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

NCT ID: NCT00841685

Last Updated: 2023-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-05-01

Brief Summary

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

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

Goldlock

Group Type EXPERIMENTAL

Goldlock

Intervention Type DEVICE

Insertion of Goldlock marker

2

Visicoil smallest size

Group Type ACTIVE_COMPARATOR

Visicoil smallest size

Intervention Type DEVICE

Insertion of Visicoil, smallest size, marker

3

Visicoil larger size

Group Type ACTIVE_COMPARATOR

Visicoil larger size

Intervention Type DEVICE

Insertion of Visicoil, larger size, marker

4

Bard goldmarker smallest size

Group Type ACTIVE_COMPARATOR

Bard goldmarker smallest size

Intervention Type DEVICE

Insertion of Bard goldmarker, smallest size

5

Bard goldmarker larger size

Group Type ACTIVE_COMPARATOR

Bard goldmarker larger size

Intervention Type DEVICE

Insertion of Bard goldmarker, larger size

Interventions

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Goldlock

Insertion of Goldlock marker

Intervention Type DEVICE

Visicoil smallest size

Insertion of Visicoil, smallest size, marker

Intervention Type DEVICE

Visicoil larger size

Insertion of Visicoil, larger size, marker

Intervention Type DEVICE

Bard goldmarker smallest size

Insertion of Bard goldmarker, smallest size

Intervention Type DEVICE

Bard goldmarker larger size

Insertion of Bard goldmarker, larger size

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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IBA, Germany

UNKNOWN

Sponsor Role collaborator

Hospimed, Netherland

UNKNOWN

Sponsor Role collaborator

Bard Ltd

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gert De Meerleer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2008/109

Identifier Type: -

Identifier Source: org_study_id

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