4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / High-intensity Focused Ultrasound Study

High-intensity Focused Ultrasound Study

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: High-intensity focused ultrasound Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness of High-intensity Focused Ultrasound for the Treatment of Prostate Cancer
Actual Study Start Date : June 25, 2019
Actual Primary Completion Date : January 28, 2021
Actual Study Completion Date : January 28, 2021
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. Absence of Prostate Cancer on Biopsy [ Time Frame: 3 months ]
    Oncological outcome 1: percentage in absence of prostate cancer on biopsy


Secondary Outcome Measures :
  1. Change in Urodynamic [ Time Frame: 3 months and 6 months ]
    Functional outcome 1: change in urodynamic function assessed by flowrate

  2. 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. 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

  4. Change in Prostate specific antigen (PSA) [ Time Frame: 3 months and 6 months ]
    Oncological outcome 3: PSA change after treatment

  5. Pain score [ Time Frame: Post treatment (day 1) ]
    Post-treatment pain score ranges from 1 to 10

  6. Change in Prostate Symptom Score [ Time Frame: 3 months and 6 months ]
    Functional outcome 3: change in symptom scores in EPIC-26 questionnaire


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only man will develop prostate cancer
Accepts Healthy Volunteers:   No
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:

    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
Contacts and Locations

Locations
Layout table for location information
Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date June 4, 2021
Actual Study Start Date  ICMJE June 25, 2019
Actual Primary Completion Date January 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		Absence of Prostate Cancer on Biopsy [ Time Frame: 3 months ]
Oncological outcome 1: percentage in absence of prostate cancer on biopsy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Change in Urodynamic [ Time Frame: 3 months and 6 months ]
    Functional outcome 1: change in urodynamic function assessed by flowrate
  • 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
  • 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
  • Change in Prostate specific antigen (PSA) [ Time Frame: 3 months and 6 months ]
    Oncological outcome 3: PSA change after treatment
  • Pain score [ Time Frame: Post treatment (day 1) ]
    Post-treatment pain score ranges from 1 to 10
  • Change in Prostate Symptom Score [ Time Frame: 3 months and 6 months ]
    Functional outcome 3: change in symptom scores in EPIC-26 questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-intensity Focused Ultrasound Study
Official Title  ICMJE Evaluation of the Effectiveness of High-intensity Focused Ultrasound for the Treatment of Prostate Cancer
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Procedure: High-intensity focused ultrasound
Energy employed to exert its effect through thermal and mechanical destruction of cancer tissue
Study Arms  ICMJE Experimental: High-intensity focused ultrasound
Intervention: Procedure: High-intensity focused ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 2, 2021) 		5
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		20
Actual Study Completion Date  ICMJE January 28, 2021
Actual Primary Completion Date January 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Only man will develop prostate cancer
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927924
Other Study ID Numbers  ICMJE CRE 2018.556
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chi Hang Yee, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese University of Hong Kong
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

治疗案例

前沿医讯