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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00841685

2008/109

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 5 patient groups

1

Experimental group

Description:

Goldlock

Treatment:

Device: Goldlock

2

Active Comparator group

Description:

Visicoil smallest size

Treatment:

Device: Visicoil smallest size

3

Active Comparator group

Description:

Visicoil larger size

Treatment:

Device: Visicoil larger size

4

Active Comparator group

Description:

Bard goldmarker smallest size

Treatment:

Device: Bard goldmarker smallest size

5

Active Comparator group

Description:

Bard goldmarker larger size

Treatment:

Device: Bard goldmarker larger size