This is a pilot prospective biomedical study of interventional type which includes 17 patients on 24 months (12 months of inclusion and 12 months of follow-up). The objective of this study is to verify that the focal therapy technique used (with the help of Koelis® system) allows to obtain optimal dosimetric coverage of the prostate target (ie dose of 160 Gy +-5% delivered on the envelope isodose) evaluated by CT scan performed 30 days after implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Focal brachytherapy with permanent I125 localized implant.
Institut Claudius REGAUD
Toulouse, France
Feasibility of focal therapy will be evaluated with dosimetric study by CT scan / MRI performed 30 days after implantation
Feasibility of focal therapy will be evaluated in terms of "success" or "failure" : success will be obtained in case of delivered dose of at least 152 Gy on the 1st dose enveloping the Planning Target Volume, evaluated on CT scan/MRI performed at Day 30
Time frame: 3 years
Progression-free-survival according to Phoenix criterion
Progression-free-survival is defined as the time from patient inclusion to the date of biological progression according to Phoenix criterion
Time frame: 3 years
Quality of life study using 3 Patient questionnaires
Quality of life will be evaluated using 3 Patient questionnaires : the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)C30 Questionnaire, the International Index of Erectile Function Questionnaire and the International Prostate Symptom Score Questionnaire
Time frame: 3 years
Absence of tumor residuals in the target treated zone
The absence of tumor residuals in the target treated zone will be evaluated on on biopsies performed 1 year after implantation
Time frame: 3 years
Toxicity evaluation
Toxicity will be evaluated according to the classification of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0
Time frame: 3 years
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