Transperineal Laser Ablation Treatment (TPLA) for Prostate Cancer (PCa) Registry

Study Overview
=================
Brief Summary
-----------------
Rationale: Transperineal laser ablation (TPLA) treatment for prostate cancer (PCa) is a minimal invasive focal therapy technique studied worldwide to determine its efficacy. In pilot studies it has shown to be a safe and feasible technique and it has potential to preserve continence and potency over current standard radical therapies. However, (long-term) treatment outcomes of TPLA for PCa remain largely unknown. The aim of this international retrospective registry is to collect and combine data on patients treated TPLA for PCa in order to provide data on safety, feasibility, functional and oncological outcomes. Objective: To assess safety and feasibility of TPLA for PCa, to assess functional and oncological outcomes of TPLA for PCa and to determine baseline patient characteristics in a multicentre cohort. Study design: This is an international, retrospective observational registry in which data is recorded of patients who have been treated with TPLA for PCa. Study population: Male patients treated with TPLA for PCa. Main study parameters/endpoints: The primary endpoint of this registry is oncological outcomes of TPLA for PCa. Secondary endpoints are safety, feasibility and functional outcomes of TPLA for PCa.

Official Title
-----------------
Transperineal Laser Ablation Treatment for Prostate Cancer Registry: a Retrospective and Multicenter Evaluation

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Transperineal Laser Ablation of Prostate Cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, histological-confirmed disease of localized prostate cancer, TPLA treatment for PCa is performed Exclusion Criteria: Age < 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transperineal Laser Ablation of Prostate Cancer|Minimal invasive transperineal laser ablation treatment for prostate cancer|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological control | Oncological control is defined as: a PSA <=2.0ng/mL than initial PSA and/or no residual tumor or other lesion suspicious for prostate cancer on magnetic resonance imaging and/or no gleason score upgrading on re-biopsy and/or no clinical up-staging of prostate cancer T-stage | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continence rate | Continence is assessed by usage of number of pads per day, and 0-1 pad per day usage is defined as continent. | 12 months | 
| Potency rate | Potency is defined as erectile function sufficient for sexual intercourse, with or without medical aid | 12 months | 
| Urinary flow | Urinary flow is assessed by peak urinary flow (mL/s) and residual urine (mL). The higher the peak urinary flow and the lower the residual urine, the better the urinary flow. | 12 months | 
| PROM regarding voiding | International Prostate Symptom Score (IPSS) is used to determine functional outcome regarding voiding. IPSS is on a score of 0 to 35, and the higher the score the worse the outcome. | 12 months | 
| PROM regarding erectile function | International Index of Erectile Function (IIEF-5) is used to determine erectile function based on a validated questionnaire. IIEF-5 is on a scale of 5 to 25, and the higher the score the better the outcome. | 12 months | 
| Safety of TPLA for PCa | Safety is defined as 10% or less CTCAE (version 5) grade 3 and no CTCAE grade 4 or 5 | Up to 12 weeks | 
| Feasibility of TPLA for PCa | Feasibility is assessed by amount of machine failures perioperatively of TPLA and hospital duration (hours) directly after TPLA. | Up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laser Ablation, Minimal invasive, Focal therapy