Focal Therapy Using HIFU for Localised Prostate Cancer

Focal Therapy Using High Intensity Focused Ultrasound (ABLATHERM®) for Localised Prostate Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: High Intensity Focused Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital,Urology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HIFU hemi-ablation; Focal Therapy Using High Intensity Focused Ultrasound (Ablatherm)	Procedure: High Intensity Focused Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients without cancer	MRI,Biopsy,PSA	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate tolerance of hemi-ablation	Adverse events	One year
Impact of the hemi-ablation HIFU treatment on continence, sexuality and quality of life	Questionnaires	One year
Cost of hemi-ablation HIFU treatment		One year

Collaborators and Investigators

• Sponsor: Jewish General Hospital
• Investigators: Principal Investigator: Franck Bladou, MD, Jewish General Hospital,Urology Department

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2013
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (Estimate): December 19, 2013

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Prostate cancer; HIFU Hemi-ablation; Prostate biopsies
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: #12-030