High-intensity Focused Ultrasound Study

The Chinese University of Hong Kong

Status: Terminated

Conditions: Prostate Cancer

Treatments: Procedure: High-intensity focused ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT03927924

CRE 2018.556

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

High-intensity focused ultrasound

Experimental group

Treatment:

Procedure: High-intensity focused ultrasound