Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
Status: Recruiting
Phase: Phase 2
Diagnosis: Prostate Cancer
NCT ID: NCT00936975
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:
RATIONALE: Diagnostic procedures, such as fluorine F 18 sodium fluoride positron emission tomography (PET), may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase II trial is studying how well fluorine F 18 sodium fluoride PET works in evaluating response to dasatinib in patients with prostate cancer and bone metastases.
Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital
Overall PI:
Glenn Bubley, MD,
Beth Israel Deaconess Medical Center
Site-responsible Investigators:
Mary-Ellen Taplin, MD,
Dana-Farber Cancer Institute
Contacts:
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute:
Judith Prisby, 617-632-5068,
jprisby@partners.org
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- Metastatic disease
- Has ≥ 1 convincing bone metastasis by bone scintigraphy, CT scan/MRI, or
plain x-ray
- Castration-resistant disease
- Castrate testosterone levels (< 50 ng/dL)
- Has undergone prior orchiectomy OR is currently on maintenance luteinizing
hormone-releasing hormone (LHRH) agonist or LHRH antagonist
- Scheduled to receive treatment with dasatinib on the Febbo clinical trial
PATIENT CHARACTERISTICS:
- Life expectancy > 12 weeks
- Able to lie still for imaging
- Weighs ≤ 300 lbs.
- No condition that would alter mental status and preclude the basic understanding
and/or authorization of informed consent
- No serious underlying condition that would otherwise impair the patient's ability to
receive treatment and undergo imaging studies
- No extremely poor IV access that would preclude the placement of a peripheral IV line
for injection of a radiotracer
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior initiation of bisphosphonate therapy
- At least 4 weeks since prior radiotherapy to the bone
- At least 4 weeks since prior radiopharmaceutical treatment to the bone
- More than 4 weeks since prior GM-CSF or G-CSF