Trans-Rectal Ultrasound-Guided (TRUS) Adverse Events

Overview

The goal of this study is to identify any side effects caused by the implanting of markers via the rectum. The investigators will also try to determine if any other factors (such as the position of the markers) influence the risk of side effects. The study procedures consist of two questionnaires:The first will be completed immediately after the marker implantation and the second questionnaire will be completed during your radiotherapy planning.

Full Title of Study: “A Prospective Quantification of Patient-Reported Adverse Events Following Trans-Rectal Ultrasound-Guided Intra-Prostatic Marker Insertion”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2010

Detailed Description

Precise localisation of target organs has become increasingly important with the routine use of steep dose gradients from conformal and intensity modulated radiotherapy. This is particularly challenging when soft tissue target organs, such as the prostate, displace relative to bony anatomy. Although novel imaging techniques are being developed for the direct visualisation of such soft tissue structures, contrast and image quality is currently limited. However, the use of radio-opaque intra-prostatic fiducial markers(IPM) during high dose radiotherapy has proven very effective in terms of improving accuracy, and decreasing toxicity.

Arms, Groups and Cohorts

  • Prostate Cancer

Clinical Trial Outcome Measures

Primary Measures

  • Quantify adverse events reported by prostate patients following trans-rectal ultrasound-guided implantation of intra-prostatic markers for RT
    • Time Frame: 1.5 years

Participating in This Clinical Trial

Inclusion Criteria

  • Have biopsy confirmed prostate cancer (any risk category) – Have 3 intra-prostatic markers inserted at PMH prior to radiotherapy – Be willing to provide written informed consent – Be willing to complete the adverse event questionnaires

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tara Rosewall, Principal Investigator, University Health Network, Princess Margaret Hospital

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