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High-intensity Focused Ultrasound Study

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
High-intensity focused ultrasound
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Focal Therapy, High-intensity focused ultrasound

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High-intensity focused ultrasound

Arm Description

Outcomes

Primary Outcome Measures

Absence of Prostate Cancer on Biopsy
Oncological outcome 1: percentage in absence of prostate cancer on biopsy

Secondary Outcome Measures

Change in Urodynamic
Functional outcome 1: change in urodynamic function assessed by flowrate
Change in Urinating Symptom Score
Functional outcome 2: change in total scores in International Prostate Symptom Score (IPSS) questionnaires
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
Change in Prostate specific antigen (PSA)
Oncological outcome 3: PSA change after treatment
Pain score
Post-treatment pain score ranges from 1 to 10
Change in Prostate Symptom Score
Functional outcome 3: change in symptom scores in EPIC-26 questionnaire

Full Information

First Posted
April 22, 2019
Last Updated
June 2, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03927924
Brief Title
High-intensity Focused Ultrasound Study
Official Title
Evaluation of the Effectiveness of High-intensity Focused Ultrasound for the Treatment of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
due to funding
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
January 28, 2021 (Actual)
Study Completion Date
January 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Focal Therapy, High-intensity focused ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity focused ultrasound
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
High-intensity focused ultrasound
Intervention Description
Energy employed to exert its effect through thermal and mechanical destruction of cancer tissue
Primary Outcome Measure Information:
Title
Absence of Prostate Cancer on Biopsy
Description
Oncological outcome 1: percentage in absence of prostate cancer on biopsy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Urodynamic
Description
Functional outcome 1: change in urodynamic function assessed by flowrate
Time Frame
3 months and 6 months
Title
Change in Urinating Symptom Score
Description
Functional outcome 2: change in total scores in International Prostate Symptom Score (IPSS) questionnaires
Time Frame
3 months and 6 months
Title
Presence of Significant Prostate Cancer
Description
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
Title
Change in Prostate specific antigen (PSA)
Description
Oncological outcome 3: PSA change after treatment
Time Frame
3 months and 6 months
Title
Pain score
Description
Post-treatment pain score ranges from 1 to 10
Time Frame
Post treatment (day 1)
Title
Change in Prostate Symptom Score
Description
Functional outcome 3: change in symptom scores in EPIC-26 questionnaire
Time Frame
3 months and 6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only man will develop prostate cancer
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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High-intensity Focused Ultrasound Study

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