Clinical trial · Interventional
MRI-guided Focal Laser Ablation Prostate Cancer
Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate 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)
Prostate cancer is the most frequent malignancy in the male population of developed countries and has a substantial socio-economic impact. Focal therapies, including focal laser ablation (FLA), are gaining ground as a novel strategy to treat organ-confined low- to intermediate risk PCa while preserving healthy tissue and reduce treatment-related morbidity associated with radical treatments. This project has the goal to perform a feasibility study on magnetic resonance imaging (MRI)-guided focal laser ablation using the TRANBERG®\|Thermoguide Therapy System including TRANBERG®Thermoguide Workstation for MR thermometry developed by the company CLS AB.
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 Neoplams, Magnetic Resonance Imaging, Laser Ablation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focal laser ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI-guided focal laser ablation
- interventionNames
- Device: Focal laser ablation
Primary outcomes (2)
- measure
- completion of complete ablation without technical failures
- timeFrame
- 1 day
- description
- completion of laser ablation without technical failures, achievement of complete ablation shown by MRI after treatment calculated using image co-registration software, total procedure time, total numver of fiber positions and ablations needed
- measure
- procedure-related adverse events and complications following SIR criteria
- timeFrame
- 6 months
- description
- procedure-related adverse events and complications following SIR criteria
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: * MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging); * maximum MRI visible lesion size is ≤ 20 mm large axis; * age 45 to 76 years old; * life expectancy at inclusion of more 10 years; * diagnosis of prostate cancer confirmed by targeted biopsy; * criteria of low and intermediate risk of progression and eligibility for focal therapy; * clinical stage of maximum T2c * maximum biopsy Gleason score of 4 + 3 on targeted biopsies * serum prostate specific antigen \< 15 ng/ml * patient accepting to be included in an active surveillance protocol at the end of the study, in accordance with the recommendations of good practice. Exclusion Criteria: * History of prostate surgery; * history of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis; * history of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer); * severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an IPSS score \> 18; * tumor with extra-capsular extension or invasion of the seminal vesicles; * patients with \>2 lesions; * impossibility to obtain a valid informed consent; * patients unable to undergo MR imaging, including those with contra-indications; * contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection); * metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging; * patients with evidence for nodal or metastatic disease; * patients with an estimated Glomerular Filtration Ratio (eGFR) \< 40 mL/min/1.73 m2
References
Publications (0)
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