Focal Therapy Using HIFU for Localised Prostate Cancer

Jewish General Hospital

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Prostate Cancer

Treatments

Procedure: High Intensity Focused Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT02016040

#12-030

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

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