Clinical trial · Interventional
High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate Cancer
An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
NCT00561314CI-TRIAL-00011879completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the tumor without affecting the surrounding tissue. PURPOSE: This phase II trial is studying the side effects and how well highly focused ultrasound energy works in treating patients with localized prostate cancer.
Conditions
Conditions (3)
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 |
| Sexual Dysfunction | — | UNRESOLVED | — |
| Urinary Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| high-intensity focused ultrasound ablation | Procedure | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events
- measure
- Patient acceptability, urinary symptoms, and erectile function as assessed by Functional Assessment of Cancer Treatment-Prostate (FACT-P); Item International Index of Erectile Dysfunction (IIEF-15); International Prostate Symptom Score (IPSS); I ...
Secondary outcomes (1)
- measure
- Effectiveness of high-intensity focal ultrasound ablation to control prostate cancer as determined by time to PSA nadir, MRI at 10-20 days and again at 6 months, biopsies of treated areas at 6 months, and by recording the need for secondary or adjuva ...
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Low-risk disease, as defined by the following criteria:
* Gleason grade total ≤ 7 (patterns 3+4 or 4+3 or less acceptable)
* Localized disease (unilateral or bilateral) (stage T2c, N0, M0 or less)
* Serum PSA ≤ 15 ng/mL
* Prostate volume ≤ 40 cc or maximum anterior-posterior length ≤ 40 mm
* Multi-sequence-MRI and transperineal template 5 mm-spaced biopsies performed within the past 6 months
* All malignant areas must be treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and ≥ 1 neurovascular bundle is preserved
* No intraprostatic calcifications making high-intensity focused ultrasound of focal areas of cancer untreatable
* No metastatic disease
PATIENT CHARACTERISTICS:
* Life expectancy ≥ 5 years
* Must be fit for general or regional anesthesia as assessed by Consultant Anesthetist
* No prior rectal fistula
* No American Society of Anesthesiology grades III-IV
* No latex allergies
* No contraindication to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artifact to images)
* No moderate to severe inflammatory bowel disease
PRIOR CONCURRENT THERAPY:
* No androgen suppression treatment within the past 6 months
* No transurethral resection of the prostate or laser prostatectomy within the past 5 years
* No prior treatment (i.e., radiotherapy, brachytherapy, surgery, laser therapy, chemotherapy, high-intensity focused ultrasound, cryosurgery, thermal therapy, or microwave therapy) for prostate cancer
* No prior significant rectal surgery preventing insertion of transrectal probeReferences
Publications (1)
- RESULTAhmed HU, Hindley RG, Dickinson L, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study. Lancet Oncol. 2012 Jun;13(6):622-32. doi: 10.1016/S1470-2045(12)70121-3. Epub 2012 Apr 17. PMID 22512844