Status:
COMPLETED
Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Hormone-Resistant Prostate Cancer
Metastatic Malignant Neoplasm in the Bone
Eligibility:
MALE
18+ years
Phase:
PHASE2
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...
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 norma...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00936975
Start Date
September 1 2009
End Date
December 1 2014
Last Update
July 16 2015
Active Locations (4)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
Oregon Health and Science University
Portland, Oregon, United States, 97239
4
University of Washington Medical Center
Seattle, Washington, United States, 98195