Clinical trial · Interventional
High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized Prostate Cancer
An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
NCT00561262CI-TRIAL-00011907completedPhase 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 energy may be able to kill tumor cells by heating them without affecting normal tissue. PURPOSE: This phase II trial is studying how well high-intensity focused ultrasound ablation therapy works in treating patients with localized 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high-intensity focused ultrasound ablation | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Feasibility
- measure
- Adverse events
- measure
- Patient acceptability as assessed by Assessment of Cancer Therapy - Prostate (FACT-P), International Prostate Symptom Score (IPSS) , IPSS-Quality of Life, Continence Questionnaire, and 15-Item International Index of Erectile Function
- measure
- Side effect profile
Secondary outcomes (4)
- measure
- Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir
- measure
- Exclusion of cancer on MRI at 2-7 days and at 6 months
- measure
- Transrectal ultrasound biopsies at 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 79 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria: * Gleason score ≤ 7 (patterns 3+4 or 4+3 or less are acceptable) * Cancer prostate-confined only * Cancer confined to one lobe as defined by transrectal ultrasound (TRUS) biopsy * Serum prostate-specific antigen (PSA) ≤ 15 ng/mL * Prostate volume ≤ 40 cc OR AP length of prostate \< 4 cm * Unilateral prostate adenocarcinoma must be verified in stage 1 of this trial unless the patient has had multi-sequence MRI and transperineal template biopsies outside of this trial in similar procedure protocols to this trial * No evidence of metastatic disease * No intraprostatic calcifications ≥ 10 mm in size in cancer-positive side of prostate PATIENT CHARACTERISTICS: * Life expectancy ≥ 5 years * No latex allergies * No American Society of Anesthesiology surgical risk score III or IV * No contraindications to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artefact to images) * Must be fit for general anesthesia or regional anesthesia as assessed by the consultant anesthetist PRIOR CONCURRENT THERAPY: * More than 6 months since prior androgen suppression therapy * No prior radiotherapy for prostate cancer * No prior chemotherapy for prostate cancer * No prior significant rectal surgery preventing insertion of transrectal probe * No prior transurethral resection of the prostate or laser prostatectomy * No prior high-intensity focused ultrasound, cryosurgery, thermal, or microwave therapy to the prostate
References
Publications (1)
- RESULTAhmed HU, Freeman A, Kirkham A, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localized prostate cancer: a phase I/II trial. J Urol. 2011 Apr;185(4):1246-54. doi: 10.1016/j.juro.2010.11.079. Epub 2011 Feb 22. PMID 21334018