Focal Therapy Using HIFU for Localised Prostate Cancer
Conditions
Prostate Cancer
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
Prostate cancer, HIFU Hemi-ablation, Prostate biopsies
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: High Intensity Focused Ultrasound
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 50 Years
Gender: Male
Criteria: 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
Location
Jewish General Hospital,Urology Department
Montreal, Quebec, Canada
Status: Recruiting
Contact: Franck Bladou, MD - 1-514-340-8222 - fbladou@jgh.mcgill.ca
Start Date
September 2013
Completion Date
September 2016
Sponsors
Jewish General Hospital
Source
Jewish General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page