- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03927924
High-intensity Focused Ultrasound Study
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Chinese University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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
Study Plan
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
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE 2018.556
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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Clinical Trials on High-intensity focused ultrasound
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Marc Dall'Era, MDNational Cancer Institute (NCI)RecruitingLocalized Prostate Carcinoma | Stage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8United States
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Philips HealthcareCompletedSecondary Malignant Neoplasm of BoneFrance
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Shufang ChangRecruitingCervical Intraepithelial NeoplasiaChina
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Hospices Civils de LyonWithdrawnPlacenta AccretaFrance
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Centre Antoine LacassagneWithdrawn
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Virginia Polytechnic Institute and State UniversityNot yet recruiting
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National Taiwan University HospitalUnknownSymptomatic Abdominal TumourTaiwan
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Imperial College LondonSonaCare MedicalUnknownCervical Cancer | Rectal Cancer | Rectal Neoplasms | Pelvic Cancer | Endometrial CancerUnited Kingdom
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Jewish General HospitalUnknown
-
University Women's Hospital TübingenTheraclionCompletedBreast FibroadenomaGermany