Clinical trial · Observational
Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Microtubule Directed Chemo or AR-directed Therapy
NaF PET/CT Repeatability, Responsiveness, and Response Assessment in Patients With Metastatic Castrate-resistant Prostate Cancer to Bone Treated With Either an Antimicrotubule Directed Agent or Androgen Receptor (AR)-Directed Therapies
- 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)
The purpose of this research study is to evaluate a newer imaging technique, called 18F-Sodium Fluoride (NaF) positron emission tomography (PET). NaF is a tracer (dye) that is very sensitive for changes in bone. By using this tracer with positron emission tomography/computed tomography (PET/CT) imaging, our ability to evaluate and measure changes in bone lesions could be greatly improved.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A: Microtubule directed chemotherapy treatment
- description
- Subjects receiving antimicrotubule chemotherapy-based treatment will have NaF PET/CT scans at baseline and again after 8 weeks of starting treatment. A subset of subjects will have a second NaF PET/CT scan at baseline 1-8 days after the first baseline scan.
- interventionNames
- Procedure: Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging
- label
- Cohort B: AR-directed therapy
- description
- Subjects receiving AR-directed therapy will undergo a baseline NaF PET/CT scan at baseline and again after having been on treatment for 6 weeks and again at 12 weeks. A subset of subjects will also undergo a second baseline NaF PET/CT scan 1-8 days after the first baseline scan.
- interventionNames
- Procedure: Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging
Primary outcomes (1)
- measure
- The repeatability of NaF PET/CT imaging for evaluating bone metastases in patients with metastatic castrate-resistant prostate cancer.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Identifiable prostate cancer-related bone metastases on bone scan in the spine, pelvis or other bone * Patients must be starting a microtubule directed chemotherapy regimen for metastatic castrate-resistant prostate cancer OR * Patients must be starting a AR-directed regimen (e.g. Abiraterone, MDV-3100, TAK-700, etc) for treatment of metastatic castrate-resistant prostate Exclusion Criteria: * Concurrent treatment with any other agent that is being used with the expressed purpose of treating of prostate cancer outside of the planned treatment regimen * Patients who have received radiotherapy less than 4 weeks prior to registration. * Patients who have received prior Strontium-89, Samarium-153, or other radioisotope. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to sodium fluoride F-18 (NaF).
References
Publications (0)
Data not yet available