NCT04170478

Transperineal Laser Ablation for Focal Treatment of Prostate Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Focal Laser Ablation
• Transperineal Laser Ablation

Interventions

Type	Name	Description
DEVICE	Echolaser X4 system	Transperineal laser ablation

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-10-15
• Completion: 2021-10-15
• First posted: 2019-11-20
• Last updated: 2021-10-18

Locations

1 site across 1 country: Netherlands