Clinical trial · Interventional
High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer
NCT00988130CI-TRIAL-00011920unknownPhase 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: High-intensity focused ultrasound focal ablation uses high-energy sound waves to kill tumor cells. PURPOSE: This phase II trial is studying the side effects of high-intensity focused ultrasound focal ablation and to see how well it works in treating patients with progressive prostate cancer.
Conditions
Conditions (2)
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 | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| high-intensity focused ultrasound ablation | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Total proportion of men with erectile dysfunction and/or incontinence
- measure
- Quality of life
Secondary outcomes (3)
- measure
- Success of index lesion ablation with HIFU at 6 months
- measure
- Prostate-specific antigen kinetics
- measure
- Proportion of men requiring androgen blockade at 12 months
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer by transrectal or transperineal template prostate biopsies * Stage ≤ T3bN0M0 * Gleason grade ≤ 8 * Serum PSA ≤ 20 ng/mL * Bone scan- or cross-sectional imaging-negative for metastatic or nodal (outside prostate) disease * No metastatic disease and/or nodal spread by CT scan or MRI * Index lesion or other secondary lesions with a volume ≥ 0.5 cc by MRI * No prostatic calcification and cysts (on transrectal ultrasound) that would interfere with effective delivery of therapy PATIENT CHARACTERISTICS: * Able to tolerate a transrectal ultrasound * Not allergic to latex * Fit for major surgery as assessed by a consultant anaesthetist * Able to have MRI scanning (i.e., none of the following conditions: severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc.) PRIOR CONCURRENT THERAPY: * No prior radiotherapy * No androgen suppression and/or hormone treatment within the past 12 months * No prior significant rectal surgery preventing insertion of transrectal high-intensity focused ultrasound (HIFU) probe (decided on the type of surgery in individual cases) * No prior transurethral resection of the prostate (or equivalent procedures) within the past 2 years * No prior HIFU, cryosurgery, thermal, or microwave therapy to the prostate
References
Publications (1)
- DERIVEDAhmed HU, Dickinson L, Charman S, Weir S, McCartan N, Hindley RG, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal Ablation Targeted to the Index Lesion in Multifocal Localised Prostate Cancer: a Prospective Development Study. Eur Urol. 2015 Dec;68(6):927-36. doi: 10.1016/j.eururo.2015.01.030. Epub 2015 Feb 11. PMID 25682339