Clinical trial · Interventional
High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
Feasibility Study for Locally Recurrent Prostate Cancer Treatment With HIFU Using the SONABLATE System
NCT00030277CI-TRIAL-00011307completedPhase 1ClinicalTrials.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 cancer cells by heating the tumor without affecting the surrounding tissue. PURPOSE: This phase I trial is studying focused ultrasound energy to see how well it works in treating patients with locally recurrent 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 ablation | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed locally recurrent prostate cancer after prior brachytherapy or external-beam radiotherapy for initial diagnosis of organ-confined disease (clinical stage T1 or T2 only) * Prostatic fossa biopsy positive for cancer cells * Gleason score no greater than 7 * PSA levels 0.5-10 ng/mL * Able to adequately visualize local recurrence on transrectal ultrasound imaging * No prostate calcification greater than 5 mm * No metastases by bone scan PATIENT CHARACTERISTICS: Age: * 40 to 80 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No bleeding disorder as determined by abnormal PT and PTT Renal: * No active urinary tract infection * No history of urinary bladder neck contracture Other: * No prior allergy to latex * No Anesthesia Surgical Assignment (ASA) category IV or greater * No interest in future fertility * No history of inflammatory bowel disease * No other concurrent major nonmalignant debilitating illness * No other prior or concurrent malignancy except skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy for prostate cancer Chemotherapy: * No prior chemotherapy for prostate cancer Endocrine therapy: * At least 3 months since prior hormonal therapy (including finasteride) for prostate cancer Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics * No prior radical prostatectomy * No prior transurethral resection of prostate * No prior urethral stent * No prior major rectal surgery Other: * No prior thermotherapy * No other prior therapy for prostate cancer * No concurrent warfarin or other anticoagulant
References
Publications (0)
Data not yet available
No reference posted for this study.