Transperineal Laser Ablation for Focal Treatment of Prostate Cancer

Prostate Cancer Clinical Trial

— TPLA for PCa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04170478
• Other study ID #: 2019_161
• Secondary ID: NL69903.018.19
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: October 2021
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Focal Laser Ablation
• Prostate Cancer
• Prostatic Neoplasms
• Transperineal Laser Ablation

Intervention

Device:
• Echolaser X4 system
Transperineal laser ablation

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland

Sponsors (4)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Elesta S.R.L., The Netherlands Cancer Institute, VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Size of ablation zone	Determination of the size of the ablated area	30 days following TPLA treatment
Secondary	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
Secondary	Functional outcomes measured using PROMs (VAS, IPSS, IIEF-15, EPIC)	Determination of short-term functional outcomes following TPLA treatment	30 days following TPLA treatment