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
- Conditions
- Prostate Cancer
- Interventions
- Procedure: Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging
- Registration Number
- NCT01516866
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
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.
- Detailed Description
The study will look at how repeatable the NaF PET scans are before treatment. Scans will also be performed after standard chemotherapy or hormone-directed treatment. This will allow evaluation of how the NaF PET scans change with the chemotherapy or hormone-directed therapy. In addition, NaF PET scans will be compared with standard computed tomography (CT) and bone scans, as well as prostate specific antigen (PSA). This information could be used to develop better ways to measure prostate cancer bone lesions. In turn, this could be used to better evaluate treatment effects of standard chemotherapy and other new drugs being developed to treat prostate cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 58
- 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
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort B: AR-directed therapy Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging 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. Cohort A: Microtubule directed chemotherapy treatment Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging 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.
- Primary Outcome Measures
Name Time Method The repeatability of NaF PET/CT imaging for evaluating bone metastases in patients with metastatic castrate-resistant prostate cancer. 2 years NaF PET/CT scan will be performed within 14 days prior to starting chemotherapy (antimicrotubule directed chemotherapy) or hormone-directed therapy (baseline #1). A portion of subjects (up to 20 subjects at each site, 60 subjects total) will have a second NaF PET/CT scan performed (baseline #2) within 1-8 days of the initial scan to see if measurements repeated over a short period of time are similar.
- Secondary Outcome Measures
Name Time Method Radiographic progression free survival 2 years Evaluate changes on NaF PET/CT images in response to chemotherapy (antimicrotubule directed chemotherapy) or androgen receptor (AR)-directed therapy. 2 years All subjects will undergo NaF PET/CT scanning at baseline and again either 8 weeks after starting treatment with antimicrotubule chemotherapy based treatment (Cohort A) OR at both 6 weeks and 12 weeks after starting AR-directed treatment (Cohort B).
Prostate Specific Antigen (PSA) response 2 years Results from the NaF PET/CT scans will be compared with PSA and bone scan and CT scan results.
Response Evaluation Criteria in Solid Tumors (RECIST) response 2 years
Trial Locations
- Locations (3)
National Cancer Institute
🇺🇸Bethesda, Maryland, United States
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States
Memorial Sloan Kettering
🇺🇸New York, New York, United States