Clinical trial · Interventional
Focal Prostate Ablation Versus Radical Prostatectomy
A Randomized Control Trial of Focal Prostate Ablation Versus Radical Prostatectomy
NCT03668652CI-TRIAL-00088074FARPcompletedN/AClinicalTrials.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)
This study aims to compare the treatment results of HIFU and Radical prostatectomy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical) | Device | — | UNRESOLVED |
| Radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Focal prostate cancer treatment by HIFU
- description
- Patients with target lesion distance \< 30 mm from the rectum will be treated with High Intensity Focused Ultrasound (HIFU) applied by FocalOne HIFU device and patients with lesion localized \> 30 mm from the rectum will be treated with TULSA applied by TULSA-PRO device.
- interventionNames
- Device: Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical)
- type
- ACTIVE_COMPARATOR
- label
- Radical Prostatectomy
- description
- Robot assisted laparoscopic radical prostatectomy or open retro-pubic radical prostatectomy will be performed using validated radical prostatectomy technique. Nerve sparing surgery on side of cancer free prostate lobe will be performed and type of nerve sparing procedure will be specified.
- interventionNames
- Procedure: Radical prostatectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Positive MRI (PIRAD 3-5) and biopsy proven unilateral prostate cancer classified as ISUP 1 (with cancer core length \> 5mm) or ISUP 2-3 (any length) not eligible to active surveillance or watchful waiting * PSA ≤ 20 ng/ml * Treatment naive patients with localized prostate cancer (stage ≤ T2b) Exclusion Criteria: * Clinical stage T\> 2b * Metastatic lymph node on imaging * Patients already treated for Pca (hormone therapy, EBRT) * Patients with contra-indications to MRI * Patients with active inflammatory bowel disease or previous rectal fistula * History of previous pelvic radiotherapy * History of bladder cancer * History of bladder neck or urethral stricture * Urogenital infection in progress * Allergy to latex or gadolinium * Patients on life support or suffering form unstable neurological diseases
References
Publications (0)
Data not yet available
No reference posted for this study.