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

Sponsor
NRG Oncology (Other)
Overall Status
Recruiting
CT.gov ID
NCT04134260
Collaborator
National Cancer Institute (NCI) (NIH)
586
Enrollment
243
Locations
2
Arms
79.9
Anticipated Duration (Months)
2.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Apalutamide
  • Drug: Hormone Therapy
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Radiation: Radiation Therapy
 Phase 3

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:

  1. 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.

  2. Compare overall survival, biochemical progression-free survival, time to local-regional progression, time to castrate resistance, and cancer-specific survival among the treatment arms.

  3. Compare the short-term and long-term treatment-related adverse events among the treatment arms.

EXPLORATORY OBJECTIVES:

  1. 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.

  2. 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.

  3. To optimize quality assurance methodologies and processes for radiotherapy and imaging with machine learning strategies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care hormone therapy per physician discretion for 24 months. Patients also undergo standard of care pelvis and prostate bed radiation therapy 5 days per week over 5-6 or 7-8 weeks beginning within 90 days of randomization in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo standard of care hormone therapy and radiation therapy as in Arm I. Patients also receive apalutamide orally (PO) once daily (QD) on days 1-90. Cycles repeat every 90 days for 8 cycles in the absence of disease progression or unacceptable toxicity.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
586 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 5, 2020
Anticipated Primary Completion Date :
Nov 1, 2026
Anticipated Study Completion Date :
Nov 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (hormone therapy, radiation therapy)

Patients receive standard of care hormone therapy per physician discretion for 24 months. Patients also undergo standard of care pelvis and prostate bed radiation therapy 5 days per week over 5-6 or 7-8 weeks beginning within 90 days of randomization in the absence of disease progression or unacceptable toxicity.

Drug: Hormone Therapy
Receive hormone therapy
Other Names:
  • Chemotherapy-Hormones/Steroids
  • Endocrine Therapy
  • Hormonal Therapy
  • hormone treatment
  • Hormones

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Radiation: Radiation Therapy
    Undergo pelvis and prostate bed radiation therapy
    Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

    		•
    Experimental: Arm II (hormone therapy, radiation therapy, apalutamide)

    Patients undergo standard of care hormone therapy and radiation therapy as in Arm I. Patients also receive apalutamide PO QD on days 1-90. Cycles repeat every 90 days for 8 cycles in the absence of disease progression or unacceptable toxicity.

    Drug: Apalutamide
    Given PO
    Other Names:
  • ARN 509
  • ARN-509
  • ARN509
  • Erleada
  • JNJ 56021927
  • JNJ-56021927

    • Drug: Hormone Therapy
    Receive hormone therapy
    Other Names:
  • Chemotherapy-Hormones/Steroids
  • Endocrine Therapy
  • Hormonal Therapy
  • hormone treatment
  • Hormones

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Radiation: Radiation Therapy
    Undergo pelvis and prostate bed radiation therapy
    Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Metastasis-free survival (MFS) [From randomization to detection of metastatic disease or death from any cause, assessed up to 7.5 years]

      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.

    Secondary Outcome Measures

    1. Quality of life (QOL) between the two treatment arms [Up to 3 years post treatment]

      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.

    2. Overall survival (OS) [From randomization until date of death or censored at last date known alive, assessed up to 7.5 years]

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

    3. Biochemical progression-free survival (bPFS) [From randomization until biochemical recurrence or death from prostate cancer, assessed up to 7.5 years]

      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.

    4. Time to local-regional progression [Up to 7.5 years]

      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.

    5. Time to castrate resistance [Up to 7.5 years]

      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.

    6. Cancer-specific survival [Up to 7.5 years]

      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.

    7. Incidence of adverse events [Up to 7.5 years]

      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.

    Other Outcome Measures

    1. MFS by Decipher genomic score [Up to 7.5 years]

      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.

    2. OS by Decipher genomic score [Up to 7.5 years]

      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.

    3. PAM50-based classification of prostate cancer [Up to 7.5 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Pathologically (histologically) proven diagnosis of prostate adenocarcinoma. Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted

    • Any T-stage is eligible (American Joint Committee on Cancer [AJCC] 8th edition [ed])

    • Appropriate stage for study entry based on fluciclovine F-18 positron emission tomography (PET) scan (FACBC, Axumin) within 90 days prior to registration that is negative for distant metastatic (M1a, M1b, M1c) disease; Note that though every effort should be made to obtain a fluciclovine F-18 PET (FACBC, Axumin) scan; however, if the patient has already had a recent F-18 PSMA PET scan or gallium Ga 68-labeled PSMA-11 (Ga-68 PSMA) PET scan or C-11 or F-18 choline PET scan within 90 days prior to registration (to include scan report) then repeat molecular imaging with a fluciclovine F-18 PET (FACBC, Axumin) scan will not be required.

    • Pathologically node positive disease with nodal involvement only in the pelvis in the prostatectomy specimen (including external iliacs, internal iliacs, and/or obturator nodes); peri-rectal nodes can also be considered regional lymphadenopathy and are allowed

    • History/physical examination within 90 days prior to registration

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 90 days prior to registration

    • Detectable PSA after radical prostatectomy. Detectable PSA is defined as serum PSA > 0 ng/mL at least 30 days after prostatectomy and within 180 days of registration and before start of GnRH agonist/antagonist

    • Patients who have already started on post-prostatectomy GnRH agonist/antagonist for =< 180 days prior to registration are eligible (Note: patients who started on an oral antiandrogen are eligible if started =< 180 days and stopped prior to registration)

    • Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors (within 90 days prior to registration)

    • Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors (within 90 days prior to registration)

    • Serum potassium >= 3.5 mmol/L within 90 days prior to registration

    • Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault (please use actual weight for calculation unless greater than 30% above ideal body weight then use the adjusted body weight) (within 90 days prior to registration)

    • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject is eligible) (within 90 days prior to registration)

    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (within 90 days prior to registration)

    • Serum albumin >= 3.0 g/dL (within 90 days prior to registration)

    • Discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to registration

    • The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug

    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count >= 200 cells/microliter within 30 days prior to registration. Note: HIV testing is not required for eligibility for this protocol

    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy within 30 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol

    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 30 days prior to registration

    • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ) who has no evidence of disease for < 3 years must contact the principal investigator, Ronald Chen, Doctor of Medicine (MD)

    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

    Exclusion Criteria:

    • Definitive radiologic evidence of metastatic disease (M1a, M1b or M1c) on molecular imaging (e.g. fluciclovine F-18 PET, F-18 PSMA, PSMA, F-18 choline 11)

    • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration)

    • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

    • Androgen deprivation therapy (ADT) prior to radical prostatectomy

    • Prior treatment with androgen receptor signaling inhibitor (including but not exclusive to a growing list of: abiraterone acetate, enzalutamide, apalutamide, darolutamide), unless started =< 180 days and stopped prior to registration, which is allowed

    • Current use of 5-alpha reductase inhibitor. NOTE: if the alpha reductase inhibitor is stopped prior to randomization the patient is eligible

    • History of any of the following:

    • Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to registration, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)

    • Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 12 months prior to registration

    • New York Heart Association functional classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification.)

    • History of any condition that in the opinion of the investigator, would preclude participation in this study

    • Current evidence of any of the following:

    • Known gastrointestinal disorder affecting absorption of oral medications

    • Active uncontrolled infection

    • Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment

    • Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily

    • Baseline moderate and severe hepatic impairment (Child-Pugh Class B & C)

    • Inability to swallow oral pills

    • Any current condition that in the opinion of the investigator, would preclude participation in this study

    • Patients must not plan to participate in any other therapeutic clinical trials while receiving treatment on this study

    • Patients with inflammatory bowel disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    2 Marin General Hospital Greenbrae California United States 94904
    3 Tibor Rubin VA Medical Center Long Beach California United States 90822
    4 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    5 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    6 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095
    7 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    8 UCSF Medical Center-Mount Zion San Francisco California United States 94115
    9 UCSF Medical Center-Parnassus San Francisco California United States 94143
    10 UCSF Medical Center-Mission Bay San Francisco California United States 94158
    11 Ridley-Tree Cancer Center Santa Barbara California United States 93105
    12 Beebe South Coastal Health Campus Frankford Delaware United States 19945
    13 Helen F Graham Cancer Center Newark Delaware United States 19713
    14 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    15 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    16 Beebe Health Campus Rehoboth Beach Delaware United States 19971
    17 Grady Health System Atlanta Georgia United States 30303
    18 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    19 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
    20 Alton Memorial Hospital Alton Illinois United States 62002
    21 Rush - Copley Medical Center Aurora Illinois United States 60504
    22 Advocate Good Shepherd Hospital Barrington Illinois United States 60010
    23 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    24 Illinois CancerCare-Canton Canton Illinois United States 61520
    25 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    26 Northwestern University Chicago Illinois United States 60611
    27 Rush University Medical Center Chicago Illinois United States 60612
    28 University of Illinois Chicago Illinois United States 60612
    29 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    30 Advocate Illinois Masonic Medical Center Chicago Illinois United States 60657
    31 AMG Crystal Lake - Oncology Crystal Lake Illinois United States 60014
    32 Carle on Vermilion Danville Illinois United States 61832
    33 Decatur Memorial Hospital Decatur Illinois United States 62526
    34 Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois United States 60115
    35 Illinois CancerCare-Dixon Dixon Illinois United States 61021
    36 Advocate Good Samaritan Hospital Downers Grove Illinois United States 60515
    37 Carle Physician Group-Effingham Effingham Illinois United States 62401
    38 Crossroads Cancer Center Effingham Illinois United States 62401
    39 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    40 NorthShore University HealthSystem-Evanston Hospital Evanston Illinois United States 60201
    41 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    42 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    43 Northwestern Medicine Cancer Center Delnor Geneva Illinois United States 60134
    44 NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois United States 60026
    45 Advocate South Suburban Hospital Hazel Crest Illinois United States 60429
    46 NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois United States 60035
    47 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    48 AMG Libertyville - Oncology Libertyville Illinois United States 60048
    49 Condell Memorial Hospital Libertyville Illinois United States 60048
    50 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    51 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    52 Loyola University Medical Center Maywood Illinois United States 60153
    53 UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois United States 60451
    54 University of Chicago Medicine-Orland Park Orland Park Illinois United States 60462
    55 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    56 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
    57 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    58 OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois United States 61554
    59 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    60 OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois United States 61615
    61 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    62 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    63 Illinois CancerCare-Peru Peru Illinois United States 61354
    64 Valley Radiation Oncology Peru Illinois United States 61354
    65 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    66 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    67 Springfield Clinic Springfield Illinois United States 62702
    68 Memorial Medical Center Springfield Illinois United States 62781
    69 Carle Cancer Center Urbana Illinois United States 61801
    70 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    71 Reid Health Richmond Indiana United States 47374
    72 McFarland Clinic PC - Ames Ames Iowa United States 50010
    73 Saint Luke's Hospital Cedar Rapids Iowa United States 52402
    74 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    75 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    76 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    77 Methodist West Hospital West Des Moines Iowa United States 50266-7700
    78 University of Kansas Cancer Center Kansas City Kansas United States 66160
    79 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    80 University of Kansas Health System Saint Francis Campus Topeka Kansas United States 66606
    81 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    82 East Jefferson General Hospital Metairie Louisiana United States 70006
    83 LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana United States 70006
    84 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
    85 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    86 Lafayette Family Cancer Center-EMMC Brewer Maine United States 04412
    87 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    88 Brigham and Women's Hospital Boston Massachusetts United States 02115
    89 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    90 Henry Ford Hospital Detroit Michigan United States 48202
    91 McLaren Cancer Institute-Flint Flint Michigan United States 48532
    92 Singh and Arora Hematology Oncology PC Flint Michigan United States 48532
    93 Karmanos Cancer Institute at McLaren Greater Lansing Lansing Michigan United States 48910
    94 Mid-Michigan Physicians-Lansing Lansing Michigan United States 48912
    95 McLaren Cancer Institute-Macomb Mount Clemens Michigan United States 48043
    96 McLaren Cancer Institute-Owosso Owosso Michigan United States 48867
    97 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
    98 Mercy Hospital Coon Rapids Minnesota United States 55433
    99 Fairview Southdale Hospital Edina Minnesota United States 55435
    100 Unity Hospital Fridley Minnesota United States 55432
    101 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
    102 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    103 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    104 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    105 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    106 Monticello Cancer Center Monticello Minnesota United States 55362
    107 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    108 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
    109 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    110 Regions Hospital Saint Paul Minnesota United States 55101
    111 United Hospital Saint Paul Minnesota United States 55102
    112 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    113 Lakeview Hospital Stillwater Minnesota United States 55082
    114 Ridgeview Medical Center Waconia Minnesota United States 55387
    115 Rice Memorial Hospital Willmar Minnesota United States 56201
    116 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    117 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
    118 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    119 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
    120 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    121 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
    122 Washington University School of Medicine Saint Louis Missouri United States 63110
    123 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    124 Siteman Cancer Center at Christian Hospital Saint Louis Missouri United States 63136
    125 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    126 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
    127 Billings Clinic Cancer Center Billings Montana United States 59101
    128 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    129 Cancer Partners of Nebraska - Pine Lake Lincoln Nebraska United States 68516
    130 Southeast Nebraska Cancer Center - 68th Street Place Lincoln Nebraska United States 68516
    131 Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada United States 89052
    132 OptumCare Cancer Care at Seven Hills Henderson Nevada United States 89052
    133 OptumCare Cancer Care at Charleston Las Vegas Nevada United States 89102
    134 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
    135 GenesisCare USA - Las Vegas Las Vegas Nevada United States 89109
    136 Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada United States 89119
    137 Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada United States 89128
    138 OptumCare Cancer Care at MountainView Las Vegas Nevada United States 89128
    139 Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada United States 89144
    140 Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada United States 89144
    141 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    142 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
    143 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
    144 Renown Regional Medical Center Reno Nevada United States 89502
    145 New Hampshire Oncology Hematology PA-Concord Concord New Hampshire United States 03301
    146 Solinsky Center for Cancer Care Manchester New Hampshire United States 03103
    147 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
    148 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    149 Saint Barnabas Medical Center Livingston New Jersey United States 07039
    150 Memorial Sloan Kettering Monmouth Middletown New Jersey United States 07748
    151 Memorial Sloan Kettering Bergen Montvale New Jersey United States 07645
    152 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    153 Rutgers New Jersey Medical School Newark New Jersey United States 07101
    154 MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey United States 08043
    155 Memorial Sloan Kettering Commack Commack New York United States 11725
    156 Memorial Sloan Kettering Westchester Harrison New York United States 10604
    157 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
    158 Garnet Health Medical Center Middletown New York United States 10940
    159 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    160 Highland Hospital Rochester New York United States 14620
    161 University of Rochester Rochester New York United States 14642
    162 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
    163 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    164 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
    165 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    166 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    167 Armes Family Cancer Center Findlay Ohio United States 45840
    168 Cleveland Clinic Cancer Center Mansfield Mansfield Ohio United States 44906
    169 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
    170 North Coast Cancer Care Sandusky Ohio United States 44870
    171 Cleveland Clinic Cancer Center Strongsville Strongsville Ohio United States 44136
    172 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
    173 Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio United States 44691
    174 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    175 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    176 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    177 UPMC Altoona Altoona Pennsylvania United States 16601
    178 UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania United States 15009
    179 Crozer-Keystone Regional Cancer Center at Broomall Broomall Pennsylvania United States 19008
    180 Carlisle Regional Cancer Center Carlisle Pennsylvania United States 17015
    181 Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania United States 19317
    182 Delaware County Memorial Hospital Drexel Hill Pennsylvania United States 19026
    183 UPMC Hillman Cancer Center Erie Erie Pennsylvania United States 16505
    184 UPMC Cancer Center at UPMC Horizon Farrell Pennsylvania United States 16121
    185 Crozer Regional Cancer Center at Brinton Lake Glen Mills Pennsylvania United States 19342
    186 UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania United States 15601
    187 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
    188 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    189 UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania United States 15901
    190 UPMC Cancer Center at UPMC McKeesport McKeesport Pennsylvania United States 15132
    191 UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg Pennsylvania United States 17050
    192 UPMC Cancer Center - Monroeville Monroeville Pennsylvania United States 15146
    193 UPMC-Coraopolis/Heritage Valley Radiation Oncology Moon Pennsylvania United States 15108
    194 UPMC-Magee Womens Hospital Pittsburgh Pennsylvania United States 15213
    195 UPMC-Saint Margaret Pittsburgh Pennsylvania United States 15215
    196 UPMC-Shadyside Hospital Pittsburgh Pennsylvania United States 15232
    197 UPMC-Passavant Hospital Pittsburgh Pennsylvania United States 15237
    198 UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania United States 15243
    199 UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania United States 16346
    200 UPMC Uniontown Hospital Radiation Oncology Uniontown Pennsylvania United States 15401
    201 Crozer-Chester Medical Center Upland Pennsylvania United States 19013
    202 UPMC Washington Hospital Radiation Oncology Washington Pennsylvania United States 15301
    203 Chester County Hospital West Chester Pennsylvania United States 19380
    204 Reading Hospital West Reading Pennsylvania United States 19611
    205 UPMC Memorial York Pennsylvania United States 17408
    206 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    207 UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas United States 76104
    208 UT Southwestern Clinical Center at Richardson/Plano Richardson Texas United States 75080
    209 Audie L Murphy VA Hospital San Antonio Texas United States 78229
    210 VCU Massey Cancer Center at Hanover Medical Park Mechanicsville Virginia United States 23116
    211 VCU Massey Cancer Center at Stony Point Richmond Virginia United States 23235
    212 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    213 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    214 West Virginia University Charleston Division Charleston West Virginia United States 25304
    215 ThedaCare Regional Cancer Center Appleton Wisconsin United States 54911
    216 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
    217 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    218 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
    219 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
    220 Bellin Memorial Hospital Green Bay Wisconsin United States 54301
    221 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    222 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
    223 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin United States 54143
    224 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    225 Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin United States 53051
    226 Aurora Cancer Care-Milwaukee Milwaukee Wisconsin United States 53209
    227 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    228 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    229 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
    230 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    231 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    232 Drexel Town Square Health Center Oak Creek Wisconsin United States 53154
    233 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
    234 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
    235 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    236 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    237 Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin United States 54482
    238 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    239 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    240 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
    241 Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin United States 53095
    242 Diagnostic and Treatment Center Weston Wisconsin United States 54476
    243 Marshfield Medical Center - Weston Weston Wisconsin United States 54476

    Sponsors and Collaborators

    • NRG Oncology
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Ronald C Chen, NRG Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NRG Oncology
    ClinicalTrials.gov Identifier:
    NCT04134260
    Other Study ID Numbers:
    • NRG-GU008
    • NCI-2019-06838
    • NRG-GU008
    • NRG-GU008
    • U10CA180868
    First Posted:
    Oct 22, 2019
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Hormones

    Study Results

    No Results Posted as of Aug 12, 2022