High-intensity Focused Ultrasound Study

Not Applicable

Terminated

• Conditions: Prostate Cancer
• Interventions: Procedure: High-intensity focused ultrasound

• Registration Number: NCT03927924
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-25
• Study Start: 2019-06-25
• Primary Completion: 2021-01-28
• Study Completion: 2021-01-28
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High-intensity focused ultrasound	High-intensity focused ultrasound	-

Primary Outcome Measures

Name	Time	Method
Absence of Prostate Cancer on Biopsy	3 months	Oncological outcome 1: percentage in absence of prostate cancer on biopsy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong