Multi-modality Prostate Cancer Image Guided Interventions

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Imaging Panel

• Registration Number: NCT04009174
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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

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 Timeline

• Study Start: 2012-02-12
• Primary Completion: 2018-06-30
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Study Completion: 2023-06-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging Panel	Imaging Panel	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.

Primary Outcome Measures

Name	Time	Method
Hybrid Imaging Map (HIM) Validation	Within two years of study completion.	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.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada