Clinical trial NCT04170478: Transperineal Laser Ablation for Focal Treatment of Prostate Cancer
Official title: Transperineal Laser Ablation for Focal Prostate Cancer: Safety and Ablative Efficacy Evaluation Using Postradical Prostatectomy Histological Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Focal Laser Ablation
Transperineal Laser Ablation
Keywords: Prostate Cancer
Transperineal laser ablation
Prostate neoplasma
Focal laser ablation
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Elesta S.R.L.
name: Amsterdam UMC, location VUmc
name: The Netherlands Cancer Institute
First posted: 2019-11-20
Enrollment: 12
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 30 days following TPLA treatment
Secondary outcomes:
measure: 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.
timeFrame: 30 days following TPLA treatment
measure: Size of ablation zone
timeFrame: 30 days following TPLA treatment
measure: Observation of tissue changes seen on imaging during and after treatment compared to histopathology
timeFrame: 30 days following TPLA treatment
measure: Functional outcomes measured using PROMs (VAS, IPSS, IIEF-15, EPIC)
timeFrame: 30 days following TPLA treatment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
Study officials:
affiliation: Urologist
name: J R Oddens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: