Clinical trial · Interventional
Focal Laser Ablation for the Treatment of Focal Low-Intermediate Risk Prostate Cancer
Short-term Efficacy of Transperineal Laser Ablation (TPLA) With Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer: Interventional Pilot Study
- 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)
Short-term Efficacy of Transperineal Laser Ablation (TPLA) with Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer. It is an interventional pilot study. The clinical evaluation will be carried out at different times as follows: Time 0: recruitment and eligibility assessment (patient selection) Time 1: interview, signing of informed consent and enrollment Time 2: FLA treatment and control with multiparametric MRI of the post-procedural prostate. Time 3-4-5-6: follow up to 1 (T3), 6 (T4), 12 (T5) and 24 (T6) months from the procedure. The primary objective of the study is to evaluate the short-term (2 years) efficacy of FLA treatment of low-intermediate risk prostate cancer Secondary objective is to investigate multiparametric prostate MRI as a follow-up diagnostic investigation, evaluating possible glandular morphostructural changes and their correlation with clinical data.
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 |
|---|---|---|---|
| Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ECHOLASER X4 Socratelite
- description
- Optic fiber of 300um will be inserted at a distance of 8-10mm from the urethra. Each ablation lasts 6 minutes. Each fiber ablates at an energy of 1800J with a power of 2-3W. Treatment lasts for about 30 minutes.
- interventionNames
- Device: Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA)
Primary outcomes (2)
- measure
- Disease free survival
- timeFrame
- 5 years
- description
- Cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results in a 5 year period.
- measure
- Evaluation of Complications of prostate Laser Ablation on the Treatment of Focal Low-Intermediate Risk Prostate Cancer by use of mp-MRI.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 46 Years
- Maximum age
- 86 Years
Show eligibility criteria text
Inclusion Criteria: * Male * Over 45 years old * Prostate cancer identified after prostatic biopsy with fusion of images with target and systematic samples (\> 12) * Intermediate progression risk (Gleason Score 3 + 4 or 4 + 3; PSA \<15 ng / ml; clinical stage T1-T2a) * Low risk of progression (Gleason score 3 + 3) only in patients who wish to leave or who refuse the active surveillance protocol and who refuse validated treatments for the treatment of organo-confined prostate cancer: radical surgery and / or radiotherapy Exclusion Criteria: * Prostate cancer Gleason Score\> = 4 + 4. * Clinical stage\> T2a * PSA\> 15 ng / ml * Presence of metastases from prostate lymph node, bone or visceral carcinoma detected by bone scintigraphy, total body CT or PET-CT * Serious coagulation disorders not correctable * Unavailable or replaceable anticoagulant and / or antiplatelet therapy * Inadequate compliance * Presence of pacemakers * Contraindications to MRI (claustrophobia, ear implants, metal prostheses) * Paramagnetic contrast agent allergy * Acute and / or chronic renal failure (GFR \<50 mL / min and serum creatinine\> 1.5 mg / dl) * Tumor volume \<15 ml measured on MRI
References
Publications (11)
- BACKGROUNDPatelli G, Ranieri A, Paganelli A, Mauri G, Pacella CM. Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1440-1446. doi: 10.1007/s00270-017-1662-9. Epub 2017 May 4. PMID 28474112
- BACKGROUNDLindner U, Lawrentschuk N, Trachtenberg J. Image guidance for focal therapy of prostate cancer. World J Urol. 2010 Dec;28(6):727-34. doi: 10.1007/s00345-010-0604-9. Epub 2010 Oct 21. PMID 20963422
- BACKGROUNDLindner U, Weersink RA, Haider MA, Gertner MR, Davidson SR, Atri M, Wilson BC, Fenster A, Trachtenberg J. Image guided photothermal focal therapy for localized prostate cancer: phase I trial. J Urol. 2009 Oct;182(4):1371-7. doi: 10.1016/j.juro.2009.06.035. Epub 2009 Aug 14. PMID 19683262
- BACKGROUNDGoldberg SN, Grassi CJ, Cardella JF, Charboneau JW, Dodd GD 3rd, Dupuy DE, Gervais D, Gillams AR, Kane RA, Lee FT Jr, Livraghi T, McGahan J, Phillips DA, Rhim H, Silverman SG; Society of Interventional Radiology Technology Assessment Committee. Image-guided tumor ablation: standardization of terminology and reporting criteria. J Vasc Interv Radiol. 2005 Jun;16(6):765-78. doi: 10.1097/01.RVI.0000170858.46668.65. PMID 15947040
- BACKGROUNDBremer C, Kreft G, Roggan A, Filler T, Reimer P. Ex vivo evaluation of novel miniaturized laser-induced interstitial thermotherapy applicators for effective small-volume tissue ablation. Invest Radiol. 2001 Jun;36(6):327-34. doi: 10.1097/00004424-200106000-00005. PMID 11410753
- BACKGROUNDCostello AJ, Johnson DE, Bolton DM. Nd:YAG laser ablation of the prostate as a treatment for benign prostatic hypertrophy. Lasers Surg Med. 1992;12(2):121-4. doi: 10.1002/lsm.1900120202. PMID 1374142
- BACKGROUNDOto A, Sethi I, Karczmar G, McNichols R, Ivancevic MK, Stadler WM, Watson S, Eggener S. MR imaging-guided focal laser ablation for prostate cancer: phase I trial. Radiology. 2013 Jun;267(3):932-40. doi: 10.1148/radiol.13121652. Epub 2013 Feb 25.