Multi-modality Prostate Cancer Image Guided Interventions

NCT04009174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Imaging Panel

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Dr. Glenn Bauman, MD · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-12
Primary Completion
2018-06-30
Completion
2023-06-21

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04009174 on ClinicalTrials.gov