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

Withdrawn before enrolling · Not applicable

Conditions studied: Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02169063

Run by

University of Washington

People needed

0

Starts

2015-12-01

Last updated by the study team

2016-08-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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