Fiducial Localization and Individualized Radiotherapy -Prostate Cancer (FLIP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00789607
First received: November 11, 2008
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Device: Transrectal APT Device or Transperineal Device will be used
Device: TRUS probe
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fiducial Localization and Individualized Radiotherapy in Prostate Cancer (FLIP)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure the needle targeting accuracy of the MRI-guided technique. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To validate the accuracy of identifying the GTV on MRI. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To evaluate MRI methods for the characterization of tissue oxygenation. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To evaluate the effect of neoadjuvant hormone therapy on tissue oxygenation. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789607

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Cynthia Ménard, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00789607     History of Changes
Other Study ID Numbers: UHN REB 08-0271-C
Study First Received: November 11, 2008
Last Updated: June 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
prostate cancer
individualized radiotherapy
fiducial markers
MRI
ultrasound
High-Risk Localized Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014