Prostate CancerNCT03927924
High-intensity Focused Ultrasound Study
A study testing High-intensity focused ultrasound in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High-intensity focused ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Jun 2019to 28 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients with urethral stricture
- Patients with neurogenic bladder and/or sphincter abnormalities
- Fail to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- High-intensity focused ultrasound
- Keywords
- Prostate Cancer, Focal Therapy, High-intensity focused ultrasound
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity focused ultrasoundProcedure or surgery
Energy employed to exert its effect through thermal and mechanical destruction of cancer tissue
| Study group | Role | What they receive |
|---|---|---|
| High-intensity focused ultrasound | Experimental | Not described Receives: Procedure: High-intensity focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Prostate Cancer on Biopsy
Oncological outcome 1: percentage in absence of prostate cancer on biopsy
Measured: 3 months
Secondary outcomes (6)
Change in Urodynamic
Functional outcome 1: change in urodynamic function assessed by flowrate
Measured: 3 months and 6 months
Change in Urinating Symptom Score
Functional outcome 2: change in total scores in International Prostate Symptom Score (IPSS) questionnaires
Measured: 3 months and 6 months
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
Measured: 3 months
Change in Prostate specific antigen (PSA)
Oncological outcome 3: PSA change after treatment
Measured: 3 months and 6 months
Pain score
Post-treatment pain score ranges from 1 to 10
Measured: Post treatment (day 1)
Change in Prostate Symptom Score
Functional outcome 3: change in symptom scores in EPIC-26 questionnaire
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start25 Jun 2019
- Primary completion28 Jan 2021
- Study completion28 Jan 2021
Why it stopped: due to funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Hang Yee, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927924
- Sponsor's protocol ID
- CRE 2018.556
- Status last verified
- Jun 2021
- First submitted
- 22 Apr 2019
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of High-intensity Focused Ultrasound for the Treatment of Prostate Cancer
- ClinicalTrials.gov ID
- NCT03927924
- Acronym / sponsor ID
- CRE 2018.556
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Focal Therapy, High-intensity focused ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-intensity focused ultrasound | Experimental | Procedure: High-intensity focused ultrasound |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity focused ultrasoundEnergy employed to exert its effect through thermal and mechanical destruction of cancer tissue | Procedure or surgery | High-intensity focused ultrasound |
Primary outcome
Absence of Prostate Cancer on Biopsy
Time frame: 3 months
Oncological outcome 1: percentage in absence of prostate cancer on biopsy
6 secondary outcomes
Change in Urodynamic
Time frame: 3 months and 6 months
Change in Urinating Symptom Score
Time frame: 3 months and 6 months
Presence of Significant Prostate Cancer
Time frame: 3 months
Change in Prostate specific antigen (PSA)
Time frame: 3 months and 6 months
Pain score
Time frame: Post treatment (day 1)
Change in Prostate Symptom Score
Time frame: 3 months and 6 months
Results and safety
The study was stopped early (reason given: due to funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity focused ultrasound in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of Prostate Cancer on Biopsy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.