Up to 30 men with metastatic prostate cancer will undergo up to 2 FTT PET/CT scans to look at PARP activity in sites of known cancer. Subjects will undergo a baseline scan prior to starting new therapy and a second, optional, post-therapy scan 1-21 days after the start of treatment. Tissue from a clinical or research biopsy will be compared to imaging measures, if available.
Up to 30 evaluable patients with a histological diagnosis of prostate cancer with clinical evidence of metastatic disease who are being considered for new therapy or for a change in therapy with a PARP inhibitor, androgen deprivation therapy, and/or chemotherapy as part of their clinical care will be enrolled in this study. A pre-treatment 18F-FluorThanatrace (\[18F\]FTT) positron emission tomography/ computed tomography (PET/CT) scan will be done prior to the start of a new therapy regimen. PET/CT imaging will be used to evaluate PARP-1 expression in sites of prostate cancer using the investigational radiotracer \[18F\]FTT. This is an observational study in that \[18F\]FTT PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the \[18F\]FTT PET/CT results, treatment decisions will be made by the treating physicians based upon clinical criteria. After injection of \[18F\]FTT patients will undergo a skull base to mid-thigh scan, starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an injection of 12 mCi of \[18F\]FTT intravenously (approximate range for most studies is anticipated to be 8-12 mCi ). of \[18F\] FTT. Data will be collected to evaluate uptake of \[18F\]FTT in sites of prostate cancer, which will be compared with PARP-1 expression in tissue, when available. All evaluable patients may start new therapy following the \[18F\]FTT PET/CT scan. It is expected that due to patient preference and time considerations, approximately 80% will also undergo a second (optional) scan that will be performed approximately 1-21 days after new therapy has started. The second scan is obtained to evaluate whether the initiation of a PARP inhibitor and/or androgen deprivation therapy and/or chemotherapy alters \[18F\] FTT uptake.
Study Type
OBSERVATIONAL
Enrollment
30
Investigational radiopharmaceutical used with Positron Emission Tomography (PET/CT) imaging that may provide a non-invasive measurement of PARP-1 expression
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGMeasurement of effect size
To establish effect size of change in FTT uptake before and after systemic therapy in men with prostate cancer metastasis using \[18F\]FluorThanatrace (\[18F\]FTT)
Time frame: 21 days
Evaluation of PARP expression
Evaluation of PARP-1 expression in prostate cancer using measures of uptake of \[18F\]FTT before and after PARPi and/or androgen deprivation therapy and/or chemotherapy
Time frame: 21 days
Correlation with PARP-1 IHC
Correlation of \[18F\]FTT uptake measures with PARP-1 IHC expression in the tissue specimen, when available
Time frame: 6 months
Correlation with PARP-1 autoradiography
Correlation of \[18F\]FTT uptake measures with PARP-1 \[125I\]KX1 autoradiography expression in the tissue specimen, when available
Time frame: 6 months
Predication of clinical response
Determination of whether baseline and/or pre-/post-treatment changes in \[18F\]FTT uptake predict clinical response as measured by progression-free survival (PFS) and anatomic criteria on standard of care imaging
Time frame: 1 year
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