Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
Completed · Phase 2
Conditions studied: Hormone-Resistant Prostate Cancer, Metastatic Malignant Neoplasm in the Bone, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00936975
- Run by
- National Cancer Institute (NCI)
- People needed
- 18
- Starts
- 2009-09-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-07-16
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- 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, United States
Full record on ClinicalTrials.gov
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