Skip to main content
OpenTrials
Completed

NCT Number: NCT04170478

Transperineal Laser Ablation for Focal Treatment of Prostate Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Focal Laser Ablation Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Transperineal Laser Ablation Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echolaser X4 system

Device

Transperineal laser ablation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Size of ablation zone

    Time frame: 30 days following TPLA treatment

    Determination of the size of the ablated area

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Amsterdam UMC, location VUmc
  • Elesta S.R.L.
  • The Netherlands Cancer Institute

Registry information

Official study title

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

Acronym: TPLA for PCa

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2019
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.