Clinical trial · Interventional
High-Intensity Focused Ultrasound Ablation in Treating Patients With Progressive Prostate Cancer
An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer
NCT00987675CI-TRIAL-00011899unknownPhase 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 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 ablation and to see how well it works in treating patients with progressive 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| high-intensity focused ultrasound ablation | Procedure | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months
Secondary outcomes (3)
- measure
- Success of treatment as demonstrated by the absence of cancer at 6 months
- measure
- PSA kinetics after completion of treatment
- measure
- Proportion of patients requiring androgen blockade at 12 months
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed prostate cancer on transrectal ultrasound or transperineal template prostate biopsies meeting the following criteria:
* Stage ≤ T3b, N0, M0 disease
* Gleason score ≤ 8
* Serum PSA ≤ 20 ng/mL
* No metastatic disease and nodal spread by staging CT or MRI
* Negative bone scan within the past 6 months
* Index lesion or other secondary lesions with a volume of ≥ 0.5 cc by MRI
* Secondary lesions are included in the treatment provided ≥ 1 neurovascular bundle and 40-50% of prostatic tissue can be preserved
PATIENT CHARACTERISTICS:
* Able to tolerate a transrectal ultrasound
* Able to undergo major surgery as assessed by a consultant anesthesiologist
* Able to undergo MRI scanning (i.e., no severe claustrophobia, permanent cardiac pacemaker, metallic implant)
* No urethral stricture or presence of metal implants or stents in the urethra
* No prostatic calcification or cysts (on transrectal ultrasound) that would interfere with effective delivery of HIFU therapy
* No allergy to latex
PRIOR CONCURRENT THERAPY:
* No prior radiotherapy
* No prior treatment with any of the following:
* Transurethral resection of the prostate or equivalent procedures within the past 2 years
* High-intensity focused ultrasound ablation (HIFU)
* Cryosurgery
* Thermal or microwave therapy to the prostate
* No prior significant rectal surgery that prevents insertion of the transrectal HIFU probe
* More than 12 months since prior androgen suppression or hormone treatment for prostate cancerReferences
Publications (0)
Data not yet available
No reference posted for this study.