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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

High-intensity Focused Ultrasound Study

Clinicaltrials.gov identifier NCT03927924

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted March 10, 2020

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:Prostate Cancer
  • Intervention/Treatment: Procedure: High-intensity focused ultrasound
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: March 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
  • Ages Eligible for Study: 40 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • 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
Contacts

Contact: CHI HANG YEE, MBBS 35052625 yeechihang@surgery.cuhk.edu.hk

Contact: SIU YING YIP, MPH siuying@surgery.cuhk.edu.hk

Locations

Hong Kong
The Chinese University of Hong Kong
Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

More Information
  • Responsible Party: 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: March 10, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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 Chinese University of Hong Kong: Prostate Cancer
    Focal Therapy
    High-intensity focused ultrasound
  • Additional relevant MeSH terms: Prostatic Neoplasms