Prostate Cancer
Conditions
Keywords
Prostate Cancer, Focal Therapy, High-intensity focused ultrasound
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.
Interventions
PROCEDUREHigh-intensity focused ultrasound
Energy employed to exert its effect through thermal and mechanical destruction of cancer tissue
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Prostate Cancer on Biopsy | 3 months | Oncological outcome 1: percentage in absence of prostate cancer on biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinating Symptom Score | 3 months and 6 months | Functional outcome 2: change in total scores in International Prostate Symptom Score (IPSS) questionnaires |
| Presence of Significant Prostate Cancer | 3 months | Oncological outcome 2: presence of significant prostate cancer, defined by presence of Gleason score (ranges from 6 to 10) equals or more than 7 |
| Change in Urodynamic | 3 months and 6 months | Functional outcome 1: change in urodynamic function assessed by flowrate |
| Pain score | Post treatment (day 1) | Post-treatment pain score ranges from 1 to 10 |
| Change in Prostate Symptom Score | 3 months and 6 months | Functional outcome 3: change in symptom scores in EPIC-26 questionnaire |
| Change in Prostate specific antigen (PSA) | 3 months and 6 months | Oncological outcome 3: PSA change after treatment |
Countries
Hong Kong
Outcome results
None listed