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Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer

16 november 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

100

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Läkemedel: Prednison
Läkemedel: Abirateronacetat
Andra namn:
  • Zytiga

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Median Radiographic Progression Free Survival (PFS)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in PSA Response
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: up to 3 years
Length of patient's life after starting study
up to 3 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Duke University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 oktober 2013

Primärt slutförande (Faktisk)

8 oktober 2019

Avslutad studie (Faktisk)

8 oktober 2019

Studieregistreringsdatum

Först inskickad

9 september 2013

Först inskickad som uppfyllde QC-kriterierna

11 september 2013

Första postat (Uppskatta)

12 september 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 december 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 november 2020

Senast verifierad

1 november 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Pro00046383
  • 212082PCR2018 (Annan identifierare: Janssen)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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