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

This study is currently recruiting participants.

Verified August 2011 by University Hospital, Ghent

First Received on February 10, 2009. Last Updated on August 16, 2011 History of Changes

Sponsor:	University Hospital, Ghent
Collaborators:	IBA, Germany Hospimed, Netherland C. R. 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
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:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

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

Hospimed, Netherland

C. R. 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:	Gert De Meerleer, University Hospital Ghent
ClinicalTrials.gov Identifier:	NCT00841685 History of Changes
Other Study ID Numbers:	2008/109
Study First Received:	February 10, 2009
Last Updated:	August 16, 2011
Health Authority:	Belgium: Institutional Review Board

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012