Clinical trial NCT00789607: Fiducial Localization and Individualized Radiotherapy -Prostate Cancer
Official title: Fiducial Localization and Individualized Radiotherapy in Prostate Cancer (FLIP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
individualized radiotherapy
fiducial markers
MRI
ultrasound
High-Risk Localized Prostate Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2008-11-13
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: To compare the performance of MRI and TRUS images in guiding the insertion of a fiducial marker within the Gross Target Volume (GTV)
timeFrame: 5 years
Secondary outcomes:
measure: To measure the needle targeting accuracy of the MRI-guided technique.
timeFrame: 5 years
measure: To validate the accuracy of identifying the GTV on MRI.
timeFrame: 5 years
measure: To evaluate MRI methods for the characterization of tissue oxygenation.
timeFrame: 5 years
measure: To evaluate the effect of neoadjuvant hormone therapy on tissue oxygenation.
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Peter Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: