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

Tracking Information
First Submitted Date ICMJE	February 10, 2009
First Posted Date ICMJE	February 11, 2009
Last Update Posted Date	December 5, 2014
Study Start Date ICMJE	December 2008
Estimated Primary Completion Date	May 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 10, 2009)	Acute toxicity after implantation of the fiducial gold markers [ Time Frame: 1 week after implantation ]
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; (submitted: February 10, 2009)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
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	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label)
Condition ICMJE	Prostate Cancer
Intervention ICMJE	Device: Goldlock Insertion of Goldlock marker; Device: Visicoil smallest size Insertion of Visicoil, smallest size, marker; Device: Visicoil larger size Insertion of Visicoil, larger size, marker; Device: Bard goldmarker smallest size Insertion of Bard goldmarker, smallest size; Device: Bard goldmarker larger size Insertion of Bard goldmarker, larger size
Study Arms	Experimental: 1 Goldlock Intervention: Device: Goldlock; Active Comparator: 2 Visicoil smallest size Intervention: Device: Visicoil smallest size; Active Comparator: 3 Visicoil larger size Intervention: Device: Visicoil larger size; Active Comparator: 4 Bard goldmarker smallest size Intervention: Device: Bard goldmarker smallest size; Active Comparator: 5 Bard goldmarker larger size Intervention: Device: Bard goldmarker larger size
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: February 10, 2009)	20
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	May 2015
Estimated Primary Completion Date	May 2015 (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
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00841685
Other Study ID Numbers ICMJE	2008/109
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University Hospital, Ghent
Study Sponsor ICMJE	University Hospital, Ghent
Collaborators ICMJE	IBA, Germany; Hospimed, Netherland; Bard Ltd
Investigators ICMJE	Principal Investigator: Gert De Meerleer, MD, PhD University Hospital, Ghent
PRS Account	University Hospital, Ghent
Verification Date	December 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP