Transperineal Laser Ablation for Focal Treatment of Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-10-15

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.

Detailed Description

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Conditions

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Prostate Cancer Focal Laser Ablation Transperineal Laser Ablation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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Echolaser X4 system

Transperineal laser ablation

Intervention Type DEVICE

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

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Prof.dr. H.P. Beerlage

Head of Urology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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J R Oddens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Urologist

Locations

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Academic Medical Center

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL69903.018.19

Identifier Type: OTHER

Identifier Source: secondary_id

2019_161

Identifier Type: -

Identifier Source: org_study_id