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

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.

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)