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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: Bard goldmarker larger size; Device: Goldlock; Device: Visicoil smallest size; Device: Visicoil larger size; Device: Bard goldmarker smallest size

• Registration Number: NCT00841685
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2012-05-01
• Study Completion: 2012-05-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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
• WHO 0-2

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5	Bard goldmarker larger size	Bard goldmarker larger size
1	Goldlock	Goldlock
2	Visicoil smallest size	Visicoil smallest size
3	Visicoil larger size	Visicoil larger size
4	Bard goldmarker smallest size	Bard goldmarker smallest size

Primary Outcome Measures

Name	Time	Method
Acute toxicity after implantation of the fiducial gold markers	1 week after implantation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium