Prostate Cancer
Conditions
Keywords
Androgen receptor-directed therapy, NaF PET/CT, antimicrotubule directed chemotherapy
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.
Interventions
PROCEDURESodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging
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).
Sponsors
University of Wisconsin, Madison
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| Response Evaluation Criteria in Solid Tumors (RECIST) response | 2 years | — |
| Radiographic progression free survival | 2 years | — |
Countries
United States
Outcome results
None listed