Clinical trial · Interventional
MRI-guided Focal Laser Ablation
Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer
NCT04379362CI-TRIAL-00054036UnicornunknownPhase 2ClinicalTrials.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)
Magnetic resonance imaging-guided focal laser ablation of 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 |
|---|---|---|---|
| Focal laser ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Low or intermediate grade prostate cancer
- interventionNames
- Procedure: Focal laser ablation
Primary outcomes (1)
- measure
- Urine incontinence incontinence
- timeFrame
- At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
- description
- To evaluate a change in the functional outcome urine incontinence before and after FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3).
Secondary outcomes (6)
- measure
- Local cancer control
- timeFrame
- At inclusion , 3 months, 6 months, 12 months and 24 months follow up.
- description
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 ≤ 15 mm large axis; * Life expectancy at inclusion of more 10 years; * Diagnosis of prostate cancer confirmed by targeted biopsy using TRUS-MRI fusion or in-bore MRI guided biopsies; * 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 MRI signs of extra-capsular extension or invasion of the seminal vesicles; * Maximum cancer core length \>3 mm and/or maximum Gleason score of 3+4 on systematic biopsies outside the visible tumor area on mpMRI; * 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)
Data not yet available
No reference posted for this study.