Clinical trial NCT02016040: Focal Therapy Using HIFU for Localised Prostate Cancer
Official title: Focal Therapy Using High Intensity Focused Ultrasound (ABLATHERM®) for Localised Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Prostate cancer
HIFU Hemi-ablation
Prostate biopsies
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 25
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Rate of patients without cancer
timeFrame: Six months
Secondary outcomes:
measure: Immediate tolerance of hemi-ablation
timeFrame: One year
measure: Impact of the hemi-ablation HIFU treatment on continence, sexuality and quality of life
timeFrame: One year
measure: Cost of hemi-ablation HIFU treatment
timeFrame: One year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital,Urology Department
state: Quebec
Study officials:
affiliation: Jewish General Hospital,Urology Department
name: Franck Bladou, MD
role: PRINCIPAL_INVESTIGATOR
References: