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

Stage IV Prostate Cancer Clinical Trial

Official title:

A Phase 2, Multicenter Evaluation of 18F-Fluoride PET as a Pharmacodynamic Biomarker for Dasatinib, a Src Kinase Inhibitor, in Men With Castration-Resistant Prostate Cancer and Bone Metastases (BMS #180-279)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936975
• Other study ID #: NCI-2010-01292
• Secondary ID: NCI-2010-01292CD
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2009
• Last updated: June 22, 2015
• Start date: September 2009
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Neoplasms
• Hormone-Resistant Prostate Cancer
• Metastatic Malignant Neoplasm in the Bone
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Prostatic Neoplasms
• Recurrent Prostate Carcinoma
• Stage IV Prostate Cancer

Intervention

Radiation:
• Fluorine F 18 Sodium Fluoride
Undergo fluorine F 18 sodium fluoride PET scan

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina
United States	Oregon Health and Science University	Portland	Oregon
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in 18F-fluoride PET (SUV) - Tumor Bone	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	Baseline and 12 weeks	No
Primary	Changes in 18F-fluoride PET SUV - Normal Bone	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	Baseline and 12 weeks	No
Primary	Changes in 18F-fluoride Ki - Tumor Bone	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	Baseline and 12 weeks	No
Primary	Changes in 18F-fluoride Ki - Normal Bone	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	Baseline and 12 weeks	No
Secondary	Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor	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.	Baseline and 12 weeks	No
Secondary	Changes in 18F-fluoride Transport (by Patlak Flux) - Normal	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.	Baseline and 12 weeks	No