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Testing av tilsetning av docetaxel (cellegift) til vanlig behandling (hormonbehandling og apalutamid) for metastatisk prostatakreft, Aspire -studie

2. november 2026 oppdatert av: Alliance for Clinical Trials in Oncology

Docetaxel-tillegg i metastatisk kastratfølsom prostatakreft (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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

1260

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CAT-skanning
  • CT skann
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
Legemiddel: Apalutamide

Given PO

Fremgangsmåte: Bone Scan

Undergo Bone Scan

Fremgangsmåte: PSMA PET Scan

Undergo PSMA PET Scan

Legemiddel: Androgen Therapy

Given ADT

Annen: Questionnaire Administration

undergo Questionnaire Administration
Eksperimentell: 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.
Legemiddel: Docetaxel

Given IV

Andre navn:
  • Taxotere
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CAT-skanning
  • CT skann
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
Legemiddel: Apalutamide

Given PO

Fremgangsmåte: Bone Scan

Undergo Bone Scan

Fremgangsmåte: PSMA PET Scan

Undergo PSMA PET Scan

Legemiddel: Androgen Therapy

Given ADT

Annen: Questionnaire Administration

undergo Questionnaire Administration

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall survival (OS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: At 6 weeks and 6 months

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Estimates of treatment effect
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. desember 2025

Primær fullføring (Antatt)

11. november 2031

Studiet fullført (Antatt)

8. mai 2039

Datoer for studieregistrering

Først innsendt

9. april 2025

Først innsendt som oppfylte QC-kriteriene

9. april 2025

Først lagt ut (Faktiske)

17. april 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A032302
  • NCI-2025-00838 (Annen identifikator: NCI Clinical Trial Reporting Program)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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