The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate
1 other identifier
interventional
25
1 country
1
Brief Summary
Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Dec 2008
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 10, 2009
CompletedFirst Posted
Study publicly available on registry
February 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJanuary 5, 2023
January 1, 2023
3.4 years
February 10, 2009
January 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Acute toxicity after implantation of the fiducial gold markers
1 week after implantation
Secondary Outcomes (2)
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 Arms (5)
1
EXPERIMENTALGoldlock
2
ACTIVE COMPARATORVisicoil smallest size
3
ACTIVE COMPARATORVisicoil larger size
4
ACTIVE COMPARATORBard goldmarker smallest size
5
ACTIVE COMPARATORBard goldmarker larger size
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Other primary tumor, except non-melanoma skin cancer
- No written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- IBA, Germanycollaborator
- Hospimed, Netherlandcollaborator
- Bard Ltdcollaborator
Study Sites (1)
University Hospital Ghent
Ghent, 9000, Belgium
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gert De Meerleer, MD, PhD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2009
First Posted
February 11, 2009
Study Start
December 1, 2008
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
January 5, 2023
Record last verified: 2023-01