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Test de l'ajout de docétaxel (chimiothérapie) au traitement habituel (thérapie hormonale et apalutamide) pour le cancer de la prostate métastatique, essai Aspire

2 novembre 2026 mis à jour par: Alliance for Clinical Trials in Oncology

Ajout de docétaxel dans le cancer de la prostate sensible aux castrats métastatiques (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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

1260

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Procédure: Biospecimen Collection

Undergo blood sample collection

Procédure: Computed Tomography

Undergo CT

Autres noms:
  • Scanner
  • Tomodensitométrie
Procédure: Magnetic Resonance Imaging

Undergo MRI

Autres noms:
  • IRM
Médicament: Apalutamide

Given PO

Procédure: Bone Scan

Undergo Bone Scan

Procédure: PSMA PET Scan

Undergo PSMA PET Scan

Médicament: Androgen Therapy

Given ADT

Autre: Questionnaire Administration

undergo Questionnaire Administration
Expérimental: 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.
Médicament: Docetaxel

Given IV

Autres noms:
  • Taxotère
Procédure: Biospecimen Collection

Undergo blood sample collection

Procédure: Computed Tomography

Undergo CT

Autres noms:
  • Scanner
  • Tomodensitométrie
Procédure: Magnetic Resonance Imaging

Undergo MRI

Autres noms:
  • IRM
Médicament: Apalutamide

Given PO

Procédure: Bone Scan

Undergo Bone Scan

Procédure: PSMA PET Scan

Undergo PSMA PET Scan

Médicament: Androgen Therapy

Given ADT

Autre: Questionnaire Administration

undergo Questionnaire Administration

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall survival (OS)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall Survival (OS)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: At 6 weeks and 6 months

Will determine PSA 90 response rate.
At 6 weeks and 6 months
Time to PSA progression
Délai: 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)
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Estimates of treatment effect
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Alliance for Clinical Trials in Oncology

Collaborateurs

National Cancer Institute (NCI)

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 décembre 2025

Achèvement primaire (Estimé)

11 novembre 2031

Achèvement de l'étude (Estimé)

8 mai 2039

Dates d'inscription aux études

Première soumission

9 avril 2025

Première soumission répondant aux critères de contrôle qualité

9 avril 2025

Première publication (Réel)

17 avril 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • A032302
  • NCI-2025-00838 (Autre identifiant: NCI Clinical Trial Reporting Program)

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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