Clinical trial · Interventional
MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer
Evaluation of an Alternative Treatment of Localized Prostate Cancer by Guided MRI Transurtral Ultrasound With 1-year Control of the Absence of Cancer
- 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)
Primary purpose : Evaluation of the efficiency and safety of an alternative global prostate treatment in localized prostate cancer. Primary Objective: Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up. Secondary Objectives: 1. Biochemical response 2. Presence of any CSC on biopsy at 1- and 2-year follow-up 3. Radical treatment free survival 4. Adverse events, clinical tolerance 5. Urinary continence 6. Erectile function 7. Quality of life
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 |
|---|---|---|---|
| Ablation Therapy | — | UNRESOLVED | — |
| Localized Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| MRI Guided Transurethral Ultrasound Ablation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI Guided Transurethral Ultrasound
- description
- Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
- interventionNames
- Procedure: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Primary outcomes (1)
- measure
- Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up.
- timeFrame
- 1 year
- description
- Clinically significant cancer (CSC) defined by at least one of the following criteria: * Gleason score ≥ 7 * cancer core length \> 3 mm regardless of Gleason score * \> 2 positive cores.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Male patient ≥ 50 years old * Histologically confirmed adenocarcinoma of the prostate * Gleason ≤ 7 (3 + 4) ; Grade group ≤ 2 according to Epstein * Clinically \<T3, N0, M0 * PSA \< 15 ng/mL * Prostate volume \<100g * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Life expectancy higher than 12 months in the judgement of the investigator * Radiological TNM (prostate MRI) T ≤ 2 (absence of extra-capsular extension, absence of seminal vesicle invasion), N = 0, M = 0 * First line of treatment or relapse after initial radiotherapy * Willing to give signed, informed consent freely * Able to adhere to the follow-up schedule and other protocol requirements. Exclusion Criteria: * Contraindication to MRI * Contraindication to general anesthesia * Presence or history of any other malignancy except for non-melanoma skin cancer adequately treated at least 2 years before study entry * Unreversible haemostasis disorder
References
Publications (1)
- RESULTTricard T, Cazzato RL, Schroeder A, De Mathelin M, Barhoumi C, Gaillard V, Sauleau E, Gangi A, Lang H. Magnetic Resonance Imaging-guided Transurethral Ultrasound Ablation (TULSA) of Localized Prostate Cancer: A prospective Trial. J Vasc Interv Radiol. 2025 Sep;36(9):1401-1408. doi: 10.1016/j.jvir.2025.05.024. Epub 2025 May 27. PMID 40441432