Transperineal Laser Ablation for Focal Treatment of Prostate Cancer (TPLA for PCa)
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|ClinicalTrials.gov Identifier: NCT04170478|
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : May 15, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Focal Laser Ablation Transperineal Laser Ablation||Device: Echolaser X4 system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transperineal Laser Ablation for Focal Prostate Cancer: Safety and Ablative Efficacy Evaluation Using Postradical Prostatectomy Histological Analysis|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
- Device: Echolaser X4 system
Transperineal laser ablation
- 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 [ Time Frame: 30 days following TPLA 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
- 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. [ Time Frame: 30 days following 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.
- Size of ablation zone [ Time Frame: 30 days following TPLA treatment ]Determination of the size of the ablated area
- Observation of tissue changes seen on imaging during and after treatment compared to histopathology [ Time Frame: 30 days following TPLA treatment ]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.
- Functional outcomes measured using PROMs (VAS, IPSS, IIEF-15, EPIC) [ Time Frame: 30 days following TPLA treatment ]Determination of short-term functional outcomes following TPLA treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04170478
|Contact: J R Oddens, MD, PhD||+31 20 firstname.lastname@example.org|
|Contact: L A van Riel, MD||+31 20 email@example.com|
|Principal Investigator:||J R Oddens, MD, PhD||Urologist|