Multi-modality Prostate Cancer Image Guided Interventions

NCT04009174 | Completed

• 1 other identifier: 101038
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; PET/CT; PET/MRI; Fluorocholine; PSMA; Sodium (Na) MRI; [18-F]-FCH; [18-F]-DCFPyL; Hybrid imaging; Whole mount histopathology

Outcome Measures

Primary Outcomes (1)

• 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.

Other Outcomes (1)

• MRI Prostate Sodium Imaging Validation

  Within two years of study completion

Study Arms (1)

Imaging Panel

EXPERIMENTAL

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

Interventions

Imaging Panel OTHER

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

Imaging Panel

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male with a prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (3)

• Ward A, Crukley C, McKenzie C, Montreuil J, Gibson E, Gomez JA, et al. Registration of in vivo prostate magnetic resonance images to digital histopathology images. MICCAI'10 Proceedings of the 2010 international conference on Prostate cancer imaging: computer-aided diagnosis, prognosis, and intervention; Bejing, China. Berlin: Springer-Verlag; 2010.

  BACKGROUND

• Yang DM, Alfano R, Bauman G, Thiessen JD, Chin J, Pautler S, Moussa M, Gomez JA, Rachinsky I, Gaed M, Chung KJ, Ward A, Lee TY. Short-duration dynamic [18F]DCFPyL PET and CT perfusion imaging to localize dominant intraprostatic lesions in prostate cancer: validation against digital histopathology and comparison to [18F]DCFPyL PET/MR at 120 minutes. EJNMMI Res. 2021 Oct 15;11(1):107. doi: 10.1186/s13550-021-00844-0.

  PMID: 34652551 DERIVED

• Yang DM, Li F, Bauman G, Chin J, Pautler S, Moussa M, Rachinsky I, Valliant J, Lee TY. Kinetic analysis of dominant intraprostatic lesion of prostate cancer using quantitative dynamic [18F]DCFPyL-PET: comparison to [18F]fluorocholine-PET. EJNMMI Res. 2021 Jan 4;11(1):2. doi: 10.1186/s13550-020-00735-w.

  PMID: 33394284 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Dr. Glenn Bauman, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: July 5, 2019
• Study Start: February 12, 2012
• Primary Completion: June 30, 2018
• Study Completion: June 21, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Institutionally approved material sharing agreement.

Locations

CA (1)