Stage IV Prostate Cancer Clinical Trial
Official title:
A Phase 2, Multicenter Evaluation of 18F-Fluoride PET as a Pharmacodynamic Biomarker for Dasatinib, a Src Kinase Inhibitor, in Men With Castration-Resistant Prostate Cancer and Bone Metastases (BMS #180-279)
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | December 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 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) |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in 18F-fluoride PET (SUV) - Tumor Bone | Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET in tumor bone as measured by SUVmax | Baseline and 12 weeks | No |
Primary | Changes in 18F-fluoride PET SUV - Normal Bone | Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (SUV) in normal bone as measured by SUVmax | Baseline and 12 weeks | No |
Primary | Changes in 18F-fluoride Ki - Tumor Bone | Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in tumor bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone | Baseline and 12 weeks | No |
Primary | Changes in 18F-fluoride Ki - Normal Bone | Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in normal bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone | Baseline and 12 weeks | No |
Secondary | Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor | Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in Tumor. This measurement uses the Patlak method for determining the influx constant. | Baseline and 12 weeks | No |
Secondary | Changes in 18F-fluoride Transport (by Patlak Flux) - Normal | Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in normal bone. Palak flux is an indicator of blood flow and an indirect marker of angiogenesis. | Baseline and 12 weeks | No |
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