NCT00789607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

9 years

First QC Date

November 11, 2008

Last Update Submit

March 15, 2024

Conditions

Prostate Cancer

Keywords

prostate cancerindividualized radiotherapyfiducial markersMRIultrasoundHigh-Risk Localized Prostate Cancer

Outcome Measures

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)

    5 years

Secondary Outcomes (4)

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

    5 years

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

    5 years

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

    5 years

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

    5 years

Study Arms (2)

MRI-guided FM

ACTIVE COMPARATOR
Device: Transrectal APT Device or Transperineal Device will be used

TRUS-guided FM

ACTIVE COMPARATOR
Device: TRUS probe

Interventions

Transrectal APT Device or Transperineal Device will be usedDEVICE

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

MRI-guided FM
TRUS probeDEVICE

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

TRUS-guided FM

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Peter Chung, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2017

Study Completion

May 12, 2023

Last Updated

March 18, 2024

Record last verified: 2024-03

Locations

CA(1)