Multi-modality Prostate Cancer Image Guided Interventions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-modality Prostate Cancer Image Guided Interventions

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Imaging Panel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging Panel<br>Patients who provided written informed consent and found to be eligible for study were asked to complete Positron Emission Tomography (PET) + Dynamic CT imaging, PET/MRI (with endorectal coil) and 3D-Transrectal ultrasound prior to standard of care radical prostatectomy. | Other: Imaging Panel<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within two years of study completion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, PET/CT, PET/MRI, Fluorocholine, PSMA, Sodium (Na) MRI, [18-F]-FCH, [18-F]-DCFPyL, Hybrid imaging, Whole mount histopathology