Prostate Cancer
Conditions
Brief summary
Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers
Interventions
DEVICEGoldlock
Insertion of Goldlock marker
DEVICEVisicoil smallest size
Insertion of Visicoil, smallest size, marker
DEVICEVisicoil larger size
Insertion of Visicoil, larger size, marker
DEVICEBard goldmarker smallest size
Insertion of Bard goldmarker, smallest size
DEVICEBard goldmarker larger size
Insertion of Bard goldmarker, larger size
Sponsors
IBA, Germany
Hospimed, Netherland
Bard Ltd
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute toxicity after implantation of the fiducial gold markers | 1 week after implantation |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 1 week after implantation |
| Visualization of the implanted gold markers by ultrasound | After implantation |
Countries
Belgium
Outcome results
None listed