AzTrials
AzTrials

Prostate CancerIGPC-2NCT04009174

Multi-modality Prostate Cancer Image Guided Interventions

A study testing Imaging Panel in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Imaging Panel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteCanada
Study dates
12 Feb 2012to 21 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Imaging Panel
Keywords
Prostate Cancer, PET/CT, PET/MRI, Fluorocholine, PSMA, Sodium (Na) MRI, [18-F]-FCH, [18-F]-DCFPyL, Hybrid imaging, Whole mount histopathology
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imaging PanelOther

    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
Study groups in NCT04009174
Study groupRoleWhat they receive
Imaging PanelExperimentalPatients 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.
Receives: Other: Imaging Panel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within two years of study completion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start12 Feb 2012
  3. Primary completion30 Jun 2018
  4. Study completion21 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04009174
Sponsor's protocol ID
101038
Acronym
IGPC-2
Status last verified
Feb 2024
First submitted
24 Oct 2018
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Fully anonymized study data such as de-identified images, digital pathology slides, prostate tissue slides and prostate cancer diagnosis information can be available for data analysis.

Publications

  • 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.

  • 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.

    PubMed 34652551

  • 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.

    PubMed 33394284

Questions about this trial

What is this clinical trial studying?

A study testing Imaging Panel in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hybrid Imaging Map (HIM) Validation (time frame: Within two years of study completion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04009174, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in