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Trans-Rectal Ultrasound-Guided (TRUS) Adverse Events

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00923416
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Prostate Cancer

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 Design

Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Quantification of Patient-Reported Adverse Events Following Trans-Rectal Ultrasound-Guided Intra-Prostatic Marker Insertion
Study Start Date : September 2008
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Prostate Cancer


Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Prostate Cancer Patients who has trans-rectal ultrasound-guided implantation of intra-prostatic markers for radiotherapy treatment
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923416


Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Tara Rosewall University Health Network, Princess Margaret Hospital
More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00923416     History of Changes
Other Study ID Numbers: UHN REB 08-0136-CE
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

Keywords provided by University Health Network, Toronto:
Intra-Prostate Markers
Transrectal Ultrasound
Prostate Cancer Patients

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases