High-intensity Focused Ultrasound Study

Chinese University of Hong Kong5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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: 1. Clinical tumour stage T2, or 2. Gleason score 7, or 3. 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

Outcomes

Primary Outcomes

Absence of Prostate Cancer on Biopsy

Oncological outcome 1: percentage in absence of prostate cancer on biopsy

Time frame: 3 months

Secondary Outcomes

Change in Urodynamic

Functional outcome 1: change in urodynamic function assessed by flowrate

Time frame: 3 months and 6 months

Change in Urinating Symptom Score

Functional outcome 2: change in total scores in International Prostate Symptom Score (IPSS) questionnaires

Time frame: 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

Time frame: 3 months

Change in Prostate specific antigen (PSA)

Oncological outcome 3: PSA change after treatment

Time frame: 3 months and 6 months

Pain score

Post-treatment pain score ranges from 1 to 10

Time frame: Post treatment (day 1)

Change in Prostate Symptom Score

Functional outcome 3: change in symptom scores in EPIC-26 questionnaire

Time frame: 3 months and 6 months

High-intensity Focused Ultrasound Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes