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Clinical Trials/NCT00841685
NCT00841685
Completed
Not Applicable

The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate

University Hospital, Ghent1 site in 1 country25 target enrollmentDecember 2008
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
University Hospital, Ghent
Enrollment
25
Locations
1
Primary Endpoint
Acute toxicity after implantation of the fiducial gold markers
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
May 1, 2012
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • histological proven adenocarcinoma of the prostate
  • T1-T4 tumors
  • Radiotherapy as primary therapy +/- androgen deprivation
  • Presence of an intraprostatic lesion (IPL) on MRI/MRS
  • Presence of an intraprostatic lesion (IPL) on ultrasound

Exclusion Criteria

  • Other primary tumor, except non-melanoma skin cancer
  • No written informed consent

Outcomes

Primary Outcomes

Acute toxicity after implantation of the fiducial gold markers

Time Frame: 1 week after implantation

Secondary Outcomes

  • Feasibility of insertion 1 fiducial gold marker in the intraprostatic lesion combined with extra gold markers in the rest of the prostate upto 3 goldmarkers in total(1 week after implantation)
  • Visualization of the implanted gold markers by ultrasound(After implantation)

Study Sites (1)

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