TheranosticTrials.org

Clinical Trial · NCT02169063

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

Overview

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.

Sponsor

University of Washington

Phase

N/A

Contacts

Evan Yu (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02169063

Drug / Compound

acetate

Isotope(s):
Target(s):
  • Lipid/fatty acid synthesis
Ligand Class: Small Molecules

sodium fluoride

Isotope(s):
Target(s):
  • Phospholipid Metabolism
Ligand Class: Small Molecules

Eligibility

Inclusion

  • * Patients preparing to receive systemic therapy to treat metastatic castration-resistant prostate cancer
  • 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
  • Be willing and able to comply with scheduled visits and other trial procedures
  • 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
  • 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

Exclusion

  • 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
  • A serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and imaging studies
  • * Any condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent