Trans-Rectal Ultrasound-Guided (TRUS) Adverse Events

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00923416
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-18
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 240

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Health Network, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada