Transperineal Laser Ablation for Focal Treatment of Prostate Cancer

Study Overview
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Brief Summary
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Rationale: Prostate cancer (PCa) is the second cause of cancer-related deaths for men. The standard surgical treatment for localised prostate cancer is radical prostatectomy. Possible side effects of this treatment are incontinence and erectile dysfunction and this is related to the whole-gland resection. A focal treatment with fewer side effects is desired for patients with only a small focus of PCa. For this purpose, focal laser ablation is feasible. Current focal laser ablation techniques use a single fibre setup with the need for fibre replacement revisualisation of the tumour side accordingly. This leads to a long treatment duration. The Echolaser® system is a laser ablation system with four simultaneously operating laser sources. This provides a potential larger treatment area, without the need for fibre replacement. This makes the system advantageous for focal laser ablation of prostate cancer, especially since it can be applied under local anaesthesia. This pilot study aims to evaluate histological ablative efficacy on radical prostatectomy specimens following TPLA, feasibility and safety using a (multi)fibre setup in men with localized prostate cancer. The investigators hypothesize that TPLA will show adequate histological ablative efficacy and will be feasible and safe.

Official Title
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Transperineal Laser Ablation for Focal Prostate Cancer: Safety and Ablative Efficacy Evaluation Using Postradical Prostatectomy Histological Analysis

Conditions
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Prostate Cancer, Focal Laser Ablation, Transperineal Laser Ablation

Intervention / Treatment
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* Device: Echolaser X4 system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male ≥40 years of age Histopathological confirmed organ-confined prostate cancer Indication for a radical prostatectomy Prostate volume ≥40 mL Ability of the patient to stop anticoagulant therapy prior to TPLA according to standard hospital pre-operative protocol Signed informed consent Exclusion Criteria: Refusal of participation or clinically ineligible for treatment under local anaesthesia Prior or concurrent treatment for prostate cancer Other conditions / status

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Echolaser X4 system|Transperineal laser ablation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablative efficacy of transperineal laser ablation determined by size of the ablation zone in histopathology, which is measured by absence of vital prostatic cells, compared to the size measured on imaging (CEUS/MRI) during and after treatment | Histological ablative efficacy is assessed on histopathological analysis of the prostatic tissue after radical prostatectomy by means of the absence of vital cells in the treated prostate zone | 30 days following TPLA treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety is assessed by device and procedural adverse events using the CTCAEv5.0 until radical prostatectomy and feasibility is determined by procedural success of the TPLA treatment. | Safety is assessed by device and procedural adverse events using the CTCAE v5.0 until radical prostatectomy. TPLA is definitely safe when ≤10% of patients experience major adverse events, defined as grade 3 or higher. Technical feasibility is determined by procedural success of the TPLA treatment. TPLA is definitely feasible when ≥90% of procedures is performed successfully without any problems regarding needle placement, fibre introduction or device malfunctioning. | 30 days following TPLA treatment | 
| Size of ablation zone | Determination of the size of the ablated area | 30 days following TPLA treatment | 
| Observation of tissue changes seen on imaging during and after treatment compared to histopathology | Ablation zone volumes are measured using CEUS and mpMRI and these are used to determine ablation zone compared to histopathological changes. Visual changes are identified and described. | 30 days following TPLA treatment | 
| Functional outcomes measured using PROMs (VAS, IPSS, IIEF-15, EPIC) | Determination of short-term functional outcomes following TPLA treatment | 30 days following TPLA treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Transperineal laser ablation, Prostate neoplasma, Focal laser ablation