To evaluate the rate of patients without cancer detected by biopsies performed six months after hemi-ablation with high intensity focused ultrasound (HIFU) (Ablatherm ®). Evaluate the impact of the HIFU treatment on continence, sexuality and quality of life at one year. Evaluate the cost of hemi-ablation HIFU treatment. A prospective single -centre phase II, single arm, cohort study (therapeutic confirmatory) offering focal therapy using HIFU (Ablatherm ®) to 25 men with histologically proven localised low to intermediate risk prostate cancer (PSA ≤10ng/ml, Gleason score ≤ 7 ,T1c or T2b ). Precise mapping and characterisation of the disease will be established using multi-parametric (mp)-MRI and prostate biopsies. Only the lobe with disease will be treated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Jewish General Hospital,Urology Department
Montreal, Quebec, Canada
Rate of patients without cancer
MRI,Biopsy,PSA
Time frame: Six months
Immediate tolerance of hemi-ablation
Adverse events
Time frame: One year
Impact of the hemi-ablation HIFU treatment on continence, sexuality and quality of life
Questionnaires
Time frame: One year
Cost of hemi-ablation HIFU treatment
Time frame: One year
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