Prostate Cancer
Conditions
Keywords
Prostate cancer, HIFU Hemi-ablation, Prostate biopsies
Brief summary
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.
Interventions
PROCEDUREHigh Intensity Focused Ultrasound
Sponsors
Jewish General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients without cancer | Six months | MRI,Biopsy,PSA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate tolerance of hemi-ablation | One year | Adverse events |
| Impact of the hemi-ablation HIFU treatment on continence, sexuality and quality of life | One year | Questionnaires |
| Cost of hemi-ablation HIFU treatment | One year | — |
Countries
Canada
Outcome results
None listed