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Clinical Trial · NCT00936975
Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
Overview
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.
Sponsor
National Cancer Institute
Phase
Phase 2
Contacts
Evan Yu (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT00936975Drug / Compound
Sodium Fluoride
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Bone Metabolism
Ligand Class: Small Molecules
Eligibility
Inclusion
- 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)
- * 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
Exclusion
- 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
- 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
- * On the nilutamide-only arm (Arm A of the clinical therapeutic trial)
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