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Carbon-11 Acetate and Fluorine F 18 Sodium Fluoride PET as a Biomarker of Treatment Response in Patients With Hormone Resistant Metastatic Prostate Cancer

29. August 2016 aktualisiert von: University of Washington

PET Imaging as a Biomarker of Systemic Treatment Response for Men With Metastatic Castration-Resistant Prostate Cancer

This clinical trial studies carbon-11 acetate and fluorine F 18 sodium fluoride positron emission tomography (PET) as a biomarker of treatment response in patients with prostate cancer that does not respond to treatment with hormones and has spread to other parts of the body. Carbon-11 acetate and fluorine F 18 sodium fluoride are radioactive drugs that may be useful in evaluating prostate cancer activity in response to treatment. Comparing results of diagnostic procedures such as carbon-11 acetate and fluorine F 18 sodium fluoride PET done before and after therapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Studienübersicht

Status

Zurückgezogen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

PRIMARY OBJECTIVES:

I. Demonstrate that carbon-11 acetate (11C-acetate) and 18F-fluoride (fluorine F 18 sodium fluoride) PET scans change as a result of treatment for men with metastatic castration-resistant prostate cancer by comparison of pre-treatment and 6-12 week post-treatment images (standardized uptake value [SUV], influx constant [Ki], and rate constant [K1]) with clinical response measures.

SECONDARY OBJECTIVES:

I. Compare results from 11C-acetate and 18F-fluoride PET scanning with the patient's clinical bone scan and determine which predicts clinical response better.

II. Compare changes in 11C-acetate and 18F-fluoride PET with changes in prostate-specific antigen (PSA) level.

III. Compare changes in 11C-acetate and 18F-fluoride PET with changes in urinary N-telopeptide and bone alkaline phosphatase.

IV. Determine if either baseline uptake or change in uptake for 11C-acetate and/or 18F-fluoride PET is correlated with progression-free survival by Prostate Cancer Working Group 2 (PCWG2) criteria (Scher, 2008).

V. Determine if either baseline uptake or change in uptake by 11C-acetate and/or 18F-fluoride PET is correlated with skeletal-related events (SREs) defined as radiographic pathologic fracture, need for radiation to bone, need for surgery, spinal cord compression or malignant hypercalcemia.

VI. Percentage of patients that experience adverse events by Common Terminology Criteria for Adverse Events, version 4.0.

VII. For patients who have tissue/blood biomarkers obtained for other indications, directly compare baseline uptake and change in uptake by 11C-acetate and/or 18F-fluoride PET with those biomarkers.

OUTLINE:

Patients receive carbon-11 acetate intravenously (IV) and fluorine F 18 sodium fluoride IV over 1 minute and undergo PET at baseline and at 6-12 weeks after systemic therapy starts.

After completion of treatment, patients are followed up every 3 months for up to 5 years.

Studientyp

Interventionell

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Männlich

Beschreibung

Inclusion Criteria:

  • Patients preparing to receive systemic therapy to treat metastatic castration-resistant prostate cancer
  • At the time of enrollment, patients must demonstrate evidence of castration-resistant prostate cancer with a documented castrate level of serum total testosterone (< 50 ng/dL) while on continuous androgen deprivation therapy
  • Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
  • Be willing and able to comply with scheduled visits and other trial procedures
  • Presence of at least one measurable or detectable metastasis as defined by bone scintigraphy, computed tomography (CT) scan appearance (magnetic resonance imaging [MRI] if indicated), or plain x-ray appearance

Exclusion Criteria:

  • Any condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent
  • A serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and imaging studies
  • Expected lifespan of 12 weeks or less
  • Extremely poor intravenous access, prohibiting the placement of a peripheral IV line for injection of radiotracer
  • Radiation treatment to bone less than 4 weeks from the first PET scan
  • Radiopharmaceutical treatment to bone less than 4 weeks from first PET scan
  • Treatment with granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte (G-CSF) within 4 weeks prior to first PET scan; patients should avoid treatment with these agents between the baseline and 6-12 treatment week imaging sessions
  • Inability to lie still for imaging
  • Weight > 300 pounds (lbs)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Diagnostic (11C-acetate, 18F-fluoride, PET)
Patients receive carbon-11 acetate IV and fluorine F 18 sodium fluoride IV over 1 minute and undergo PET at baseline and at 6-12 weeks after systemic therapy starts.
Sonstiges: Labor-Biomarker-Analyse
Korrelative Studien
Strahlung: carbon-11 acetate
Given IV
Strahlung: fluorine F 18 sodium fluoride
Given IV
Andere Namen:
  • 18 F-NaF
  • F-18 NaF
Verfahren: positron emission tomography
Undergo 11C-acetate and 18F-fluoride PET
Andere Namen:
  • HAUSTIER
  • FDG-PET
  • PET-Scan
  • Tomographie, Emission berechnet

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in prostate cancer metastases as measured by 11C-acetate and 18F-fluoride PET in response to systemic therapy
Zeitfenster: Baseline to up to 12 weeks
Percentage change between pre-treatment and post-therapy measurements will be computed for PET measures. Log transformations will be considered if the rates of change are highly skewed. Additionally, changes in PET measures will be analyzed descriptively by a stem-and-leaf plot.
Baseline to up to 12 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical response data (response, stable disease or progression)
Zeitfenster: Up to 5 years
Molecular imaging measures and clinical measures of treatment response, percentage change in PET derived imaging data will be compared to standard clinical parameters. Association between these two types of data decline will be analyzed using the mid-P adjustment to Fisher's exact test (Lancaster, 1961) to evaluate the potential clinical utility of change in 11C-acetate and 18F-fluoride as a biomarker for response.
Up to 5 years
Proportion of both 11C-acetate and 18F-fluoride PET scans and 99mTc bone scans in discovering suspicious sites that are later confirmed by standard bone scans
Zeitfenster: Up to 5 years
Statistical significance of two proportions will be tested with a two-sample t-test for proportions (or nonparametric alternative).
Up to 5 years
Change in PSA parameters
Zeitfenster: Baseline to up to 30 days post-PET
Spearman rank correlation will be used to examine correlations between PET parameters and continuous variable changes in PSA.
Baseline to up to 30 days post-PET
Change in urinary N-telopeptide
Zeitfenster: Baseline to up to 30 days post-PET
Spearman rank correlation will be used to examine correlations between PET parameters and continuous variable changes in urinary N-telopeptide.
Baseline to up to 30 days post-PET
Change in bone alkaline phosphatase
Zeitfenster: Baseline to up to 30 days post-PET
Spearman rank correlation will be used to examine correlations between PET parameters and continuous variable changes in bone alkaline phosphatase.
Baseline to up to 30 days post-PET
Progression-free survival (PFS) using PCWG2
Zeitfenster: Up to 5 years
Cox proportional hazards model will be used to investigate the predictive value of the differences in pre- and post- treatment measures on PCWG2 PFS.
Up to 5 years
SRE defined as radiographic pathologic fracture, need for radiation to bone, need for surgery, spinal cord compression or malignant hypercalcemia
Zeitfenster: Up to 5 years
Cox proportional hazards model will be used to investigate the predictive value of the differences in pre- and post- treatment measures on time of first SRE.
Up to 5 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Washington

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Evan Yu, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2015

Primärer Abschluss (Voraussichtlich)

1. November 2018

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Juni 2014

Zuerst gepostet (Schätzen)

20. Juni 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

31. August 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. August 2016

Zuletzt verifiziert

1. August 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 8021 (Andere Kennung: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
  • P30CA015704 (US NIH Stipendium/Vertrag)
  • NCI-2014-01203 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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