High-intensity Focused Ultrasound Study

Study Overview
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Brief Summary
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Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the structures in the proximity. Active surveillance carries the risk of disease progression and psychological distress to the patients. Focal therapy employs the concept of only destroying the significant lesion, resulting in disease cure and improved functional outcome. Among the different options of focal therapy, high-intensity focused ultrasound (HIFU) is one of the most commonly employed energy sources. It exerts its effect through thermal and mechanical destruction of cancer tissue. This study aims at assess the effectiveness of such treatment in prostate cancer management. In this study, investigators evaluate the early oncological outcome and objective functional outcome of patients undergoing HIFU for the treatment of localized intermediate risk prostate cancer.

Official Title
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Evaluation of the Effectiveness of High-intensity Focused Ultrasound for the Treatment of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: High-intensity focused ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Visible index lesion(s) on MRI Index lesion(s) greater than 0.5 cm3 Found to have localized low-risk or intermediate-risk prostate cancer after MRI-USG fusion targeted biopsy and saturation biopsy: Clinical tumour stage T2, or Gleason score 7, or PSA 20 ng/ml Exclusion Criteria: Prostate size larger than 50 ml Patients unfit for contrast MRI exam Patients with previous treatment of prostate cancer Patients with previous surgery on the prostate Patients with active urinary tract infection Patients with bladder pathology including bladder stone and bladder cancer Patients with urethral stricture Patients with neurogenic bladder and/or sphincter abnormalities Fail to give informed consent

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-intensity focused ultrasound<br> | Procedure: High-intensity focused ultrasound<br>* Energy employed to exert its effect through thermal and mechanical destruction of cancer tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Prostate Cancer on Biopsy | Oncological outcome 1: percentage in absence of prostate cancer on biopsy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Urodynamic | Functional outcome 1: change in urodynamic function assessed by flowrate | 3 months and 6 months | 
| Change in Urinating Symptom Score | Functional outcome 2: change in total scores in International Prostate Symptom Score (IPSS) questionnaires | 3 months and 6 months | 
| Presence of Significant Prostate Cancer | Oncological outcome 2: presence of significant prostate cancer, defined by presence of Gleason score (ranges from 6 to 10) equals or more than 7 | 3 months | 
| Change in Prostate specific antigen (PSA) | Oncological outcome 3: PSA change after treatment | 3 months and 6 months | 
| Pain score | Post-treatment pain score ranges from 1 to 10 | Post treatment (day 1) | 
| Change in Prostate Symptom Score | Functional outcome 3: change in symptom scores in EPIC-26 questionnaire | 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Focal Therapy, High-intensity focused ultrasound