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

Tracking Information

First Received Date ^ICMJE

February 10, 2009

Last Updated Date

February 12, 2009

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00841685 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Device: Goldlock
Device: Visicoil smallest size
Device: Visicoil larger size
Device: Bard goldmarker smallest size
Device: Bard goldmarker larger size

Study Arms / Comparison Groups

Experimental: Goldlock
Active Comparator: Visicoil smallest size
Active Comparator: Visicoil larger size
Active Comparator: Bard goldmarker smallest size
Active Comparator: Bard goldmarker larger size

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Valérie Fonteyne, MD

Valerie.fonteyne@uzgent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT ID ^ICMJE

NCT00841685

Responsible Party

Gert De Meerleer, University Hospital Ghent

Study ID Numbers ^ICMJE

2008/109

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

IBA
Hospimed
Bard

Investigators ^ICMJE

Principal Investigator:

Gert De Meerleer, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP