Focal Therapy Using HIFU for Localised Prostate Cancer

NCT ID: NCT02016040

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-17
• Study Completion Date: 2017-11-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIFU hemi-ablation

Focal Therapy Using High Intensity Focused Ultrasound (Ablatherm)

Group Type: ACTIVE_COMPARATOR

High Intensity Focused Ultrasound

Intervention Type: PROCEDURE

Interventions

High Intensity Focused Ultrasound

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr.Franck Bladou

MD. Professor of Oncology and Urology, McGill University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franck Bladou, MD

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital,Urology Department

Locations

Jewish General Hospital,Urology Department

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

#12-030

Identifier Type: -

Identifier Source: org_study_id