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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-Fluoride PET

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

Group Type EXPERIMENTAL

Fluorine F 18 Sodium Fluoride

Intervention Type RADIATION

Undergo fluorine F 18 sodium fluoride PET scan

Interventions

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Fluorine F 18 Sodium Fluoride

Undergo fluorine F 18 sodium fluoride PET scan

Intervention Type RADIATION

Other Intervention Names

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18 F-NaF F-18 NaF

Eligibility Criteria

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Inclusion Criteria

* Must be able to provide a written informed consent
* 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

* 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)

Exclusion Criteria

* On the nilutamide-only arm (Arm A of the clinical therapeutic trial)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evan Yu

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States