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

This study is currently recruiting participants.

Verified by University Hospital, Ghent, February 2009

First Received: February 10, 2009 Last Updated: February 12, 2009 History of Changes

Sponsor:	University Hospital, Ghent
Collaborators:	IBA Hospimed Bard
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00841685

Purpose

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

Condition	Intervention
Prostate Cancer	Device: Goldlock Device: Visicoil smallest size Device: Visicoil larger size Device: Bard goldmarker smallest size Device: Bard goldmarker larger size

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Ultrasound

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Acute toxicity after implantation of the fiducial gold markers [ Time Frame: 1 week after implantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Visualization of the implanted gold markers by ultrasound [ Time Frame: After implantation ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Goldlock	Device: Goldlock Insertion of Goldlock marker
2: Active Comparator Visicoil smallest size	Device: Visicoil smallest size Insertion of Visicoil, smallest size, marker
3: Active Comparator Visicoil larger size	Device: Visicoil larger size Insertion of Visicoil, larger size, marker
4: Active Comparator Bard goldmarker smallest size	Device: Bard goldmarker smallest size Insertion of Bard goldmarker, smallest size
5: Active Comparator Bard goldmarker larger size	Device: Bard goldmarker larger size Insertion of Bard goldmarker, larger size

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841685

Contacts

Contact: Valérie Fonteyne, MD

Valerie.fonteyne@uzgent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Principal Investigator: Gert De Meerleer, MD, PhD
Sub-Investigator: Valérie Fonteyne, MD

Sponsors and Collaborators

University Hospital, Ghent

IBA

Hospimed

Bard

Investigators

Principal Investigator:

Gert De Meerleer, MD, PhD

University Hospital, Ghent

More Information

Additional Information:

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital Ghent ( Gert De Meerleer )
Study ID Numbers:	2008/109
Study First Received:	February 10, 2009
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00841685 History of Changes
Health Authority:	Belgium: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010