High-intensity Focused Ultrasound Study

Prostate Cancer Clinical Trial

Official title:

Evaluation of the Effectiveness of High-intensity Focused Ultrasound for the Treatment of Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03927924
• Other study ID #: CRE 2018.556
• Status: Terminated
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: January 28, 2021

Study information

• Verified date: June 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 28, 2021
• Est. primary completion date: January 28, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• High-intensity focused ultrasound
Energy employed to exert its effect through thermal and mechanical destruction of cancer tissue

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of Prostate Cancer on Biopsy	Oncological outcome 1: percentage in absence of prostate cancer on biopsy	3 months
Secondary	Change in Urodynamic	Functional outcome 1: change in urodynamic function assessed by flowrate	3 months and 6 months
Secondary	Change in Urinating Symptom Score	Functional outcome 2: change in total scores in International Prostate Symptom Score (IPSS) questionnaires	3 months and 6 months
Secondary	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	3 months
Secondary	Change in Prostate specific antigen (PSA)	Oncological outcome 3: PSA change after treatment	3 months and 6 months
Secondary	Pain score	Post-treatment pain score ranges from 1 to 10	Post treatment (day 1)
Secondary	Change in Prostate Symptom Score	Functional outcome 3: change in symptom scores in EPIC-26 questionnaire	3 months and 6 months