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Active, not recruitingNCT04134260Updated Aug 17, 2026

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

A Phase 3 interventional study of Apalutamide and Biospecimen Collection in Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, sponsored by NRG Oncology. Active, not recruiting at 350 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by NRG Oncology · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
586
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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 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 computed tomography (CT), magnetic resonance imaging (MRI), bone scan, and positron emission tomography (PET) as clinically indicated throughout the study. Patients may also undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 6 months for 3 years, then annually thereafter.

02

Conditions studied

  • 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

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 586 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

NRG Oncology is the lead sponsor of 72 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
586 participants (estimated)

Study arms

  • 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.

    Procedure: Biospecimen Collection · Procedure: Bone Scan · Procedure: Computed Tomography · Drug: Hormone Therapy · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Radiation: Radiation Therapy

  • 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.

    Drug: Apalutamide · Procedure: Biospecimen Collection · Procedure: Bone Scan · Procedure: Computed Tomography · Drug: Hormone Therapy · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Radiation: Radiation Therapy

Interventions

  • DrugApalutamide

    Given PO

    Also known as: ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

  • ProcedureBone Scan

    Undergo bone scan

    Also known as: Bone Scintigraphy

  • ProcedureComputed Tomography

    Undergo CT

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

  • DrugHormone Therapy

    Receive hormone therapy

    Also known as: Chemotherapy-Hormones/Steroids, Endocrine Therapy, Hormonal, Hormonal Therapy, hormone treatment, Hormones

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

  • ProcedurePositron Emission Tomography

    Undergo PET

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

  • OtherQuality-of-Life Assessment

    Ancillary studies

    Also known as: Quality of Life Assessment

  • OtherQuestionnaire Administration

    Ancillary studies

  • RadiationRadiation Therapy

    Undergo pelvis and prostate bed radiation therapy

    Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

06

What researchers measure

Primary outcomes

  1. Metastasis-free survival (MFS)

    Kaplan-Meier curves will be generated and metastasis-free survival compared between the two treatment groups by a logrank test, stratified by prostate specific antigen (PSA) level after prostatectomy (never detectable or rising). Cox regression modeling to assess and adjust for the effects of PSA stratum and other baseline covariates will also be performed. The proportional hazards assumption will be tested using Schoenfeld residuals and graphical methods. Martingale residual plots will be examined to determine the best functional form for incorporating covariates into the model. A competing risks analysis will also be performed with time to distant metastasis or death from prostate cancer as the event of interest and death from other causes as the competing risk. Cumulative incidence curves will be generated along with Fine-Gray's test. Patients alive and metastasis free will be censored as of the time of the last negative examination.

    Time frame: From randomization to detection of metastatic disease or death from any cause, assessed up to 7.5 years

Secondary outcomes

  1. Quality of life (QOL) between the two treatment arms

    Quality of life scores will be derived by constructing summary measures across domains from the various quality of life instruments (Expanded Prostate Cancer Index Composite-26, EuroQol (EQ)-5 Dimension (D)-5 Level (L), Brief Pain Inventory, and Patient Reported Outcome Measurement Information System-Fatigue). Calculated health utilities will be derived from the EQ-5D-5L instrument and used to produce a quality-adjusted life year survival estimate post-treatment. The area under the curve provides an estimate of the quality-adjusted, restricted mean survival time and will be compared between the two treatment arms as described in Glasziou et al (1990). QOL scores will be analyzed using mixed effects regression for longitudinal data to compare the profiles over time between the two treatment groups (Gibbons and Hedeker, 2000). The models will include treatment, time, and treatment-by-time interaction terms as fixed effects and subjects as a random effect.

    Time frame: Up to 3 years post treatment

  2. Overall survival (OS)

    Will be summarized by Kaplan-Meier curves and compared between treatment groups via logrank tests and Cox regression modeling.

    Time frame: From randomization until date of death or censored at last date known alive, assessed up to 7.5 years

  3. Biochemical progression-free survival (bPFS)

    Will be summarized by Kaplan-Meier curves and compared between treatment groups via logrank tests and Cox regression modeling. In addition, competing risks analyses will be performed and cumulative incidence curves generated for bPFS with death from other (i.e., non-prostate cancer) causes treated as a competing event. Patients who die from non-prostate cancer related causes will be censored as of the date of death.

    Time frame: From randomization until biochemical recurrence or death from prostate cancer, assessed up to 7.5 years

  4. Time to local-regional progression

    Competing risks analyses will be performed and cumulative incidence curves generated for local-regional progression with death from other (i.e., non-prostate cancer) causes treated as a competing event.

    Time frame: Up to 7.5 years

  5. Time to castrate resistance

    Will be summarized by Kaplan-Meier curves and compared between treatment groups via logrank tests and Cox regression modeling. Patients who die prior to resistance will be censored.

    Time frame: Up to 7.5 years

  6. Cancer-specific survival

    Will be summarized by Kaplan-Meier curves and compared between treatment groups via logrank tests and Cox regression modeling. In addition, competing risks analyses will be performed and cumulative incidence curves generated for cancer-specific survival with death from other (i.e., non-prostate cancer) causes treated as a competing event. Patients who die from non-prostate cancer related causes will be censored as of the date of death.

    Time frame: Up to 7.5 years

  7. Incidence of adverse events

    Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. Adverse events will be tabulated by type, level of severity, and attribution for each treatment arm and the rate of events compared between treatment groups using chi-square or Fisher's exact tests.

    Time frame: Up to 7.5 years

Other outcomes

  1. MFS by Decipher genomic score

    Will determine the ability of the Decipher test to predict for metastasis in a purely node-positive population. Subgroup analyses of MFS by Decipher genomic score (high risk or low/intermediate risk) will be performed and tests for treatment-by-risk group interaction conducted via Cox regression to explore whether any benefits of apalutamide is limited to the high (or low/intermediate) risk stratum.

    Time frame: Up to 7.5 years

  2. OS by Decipher genomic score

    Will determine the ability of the Decipher test to predict for metastasis in a purely node-positive population. Subgroup analyses of OS by Decipher genomic score (high risk or low/intermediate risk) will be performed and tests for treatment-by-risk group interaction conducted via Cox regression to explore whether any benefits of apalutamide is limited to the high (or low/intermediate) risk stratum.

    Time frame: Up to 7.5 years

  3. PAM50-based classification of prostate cancer

    Will validate the PAM50-based classification of prostate cancer into luminal A, luminal B, and basal subtypes as prognostic markers. Classifications of prostate cancer into Luminal A, Luminal B, and basal subtypes using the PAM50 method of classification. Subgroup analyses will be performed and tests for treatment-by-risk group interaction conducted via Cox regression to explore whether any benefits of apalutamide is limited to the high (or low/intermediate) risk stratum.

    Time frame: Up to 7.5 years

  4. Estimate of treatment effect by sex

    Estimates of the primary outcome treatment effect and the corresponding 95% confidence intervals (CIs) by sex.

    Time frame: Up to 7.5 years

  5. Estimate of treatment effect by race

    Estimates of the primary outcome treatment effect and the corresponding 95% CIs by race.

    Time frame: Up to 7.5 years

  6. Estimates of treatment effect by ethnicity

    Estimates of the primary outcome treatment effect and the corresponding 95% CIs by ethnicity.

    Time frame: Up to 7.5 years

07

Study locations

350 sites
  • Cancer Center at Saint Joseph's
    Phoenix, Arizona 85004, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Kaiser Permanente-Anaheim
    Anaheim, California 92806, United States
  • Kaiser Permanente-Baldwin Park
    Baldwin Park, California 91706, United States
  • Kaiser Permanente-Bellflower
    Bellflower, California 90706, United States
  • Mercy Cancer Center - Carmichael
    Carmichael, California 95608, United States
  • Mercy San Juan Medical Center
    Carmichael, California 95608, United States
  • Mercy Cancer Center - Elk Grove
    Elk Grove, California 95758, United States
  • Kaiser Permanente-Fontana
    Fontana, California 92335, United States
  • Marin General Hospital
    Greenbrae, California 94904, United States
  • Kaiser Permanente South Bay
    Harbor City, California 90710, United States
  • Kaiser Permanente-Irvine
    Irvine, California 92618, United States
  • Tibor Rubin VA Medical Center
    Long Beach, California 90822, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
  • Los Angeles General Medical Center
    Los Angeles, California 90033, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • Kaiser Permanente West Los Angeles
    Los Angeles, California 90034, United States
  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles, California 90095, United States
  • Kaiser Permanente-Ontario
    Ontario, California 91761, United States
  • Kaiser Permanente - Panorama City
    Panorama City, California 91402, United States
  • Kaiser Permanente-Riverside
    Riverside, California 92505, United States
  • Mercy Cancer Center - Rocklin
    Rocklin, California 95765, United States
  • Mercy Cancer Center - Sacramento
    Sacramento, California 95816, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • Kaiser Permanente-San Diego Zion
    San Diego, California 92120, United States
  • UCSF Medical Center-Mount Zion
    San Francisco, California 94115, United States
  • UCSF Medical Center-Parnassus
    San Francisco, California 94143, United States
  • UCSF Medical Center-Mission Bay
    San Francisco, California 94158, United States
  • Kaiser Permanente-San Marcos
    San Marcos, California 92078, United States
  • Ridley-Tree Cancer Center
    Santa Barbara, California 93105, United States
  • Woodland Memorial Hospital
    Woodland, California 95695, United States
  • Kaiser Permanente-Woodland Hills
    Woodland Hills, California 91367, United States
  • Beebe South Coastal Health Campus
    Millville, Delaware 19967, United States
  • Helen F Graham Cancer Center
    Newark, Delaware 19713, United States
  • Medical Oncology Hematology Consultants PA
    Newark, Delaware 19713, United States
  • Christiana Care Health System-Christiana Hospital
    Newark, Delaware 19718, United States
  • Beebe Health Campus
    Rehoboth Beach, Delaware 19971, United States
  • George Washington University Medical Center
    Washington D.C., District of Columbia 20037, United States
  • UM Sylvester Comprehensive Cancer Center at Aventura
    Aventura, Florida 33180, United States
  • UM Sylvester Comprehensive Cancer Center at Coral Gables
    Coral Gables, Florida 33146, United States
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
    Deerfield Beach, Florida 33442, United States
  • UM Sylvester Comprehensive Cancer Center at Doral
    Doral, Florida 33166, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
    Miami, Florida 33136, United States
  • UM Sylvester Comprehensive Cancer Center at Kendall
    Miami, Florida 33176, United States
  • UM Sylvester Comprehensive Cancer Center at Plantation
    Plantation, Florida 33324, United States
  • Tampa General Hospital
    Tampa, Florida 33606, United States
  • Grady Health System
    Atlanta, Georgia 30303, United States
  • Emory Proton Therapy Center
    Atlanta, Georgia 30308, United States
  • Emory University Hospital Midtown
    Atlanta, Georgia 30308, United States
  • Emory University Hospital/Winship Cancer Institute
    Atlanta, Georgia 30322, United States
  • Emory Saint Joseph's Hospital
    Atlanta, Georgia 30342, United States
  • Emory Decatur Hospital
    Decatur, Georgia 30033, United States
  • Emory Johns Creek Hospital
    Johns Creek, Georgia 30097, United States
  • Alton Memorial Hospital
    Alton, Illinois 62002, United States
  • Rush-Copley Medical Center
    Aurora, Illinois 60504, United States
  • Advocate Outpatient Center - Aurora
    Aurora, Illinois 60506, United States
  • Advocate Good Shepherd Hospital
    Barrington, Illinois 60010, United States
  • Illinois CancerCare-Bloomington
    Bloomington, Illinois 61704, United States
  • Illinois CancerCare-Canton
    Canton, Illinois 61520, United States
  • Illinois CancerCare-Carthage
    Carthage, Illinois 62321, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Rush MD Anderson Cancer Center
    Chicago, Illinois 60612, United States
  • University of Illinois
    Chicago, Illinois 60612, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • Advocate Illinois Masonic Medical Center
    Chicago, Illinois 60657, United States
  • AMG Crystal Lake - Oncology
    Crystal Lake, Illinois 60014, United States
  • Carle at The Riverfront
    Danville, Illinois 61832, United States
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
  • Northwestern Medicine Cancer Center Kishwaukee
    DeKalb, Illinois 60115, United States
  • Illinois CancerCare-Dixon
    Dixon, Illinois 61021, United States
  • Advocate Good Samaritan Hospital
    Downers Grove, Illinois 60515, United States
  • Carle Physician Group-Effingham
    Effingham, Illinois 62401, United States
  • Crossroads Cancer Center
    Effingham, Illinois 62401, United States
  • Advocate Sherman Hospital
    Elgin, Illinois 60123, United States
  • Elmhurst Memorial Hospital
    Elmhurst, Illinois 60126, United States
  • Illinois CancerCare-Eureka
    Eureka, Illinois 61530, United States
  • NorthShore University HealthSystem-Evanston Hospital
    Evanston, Illinois 60201, United States
  • Illinois CancerCare-Galesburg
    Galesburg, Illinois 61401, United States
  • Western Illinois Cancer Treatment Center
    Galesburg, Illinois 61401, United States
  • Northwestern Medicine Cancer Center Delnor
    Geneva, Illinois 60134, United States
  • NorthShore University HealthSystem-Glenbrook Hospital
    Glenview, Illinois 60026, United States
  • Ingalls Memorial Hospital
    Harvey, Illinois 60426, United States
  • Advocate South Suburban Hospital
    Hazel Crest, Illinois 60429, United States
  • NorthShore University HealthSystem-Highland Park Hospital
    Highland Park, Illinois 60035, United States
  • Illinois CancerCare-Kewanee Clinic
    Kewanee, Illinois 61443, United States
  • AMG Libertyville - Oncology
    Libertyville, Illinois 60048, United States
  • Condell Memorial Hospital
    Libertyville, Illinois 60048, United States
  • Illinois CancerCare-Macomb
    Macomb, Illinois 61455, United States
  • Carle Physician Group-Mattoon/Charleston
    Mattoon, Illinois 61938, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Edward Hospital/Cancer Center
    Naperville, Illinois 60540, United States
  • UC Comprehensive Cancer Center at Silver Cross
    New Lenox, Illinois 60451, United States
  • Carle BroMenn Medical Center
    Normal, Illinois 61761, United States
  • Carle Cancer Institute Normal
    Normal, Illinois 61761, United States
  • HSHS Saint Elizabeth's Hospital
    O'Fallon, Illinois 62269, United States
  • Northwestern Medicine Oak Brook
    Oak Brook, Illinois 60523, United States
  • Advocate Christ Medical Center
    Oak Lawn, Illinois 60453-2699, United States
  • Northwestern Medicine Orland Park
    Orland Park, Illinois 60462, United States
  • University of Chicago Medicine-Orland Park
    Orland Park, Illinois 60462, United States
  • Illinois CancerCare-Ottawa Clinic
    Ottawa, Illinois 61350, United States

Showing the first 100 of 350 sites across 2 countries.

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References and documents

Publications

  • Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29. PubMed 38421243 ↗

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04134260
Lead sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 22, 2019
Start date
Apr 16, 2020
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2031 (estimated)
Last update
Aug 17, 2026

Study contacts

Ronald C Chen
principal investigator · NRG Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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