Multi-modality Prostate Cancer Image Guided Interventions

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.

Inclusion criteria

• Provision of informed consent for this study
• Male, aged 18 years or older
• Pathologically confirmed prostate cancer on previous biopsy
• Suitable for and consenting to Radical Prostatectomy for treatment, or repeat biopsy as standard of care

Exclusion criteria

• Prior therapy for prostate cancer (including hormone therapy), with the exception of radiation therapy for Cohort 2 only
• Use of 5-alpha reductase inhibitors, i.e. finasteride (Proscar) or dutasteride (Avodart) within 6 months of study start. Patients undergoing a 6-month washout period prior to study start will be eligible.
• Inability to comply with the pre-operative imaging panel
• Patients scheduled for radical prostatectomy with prostate size exceeding dimensions for whole mount pathology slides
• Allergy to contrast agents to be used as part of the imaging panel
• Sickle cell disease or other anemias
• Insufficient renal function (eGFR < 60 mL/min/1.73 m2)
• Residual bladder volume > 150 cc (determined by post-void ultrasound)
• Hip prosthesis, vascular grafting that is MRI incompatible or sources of artifact within the pelvis
• Contraindication to MRI

• pacemaker or other electronic implants
• known metal in the orbit
• cerebral aneurysm clips