Fiducial Localization and Individualized Radiotherapy -Prostate Cancer (FLIP)

March 15, 2024 updated by: University Health Network, Toronto

Fiducial Localization and Individualized Radiotherapy in Prostate Cancer (FLIP)

This purpose of this study is designed to compare two types of images; magnetic resonance imaging (MRI) and Trans-Rectal Ultrasound (TRUS) to see which one performs more accurately for the image-guided insertion of Fiducial Markers(FMs) within the tumour. Though effective for guiding FM placement at the poles of the prostate gland due to excellent visualization of the prostatic boundaries, TRUS may not be ideally suited for marking the GTV. Conventional TRUS is neither sufficiently sensitive nor specific for accurate visualization of intra-prostatic tumor. A new interventional MRI technique enables needle guidance to the gross tumour Volume (GTV) for FM placement. It is of particular importance that both techniques be evaluated to enable which one is more effective so that it can be implemented in the designs of future trials involving dose-escalation to prostate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The success of dose escalation strategies in prostate cancer over the last decade has relied on high accuracy in target delineation, localization and radiation delivery. Improved biochemical control with acceptable levels of toxicity (specifically rectal) has been achieved by stringently monitoring the location of the prostate during the course of radiation treatment. Studies in the early 1990's demonstrated that daily bony alignment was a poor surrogate for prostate gland location. Since then, various strategies have been devised to localize the prostate precisely during treatment. Of these, Transrectal Ultrasound (TRUS)-guided gold fiducial marker (FM) insertion and x-ray imaging of markers has been a broadly successful approach. TRUS guidance has been used for fiducial marker insertion within the prostate since 1985 in various centers throughout the world and has also been a standard practice in PMH since 1997 in men undergoing radical external beam radiotherapy. A retrospective comparative study of 106 patients evaluating the relative accuracy of endorectal MRI and TRUS in detecting the location of tumor reported an improved performance of endorectal MRI especially in the base and midgland regions. Over the last few years, mounting experience in the interpretation of prostate MRI, and addition of physiologic imaging sequences has further improved the performance of MRI in detecting and localizing the GTV.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥ 18 years old
  2. ECOG status ≤ 1
  3. High risk localized cancer planned for RT under FM guidance
  4. Gleason > 7, PSA > 20, Clinical stage ≥ T3
  5. patients(pts) must give written informed consent

Exclusion Criteria:

  1. pts > 136 kg or > 60 cm in girth
  2. Pts with pacemakers, cerebral aneurysm clips, shrapnel injury or devices not compatible with MRI.
  3. pts with severe claustrophobia
  4. pts with bleeding diathesis and anticoagulative therapy that cannot be ceased prior to needle procedures.
  5. Contraindications to endorectal probe, surgically absent rectum, severe hemorrhoids or previous colorectal surgery.
  6. Latex Allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MRI-guided FM
Device: Transrectal APT Device or Transperineal Device will be used
Both are imaging probe devices that is inserted under local anesthetic, in the rectum using lubricant, positioning against the prostate gland, and attached to the table. This is done at baseline (Day 0) under local anesthetic with the patient in partial dorsal lithotomy position
Active Comparator: TRUS-guided FM
Device: TRUS probe
Patient is given local anesthetic transrectally to the prostate base and the probe is inserted with patient in the lateral decubitus position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the performance of MRI and TRUS images in guiding the insertion of a fiducial marker within the Gross Target Volume (GTV)
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To measure the needle targeting accuracy of the MRI-guided technique.
Time Frame: 5 years
5 years
To validate the accuracy of identifying the GTV on MRI.
Time Frame: 5 years
5 years
To evaluate MRI methods for the characterization of tissue oxygenation.
Time Frame: 5 years
5 years
To evaluate the effect of neoadjuvant hormone therapy on tissue oxygenation.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Peter Chung, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

May 12, 2023

Study Registration Dates

First Submitted

November 11, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimated)

November 13, 2008

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 08-0271-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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