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Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer

16. november 2020 opdateret af: Duke University

A Phase II Open-label, Parallel Group Study of Abiraterone Acetate Plus Prednisone in African American and Caucasian Men With Metastatic Castrate-resistant Prostate Cancer

The primary goal is to prospectively estimate the median radiographic PFS of African American and Caucasian men with mCRPC to abiraterone acetate and prednisone.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a non-comparative pilot open-label, parallel arm, multicenter study of abiraterone acetate in African American and Caucasian men with mCRPC. Patients will self-report on race and 50 patients will be enrolled into each group. Patients will be treated on open-label treatment until evidence of disease progression as defined by Prostate Cancer Working Group Two (PCWG2) definition or until two years at which point they will roll over to the standard of care at that time. The study agent abiraterone acetate will be administered by the patient at a dose of 1000mg orally once daily with prednisone 5 mg BID in 4-week cycles throughout the treatment period.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Birmingham VA Medical Center
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane Cancer Center
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Karmanos Cancer Institute
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
      • Henderson, North Carolina, Forenede Stater, 27536
        • Maria Parham Medical Center
      • Laurinburg, North Carolina, Forenede Stater, 28352
        • Scotland Memorial Hospital
      • Lumberton, North Carolina, Forenede Stater, 28359
        • Southeastern Regional
      • Raleigh, North Carolina, Forenede Stater, 27609
        • Duke Raleigh Hospital
      • Salisbury, North Carolina, Forenede Stater, 28144
        • W. G. 'Bill' Hefner VA Medical Center
      • Smithfield, North Carolina, Forenede Stater, 27577
        • Johnston Memorial Hospital
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University
    • South Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Spartanburg Regional
    • Virginia
      • Hampton, Virginia, Forenede Stater, 23666
        • Virginia Oncology Associates

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:

  • Male, age ≥ 18 years
  • Karnofsky performance status ≥ 70
  • Life expectancy of ≥ 12 months
  • Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken, and should be able to swallow tablets whole, without crushing/chewing tablets
  • Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate
  • Adequate laboratory parameters
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate. Histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are excluded
  • Radiographic evidence of metastatic disease; evaluable non-target lesions and/or bone only metastasis are permitted
  • Ongoing ADT using an LHRH agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed. Screening serum testosterone must be <50 ng/dl
  • PSA ≥ 2.0 ng/mL

  • Evidence of of castration resistant disease on ADT as evidenced by one of the following:

    • Absolute rise in PSA of 2.0 ng/mL or greater, minimum 2 consecutive rising PSA levels with an interval of ≥ 1 week between each PSA level, OR
    • 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, OR
    • CT or MRI based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to modified PCWG2 criteria or modified RECIST 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies)
  • A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug (i.e. flutamide, nilutamide, bicalutamide)
  • A minimum of 4 weeks elapsed off of sipuleucel-T prior to start of study drug
  • A minimum of 4 weeks from any major surgery prior to start of study drug
  • Self-reported race of either African American or Caucasian
  • Ability to swallow, retain, and absorb oral medication

Exclusion Criteria:

  • Prior treatment with abiraterone acetate or enzalutamide
  • Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  • Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid
  • Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients
  • Pathological finding consistent with small cell carcinoma of the prostate
  • Symptomatic Liver or visceral organ metastasis
  • Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
  • Known brain metastasis
  • Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
  • Previously treated with ketoconazole for prostate cancer for greater than 7 days
  • Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
  • Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
  • Poorly controlled diabetes
  • Active or symptomatic viral hepatitis or chronic liver disease
  • History of pituitary or adrenal dysfunction
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline
  • Atrial Fibrillation or other cardiac arrhythmia requiring therapy
  • Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
  • Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1
  • Any condition which, in the opinion of the investigator, would preclude participation in this trial

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Abiraterone Acetate and Prednisone
abiraterone acetate will be administered by the patient at a dose of 1000mg orally once daily with prednisone 5 mg BID in 4-week cycles
Medicin: Prednison
Medicin: Abirateronacetat
Andre navne:
  • Zytiga

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Median Radiographic Progression Free Survival (PFS)
Tidsramme: up to 2 years
Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Working Group 2 criteria, or to death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median rPFS was estimated using a Kaplan-Meier curve.
up to 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in PSA Response
Tidsramme: Baseline and up to 2 years
Percent of men with Prostate Specific Antigen (PSA) declines > 30%, > 50% and > 90%
Baseline and up to 2 years
Median Time to PSA Progression
Tidsramme: up to 2 years
Time to PSA progression as defined by PCWG 2 criteria is the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.
up to 2 years
Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml
Tidsramme: up to 2 years
Number of men who achieve a PSA decline to < 0.1 and < 0.2 ng/ml
up to 2 years
Percent of Subjects Experiencing Hypertension
Tidsramme: up to 2 years
Incidence and grade of hypertension in the two populations. (Grade 1: Systolic BP 120 to 139 mmHg or diastolic BP 80 to 89 mmHg, Grade 2: Systolic BP 140 to 159 mmHg or diastolic BP 90 to 99 mmHg, Grade 3: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg, Grade 4: Life-threatening consequences, urgent intervention indicated)
up to 2 years
Overall Survival
Tidsramme: up to 3 years
Length of patient's life after starting study
up to 3 years

Samarbejdspartnere og efterforskere

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

Sponsor

Duke University

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. oktober 2013

Primær færdiggørelse (Faktiske)

8. oktober 2019

Studieafslutning (Faktiske)

8. oktober 2019

Datoer for studieregistrering

Først indsendt

9. september 2013

Først indsendt, der opfyldte QC-kriterier

11. september 2013

Først opslået (Skøn)

12. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00046383
  • 212082PCR2018 (Anden identifikator: Janssen)

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 .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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