiting
38
George Washington University Medical Center
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
39
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
40
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
41
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
42
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States, 33166
Actively Recruiting
43
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
44
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
45
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
46
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
47
Grady Health System
Atlanta, Georgia, United States, 30303
Actively Recruiting
48
Emory Proton Therapy Center
Atlanta, Georgia, United States, 30308
Actively Recruiting
49
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
50
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
51
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
52
Emory Decatur Hospital
Decatur, Georgia, United States, 30033
Actively Recruiting
53
Emory Johns Creek Hospital
Johns Creek, Georgia, United States, 30097
Actively Recruiting
54
Alton Memorial Hospital
Alton, Illinois, United States, 62002
Actively Recruiting
55
Rush-Copley Medical Center
Aurora, Illinois, United States, 60504
Actively Recruiting
56
Advocate Outpatient Center - Aurora
Aurora, Illinois, United States, 60506
Actively Recruiting
57
Advocate Good Shepherd Hospital
Barrington, Illinois, United States, 60010
Actively Recruiting
58
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Actively Recruiting
59
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Actively Recruiting
60
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Actively Recruiting
61
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
62
Rush MD Anderson Cancer Center
Chicago, Illinois, United States, 60612
Active, Not Recruiting
63
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
64
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
65
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
Actively Recruiting
66
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, United States, 60014
Actively Recruiting
67
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
68
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Actively Recruiting
69
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
70
Illinois CancerCare-Dixon
Dixon, Illinois, United States, 61021
Suspended
71
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States, 60515
Actively Recruiting
72
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
73
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Actively Recruiting
74
Advocate Sherman Hospital
Elgin, Illinois, United States, 60123
Actively Recruiting
75
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60126
Actively Recruiting
76
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Actively Recruiting
77
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Actively Recruiting
78
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Actively Recruiting
79
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Suspended
80
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
81
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States, 60026
Actively Recruiting
82
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Actively Recruiting
83
Advocate South Suburban Hospital
Hazel Crest, Illinois, United States, 60429
Actively Recruiting
84
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States, 60035
Actively Recruiting
85
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Actively Recruiting
86
AMG Libertyville - Oncology
Libertyville, Illinois, United States, 60048
Actively Recruiting
87
Condell Memorial Hospital
Libertyville, Illinois, United States, 60048
Actively Recruiting
88
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Actively Recruiting
89
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
90
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
91
Edward Hospital/Cancer Center
Naperville, Illinois, United States, 60540
Actively Recruiting
92
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
93
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, United States, 62269
Actively Recruiting
94
Northwestern Medicine Oak Brook
Oak Brook, Illinois, United States, 60523
Actively Recruiting
95
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453-2699
Actively Recruiting
96
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
97
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
98
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Actively Recruiting
99
Advocate High Tech Medical Park
Palos Heights, Illinois, United States, 60463
Actively Recruiting
100
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Actively Recruiting
101
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
Actively Recruiting
102
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, United States, 61554
Actively Recruiting
103
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Actively Recruiting
104
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States, 61615
Actively Recruiting
105
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Actively Recruiting
106
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Actively Recruiting
107
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Actively Recruiting
108
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Suspended
109
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Actively Recruiting
110
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
111
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
112
Springfield Clinic
Springfield, Illinois, United States, 62702
Actively Recruiting
113
Springfield Memorial Hospital
Springfield, Illinois, United States, 62781
Actively Recruiting
114
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
115
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
116
Illinois CancerCare - Washington
Washington, Illinois, United States, 61571
Actively Recruiting
117
Reid Health
Richmond, Indiana, United States, 47374
Actively Recruiting
118
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Actively Recruiting
119
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
120
Saint Anthony Regional Hospital
Carroll, Iowa, United States, 51401
Actively Recruiting
121
Saint Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
Active, Not Recruiting
122
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
123
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
124
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
125
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
126
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
127
Broadlawns Medical Center
Des Moines, Iowa, United States, 50314
Actively Recruiting
128
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
129
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
130
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Actively Recruiting
131
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
Actively Recruiting
132
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
133
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States, 66061
Actively Recruiting
134
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
135
Salina Regional Health Center
Salina, Kansas, United States, 67401
Actively Recruiting
136
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States, 66606
Actively Recruiting
137
University of Kansas Hospital-Westwood Cancer Center
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