Phase 2
Completed N=18
Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
Hormone-Resistant Prostate Cancer · Metastatic Malignant Neoplasm in the Bone · Recurrent Prostate Carcinoma · Stage IV Prostate Cancer
Source: ClinicalTrials.gov NCT00936975 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Changes in 18F-fluoride PET (SUV) - Tumor Bone — -6.67 SUVmax — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in 18F-fluoride PET (SUV) - Tumor Bone |
-6.67 | <0.001 sig |
| PRIMARY Changes in 18F-fluoride PET SUV - Normal Bone |
0.31 | 0.32 |
| PRIMARY Changes in 18F-fluoride Ki - Tumor Bone |
-0.02 | 0.16 |
| PRIMARY Changes in 18F-fluoride Ki - Normal Bone |
0.0 | 0.53 |
| SECONDARY Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor |
-0.01 | 0.1945 |
| SECONDARY Changes in 18F-fluoride Transport (by Patlak Flux) - Normal |
0.01 | 0.0033 sig |
Eligibility Criteria
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 ( 300 lbs. (due to equipment specifications)
Data sourced from ClinicalTrials.gov (NCT00936975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.