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High-intensity Focused Ultrasound Study

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ClinicalTrials.gov Identifier: NCT03927924
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Chi Hang Yee, 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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Study Start Date : April 24, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927924


Contacts
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Contact: CHI HANG YEE, MBBS 35052625 yeechihang@surgery.cuhk.edu.hk
Contact: SIU YING YIP, MPH siuying@surgery.cuhk.edu.hk

Locations
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Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: SIU YING YIP, MPH       siuying@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: Chi Hang Yee, Honorary Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03927924     History of Changes
Other Study ID Numbers: CRE 2018.556
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Chi Hang Yee, Chinese University of Hong Kong:
Prostate Cancer
Focal Therapy
High-intensity focused ultrasound
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases