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Prueba de la adición de docetaxel (quimioterapia) al tratamiento habitual (terapia hormonal y apalutamida) para el cáncer de próstata metastásico, ensayo Aspire

2 de noviembre de 2026 actualizado por: Alliance for Clinical Trials in Oncology

Adición de Docetaxel en cáncer de próstata sensible a la castración metastásica (Aspire)

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

PRIMARY OBJECTIVE:

I. To determine if the addition of docetaxel to androgen deprivation therapy and apalutamide improves overall survival for men with metastatic castrate sensitive prostate cancer.

SECONDARY OBJECTIVES:

I. To determine if the addition of docetaxel to androgen deprivation therapy and apalutamide improves overall survival for men whose cancers have loss or inactivating mutations of TP53, PTEN, or RB1.

II. To determine if the addition of docetaxel to ADT plus apalutamide improves the time to radiographic progression per Prostate Cancer Working Group 3 (PCWG3) guidelines.

III. To determine the time to castration-resistant prostate cancer (CRPC) between arms.

IV. To determine symptomatic skeletal event free survival (SSE-FS) between arms.

V. To determine the safety and tolerability of the triplet versus doublet using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

VI. To determine radiographic progression free survival (rPFS), and overall survival (OS) in patients by the stratification factors a) volume/timing of disease (metachronous high volume, synchronous high volume, and synchronous low volume metastases on conventional imaging) and b) tumor suppressor gene alteration status (0 versus [vs] 1 vs 2+) between arms.

VII. To determine prostate specific antigen (PSA) 90 response rate at 6 weeks and 6 months between arms.

VIII. To determine time to PSA progression by PCWG3 criteria between arms. IX. To determine objective response rate (ORR) in patients with measurable disease between arms.

EXPLORATORY OBJECTIVES:

I. To determine the time to worsening of physical symptoms of disease based on functional assessment of cancer therapy/National Comprehensive Cancer Network prostate cancer symptom index 17 item questionnaire (NCCN-FACT FPSI-17) between arms.

II. To compare quality of life as measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) trial outcome index in patients with metastatic castrate-sensitive prostate cancer (mCSPC) who receive ADT + apalutamide + docetaxel vs ADT + apalutamide at the 24-month time point.

III. To compare quality of life as measured by other scales of the FACT-P in the two arms.

IV. To compare quality of life as measured by FACT-P total outcome index in the two arms at other timepoints.

V. To compare pain severity and interference as measured by the Brief Pain Inventory Short Form (BPI-SF) in the two arms.

VI. To compare quality-adjusted life years which accounts for survival and utility (measured by European Quality of Life Five Dimension Five Level Scale [EQ-5D-5L]) in the two arms.

VII. To correlate baseline volume of disease on prostate-specific membrane antigen-positron emission tomography/computed tomography (PSMA-PET/CT) with baseline volume of disease on conventional imaging (CI).

VIII. To determine if baseline PSMA-PET/CT and CI are individually and jointly associated with OS, progression-free survival (PFS), PSA90 response, and PSA < 0.2 ng/ml after 6 months, and to estimate its clinical relevance when compared to these well characterized prognostic endpoints.

IX. To correlate 6-month PSA level with the presence/absence and volume of residual disease on PSMA-PET/CT after 6 months of doublet or triplet therapy.

X. To correlate the concordance of radiographic progression on CI versus PSMA-PET/CT at the time of PSA progression.

XI. To determine rPFS, time to castration resistance, OS based on thresholds of volume of disease, and prostate-specific membrane antigen (PSMA) uptake (standardized uptake value [SUV]) based on baseline PSMA-PET/CT scan.

XII. To compare rPFS, time to castration resistance, and OS between arms in patients with de novo metastatic disease having received primary directed radiation therapy.

XIII. To determine rPFS, time to castration resistance, and OS correlation with PSA response at 6 weeks and 6 months.

XIV. To compare the impact of treatment on aging trajectory, as measured by the change in Deficit-Accumulation Frailty Index (DAFI) from baseline, 6- and 12-months, in the two arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive ADT at the discretion of the investigator and apalutamide orally (PO) once daily (QD). Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) and bone scan throughout the study. Patients may optionally undergo prostate-specific membrane antigen-positron emission tomography (PSMA-PET) scans and blood sample collection throughout the study.

ARM 2: Patients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel intravenously (IV) over 1 hour every 21 days for up to 6 doses. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 6 months for up to 10 years.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1260

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • Arizona
      • Tucson, Arizona, Estados Unidos, 85719
        • Reclutamiento
        • Banner University Medical Center - Tucson
        • Contacto:
        • Investigador principal:
          • Edward P. Gelmann
      • Tucson, Arizona, Estados Unidos, 85719
        • Reclutamiento
        • University of Arizona Cancer Center-North Campus
        • Contacto:
        • Investigador principal:
          • Edward P. Gelmann
    • California
      • Dublin, California, Estados Unidos, 94568
        • Reclutamiento
        • Kaiser Permanente Dublin
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
      • Fremont, California, Estados Unidos, 94538
        • Reclutamiento
        • Kaiser Permanente-Fremont
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • Fresno, California, Estados Unidos, 93720
        • Reclutamiento
        • Kaiser Permanente Fresno Orchard Plaza
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 833-574-2273
      • La Jolla, California, Estados Unidos, 92093
        • Reclutamiento
        • UC San Diego Moores Cancer Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 858-822-5354
          • Correo electrónico: cancercto@ucsd.edu
        • Investigador principal:
          • Yu-Wei Chen
      • Modesto, California, Estados Unidos, 95356
        • Reclutamiento
        • Kaiser Permanente-Modesto
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • Modesto, California, Estados Unidos, 95356
        • Reclutamiento
        • Kaiser Permanente- Modesto MOB II
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
      • Oakland, California, Estados Unidos, 94611
        • Reclutamiento
        • Kaiser Permanente-Oakland
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • Rancho Mirage, California, Estados Unidos, 92270
        • Reclutamiento
        • Eisenhower Medical Center
        • Investigador principal:
          • Delshad Ahmad
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 760-834-3798
      • Roseville, California, Estados Unidos, 95661
        • Reclutamiento
        • Kaiser Permanente-Roseville
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • Sacramento, California, Estados Unidos, 95814
        • Reclutamiento
        • Kaiser Permanente Downtown Commons
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: kpoct@kp.org
      • Sacramento, California, Estados Unidos, 95823
        • Reclutamiento
        • Kaiser Permanente-South Sacramento
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • San Diego, California, Estados Unidos, 92103
        • Reclutamiento
        • UC San Diego Medical Center - Hillcrest
        • Contacto:
        • Investigador principal:
          • Yu-Wei Chen
      • San Francisco, California, Estados Unidos, 94115
        • Reclutamiento
        • Kaiser Permanente-San Francisco
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • San Jose, California, Estados Unidos, 95119
        • Reclutamiento
        • Kaiser Permanente-Santa Teresa-San Jose
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • San Leandro, California, Estados Unidos, 94577
        • Reclutamiento
        • Kaiser Permanente San Leandro
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • San Rafael, California, Estados Unidos, 94903
        • Reclutamiento
        • Kaiser San Rafael-Gallinas
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • Santa Clara, California, Estados Unidos, 95051
        • Reclutamiento
        • Kaiser Permanente Medical Center - Santa Clara
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • Santa Rosa, California, Estados Unidos, 95403
        • Reclutamiento
        • Kaiser Permanente-Santa Rosa
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • South San Francisco, California, Estados Unidos, 94080
        • Reclutamiento
        • Kaiser Permanente-South San Francisco
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • Vallejo, California, Estados Unidos, 94589
        • Reclutamiento
        • Kaiser Permanente-Vallejo
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
      • Walnut Creek, California, Estados Unidos, 94596
        • Reclutamiento
        • Kaiser Permanente-Walnut Creek
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Reclutamiento
        • Rocky Mountain Regional VA Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 888-336-8262
        • Investigador principal:
          • Jessica D. McDermott
      • Denver, Colorado, Estados Unidos, 80205
        • Reclutamiento
        • Kaiser Permanente-Franklin
        • Investigador principal:
          • Matthew J. Eadens
        • Contacto:
      • Edwards, Colorado, Estados Unidos, 81632
        • Reclutamiento
        • Shaw Cancer Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 970-569-7429
        • Investigador principal:
          • Erin Schwab
      • Grand Junction, Colorado, Estados Unidos, 81501
        • Reclutamiento
        • Saint Mary's Hospital and Regional Medical Center
        • Contacto:
        • Investigador principal:
          • Wallace Jones
      • Lafayette, Colorado, Estados Unidos, 80026
        • Reclutamiento
        • Kaiser Permanente-Rock Creek
        • Investigador principal:
          • Matthew J. Eadens
        • Contacto:
      • Lone Tree, Colorado, Estados Unidos, 80124
        • Reclutamiento
        • Kaiser Permanente-Lone Tree
        • Investigador principal:
          • Matthew J. Eadens
        • Contacto:
    • Delaware
      • Dover, Delaware, Estados Unidos, 19901
        • Activo, no reclutando
        • Bayhealth Hospital Kent Campus
      • Milford, Delaware, Estados Unidos, 19963
        • Activo, no reclutando
        • Bayhealth Hospital Sussex Campus
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20007
        • Reclutamiento
        • MedStar Georgetown University Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 202-444-2223
        • Investigador principal:
          • Suthee Rapisuwon
      • Washington D.C., District of Columbia, Estados Unidos, 20010
        • Reclutamiento
        • MedStar Washington Hospital Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 202-877-8839
        • Investigador principal:
          • Suthee Rapisuwon
    • Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • Reclutamiento
        • Malcom Randall Veterans Administration Medical Center
        • Contacto:
        • Investigador principal:
          • Jess DeLaune
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30342
        • Reclutamiento
        • Northside Hospital
        • Contacto:
        • Investigador principal:
          • Shailesh R. Satpute
      • Duluth, Georgia, Estados Unidos, 30096
        • Reclutamiento
        • Northside Hospital - Duluth
        • Contacto:
        • Investigador principal:
          • Shailesh R. Satpute
      • Lawrenceville, Georgia, Estados Unidos, 30046
        • Reclutamiento
        • Northside Hospital - Gwinnett
        • Contacto:
        • Investigador principal:
          • Shailesh R. Satpute
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96819
        • Reclutamiento
        • Kaiser Permanente Moanalua Medical Center
        • Investigador principal:
          • Andrea L. Harzstark
        • Contacto:
    • Idaho
      • Boise, Idaho, Estados Unidos, 83712
        • Reclutamiento
        • Saint Luke's Cancer Institute - Boise
        • Investigador principal:
          • Alison K. Conlin
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 208-381-2774
          • Correo electrónico: eslinget@slhs.org
      • Coeur d'Alene, Idaho, Estados Unidos, 83814
        • Reclutamiento
        • Kootenai Health - Coeur d'Alene
        • Investigador principal:
          • John M. Schallenkamp
        • Contacto:
      • Fruitland, Idaho, Estados Unidos, 83619
        • Reclutamiento
        • Saint Luke's Cancer Institute - Fruitland
        • Investigador principal:
          • Alison K. Conlin
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 208-381-2774
          • Correo electrónico: eslinget@slhs.org
      • Meridian, Idaho, Estados Unidos, 83642
        • Reclutamiento
        • Saint Luke's Cancer Institute - Meridian
        • Investigador principal:
          • Alison K. Conlin
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 208-381-2774
          • Correo electrónico: eslinget@slhs.org
      • Nampa, Idaho, Estados Unidos, 83687
        • Reclutamiento
        • Saint Luke's Cancer Institute - Nampa
        • Investigador principal:
          • Alison K. Conlin
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 208-381-2774
          • Correo electrónico: eslinget@slhs.org
      • Post Falls, Idaho, Estados Unidos, 83854
        • Reclutamiento
        • Kootenai Clinic Cancer Services - Post Falls
        • Investigador principal:
          • John M. Schallenkamp
        • Contacto:
      • Sandpoint, Idaho, Estados Unidos, 83864
        • Reclutamiento
        • Kootenai Clinic Cancer Services - Sandpoint
        • Investigador principal:
          • John M. Schallenkamp
        • Contacto:
    • Illinois
      • Bloomington, Illinois, Estados Unidos, 61704
        • Reclutamiento
        • Illinois CancerCare-Bloomington
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
      • Canton, Illinois, Estados Unidos, 61520
        • Reclutamiento
        • Illinois CancerCare-Canton
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
      • Carthage, Illinois, Estados Unidos, 62321
        • Reclutamiento
        • Illinois CancerCare-Carthage
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
      • Centralia, Illinois, Estados Unidos, 62801
        • Reclutamiento
        • Centralia Oncology Clinic
        • Investigador principal:
          • Bryan A. Faller
        • Contacto:
      • Chicago, Illinois, Estados Unidos, 60612
        • Reclutamiento
        • University of Illinois
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 312-355-3046
        • Investigador principal:
          • Karine Tawagi
      • Chicago, Illinois, Estados Unidos, 60612
        • Reclutamiento
        • Rush MD Anderson Cancer Center
        • Investigador principal:
          • Manan Shah
        • Contacto:
      • Danville, Illinois, Estados Unidos, 61832
        • Reclutamiento
        • Carle at The Riverfront
        • Investigador principal:
          • Kendrith M. Rowland
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 800-446-5532
          • Correo electrónico: Research@Carle.com
      • Decatur, Illinois, Estados Unidos, 62526
        • Reclutamiento
        • Cancer Care Specialists of Illinois - Decatur
        • Investigador principal:
          • Bryan A. Faller
        • Contacto:
      • Decatur, Illinois, Estados Unidos, 62526
        • Reclutamiento
        • Decatur Memorial Hospital
        • Investigador principal:
          • Bryan A. Faller
        • Contacto:
      • Dixon, Illinois, Estados Unidos, 61021
        • Reclutamiento
        • Illinois CancerCare-Dixon
        • Investigador principal:
          • Bryan A. Faller
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 815-285-7800
      • Effingham, Illinois, Estados Unidos, 62401
        • Reclutamiento
        • Carle Physician Group-Effingham
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 800-446-5532
          • Correo electrónico: Research@carle.com
        • Investigador principal:
          • Kendrith M. Rowland
      • Effingham, Illinois, Estados Unidos, 62401
        • Reclutamiento
        • Crossroads Cancer Center
        • Investigador principal:
          • Bryan A. Faller
        • Contacto:
      • Eureka, Illinois, Estados Unidos, 61530
        • Reclutamiento
        • Illinois CancerCare-Eureka
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
      • Galesburg, Illinois, Estados Unidos, 61401
        • Reclutamiento
        • Illinois CancerCare-Galesburg
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
      • Hines, Illinois, Estados Unidos, 60141
        • Reclutamiento
        • Edward Hines Jr VA Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 708-202-8387
        • Investigador principal:
          • Elizabeth Henry
      • Kewanee, Illinois, Estados Unidos, 61443
        • Reclutamiento
        • Illinois CancerCare-Kewanee Clinic
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
      • Macomb, Illinois, Estados Unidos, 61455
        • Reclutamiento
        • Illinois CancerCare-Macomb
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
      • Mattoon, Illinois, Estados Unidos, 61938
        • Reclutamiento
        • Carle Physician Group-Mattoon/Charleston
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 800-446-5532
          • Correo electrónico: Research@carle.com
        • Investigador principal:
          • Kendrith M. Rowland
      • Mount Vernon, Illinois, Estados Unidos, 62864
        • Reclutamiento
        • SSM Health Good Samaritan
        • Investigador principal:
          • Jay W. Carlson
        • Contacto:
      • Normal, Illinois, Estados Unidos, 61761
        • Reclutamiento
        • Carle BroMenn Medical Center
        • Investigador principal:
          • Kendrith M. Rowland
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 800-446-5532
          • Correo electrónico: Research@Carle.com
      • Normal, Illinois, Estados Unidos, 61761
        • Reclutamiento
        • Carle Cancer Institute Normal
        • Investigador principal:
          • Kendrith M. Rowland
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 800-446-5532
          • Correo electrónico: Research@Carle.com
      • O'Fallon, Illinois, Estados Unidos, 62269
        • Reclutamiento
        • Cancer Care Center of O'Fallon
        • Investigador principal:
          • Bryan A. Faller
        • Contacto:
      • O'Fallon, Illinois, Estados Unidos, 62269
        • Reclutamiento
        • HSHS Saint Elizabeth's Hospital
        • Investigador principal:
          • Bryan A. Faller
        • Contacto:
      • Ottawa, Illinois, Estados Unidos, 61350
        • Reclutamiento
        • Illinois CancerCare-Ottawa Clinic
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
      • Pekin, Illinois, Estados Unidos, 61554
        • Reclutamiento
        • Illinois CancerCare-Pekin
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
      • Peoria, Illinois, Estados Unidos, 61615
        • Reclutamiento
        • Illinois CancerCare-Peoria
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
      • Peru, Illinois, Estados Unidos, 61354
        • Reclutamiento
        • Illinois CancerCare-Peru
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
      • Princeton, Illinois, Estados Unidos, 61356
        • Reclutamiento
        • Illinois CancerCare-Princeton
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
      • Shiloh, Illinois, Estados Unidos, 62269
        • Reclutamiento
        • Memorial Hospital East
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 314-747-9912
          • Correo electrónico: dschwab@wustl.edu
        • Investigador principal:
          • Eric M. Knoche
      • Springfield, Illinois, Estados Unidos, 62702
        • Reclutamiento
        • Southern Illinois University School of Medicine
        • Investigador principal:
          • Bryan A. Faller
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 217-545-7929
      • Springfield, Illinois, Estados Unidos, 62702
        • Reclutamiento
        • Springfield Clinic
        • Investigador principal:
          • Bryan A. Faller
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 800-444-7541
      • Springfield, Illinois, Estados Unidos, 62781
        • Reclutamiento
        • Springfield Memorial Hospital
        • Investigador principal:
          • Bryan A. Faller
        • Contacto:
      • Urbana, Illinois, Estados Unidos, 61801
        • Reclutamiento
        • Carle Cancer Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 800-446-5532
          • Correo electrónico: Research@carle.com
        • Investigador principal:
          • Kendrith M. Rowland
      • Washington, Illinois, Estados Unidos, 61571
        • Reclutamiento
        • Illinois CancerCare - Washington
        • Contacto:
        • Investigador principal:
          • Bryan A. Faller
    • Iowa
      • Ames, Iowa, Estados Unidos, 50010
        • Reclutamiento
        • Mary Greeley Medical Center
        • Investigador principal:
          • Joseph J. Merchant
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 515-956-4132
      • Ames, Iowa, Estados Unidos, 50010
        • Reclutamiento
        • McFarland Clinic - Ames
        • Investigador principal:
          • Joseph J. Merchant
        • Contacto:
      • Boone, Iowa, Estados Unidos, 50036
        • Suspendido
        • McFarland Clinic - Boone
      • Cedar Rapids, Iowa, Estados Unidos, 52403
        • Reclutamiento
        • Mercy Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 319-365-4673
        • Investigador principal:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, Estados Unidos, 52403
        • Reclutamiento
        • Oncology Associates at Mercy Medical Center
        • Investigador principal:
          • Deborah W. Wilbur
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 319-363-2690
      • Fort Dodge, Iowa, Estados Unidos, 50501
        • Reclutamiento
        • McFarland Clinic - Trinity Cancer Center
        • Investigador principal:
          • Joseph J. Merchant
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 515-956-4132
      • Jefferson, Iowa, Estados Unidos, 50129
        • Suspendido
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Estados Unidos, 50158
        • Reclutamiento
        • McFarland Clinic - Marshalltown
        • Investigador principal:
          • Joseph J. Merchant
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 515-956-4132
    • Kansas
      • Hays, Kansas, Estados Unidos, 67601
        • Reclutamiento
        • HaysMed
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 785-623-5774
        • Investigador principal:
          • Elizabeth M. Wulff
      • Lawrence, Kansas, Estados Unidos, 66044
        • Reclutamiento
        • Lawrence Memorial Hospital
        • Contacto:
        • Investigador principal:
          • Elizabeth M. Wulff
      • Olathe, Kansas, Estados Unidos, 66061
        • Reclutamiento
        • The University of Kansas Cancer Center - Olathe
        • Contacto:
        • Investigador principal:
          • Elizabeth M. Wulff
      • Overland Park, Kansas, Estados Unidos, 66210
        • Reclutamiento
        • University of Kansas Cancer Center-Overland Park
        • Contacto:
        • Investigador principal:
          • Elizabeth M. Wulff
      • Salina, Kansas, Estados Unidos, 67401
        • Reclutamiento
        • Salina Regional Health Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 785-452-7038
          • Correo electrónico: mleepers@srhc.com
        • Investigador principal:
          • Elizabeth M. Wulff
      • Topeka, Kansas, Estados Unidos, 66606
        • Reclutamiento
        • University of Kansas Health System Saint Francis Campus
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 785-295-8000
        • Investigador principal:
          • Elizabeth M. Wulff
      • Westwood, Kansas, Estados Unidos, 66205
        • Reclutamiento
        • University of Kansas Hospital-Westwood Cancer Center
        • Contacto:
        • Investigador principal:
          • Elizabeth M. Wulff
    • Michigan
      • Brighton, Michigan, Estados Unidos, 48114
        • Reclutamiento
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contacto:
        • Investigador principal:
          • Christopher M. Reynolds
      • Canton, Michigan, Estados Unidos, 48188
        • Reclutamiento
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contacto:
        • Investigador principal:
          • Christopher M. Reynolds
      • Chelsea, Michigan, Estados Unidos, 48118
        • Reclutamiento
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contacto:
        • Investigador principal:
          • Christopher M. Reynolds
      • Escanaba, Michigan, Estados Unidos, 49829
        • Reclutamiento
        • OSF Saint Francis Hospital and Medical Group
        • Investigador principal:
          • Anthony J. Jaslowski
        • Contacto:
      • Flint, Michigan, Estados Unidos, 48503
        • Reclutamiento
        • Genesys Hurley Cancer Institute
        • Investigador principal:
          • Christopher M. Reynolds
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 810-762-8038
          • Correo electrónico: wstrong@ghci.org
      • Flint, Michigan, Estados Unidos, 48503
        • Reclutamiento
        • Hurley Medical Center
        • Investigador principal:
          • Christopher M. Reynolds
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 810-762-8038
          • Correo electrónico: wstrong@ghci.org
      • Flint, Michigan, Estados Unidos, 48503
        • Reclutamiento
        • Cancer Hematology Centers - Flint
        • Investigador principal:
          • Christopher M. Reynolds
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 810-762-8038
          • Correo electrónico: wstrong@ghci.org
      • Lansing, Michigan, Estados Unidos, 48912
        • Reclutamiento
        • University of Michigan Health - Sparrow Lansing
        • Investigador principal:
          • Christopher M. Reynolds
        • Contacto:
      • Livonia, Michigan, Estados Unidos, 48154
        • Reclutamiento
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contacto:
        • Investigador principal:
          • Christopher M. Reynolds
      • Pontiac, Michigan, Estados Unidos, 48341
        • Reclutamiento
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contacto:
        • Investigador principal:
          • Christopher M. Reynolds
      • Ypsilanti, Michigan, Estados Unidos, 48197
        • Reclutamiento
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contacto:
        • Investigador principal:
          • Christopher M. Reynolds
    • Minnesota
      • Bemidji, Minnesota, Estados Unidos, 56601
      • Saint Cloud, Minnesota, Estados Unidos, 56303
        • Reclutamiento
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contacto:
        • Investigador principal:
          • Donald J. Jurgens
    • Missouri
      • Cape Girardeau, Missouri, Estados Unidos, 63703
        • Reclutamiento
        • Saint Francis Medical Center
        • Investigador principal:
          • Bryan A. Faller
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 573-334-2230
          • Correo electrónico: sfmc@sfmc.net
      • City of Saint Peters, Missouri, Estados Unidos, 63376
        • Reclutamiento
        • Siteman Cancer Center at Saint Peters Hospital
        • Contacto:
        • Investigador principal:
          • Eric M. Knoche
      • Creve Coeur, Missouri, Estados Unidos, 63141
        • Reclutamiento
        • Siteman Cancer Center at West County Hospital
        • Contacto:
        • Investigador principal:
          • Eric M. Knoche
      • Kansas City, Missouri, Estados Unidos, 64154
        • Reclutamiento
        • University of Kansas Cancer Center - North
        • Contacto:
        • Investigador principal:
          • Elizabeth M. Wulff
      • Kansas City, Missouri, Estados Unidos, 64108
        • Reclutamiento
        • University Health Truman Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 816-404-4375
        • Investigador principal:
          • Elizabeth M. Wulff
      • Kansas City, Missouri, Estados Unidos, 64116
        • Reclutamiento
        • University of Kansas Cancer Center - Briarcliff
        • Investigador principal:
          • Elizabeth M. Wulff
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 913-588-3671
      • Lee's Summit, Missouri, Estados Unidos, 64064
        • Reclutamiento
        • University of Kansas Cancer Center - Lee's Summit
        • Contacto:
        • Investigador principal:
          • Elizabeth M. Wulff
      • St Louis, Missouri, Estados Unidos, 63110
        • Reclutamiento
        • Washington University School of Medicine
        • Contacto:
        • Investigador principal:
          • Eric M. Knoche
      • St Louis, Missouri, Estados Unidos, 63128
        • Reclutamiento
        • Mercy Hospital South
        • Investigador principal:
          • Jay W. Carlson
        • Contacto:
      • St Louis, Missouri, Estados Unidos, 63141
        • Reclutamiento
        • Mercy Hospital Saint Louis
        • Investigador principal:
          • Jay W. Carlson
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 314-251-7066
      • St Louis, Missouri, Estados Unidos, 63129
        • Reclutamiento
        • Siteman Cancer Center-South County
        • Contacto:
        • Investigador principal:
          • Eric M. Knoche
      • St Louis, Missouri, Estados Unidos, 63136
        • Reclutamiento
        • Siteman Cancer Center at Christian Hospital
        • Contacto:
        • Investigador principal:
          • Eric M. Knoche
      • St Louis, Missouri, Estados Unidos, 63125
        • Reclutamiento
        • Veteran's Affairs Medical Center - Saint Louis
        • Contacto:
        • Investigador principal:
          • Eric M. Knoche
    • Montana
      • Anaconda, Montana, Estados Unidos, 59711
        • Reclutamiento
        • Community Hospital of Anaconda
        • Investigador principal:
          • John M. Schallenkamp
        • Contacto:
      • Billings, Montana, Estados Unidos, 59101
        • Reclutamiento
        • Billings Clinic Cancer Center
        • Investigador principal:
          • John M. Schallenkamp
        • Contacto:
      • Billings, Montana, Estados Unidos, 59102
        • Reclutamiento
        • Saint Vincent Frontier Cancer Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 800-648-6274
        • Investigador principal:
          • Wallace Jones
      • Bozeman, Montana, Estados Unidos, 59715
        • Reclutamiento
        • Bozeman Health Deaconess Hospital
        • Investigador principal:
          • John M. Schallenkamp
        • Contacto:
      • Great Falls, Montana, Estados Unidos, 59405
        • Reclutamiento
        • Benefis Sletten Cancer Institute
        • Investigador principal:
          • John M. Schallenkamp
        • Contacto:
      • Kalispell, Montana, Estados Unidos, 59901
        • Reclutamiento
        • Logan Health Medical Center
        • Investigador principal:
          • John M. Schallenkamp
        • Contacto:
      • Missoula, Montana, Estados Unidos, 59804
        • Reclutamiento
        • Community Medical Center
        • Investigador principal:
          • John M. Schallenkamp
        • Contacto:
    • New Jersey
      • Basking Ridge, New Jersey, Estados Unidos, 07920
        • Reclutamiento
        • Memorial Sloan Kettering Basking Ridge
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 212-639-7592
        • Investigador principal:
          • Kristine P. Lacuna
      • Cherry Hill, New Jersey, Estados Unidos, 08002
        • Reclutamiento
        • Jefferson Cherry Hill Hospital
        • Contacto:
        • Investigador principal:
          • Kevin K. Zarrabi
      • Middletown, New Jersey, Estados Unidos, 07748
        • Reclutamiento
        • Memorial Sloan Kettering Monmouth
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 212-639-7592
        • Investigador principal:
          • Kristine P. Lacuna
      • Montvale, New Jersey, Estados Unidos, 07645
        • Reclutamiento
        • Memorial Sloan Kettering Bergen
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 212-639-7592
        • Investigador principal:
          • Kristine P. Lacuna
      • Sewell, New Jersey, Estados Unidos, 08080
        • Reclutamiento
        • Sidney Kimmel Cancer Center Washington Township
        • Contacto:
        • Investigador principal:
          • Kevin K. Zarrabi
    • New York
      • Buffalo, New York, Estados Unidos, 14263
        • Reclutamiento
        • Roswell Park Cancer Institute
        • Contacto:
        • Investigador principal:
          • Ellis G. Levine
      • Commack, New York, Estados Unidos, 11725
        • Reclutamiento
        • Memorial Sloan Kettering Commack
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 212-639-7592
        • Investigador principal:
          • Kristine P. Lacuna
      • Cortland, New York, Estados Unidos, 13045
        • Reclutamiento
        • Guthrie Cortland Memorial Hospital
        • Investigador principal:
          • Alina Basnet
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 607-756-3130
      • Harrison, New York, Estados Unidos, 10604
        • Reclutamiento
        • Memorial Sloan Kettering Westchester
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 212-639-7592
        • Investigador principal:
          • Kristine P. Lacuna
      • New York, New York, Estados Unidos, 10065
        • Reclutamiento
        • Memorial Sloan Kettering Cancer Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 212-639-7592
        • Investigador principal:
          • Kristine P. Lacuna
      • New York, New York, Estados Unidos, 10029
        • Reclutamiento
        • Mount Sinai Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 212-824-7309
          • Correo electrónico: CCTO@mssm.edu
        • Investigador principal:
          • Eric J. Miller
      • Stony Brook, New York, Estados Unidos, 11794
        • Reclutamiento
        • Stony Brook University Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 800-862-2215
        • Investigador principal:
          • Judy Huang
      • Uniondale, New York, Estados Unidos, 11553
        • Reclutamiento
        • Memorial Sloan Kettering Nassau
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 212-639-7592
        • Investigador principal:
          • Kristine P. Lacuna
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Reclutamiento
        • Duke University Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 888-275-3853
        • Investigador principal:
          • Hannah D. McManus
      • Durham, North Carolina, Estados Unidos, 27705
        • Reclutamiento
        • Durham VA Medical Center
        • Contacto:
        • Investigador principal:
          • Rhonda L. Bitting
      • Pinehurst, North Carolina, Estados Unidos, 28374
        • Reclutamiento
        • FirstHealth of the Carolinas-Moore Regional Hospital
        • Contacto:
        • Investigador principal:
          • Charles S. Kuzma
    • North Dakota
      • Bismarck, North Dakota, Estados Unidos, 58501
      • Fargo, North Dakota, Estados Unidos, 58122
      • Fargo, North Dakota, Estados Unidos, 58122
    • Ohio
      • Canton, Ohio, Estados Unidos, 44710
        • Reclutamiento
        • Aultman Health Foundation
        • Contacto:
        • Investigador principal:
          • Mehool A. Patel
      • Columbus, Ohio, Estados Unidos, 43210
        • Reclutamiento
        • Ohio State University Comprehensive Cancer Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 800-293-5066
          • Correo electrónico: Jamesline@osumc.edu
        • Investigador principal:
          • Lingbin Meng
      • Sylvania, Ohio, Estados Unidos, 43560
        • Reclutamiento
        • ProMedica Flower Hospital
        • Contacto:
        • Investigador principal:
          • Jeffrey H. Muler
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Reclutamiento
        • University of Oklahoma Health Sciences Center
        • Contacto:
        • Investigador principal:
          • Adanma Anji Ayanambakkam Attanathi
    • Pennsylvania
      • Erie, Pennsylvania, Estados Unidos, 16544
        • Reclutamiento
        • Saint Vincent Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 814-452-5000
        • Investigador principal:
          • Shifeng S. Mao
      • Jefferson Hills, Pennsylvania, Estados Unidos, 15025
        • Reclutamiento
        • Jefferson Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 412-359-3043
          • Correo electrónico: ddefazio@wpahs.org
        • Investigador principal:
          • Shifeng S. Mao
      • Monroeville, Pennsylvania, Estados Unidos, 15146
        • Reclutamiento
        • Forbes Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 412-858-7746
        • Investigador principal:
          • Shifeng S. Mao
      • Natrona Heights, Pennsylvania, Estados Unidos, 15065
        • Reclutamiento
        • Allegheny Valley Hospital
        • Contacto:
        • Investigador principal:
          • Shifeng S. Mao
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Reclutamiento
        • Thomas Jefferson University Hospital
        • Contacto:
        • Investigador principal:
          • Kevin K. Zarrabi
      • Philadelphia, Pennsylvania, Estados Unidos, 19148
        • Suspendido
        • Jefferson Methodist Hospital
      • Philadelphia, Pennsylvania, Estados Unidos, 19114
        • Reclutamiento
        • Jefferson Torresdale Hospital
        • Contacto:
        • Investigador principal:
          • Kevin K. Zarrabi
      • Pittsburgh, Pennsylvania, Estados Unidos, 15224
        • Reclutamiento
        • West Penn Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 412-578-5000
        • Investigador principal:
          • Shifeng S. Mao
      • Pittsburgh, Pennsylvania, Estados Unidos, 15212
        • Reclutamiento
        • Allegheny General Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-284-2000
        • Investigador principal:
          • Shifeng S. Mao
      • Sayre, Pennsylvania, Estados Unidos, 18840
        • Reclutamiento
        • Guthrie Medical Group PC-Robert Packer Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 800-836-0388
        • Investigador principal:
          • Joyson Poulose
      • Wexford, Pennsylvania, Estados Unidos, 15090
        • Reclutamiento
        • Wexford Health and Wellness Pavilion
        • Contacto:
        • Investigador principal:
          • Shifeng S. Mao
      • Willow Grove, Pennsylvania, Estados Unidos, 19090
        • Reclutamiento
        • Asplundh Cancer Pavilion
        • Contacto:
        • Investigador principal:
          • Kevin K. Zarrabi
    • South Carolina
      • Greenville, South Carolina, Estados Unidos, 29601
        • Reclutamiento
        • Saint Francis Hospital
        • Investigador principal:
          • Stephen H. Dyar
        • Contacto:
      • Greenville, South Carolina, Estados Unidos, 29607
        • Reclutamiento
        • Saint Francis Cancer Center
        • Investigador principal:
          • Stephen H. Dyar
        • Contacto:
      • Greenwood, South Carolina, Estados Unidos, 29646
        • Reclutamiento
        • Self Regional Healthcare
        • Contacto:
        • Investigador principal:
          • Albert C. Lockhart
    • South Dakota
      • Rapid City, South Dakota, Estados Unidos, 57701
        • Activo, no reclutando
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Estados Unidos, 57104
        • Reclutamiento
        • Sanford Cancer Center Oncology Clinic
        • Investigador principal:
          • Daniel Almquist
        • Contacto:
      • Sioux Falls, South Dakota, Estados Unidos, 57117-5134
        • Reclutamiento
        • Sanford USD Medical Center - Sioux Falls
        • Investigador principal:
          • Daniel Almquist
        • Contacto:
    • Texas
      • Dallas, Texas, Estados Unidos, 75390
        • Reclutamiento
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contacto:
        • Investigador principal:
          • Qian Qin
      • Dallas, Texas, Estados Unidos, 75237
        • Reclutamiento
        • UT Southwestern Simmons Cancer Center - RedBird
        • Investigador principal:
          • Qian Qin
        • Contacto:
      • Fort Worth, Texas, Estados Unidos, 76104
        • Reclutamiento
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Contacto:
        • Investigador principal:
          • Qian Qin
      • Richardson, Texas, Estados Unidos, 75080
        • Reclutamiento
        • UT Southwestern Clinical Center at Richardson/Plano
        • Contacto:
        • Investigador principal:
          • Qian Qin
    • Utah
      • Murray, Utah, Estados Unidos, 84107
        • Reclutamiento
        • Intermountain Medical Center
        • Contacto:
        • Investigador principal:
          • Wallace Jones
      • Ogden, Utah, Estados Unidos, 84403
        • Reclutamiento
        • McKay-Dee Hospital Center
        • Contacto:
        • Investigador principal:
          • Wallace Jones
      • Salt Lake City, Utah, Estados Unidos, 84143
        • Reclutamiento
        • LDS Hospital
        • Contacto:
        • Investigador principal:
          • Wallace Jones
      • Sandy City, Utah, Estados Unidos, 84094
        • Reclutamiento
        • Intermountain Health Alta View Hospital
        • Investigador principal:
          • Wallace Jones
        • Contacto:
      • St. George, Utah, Estados Unidos, 84770
        • Reclutamiento
        • Saint George Regional Medical Center
        • Contacto:
        • Investigador principal:
          • Wallace Jones
    • Vermont
      • Berlin Corners, Vermont, Estados Unidos, 05602
        • Reclutamiento
        • Central Vermont Medical Center/National Life Cancer Treatment
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 802-225-5400
        • Investigador principal:
          • Rahul Anil
      • Burlington, Vermont, Estados Unidos, 05401
        • Reclutamiento
        • University of Vermont Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 802-656-4101
          • Correo electrónico: rpo@uvm.edu
        • Investigador principal:
          • Rahul Anil
      • Burlington, Vermont, Estados Unidos, 05405
        • Reclutamiento
        • University of Vermont and State Agricultural College
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 802-656-8990
          • Correo electrónico: rpo@uvm.edu
        • Investigador principal:
          • Rahul Anil
    • Virginia
      • Fredericksburg, Virginia, Estados Unidos, 22408
        • Reclutamiento
        • Hematology Oncology Associates of Fredericksburg Inc
        • Contacto:
        • Investigador principal:
          • Asit K. Paul
      • Richmond, Virginia, Estados Unidos, 23235
        • Reclutamiento
        • VCU Massey Cancer Center at Stony Point
        • Contacto:
        • Investigador principal:
          • Asit K. Paul
      • Richmond, Virginia, Estados Unidos, 23298
        • Reclutamiento
        • VCU Massey Comprehensive Cancer Center
        • Investigador principal:
          • Asit K. Paul
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 804-628-6430
          • Correo electrónico: CTOclinops@vcu.edu
      • Tappahannock, Virginia, Estados Unidos, 22560
        • Reclutamiento
        • VCU Health Tappahannock Hospital
        • Investigador principal:
          • Asit K. Paul
        • Contacto:
    • West Virginia
      • Charleston, West Virginia, Estados Unidos, 25304
        • Reclutamiento
        • Vandalia Health/CAMC Institute for Academic Medicine
        • Investigador principal:
          • Kok Hoe Chan
        • Contacto:
    • Wisconsin
      • Antigo, Wisconsin, Estados Unidos, 54409
        • Reclutamiento
        • Aspirus Cancer Care-Antigo-Volm Cancer Center
        • Contacto:
        • Investigador principal:
          • Andrew J. Huang
      • Appleton, Wisconsin, Estados Unidos, 54911
        • Reclutamiento
        • ThedaCare Regional Cancer Center
        • Contacto:
        • Investigador principal:
          • Joyce Philip
      • Appleton, Wisconsin, Estados Unidos, 54915
        • Reclutamiento
        • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
        • Investigador principal:
          • Kamal Kant Singh Abbi
        • Contacto:
      • Brookfield, Wisconsin, Estados Unidos, 53045
        • Reclutamiento
        • Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
        • Investigador principal:
          • Kamal Kant Singh Abbi
        • Contacto:
      • Chilton, Wisconsin, Estados Unidos, 53014
        • Reclutamiento
        • Ascension Calumet Hospital-Chilton
        • Investigador principal:
          • Kamal Kant Singh Abbi
        • Contacto:
      • Franklin, Wisconsin, Estados Unidos, 53132
        • Reclutamiento
        • Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson
        • Investigador principal:
          • Kamal Kant Singh Abbi
        • Contacto:
      • Green Bay, Wisconsin, Estados Unidos, 54301
        • Reclutamiento
        • Saint Vincent Hospital Cancer Center Green Bay
        • Investigador principal:
          • Anthony J. Jaslowski
        • Contacto:
      • Green Bay, Wisconsin, Estados Unidos, 54303
        • Reclutamiento
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Investigador principal:
          • Anthony J. Jaslowski
        • Contacto:
      • Madison, Wisconsin, Estados Unidos, 53705
        • Reclutamiento
        • William S Middleton VA Medical Center
        • Investigador principal:
          • David Kosoff
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 17007 608-256-1901
      • Medford, Wisconsin, Estados Unidos, 54451
        • Reclutamiento
        • Aspirus Medford Hospital
        • Investigador principal:
          • Andrew J. Huang
        • Contacto:
      • Menomonee Falls, Wisconsin, Estados Unidos, 53051
        • Reclutamiento
        • Froedtert Menomonee Falls Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 262-257-5100
        • Investigador principal:
          • Deepak Kilari
      • Mequon, Wisconsin, Estados Unidos, 53097
        • Reclutamiento
        • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
        • Investigador principal:
          • Kamal Kant Singh Abbi
        • Contacto:
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Reclutamiento
        • Medical College of Wisconsin
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 414-805-3666
        • Investigador principal:
          • Deepak Kilari
      • Milwaukee, Wisconsin, Estados Unidos, 53295
        • Reclutamiento
        • Zablocki Veterans Administration Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 888-469-6614
        • Investigador principal:
          • Sumana Devata
      • Milwaukee, Wisconsin, Estados Unidos, 53211
        • Reclutamiento
        • Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
        • Investigador principal:
          • Kamal Kant Singh Abbi
        • Contacto:
      • New Berlin, Wisconsin, Estados Unidos, 53151
        • Reclutamiento
        • Froedtert and MCW Moorland Reserve Health Center
        • Investigador principal:
          • Deepak Kilari
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 414-805-0505
      • Oak Creek, Wisconsin, Estados Unidos, 53154
        • Reclutamiento
        • Drexel Town Square Health Center
        • Investigador principal:
          • Deepak Kilari
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 414-805-0505
      • Oconto Falls, Wisconsin, Estados Unidos, 54154
        • Reclutamiento
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Investigador principal:
          • Anthony J. Jaslowski
        • Contacto:
      • Oshkosh, Wisconsin, Estados Unidos, 54904
        • Reclutamiento
        • Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
        • Investigador principal:
          • Kamal Kant Singh Abbi
        • Contacto:
      • Racine, Wisconsin, Estados Unidos, 53405
        • Reclutamiento
        • Ascension All Saints Hospital-Spring Street-Racine
        • Investigador principal:
          • Kamal Kant Singh Abbi
        • Contacto:
      • Rhinelander, Wisconsin, Estados Unidos, 54501
        • Reclutamiento
        • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
        • Investigador principal:
          • Andrew J. Huang
        • Contacto:
      • Sheboygan, Wisconsin, Estados Unidos, 53081
        • Reclutamiento
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Investigador principal:
          • Anthony J. Jaslowski
        • Contacto:
      • Sheboygan, Wisconsin, Estados Unidos, 53081
        • Reclutamiento
        • Sheboygan Physicians Group
        • Investigador principal:
          • Anthony J. Jaslowski
        • Contacto:
      • Stevens Point, Wisconsin, Estados Unidos, 54481
        • Reclutamiento
        • Aspirus Cancer Care - Stevens Point
        • Investigador principal:
          • Andrew J. Huang
        • Contacto:
      • Sturgeon Bay, Wisconsin, Estados Unidos, 54235-1495
        • Reclutamiento
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Investigador principal:
          • Anthony J. Jaslowski
        • Contacto:
      • Wausau, Wisconsin, Estados Unidos, 54401
        • Reclutamiento
        • Aspirus Cancer Care-Wausau
        • Investigador principal:
          • Andrew J. Huang
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-405-6866
      • Wauwatosa, Wisconsin, Estados Unidos, 53226
        • Reclutamiento
        • Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa
        • Investigador principal:
          • Kamal Kant Singh Abbi
        • Contacto:
      • West Bend, Wisconsin, Estados Unidos, 53095
        • Reclutamiento
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Investigador principal:
          • Deepak Kilari
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 414-805-0505
      • Wisconsin Rapids, Wisconsin, Estados Unidos, 54494
        • Reclutamiento
        • Aspirus Cancer Care - Wisconsin Rapids
        • Investigador principal:
          • Andrew J. Huang
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 715-422-7718

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Masculino

Descripción

Inclusion Criteria:

  • Documentation of disease:

    * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology

  • Must have had evidence of metastatic disease (American Joint Committee on Cancer [AJCC] metastasis [M]1 disease) based on conventional CT/MRI and/or bone scan. This will be defined as:

    • Bone metastases detected by CT, radionuclide technetium-99 (99Tc)- methylene bisphosphonate bone scan, or MRI as defined by PCWG3 criteria; OR
    • Non-pelvic lymph node metastases (measurable lymph nodes above the aortic bifurcation; lymph nodes are measurable if the short axis diameter is ≥ 15 mm) detected on CT or MRI as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Subjects with regional lymph node metastases only (nodes [N]1, below the aortic bifurcation) will not be eligible for the study; OR
    • Visceral or soft tissue metastases detected on CT or MRI as defined by RECIST version 1.1. Soft tissue/visceral lesions are measurable if the long axis diameter is ≥ 10 mm
    • Evidence of metastatic disease by PSMA-PET only and not visible by CT, radionuclide bone scan, or MRI will not satisfy eligibility criteria

  • No metachronous low-volume disease (defined as recurrent metastatic disease after definitive treatment of prostate primary) and with ≤ 4 bone metastasis and no visceral metastasis on conventional imaging by CT, radionuclide 99Tc-biphosphonate bone scan, or MRI)

  • Next generation sequencing (NGS) results from any tissue based Clinical Laboratory Improvement Act (CLIA) test must be available at the time of registration. NGS from soft tissue or visceral lesion if available is preferred. NGS from bone or primary prostate will be accepted. Patients with failed NGS testing are not eligible

  • Prior treatment

    • ADT (luteinizing hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without first generation anti-androgen, or second-generation androgen receptor signaling inhibitor (ARSI) within 120 days of registration is permitted. No washout period will be needed for the first generation- androgen or ARSI prior to registration. Anti-androgen treatment is only permitted if used within 120 days of registration
    • No prior chemotherapy for prostate cancer

  • Age ≥ 18 years

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

  • Absolute neutrophil count (ANC) ≥ 1,500/mm^3

  • Hemoglobin ≥ 9.0 g/dL

  • Platelet count ≥ 100,000/mm^3

  • Total bilirubin ≤ 1 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1 × ULN, subject may be eligible)

  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate transaminase [SGT]) ≤ 1.5 x upper limit of normal (ULN)

  • Calculated (Calc.) creatinine clearance > 30 mL/min

  • Serum potassium ≥ 3.5 mmol/L

  • Comorbid conditions

    • 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
    • Leptomeningeal metastases: Patients with treated leptomeningeal metastases are eligible if follow-up brain imaging 30 days after central nervous system (CNS)-directed therapy shows no evidence of progression
    • HIV: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
    • Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
    • Hepatitis C: 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
    • No seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation or condition requiring CNS surgery or radiation therapy)
    • 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. To be eligible for this trial, patients should be class II or better. Any condition that in the opinion of the investigator, would preclude participation in this study. Patients with stable asymptomatic deep venous thromboembolism on stable anti-coagulation will be eligible
    • Hypertension: Subjects with uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) >= 160 mmHg or diastolic BP >= 100 mmHg despite medical management are not permitted to register
    • Allergies: Subjects with known hypersensitivity to any of the study drugs, or excipients in the formulation of the study drugs are not permitted to register

  • Concomitant medications

    • Chronic concomitant treatment with strong inhibitors of cytochrome P450 3A4 (CYP3A4) is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration on the study. See Section 8.1.9 for more information
    • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
    • Medications known to lower the seizure threshold must be discontinued or substituted prior to study entry. See Section 8.1.9 for more information

  • Patient agrees to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or agrees to use a condom if having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Arm 1 (ADT, apalutamide)

Patients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study.
Procedimiento: Biospecimen Collection

Undergo blood sample collection

Procedimiento: Computed Tomography

Undergo CT

Otros nombres:
  • Análisis de gato
  • Tomografía computarizada
Procedimiento: Magnetic Resonance Imaging

Undergo MRI

Otros nombres:
  • Resonancia magnética
Droga: Apalutamide

Given PO

Procedimiento: Bone Scan

Undergo Bone Scan

Procedimiento: PSMA PET Scan

Undergo PSMA PET Scan

Droga: Androgen Therapy

Given ADT

Otro: Questionnaire Administration

undergo Questionnaire Administration
Experimental: Arm 2 (ADT, apalutamide, docetaxel)

Patients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel IV over 1 hour every 21 days for up to 6 doses. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study.
Droga: Docetaxel

Given IV

Otros nombres:
  • Taxotere
Procedimiento: Biospecimen Collection

Undergo blood sample collection

Procedimiento: Computed Tomography

Undergo CT

Otros nombres:
  • Análisis de gato
  • Tomografía computarizada
Procedimiento: Magnetic Resonance Imaging

Undergo MRI

Otros nombres:
  • Resonancia magnética
Droga: Apalutamide

Given PO

Procedimiento: Bone Scan

Undergo Bone Scan

Procedimiento: PSMA PET Scan

Undergo PSMA PET Scan

Droga: Androgen Therapy

Given ADT

Otro: Questionnaire Administration

undergo Questionnaire Administration

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall survival (OS)
Periodo de tiempo: From randomization to death due to any cause, assessed up to 10 years

Will determine OS. To assess the potential OS benefit from the triplet therapy, a group sequential efficacy/futility monitoring design will be employed. The planned analyses for OS will be tested using a one-sided type 1 error rate of 0.025. An intent-to-treat approach will be used to evaluate OS between treatments. The stratified logrank test will be the primary analysis to compare OS between treatments. The Kaplan-Meier estimate will be used to evaluate the within treatment OS distributions. In addition, the proportional hazards model will be applied to assess the treatment comparison adjusting for important covariates in predicting OS.
From randomization to death due to any cause, assessed up to 10 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS)
Periodo de tiempo: From randomization to death due to any cause, assessed up to 10 years

Will determine if the addition of docetaxel to androgen deprivation therapy and apalutamide improves OS for men whose cancers have alterations of P53, PTEN, or RB1. To assess the potential OS benefit from the triplet therapy, a group sequential efficacy/futility monitoring design will be employed. The planned analyses for OS will be tested using a one-sided type 1 error rate of 0.025. An intent-to-treat approach will be used to evaluate OS between treatments. The stratified logrank test will be the primary analysis to compare OS between treatments. The Kaplan-Meier estimate will be used to evaluate the within treatment OS distributions. In addition, the proportional hazards model will be applied to assess the treatment comparison adjusting for important covariates in predicting OS.
From randomization to death due to any cause, assessed up to 10 years
Radiographic progression
Periodo de tiempo: From randomization to first documentation of radiographic progressive disease or death due to any cause, assessed up to 10 years

Will determine the time to radiographic progression- per Prostate Cancer Working Group (PCWG3) guidelines. Tumor response will be assessed utilizing imaging measurements, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. In this study, RECIST has been modified based on PCWG3 criteria, which are specific for this patient population.
From randomization to first documentation of radiographic progressive disease or death due to any cause, assessed up to 10 years
Castration-resistant prostate cancer (CRPC)
Periodo de tiempo: Time to prostate-specific antigen progression with serum testosterone being at castrate level < 0.50 ng/mL, or the time to progression by soft tissue/visceral lesions or time to progression by bone lesions per PCWG3 guidelines, assessed up to 10 years

Will determine the time to CRPC
Time to prostate-specific antigen progression with serum testosterone being at castrate level < 0.50 ng/mL, or the time to progression by soft tissue/visceral lesions or time to progression by bone lesions per PCWG3 guidelines, assessed up to 10 years
Symptomatic skeletal event free survival (SSE-FS)
Periodo de tiempo: From randomization to first occurrence of SSE or death from any cause, assessed up to 10 years

Will determine SSE-FS. An SSE is defined as external beam radiation therapy to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first
From randomization to first occurrence of SSE or death from any cause, assessed up to 10 years
Worsening of physical symptoms of disease
Periodo de tiempo: up to 10 years

Will determine the time to worsening of physical symptoms of disease based on functional assessment of cancer therapy / National Comprehensive Cancer Network prostate cancer symptom index 17 item questionnaire.
up to 10 years
Incidence of adverse events
Periodo de tiempo: up to 10 years

Will determine the safety and tolerability of the triplet versus doublet using Common Terminology Criteria for Adverse Events version 5.0.
up to 10 years
Radiographic progression free survival (rPFS)
Periodo de tiempo: From randomization to first documentation of radiographic progressive disease or death due to any cause, assessed up to 10 years

Will determine rPFS in patients by the stratification factors a) timing/volume of disease 1) metachronous high volume, 2) synchronous high volume and 3) synchronous low volume metastases on conventional imaging. Tumor response will be assessed utilizing imaging measurements, as defined by RECIST 1.1. In this study, RECIST has been modified based on PCWG3 criteria, which are specific for this patient population. Evaluation of rPFS will be assessed by the investigator.
From randomization to first documentation of radiographic progressive disease or death due to any cause, assessed up to 10 years
OS
Periodo de tiempo: Will determine OS in patients by the stratification factors a) timing/volume of disease 1) metachronous high volume, 2) synchronous high volume and 3) synchronous low volume metastases on conventional imaging. To assess the potential OS benefit from the

Will determine OS in patients by the stratification factors a) timing/volume of disease 1) metachronous high volume, 2) synchronous high volume and 3) synchronous low volume metastases on conventional imaging. To assess the potential OS benefit from the triplet therapy, a group sequential efficacy/futility monitoring design will be employed. The planned analyses for OS will be tested using a one-sided type 1 error rate of 0.025. An intent-to-treat approach will be used to evaluate OS between treatments. The stratified logrank test will be the primary analysis to compare OS between treatments. The Kaplan-Meier estimate will be used to evaluate the within treatment OS distributions. In addition, the proportional hazards model will be applied to assess the treatment comparison adjusting for important covariates in predicting OS.
Will determine OS in patients by the stratification factors a) timing/volume of disease 1) metachronous high volume, 2) synchronous high volume and 3) synchronous low volume metastases on conventional imaging. To assess the potential OS benefit from the
Prostate specific antigen (PSA) 90 response rate
Periodo de tiempo: At 6 weeks and 6 months

Will determine PSA 90 response rate.
At 6 weeks and 6 months
Time to PSA progression
Periodo de tiempo: From randomization to the date of PSA progression based on PCWG3 criteria, assessed up to 10 years

Will determine PSA progression. PSA progression is defined as a ≥ 25% increase above the nadir (lowest screening or baseline) value, which is confirmed by a second value 3 or more weeks later, and an increase in absolute value of ≥ 2 ng/mL above nadir, at least 12 weeks from baseline. Subjects without PSA progression as of database cut-off, whether or not surviving, will be censored at the last total PSA lab assessment date.
From randomization to the date of PSA progression based on PCWG3 criteria, assessed up to 10 years
Objective response rate (ORR)
Periodo de tiempo: up to 10 years

Will determine ORR in patients with measurable disease. Tumor response will be assessed utilizing imaging measurements, as defined by RECIST 1.1. In this study, RECIST has been modified based on PCWG3 criteria, which are specific for this patient population
up to 10 years

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Estimates of treatment effect
Periodo de tiempo: up to 10 years.

Estimates of treatment effect and the corresponding 95% confidence intervals (CIs) will be provided as follows (with an understanding that sometimes the CI or estimate will not be computable because of scant data):

  • Estimates of the OS hazard ratio and the corresponding 95% CIs by race.
  • Estimates of the OS hazard ratio and the corresponding 95% CIs by ethnicity.
up to 10 years.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Alliance for Clinical Trials in Oncology

Colaboradores

National Cancer Institute (NCI)

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de diciembre de 2025

Finalización primaria (Estimado)

11 de noviembre de 2031

Finalización del estudio (Estimado)

8 de mayo de 2039

Fechas de registro del estudio

Enviado por primera vez

9 de abril de 2025

Primero enviado que cumplió con los criterios de control de calidad

9 de abril de 2025

Publicado por primera vez (Actual)

17 de abril de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A032302
  • NCI-2025-00838 (Otro identificador: NCI Clinical Trial Reporting Program)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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