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Completed

NCT Number: NCT00923416

Trans-Rectal Ultrasound-Guided (TRUS) Adverse Events

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.

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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

Observational

Primary location

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Quantify adverse events reported by prostate patients following trans-rectal ultrasound-guided implantation of intra-prostatic markers for RT

    Time frame: 1.5 years

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

A Prospective Quantification of Patient-Reported Adverse Events Following Trans-Rectal Ultrasound-Guided Intra-Prostatic Marker Insertion

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 18, 2009
Registry last updated
Dec 19, 2012

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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