High-intensity Focused Ultrasound Study

June 2, 2021 updated by: Chi Hang Yee, Chinese University of Hong Kong

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of Prostate Cancer on Biopsy
Time Frame: 3 months
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
Time Frame: 3 months and 6 months
Functional outcome 1: change in urodynamic function assessed by flowrate
3 months and 6 months
Change in Urinating Symptom Score
Time Frame: 3 months and 6 months
Functional outcome 2: change in total scores in International Prostate Symptom Score (IPSS) questionnaires
3 months and 6 months
Presence of Significant Prostate Cancer
Time Frame: 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
3 months
Change in Prostate specific antigen (PSA)
Time Frame: 3 months and 6 months
Oncological outcome 3: PSA change after treatment
3 months and 6 months
Pain score
Time Frame: Post treatment (day 1)
Post-treatment pain score ranges from 1 to 10
Post treatment (day 1)
Change in Prostate Symptom Score
Time Frame: 3 months and 6 months
Functional outcome 3: change in symptom scores in EPIC-26 questionnaire
3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2019

Primary Completion (Actual)

January 28, 2021

Study Completion (Actual)

January 28, 2021

Study Registration Dates

First Submitted

April 22, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 25, 2019

Study Record Updates

Last Update Posted (Actual)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE 2018.556

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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