Prostate Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

18

Study ID:

NCT00936975

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 4 Locations for this study

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Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
University of Washington Medical Center
Seattle Washington, 98195, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

18

Study ID:

NCT00936975

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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