High-intensity Focused Ultrasound Study

NCT03927924 | Terminated

• 1 other identifier: CRE 2018.556
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

Prostate Cancer; Focal Therapy; High-intensity focused ultrasound

Outcome Measures

Primary Outcomes (1)

• Absence of Prostate Cancer on Biopsy

  Oncological outcome 1: percentage in absence of prostate cancer on biopsy

  3 months

Secondary Outcomes (6)

• Change in Urodynamic

  3 months and 6 months

• Change in Urinating Symptom Score

  3 months and 6 months

• Presence of Significant Prostate Cancer

  3 months

• Change in Prostate specific antigen (PSA)

  3 months and 6 months

• Pain score

  Post treatment (day 1)

Study Arms (1)

High-intensity focused ultrasound

EXPERIMENTAL

Procedure: High-intensity focused ultrasound

Interventions

High-intensity focused ultrasound PROCEDURE

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

High-intensity focused ultrasound

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Only man will develop prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Associate Professor

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 25, 2019
• Study Start: June 25, 2019
• Primary Completion: January 28, 2021
• Study Completion: January 28, 2021
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)