Transperineal Laser Ablation for Focal Treatment of Prostate Cancer (TPLA for PCa)

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Focal Laser Ablation; Transperineal Laser Ablation
• Intervention / Treatment: Device: Echolaser X4 system

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Amsterdam UMC, location VUmc; The Netherlands Cancer Institute; Elesta S.R.L.
• Investigators: Principal Investigator: J R Oddens, MD, PhD, Urologist

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Prostate Cancer; Focal laser ablation; Transperineal laser ablation; Prostate neoplasma
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2019_161; NL69903.018.19 (Other Identifier: Toetsingonline)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No