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Testning af tilsætning af docetaxel (kemoterapi) til den sædvanlige behandling (hormonbehandling og apalutamid) for metastatisk prostatacancer, aspire -forsøg

2. november 2026 opdateret af: Alliance for Clinical Trials in Oncology

Docetaxel-tilsætning i metastatisk kastratfølsom prostatacancer (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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1260

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Procedure: Biospecimen Collection

Undergo blood sample collection

Procedure: Computed Tomography

Undergo CT

Andre navne:
  • CAT-scanning
  • CT-scanning
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
Medicin: Apalutamide

Given PO

Procedure: Bone Scan

Undergo Bone Scan

Procedure: PSMA PET Scan

Undergo PSMA PET Scan

Medicin: Androgen Therapy

Given ADT

Andet: Questionnaire Administration

undergo Questionnaire Administration
Eksperimentel: 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.
Medicin: Docetaxel

Given IV

Andre navne:
  • Taxotere
Procedure: Biospecimen Collection

Undergo blood sample collection

Procedure: Computed Tomography

Undergo CT

Andre navne:
  • CAT-scanning
  • CT-scanning
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
Medicin: Apalutamide

Given PO

Procedure: Bone Scan

Undergo Bone Scan

Procedure: PSMA PET Scan

Undergo PSMA PET Scan

Medicin: Androgen Therapy

Given ADT

Andet: Questionnaire Administration

undergo Questionnaire Administration

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2025

Primær færdiggørelse (Anslået)

11. november 2031

Studieafslutning (Anslået)

8. maj 2039

Datoer for studieregistrering

Først indsendt

9. april 2025

Først indsendt, der opfyldte QC-kriterier

9. april 2025

Først opslået (Faktiske)

17. april 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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