Clinical trial · Interventional
MR-guided Focal Laser Ablation of the Prostate
NCT02200809CI-TRIAL-00044805completedN/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)
Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer.
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 |
|---|---|---|---|
| Focal Laser Ablation | — | UNRESOLVED | — |
| MRI | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-guided focal laser ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MR-guided focal laser ablation
- interventionNames
- Device: MR-guided focal laser ablation
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 36 months.
- description
- The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed and biopsy proven prostate cancer * Intermediate risk patients (PSA \<= 20 ng/mL, Gleason ≤ 7, T2b) * No previous treatment for prostate cancer * Cancer lesion located at least 1 cm away from the neurovascular bundle according to Multimodality MR images * Signed informed consent by patient * Age 18 years or older * Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia) Exclusion Criteria: * 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.