Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases

Phase 2

Completed

Conditions: Stage IV Prostate Cancer
Metastatic Malignant Neoplasm in the Bone
Recurrent Prostate Carcinoma
Hormone-Resistant Prostate Cancer

Brief Summary: This phase II trial is studying how well fluorine F 18 sodium fluoride positron emission tomography (PET) works in evaluating response to dasatinib in patients with prostate cancer and bone metastases. Diagnostic procedures, such as fluorine F 18 sodium fluoride PET, may help doctors predict a patient's response to treatment and help plan the best treatment.

Detailed Description: PRIMARY OBJECTIVES:

I. Determine if changes in regional fluoride incorporation, measured by 18F-fluoride PET (SUV and Ki), occur in both castration-resistant prostate cancer bone metastases and normal bone as a response to treatment with dasatinib.

SECONDARY OBJECTIVES:

I. Determine if changes in 18F-fluoride transport (K1), an indicator of blood flow, and therefore, an indirect marker of angiogenesis, occur in both castration-resistant prostate cancer bone metastases and normal bone as a response to treatment with dasatinib.

OUTLINE: This is a multicenter study.

Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. PET parameters (SUV, Ki, and Kl) are also analyzed.

Recruitment & Eligibility

Inclusion Criteria

Must be able to provide a written informed consent
Men 18 years or older with metastatic castration-resistant prostate cancer enrolling onto the Febbo clinical trial with dasatinib therapy (must meet all inclusion criteria for dasatinib treatment study and comply with requirements of that specific clinical trial)
Histologic confirmation of original prostate cancer diagnosis
Presence of at least one convincing bone metastasis as defined by bone scintigraphy, computed tomography (CT) scan (magnetic resonance imaging [MRI] if indicated), or plain X-ray
Must currently have castrate testosterone levels (< 50 ng/dL) from orchiectomy or maintenance on a luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist

Exclusion Criteria

On the nilutamide-only arm (Arm A of the clinical therapeutic trial)
- Note: However, if a patient crosses-over from nilutamide at the time of progression to add dasatinib therapy, he may be eligible for 18F-fluoride PET imaging protocol if he meets all inclusion criteria for this trial
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
Initiation of bisphosphonate therapy less than 4 weeks from the first PET scan
Radiation treatment to bone less than 4 weeks from 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 CSF (G-CSF) within 4 weeks prior to first PET scan
Inability to lie still for the imaging
Weight > 300 lbs. (due to equipment specifications)

Arm && Interventions

Group	Intervention	Description
18F-Fluoride PET	Fluorine F 18 Sodium Fluoride	Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Dasatinib was administered under a concurrent protocol and was not considered part of the intervention on this protocol

Primary Outcome Measures

Name	Time	Method
Changes in 18F-fluoride PET (SUV) - Tumor Bone	Baseline and 12 weeks	Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET in tumor bone as measured by SUVmax
Changes in 18F-fluoride PET SUV - Normal Bone	Baseline and 12 weeks	Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (SUV) in normal bone as measured by SUVmax
Changes in 18F-fluoride Ki - Normal Bone	Baseline and 12 weeks	Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in normal bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone
Changes in 18F-fluoride Ki - Tumor Bone	Baseline and 12 weeks	Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in tumor bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone

Secondary Outcome Measures

Name	Time	Method
Changes in 18F-fluoride Transport (by Patlak Flux) - Normal	Baseline and 12 weeks	Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in normal bone. Palak flux is an indicator of blood flow and an indirect marker of angiogenesis.
Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor	Baseline and 12 weeks	Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in Tumor. This measurement uses the Patlak method for determining the influx constant.

Locations (4): Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States