Magnetic resonance imaging-guided focal laser ablation of prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Focal laser ablation
Radboudumc
Nijmegen, Netherlands
RECRUITINGUrine incontinence incontinence
To evaluate a change in the functional outcome urine incontinence before and after FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3).
Time frame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
Local cancer control
To assess the safety outcome local cancer control achieved at the ablation site after FLA by multiparametric MR imaging and targeted prostate biopsies.
Time frame: At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
International Prostate Symptom Score (IPSS)
To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. International Prostate Symptom Score (IPSS)
Time frame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)
To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)
Time frame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
International Consultation on Incontinence Questionnaire (ICIQ)
To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. the International Consultation on Incontinence Questionnaire (ICIQ).
Time frame: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
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Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25
To evaluate quality of life before and after FLA in men with prostate cancer by using a validated quality of life questionnaire (EORTC QLQ PR25).
Time frame: At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
Complication rate
To evaluate the complication rate related to the technique
Time frame: At inclusion , 3 months, 6 months, 12 months and 24 months follow up.