Focal Therapy Using HIFU for Localised Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Focal Therapy Using High Intensity Focused Ultrasound (ABLATHERM®) for Localised Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: High Intensity Focused Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥ 50 years Clinical stage T1c (normal digital rectal examination) or T2a (one palpable nodule on digital rectal examination) PSA ≤10 ng / mL Presence of cancer on biopsies (12 sampling biopsies plus 2-4 targeted biopsies on one side and limited to one or two contiguous areas of prostate: basic and middle or middle and apex). Gleason score ≤ 7 (3+4) Flowmetry > 12 mL / sec for a voided volume of 125 mL PVR <100 mL Patient with normal anal and rectal anatomy. Patient with a condition corresponding to a classification of ASA 1 or 2. Patient signing ICF and agreed for following monitoring Exclusion Criteria: Patient with an ASA score 3. Patient in clinical stage T1a, T1b, T2b, T2c or T3. Patient with a tumor visible on MRI: Located at a distance less than 5 mm from the midline. Located less than 6 mm from the apex real Metastatic lymph node or metastasis discovered by MRI and bone scan. Patient previously treated for his prostate cancer by hormone therapy. Patient with a distance between the rectal mucosa and prostate capsule over 8 mm thick History of inflammatory bowel disease Rectal fistula. History of pelvic radiotherapy. History of bladder cancer. History of bladder neck sclerosis or urethral stenosis. Patient with an implant located less than 1 cm from the treatment zone (stent, catheter). Urogenital infection. Latex allergy Contraindication to MRI (pacemaker,metal prosthesis ...) Patient participated in another clinical study within 30 days. Illiterate patients Legally incapable patients

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIFU hemi-ablation<br>Focal Therapy Using High Intensity Focused Ultrasound (Ablatherm) | Procedure: High Intensity Focused Ultrasound<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients without cancer | MRI,Biopsy,PSA | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate tolerance of hemi-ablation | Adverse events | One year | 
| Impact of the hemi-ablation HIFU treatment on continence, sexuality and quality of life | Questionnaires | One year | 
| Cost of hemi-ablation HIFU treatment |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, HIFU Hemi-ablation, Prostate biopsies