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CompletedNCT00841685Updated Jan 5, 2023

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

An interventional study of Goldlock and Visicoil smallest size in Prostate Cancer, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-05.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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

02

Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 25 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 685 studies on the registry; 158 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Browse University Hospital, Ghent studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Other primary tumor, except non-melanoma skin cancer
  • No written informed consent
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    1

    Goldlock

    Device: Goldlock

  • Active comparator
    2

    Visicoil smallest size

    Device: Visicoil smallest size

  • Active comparator
    3

    Visicoil larger size

    Device: Visicoil larger size

  • Active comparator
    4

    Bard goldmarker smallest size

    Device: Bard goldmarker smallest size

  • Active comparator
    5

    Bard goldmarker larger size

    Device: Bard goldmarker larger size

Interventions

  • DeviceGoldlock

    Insertion of Goldlock marker

  • DeviceVisicoil smallest size

    Insertion of Visicoil, smallest size, marker

  • DeviceVisicoil larger size

    Insertion of Visicoil, larger size, marker

  • DeviceBard goldmarker smallest size

    Insertion of Bard goldmarker, smallest size

  • DeviceBard goldmarker larger size

    Insertion of Bard goldmarker, larger size

06

What researchers measure

Primary outcomes

  1. Acute toxicity after implantation of the fiducial gold markers

    Time frame: 1 week after implantation

Secondary outcomes

  1. 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

    Time frame: 1 week after implantation

  2. Visualization of the implanted gold markers by ultrasound

    Time frame: After implantation

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2008 to primary completion in May 2012, 41 months.

Of 1,018 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 87. This study's 41 months is close to that.

Counting every sponsor, half of 1,063 studies reached it within 45 months; a quarter within 22 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2009
First posted
Feb 11, 2009
StartActual
Dec 2008
Primary completionActual
May 1, 2012
CompletionActual
May 1, 2012
Last update
Jan 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00841685
Lead sponsor
University Hospital, Ghent
Collaborators
IBA, Germany, Hospimed, Netherland, Bard Ltd
Responsible party
Sponsor
First posted
Feb 11, 2009
Start date
Dec 2008
Primary completion
May 1, 2012
Completion
May 1, 2012
Last update
Jan 5, 2023

Study contacts

Gert De Meerleer, MD, PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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