Prostate CancerNCT00841685
The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate
A study testing Goldlock, Visicoil smallest size and Visicoil larger size in people with Prostate Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Goldlock, Visicoil smallest size and Visicoil larger size
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2008to 1 May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other primary tumor, except non-melanoma skin cancer
- No written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers
- Conditions
- Prostate Cancer
- Being tested
- Goldlock, Visicoil smallest size, Visicoil larger size, Bard goldmarker smallest size, Bard goldmarker larger size
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoldlockDevice
Insertion of Goldlock marker
Visicoil smallest sizeDevice
Insertion of Visicoil, smallest size, marker
Visicoil larger sizeDevice
Insertion of Visicoil, larger size, marker
Bard goldmarker smallest sizeDevice
Insertion of Bard goldmarker, smallest size
Bard goldmarker larger sizeDevice
Insertion of Bard goldmarker, larger size
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Goldlock Receives: Device: Goldlock |
| 2 | Active comparator | Visicoil smallest size Receives: Device: Visicoil smallest size |
| 3 | Active comparator | Visicoil larger size Receives: Device: Visicoil larger size |
| 4 | Active comparator | Bard goldmarker smallest size Receives: Device: Bard goldmarker smallest size |
| 5 | Active comparator | Bard goldmarker larger size Receives: Device: Bard goldmarker larger size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity after implantation of the fiducial gold markers
Measured: 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
Measured: 1 week after implantation
Visualization of the implanted gold markers by ultrasound
Measured: After implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startDec 2008
- Primary completion1 May 2012
- Study completion1 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- IBA, Germany, Hospimed, Netherland, Bard Ltd
- Responsible party
- Sponsor
- Investigators
- Gert De Meerleer, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841685
- Sponsor's protocol ID
- 2008/109
- Status last verified
- Jan 2023
- First submitted
- 10 Feb 2009
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate
- ClinicalTrials.gov ID
- NCT00841685
- Acronym / sponsor ID
- 2008/109
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- IBA, Germany, Hospimed, Netherland, Bard Ltd
- Study start
- Dec 2008 (actual)
- Primary completion
- 1 May 2012 (actual)
- Study completion
- 1 May 2012 (actual)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: GoldlockGoldlock |
| 2 | Active comparator | Device: Visicoil smallest sizeVisicoil smallest size |
| 3 | Active comparator | Device: Visicoil larger sizeVisicoil larger size |
| 4 | Active comparator | Device: Bard goldmarker smallest sizeBard goldmarker smallest size |
| 5 | Active comparator | Device: Bard goldmarker larger sizeBard goldmarker larger size |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Other primary tumor, except non-melanoma skin cancer
- No written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GoldlockInsertion of Goldlock marker | Device | 1 |
| Visicoil smallest sizeInsertion of Visicoil, smallest size, marker | Device | 2 |
| Visicoil larger sizeInsertion of Visicoil, larger size, marker | Device | 3 |
| Bard goldmarker smallest sizeInsertion of Bard goldmarker, smallest size | Device | 4 |
| Bard goldmarker larger sizeInsertion of Bard goldmarker, larger size | Device | 5 |
Primary outcome
Acute toxicity after implantation of the fiducial gold markers
Time frame: 1 week after implantation
2 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
Time frame: 1 week after implantation
Visualization of the implanted gold markers by ultrasound
Time frame: After implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Website of the University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gert De Meerleer, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goldlock, Visicoil smallest size and Visicoil larger size in people with Prostate Cancer, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity after implantation of the fiducial gold markers (time frame: 1 week after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.