Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in… (NCT00936975) | Clinical Trial Compass
CompletedPhase 2
Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
United States18 participantsStarted 2009-09
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 radiotrac…