Transperineal Laser Ablation for Focal Prostate Cancer: Safety and Ablative Efficacy Evaluation Using Postradical Prostatectomy Histological Analysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Prof.dr. H.P. Beerlage
Head of Urology department
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eligibility Criteria
Inclusion Criteria
- •≥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
Outcomes
Primary Outcomes
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
Time Frame: 30 days following TPLA 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
Secondary Outcomes
- 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)
- Observation of tissue changes seen on imaging during and after treatment compared to histopathology(30 days following TPLA treatment)
- Size of ablation zone(30 days following TPLA treatment)
- Functional outcomes measured using PROMs (VAS, IPSS, IIEF-15, EPIC)(30 days following TPLA treatment)