Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-02 @ 3:56 AM
Study NCT ID:
NCT04134260
Status:
RECRUITING
Last Update Posted:
2025-11-10
First Post:
2019-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572045', 'term': 'apalutamide'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 586}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2019-10-18', 'studyFirstSubmitQcDate': '2019-10-18', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'MFS by Decipher genomic score', 'timeFrame': 'Up to 7.5 years', 'description': '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.'}, {'measure': 'OS by Decipher genomic score', 'timeFrame': 'Up to 7.5 years', 'description': '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.'}, {'measure': 'PAM50-based classification of prostate cancer', 'timeFrame': 'Up to 7.5 years', 'description': '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.'}, {'measure': 'Estimate of treatment effect by sex', 'timeFrame': 'Up to 7.5 years', 'description': 'Estimates of the primary outcome treatment effect and the corresponding 95% confidence intervals (CIs) by sex.'}, {'measure': 'Estimate of treatment effect by race', 'timeFrame': 'Up to 7.5 years', 'description': 'Estimates of the primary outcome treatment effect and the corresponding 95% CIs by race.'}, {'measure': 'Estimates of treatment effect by ethnicity', 'timeFrame': 'Up to 7.5 years', 'description': 'Estimates of the primary outcome treatment effect and the corresponding 95% CIs by ethnicity.'}], 'primaryOutcomes': [{'measure': 'Metastasis-free survival (MFS)', 'timeFrame': 'From randomization to detection of metastatic disease or death from any cause, assessed up to 7.5 years', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Quality of life (QOL) between the two treatment arms', 'timeFrame': 'Up to 3 years post treatment', 'description': '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.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From randomization until date of death or censored at last date known alive, assessed up to 7.5 years', 'description': 'Will be summarized by Kaplan-Meier curves and compared between treatment groups via logrank tests and Cox regression modeling.'}, {'measure': 'Biochemical progression-free survival (bPFS)', 'timeFrame': 'From randomization until biochemical recurrence or death from prostate cancer, assessed up to 7.5 years', 'description': '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.'}, {'measure': 'Time to local-regional progression', 'timeFrame': 'Up to 7.5 years', 'description': '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.'}, {'measure': 'Time to castrate resistance', 'timeFrame': 'Up to 7.5 years', 'description': '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.'}, {'measure': 'Cancer-specific survival', 'timeFrame': 'Up to 7.5 years', 'description': '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.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 7.5 years', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Adenocarcinoma', 'Stage I Prostate Cancer AJCC v8', 'Stage II Prostate Cancer AJCC v8', 'Stage III Prostate Cancer AJCC v8', 'Stage IVA Prostate Cancer AJCC v8']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. 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).\n\nSECONDARY OBJECTIVES:\n\nI. 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.\n\nII. Compare overall survival, biochemical progression-free survival, time to local-regional progression, time to castrate resistance, and cancer-specific survival among the treatment arms.\n\nIII. Compare the short-term and long-term treatment-related adverse events among the treatment arms.\n\nEXPLORATORY OBJECTIVES:\n\nI. 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.\n\nII. 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.\n\nIII. To optimize quality assurance methodologies and processes for radiotherapy and imaging with machine learning strategies.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM 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.\n\nARM 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.\n\nPatients 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.\n\nAfter completion of study treatment, patients are followed up every 6 months for 3 years, then annually thereafter.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically (histologically) proven diagnosis of prostate adenocarcinoma. Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted\n* Any T-stage is eligible (American Joint Committee on Cancer \\[AJCC\\] 8th edition \\[ed\\])\n* 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\n* 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\n* History/physical examination within 90 days prior to registration\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 90 days prior to registration\n* Detectable PSA after radical prostatectomy. Detectable PSA is defined as serum PSA \\> 0 ng/mL at least 30 days after prostatectomy\n* 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)\n* Hemoglobin \\>= 9.0 g/dL, independent of transfusion and/or growth factors (within 90 days prior to registration)\n* Platelet count \\>= 100,000 x 10\\^9/uL independent of transfusion and/or growth factors (within 90 days prior to registration)\n* Serum potassium \\>= 3.5 mmol/L within 90 days prior to registration\n* 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)\n* 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)\n* 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)\n* Serum albumin \\>= 3.0 g/dL (within 90 days prior to registration)\n* Discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to registration\n* 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\n* 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\n* 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\n* 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\n* 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)\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n\nExclusion Criteria:\n\n* 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)\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed (completed \\> 3 years prior to registration)\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Androgen deprivation therapy (ADT) prior to radical prostatectomy\n* 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\n* Current use of 5-alpha reductase inhibitor. NOTE: if the alpha reductase inhibitor is stopped prior to randomization the patient is eligible\n* History of any of the following:\n\n * 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)\n * 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\n * 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.)\n * History of any condition that in the opinion of the investigator, would preclude participation in this study\n* Current evidence of any of the following:\n\n * Known gastrointestinal disorder affecting absorption of oral medications\n * Active uncontrolled infection\n * 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\n * Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily\n * Baseline moderate and severe hepatic impairment (Child-Pugh Class B \\& C)\n * Inability to swallow oral pills\n * Any current condition that in the opinion of the investigator, would preclude participation in this study\n* Patients must not plan to participate in any other therapeutic clinical trials while receiving treatment on this study\n* Patients with inflammatory bowel disease"}, 'identificationModule': {'nctId': 'NCT04134260', 'briefTitle': 'Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial', 'organization': {'class': 'OTHER', 'fullName': 'NRG Oncology'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NRG-GU008'}, 'secondaryIdInfos': [{'id': 'NCI-2019-06838', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'NRG-GU008', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'NRG-GU008', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180868', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180868', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (hormone therapy, radiation therapy)', 'description': '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.', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (hormone therapy, radiation therapy, apalutamide)', 'description': '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.', 'interventionNames': ['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': [{'name': 'Apalutamide', 'type': 'DRUG', 'otherNames': ['ARN 509', 'ARN-509', 'ARN509', 'Erleada', 'JNJ 56021927', 'JNJ-56021927'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (hormone therapy, radiation therapy, apalutamide)']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Arm I (hormone therapy, radiation therapy)', 'Arm II (hormone therapy, radiation therapy, apalutamide)']}, {'name': 'Bone Scan', 'type': 'PROCEDURE', 'otherNames': ['Bone Scintigraphy'], 'description': 'Undergo bone scan', 'armGroupLabels': ['Arm I (hormone therapy, radiation therapy)', 'Arm II (hormone therapy, radiation therapy, apalutamide)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'tomography'], 'description': 'Undergo CT', 'armGroupLabels': ['Arm I (hormone therapy, radiation therapy)', 'Arm II (hormone therapy, radiation therapy, apalutamide)']}, {'name': 'Hormone Therapy', 'type': 'DRUG', 'otherNames': ['Chemotherapy-Hormones/Steroids', 'Endocrine Therapy', 'Hormonal', 'Hormonal Therapy', 'hormone treatment', 'Hormones'], 'description': 'Receive hormone therapy', 'armGroupLabels': ['Arm I (hormone therapy, radiation therapy)', 'Arm II (hormone therapy, radiation therapy, apalutamide)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['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'], 'description': 'Undergo MRI', 'armGroupLabels': ['Arm I (hormone therapy, radiation therapy)', 'Arm II (hormone therapy, radiation therapy, apalutamide)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron emission tomography (procedure)', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'PT'], 'description': 'Undergo PET', 'armGroupLabels': ['Arm I (hormone therapy, radiation therapy)', 'Arm II (hormone therapy, radiation therapy, apalutamide)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (hormone therapy, radiation therapy)', 'Arm II (hormone therapy, radiation therapy, apalutamide)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (hormone therapy, radiation therapy)', 'Arm II (hormone therapy, radiation therapy, apalutamide)']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Cancer Radiotherapy', 'Energy Type', 'ENERGY_TYPE', 'Irradiate', 'Irradiated', 'Irradiation', 'Radiation', 'Radiation Therapy, NOS', 'Radiotherapeutics', 'Radiotherapy', 'RT', 'Therapy, Radiation'], 'description': 'Undergo pelvis and prostate bed radiation therapy', 'armGroupLabels': ['Arm I (hormone therapy, radiation therapy)', 'Arm II (hormone therapy, radiation therapy, apalutamide)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'ResearchInstituteInquiries@CommonSpirit.org', 'phone': '720-874-1881'}, {'name': 'Shahzad Siddique', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cancer Center at Saint Joseph's", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '501-686-8274'}, {'name': 'Sanjay Maraboyina', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92806', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 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