This is a non-randomized, prospective trial of men who are scheduled for radical prostatectomy for treatment of prostate cancer, or repeat biopsy for localized prostate cancer as standard of care and who will undergo a series of pre-operative multi-modality imaging studies. Post intervention, hybrid imaging maps (HIM) will be generated and the predictions of the HIM (3D location, volume and grade of cancer) will be correlated with actual pathology results to gauge the performance of the HIM in both radical prostatectomy and biopsy settings.
This study was built on our first study (IGPC-1, REB number 15551) which acquired multi-modality imaging in 36 patients undergoing radical prostatectomy. We successfully demonstrated the ability to accurately co-register pre-operative multi-modality images (MRI: T1, T2, Diffusion Weighed (DW), Dynamic Contrast enhanced (DCE); Dynamic Contrast Enhanced CT, 3D Ultrasound with post-operative whole mount pathology specimens. We have developed a platform for the segmentation of prostate cancer on the whole mount pathology specimens and are in the process of analyzing the data to develop a hybrid imaging map (HIM) of prostate cancer distribution (location and grade) based on the correlation of the pre-operative imaging signals and the post-operative pathology (citation provided below). The HIM will need subsequent validation in a separate cohort of radical prostatectomy patients and evaluated as to its ability to be incorporated as a targeting tool for prostate interventions such as prostate biopsy and this is the purpose of this follow-up study. On the IGPC-2 study, pre-operative imaging panels were successfully obtained in 24 patients accrued to cohort 1. The protocol was then amended to include \[18-F\]-DCFPyl instead of \[18F\]-FCH. \[18-F\]-DCFPyl was a newer PET probe that may possess superior performance because it is directed against prostate specific membrane antigen (PSMA), a protein commonly expressed on prostate cancer cells. Imaging-pathology correlations in the first 6 patients imaged with \[18-F\]-DCFPyl were compared to the correlations obtained with \[18F\]-FCH imaging in the first 24 patients. IGPC-2 Cohort 1 (Radical Prostatectomy) was expanded to provide an additional 20 men imaged with \[18-F\]-DCFPyl as part of the imaging panel. The goal was to acquire 24 complete imaging datasets with \[18-F\]-DCFPyl as the PET imaging agent to enable us to draw comparisons with the 24 \[18F\]-FCH imaging data sets acquired.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
52
Initial Protocol (REB approval date 08-Sept-2011) Pre-operative Imaging Panel * \[18F\]-FCH PET + Dynamic CT * MRI of the pelvis with endorectal coil (T1, T2, DW, DCE, MRS) * 3D-Transrectal ultrasound * Optional PET/MRI (added with Protocol Amend 1, REB approval date 22-Aug-2012) * Optional Sodium (23Na) MRI (added with Protocol Amend 2, REB approval date 25-Feb-2013) Protocol Amendment #3, REB approval date 20-Oct-2015: Pre-operative Imaging Panel * \[18-F\]-DCFPyL PET+Dynamic CT * PET/MRI with endorectal coil * 3D-Transrectal Ultrasound * Optional Sodium (23Na) MRI
London Health Sciences Centre
London, Ontario, Canada
Hybrid Imaging Map (HIM) Validation
We will determine if individualized hybrid imaging maps (HIMs) based on a pre-operative imaging panel accurately predicts the actual cancer distribution found in the whole mount prostatectomy specimens obtained from the surgery.
Time frame: Within two years of study completion.
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