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NCT Number: NCT00789607

Fiducial Localization and Individualized Radiotherapy -Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Transrectal APT Device or Transperineal Device will be used

Device

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

TRUS probe

Device

Patient is given local anesthetic transrectally to the prostate base and the probe is inserted with patient in the lateral decubitus position.

Primary outcomes

  1. 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

Secondary outcomes

  1. To measure the needle targeting accuracy of the MRI-guided technique.

    Time frame: 5 years

  2. To validate the accuracy of identifying the GTV on MRI.

    Time frame: 5 years

  3. To evaluate MRI methods for the characterization of tissue oxygenation.

    Time frame: 5 years

  4. To evaluate the effect of neoadjuvant hormone therapy on tissue oxygenation.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

Fiducial Localization and Individualized Radiotherapy in Prostate Cancer (FLIP)

Acronym: FLIP

Important dates

Study start
2008
Primary completion
2017
Study completion
2023
First posted
Nov 13, 2008
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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