Clinical trial · Interventional
High-Intensity Focused Ultrasound in Treating Participants With Intermediate and High-risk Prostate Cancer
Translation of High-intensity Focused Ultrasound (HIFU) or Treatment of Intermediate and High-Risk Prostate Cancer
NCT03514927CI-TRIAL-00040197withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No funding
Summary
Brief summary (as posted)
This phase II trial studies how well high-intensity focused ultrasound works in treating participants with intermediate and high-risk prostate cancer. High-intensity focused ultrasound uses high frequency sound waves to deliver a strong beam which may target and destroy a specific part of the prostate, while minimizing damage to surrounding structures and tissue.
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 Stage I AJCC V6 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer Stage II | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer Stage III | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-Enhanced Ultrasound | Procedure | — | UNRESOLVED |
| High-Intensity Focused Ultrasound | Device | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Multiparametric Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (HIFU, radical prostatectomy)
- description
- HIFU PHASE: Participants undergo mpMRI and CEUS pre-HIFU treatment and then CEUS post-HIFU treatment. Participants then undergo HIFU treatment over 2-2.5 hours. PROSTATECTOMY PHASE: Within 2-4 weeks post-HIFU treatment, participants undergo mpMRI 1-2 days prior to radical prostatectomy. On the day of surgery, participants undergo CEUS prior to radical prostatectomy.
- interventionNames
- Procedure: Contrast-Enhanced Ultrasound
- Device: High-Intensity Focused Ultrasound
- Other: Laboratory Biomarker Analysis
- Procedure: Multiparametric Magnetic Resonance Imaging
- Procedure: Radical Prostatectomy
Primary outcomes (1)
- measure
- Mean percentage of viable clinically-significant prostate cancer (Gleason pattern 4 or 5) after high-intensity focused ultrasound (HIFU) treatment
- timeFrame
- Up to 3 months
- description
- Determined by calculating the mean percent of viable cancer tissue remaining after HIFU using two different measurements: histologic examination of excised prostate specimen and histologic examination of post HIFU needle biopsy. Each of these two measurements will be investigated independently using two types of analyses as follows: percent viable cancer in excised prostate specimen and percent viable cells using post-HIFU needle biopsy. Will calculate the mean percent viable cancer across patients along with a corresponding 95% confidence interval based on all 32 fully evaluable patients.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Male having a diagnosis of clinically-significant prostate cancer (CsPCa) made within the past 12 months (Gleason 7-9) with no evidence of metastatic disease; all outside pathology will be re-reviewed at University of Southern California (USC) to verify diagnosis * Patients have elected to undergo radical prostatectomy (RP) as treatment of choice and have to be a surgical candidate for RP; this determination will be made by the patient in conjunction with their treating urologist and is current standard of practice * Standard preoperative evaluation is performed and deemed satisfactory to proceed to surgery as per their treating urologist * Ability to understand AND willingness to sign a written informed consent * Patients must be willing to undergo HIFU, CEUS, MRI and prostate biopsy pre-RP for research purposes Exclusion Criteria: * Patients may not be receiving any other investigational agents or have received any definitive prostate cancer (PCa)-specific treatment (en-bloc resection of bladder tumors \[EBRT\], Brachytherapy etc) prior * Patients with known metastases would be excluded from this clinical trial * Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinical significant cardiac arrhythmia (rate controlled atrial fibrillation allowed), or psychiatric illness/social situations that would limit compliance with study requirements * Patients with active autoimmune diseases or active immune suppressive therapy or inflammatory bowel disease; a low dose steroid daily administration (equivalent dexamethasone \< 10mg/day) is acceptable * Patients with rectal disease * Patients who are unable to undergo MRI * Patients with convincing evidence of extraprostatic extension or T4 disease on digital rectal examination (DRE)
References
Publications (0)
Data not yet available
No reference posted for this study.