Clinical trial · Interventional
High-intensity Focused Ultrasound Study
Evaluation of the Effectiveness of High-intensity Focused Ultrasound for the Treatment of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to funding
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-intensity focused ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High-intensity focused ultrasound
- interventionNames
- Procedure: High-intensity focused ultrasound
Primary outcomes (1)
- measure
- Absence of Prostate Cancer on Biopsy
- timeFrame
- 3 months
- description
- Oncological outcome 1: percentage in absence of prostate cancer on biopsy
Secondary outcomes (6)
- measure
- Change in Urodynamic
- timeFrame
- 3 months and 6 months
- description
- Functional outcome 1: change in urodynamic function assessed by flowrate
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available