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.
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.
Study Type
OBSERVATIONAL
Enrollment
58
Subjects who will be enrolled will be those who will be starting treatment (as part of standard of care or as part of another trial) with either a microtubule directed chemotherapy regimen (cohort A), or AR-directed therapy (cohort B). All subjects will have a baseline NaF PET/CT scan (baseline #1), performed within days prior to starting either chemotherapy or AR-directed therapy. A subset of subjects (up to 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 1-8 days of the initial scan to determine repeatability of NaF PET/CT scanning. Subjects in cohort A will undergo another NaF PET/CT scan at week 8 (+/- 1 week). Subjects in cohort B will undergo two additional NaF PET/CT scans at weeks 6 and 12 (+/- 1 week).
National Cancer Institute
Bethesda, Maryland, United States
Memorial Sloan Kettering
New York, New York, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
The repeatability of NaF PET/CT imaging for evaluating bone metastases in patients with metastatic castrate-resistant prostate cancer.
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.
Time frame: 2 years
Evaluate changes on NaF PET/CT images in response to chemotherapy (antimicrotubule directed chemotherapy) or androgen receptor (AR)-directed therapy.
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).
Time frame: 2 years
Prostate Specific Antigen (PSA) response
Results from the NaF PET/CT scans will be compared with PSA and bone scan and CT scan results.
Time frame: 2 years
Response Evaluation Criteria in Solid Tumors (RECIST) response
Time frame: 2 years
Radiographic progression free survival
Time frame: 2 years
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