Transperineal Laser Ablation for Focal Treatment of Prostate Cancer

NCT04170478 | Completed DMC

• 2 other identifiers: 2019_161NL69903.018.19
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Focal Laser Ablation; Transperineal Laser Ablation

Keywords

Prostate Cancer; Transperineal laser ablation; Prostate neoplasma; Focal laser ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

  30 days following TPLA treatment

• Size of ablation zone

  30 days following TPLA treatment

• Observation of tissue changes seen on imaging during and after treatment compared to histopathology

  30 days following TPLA treatment

• Functional outcomes measured using PROMs (VAS, IPSS, IIEF-15, EPIC)

  30 days following TPLA treatment

Interventions

Echolaser X4 system DEVICE

Transperineal laser ablation

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refusal of participation or clinically ineligible for treatment under local anaesthesia
• Prior or concurrent treatment for prostate cancer
• Other conditions / status

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Elesta S.R.L.: collaborator
• Amsterdam UMC, location VUmc: collaborator
• The Netherlands Cancer Institute: collaborator

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• J R Oddens, MD, PhD

  Urologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Urology department

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 20, 2019
• Study Start: August 1, 2020
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

NL (1)