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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

Conditions: Prostate Cancer; Focal Laser Ablation; Transperineal Laser Ablation

Treatments: Device: Echolaser X4 system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04170478

NL69903.018.19 (Other Identifier)

2019_161

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)