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Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T (PRIME)

16. juli 2019 opdateret af: Dendreon
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Subjects will receive sipuleucel-T, and potentially other medications, as part of the clinical trial in which they are concurrently enrolled. For this study, cellular and humoral immune responses will be assessed. No additional study treatments will be conducted beyond what is required for the subject's concurrent clinical trial.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

139

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85251
        • 21st Century Oncology
    • California
      • Los Angeles, California, Forenede Stater, 90048
        • Tower Urology / Tower Research Institute
      • Marina Del Rey, California, Forenede Stater, 90292
        • Prostate Oncology Specialists, Inc.
    • Colorado
      • Denver, Colorado, Forenede Stater, 80211
        • The Urology Center of Colorado
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20060
        • Howard University Cancer Center
    • Indiana
      • Jeffersonville, Indiana, Forenede Stater, 47130
        • First Urology, PSC
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University
      • Shreveport, Louisiana, Forenede Stater, 71106
        • Highland Clinic
    • Maryland
      • Towson, Maryland, Forenede Stater, 21204
        • Chesapeake Urology Research Associates
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Health System
      • Troy, Michigan, Forenede Stater, 48084
        • Michigan Institute of Urology
    • Missouri
      • Bridgeton, Missouri, Forenede Stater, 63044
        • St. Louis Cancer Care, LLP
      • Saint Louis, Missouri, Forenede Stater, 63127
        • St. Louis Cancer Care, LLP
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89052, 89014, 89074
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Forenede Stater, 89169, 89128, 98148
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Mount Laurel, New Jersey, Forenede Stater, 08054
        • Delaware Valley Urology, LLC
    • New York
      • Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center
      • East Setauket, New York, Forenede Stater, 11733
        • National Translational Research Group, Inc.
      • Poughkeepsie, New York, Forenede Stater, 12601
        • Premier Medical Group of the Hudson Valley
      • Syracuse, New York, Forenede Stater, 13210
        • Associated Medical Professionals of NY, PLLC
    • North Carolina
      • Gastonia, North Carolina, Forenede Stater, 28054
        • Carolina Urology Partners
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45212
        • TriState urologic Services PSC Inc., dba The Urology Group
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74146
        • Urologic Specialists of Oklahoma
    • Oregon
      • Portland, Oregon, Forenede Stater, 97213
        • Providence Health & Services
      • Springfield, Oregon, Forenede Stater, 97477
        • Oregon Urology Institute
      • Tualatin, Oregon, Forenede Stater, 97062
        • Northwest Cancer Specialists, PC
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, Forenede Stater, 19004
        • Urologic Consultants of SE PA
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29210
        • South Carolina Oncology Associates
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37209
        • Urology Associates, P.C.
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104, 76132
        • Texas Oncology - Fort Worth
    • Virginia
      • Virginia Beach, Virginia, Forenede Stater, 23462
        • Urology Of Virginia, Pllc
    • Washington
      • Seattle, Washington, Forenede Stater, 98109-1023
        • Seattle Cancer Care Alliance
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Centerl
      • Vancouver, Washington, Forenede Stater, 98684, 98683
        • Northwest Cancer Specialists

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Men at least 18 years of age with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT), and have not yet undergone leukapheresis for their first dose of sipuleucel-T.

Beskrivelse

Inclusion Criteria:

  • Subjects must be at least 18 years of age
  • Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
  • Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
  • Subjects must understand and sign an informed consent form prior to their first leukapheresis

Exclusion Criteria:

•None

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Sipuleucel-T
Biologisk: Sipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Andre navne:
  • APC8015
  • HÆVN

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T).
Tidsramme: Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.
The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T).
Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.

Samarbejdspartnere og efterforskere

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

Sponsor

Dendreon

Efterforskere

  • Studieleder: Bruce Brown, MD, Dendreon Pharmaceuticals, LLC

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

1. oktober 2012

Primær færdiggørelse (Faktiske)

1. juli 2017

Studieafslutning (Faktiske)

1. juli 2017

Datoer for studieregistrering

Først indsendt

12. november 2012

Først indsendt, der opfyldte QC-kriterier

14. november 2012

Først opslået (Skøn)

15. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P11-4

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sipuleucel-T

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Benin

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner