Clinical trial · Interventional
Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
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)
NCT00936975CI-TRIAL-00018560completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone-Resistant Prostate Cancer | — | UNRESOLVED | — |
| Metastatic Malignant Neoplasm in the Bone | — | UNRESOLVED | — |
| Recurrent Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorine F 18 Sodium Fluoride | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-Fluoride PET
- description
- Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Dasatinib was administered under a concurrent protocol and was not considered part of the intervention on this protocol
- interventionNames
- Radiation: Fluorine F 18 Sodium Fluoride
Primary outcomes (4)
- measure
- Changes in 18F-fluoride PET (SUV) - Tumor Bone
- timeFrame
- Baseline and 12 weeks
- description
- 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
- measure
- Changes in 18F-fluoride PET SUV - Normal Bone
- timeFrame
- Baseline and 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.