High-intensity Focused Ultrasound Study

NCT ID: NCT03927924

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-25
• Study Completion Date: 2021-01-28

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High-intensity focused ultrasound

Group Type: EXPERIMENTAL

High-intensity focused ultrasound

Intervention Type: PROCEDURE

Energy employed to exert its effect through thermal and mechanical destruction of cancer tissue

Interventions

High-intensity focused ultrasound

Energy employed to exert its effect through thermal and mechanical destruction of cancer tissue

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Chi Hang Yee

Honorary Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

CRE 2018.556

Identifier Type: -

Identifier Source: org_study_id