Transperineal Laser Ablation for Low- and Intermediate Risk Prostate Cancer: a Single Cohort Analysis

Study Overview
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Brief Summary
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The goal of this prospective study is to test the efficacy of Echolaser transperineal focal therapy in patients with low- and intermediate risk prostate cancer. The main question it aims to answer are: 1. short and intermediate term oncological outcomes after laser focal therapy, 2. functional outcomes and quality of life after treatment. Participants affected by low risk prostate cancer will undergo trans perineal laser focal therapy. Multiparametric prostate MRI will be perform after 3 and 12 months for oncological control. Re-fusion biopsy will be perform after 12 months. Functional outcomes and quality of life will be assess at 3, 6 and 12 months.

Official Title
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Transperineal Laser Ablation for Low and Intermediate Risk Prostate Cancer: a Single Cohort Analysis

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Soractelite Echolaser Transperineal focal laser ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with low- and intermediate risk prostate cancer classified as International Society for Urological Pathology, ISUP 1-2. Exclusion Criteria: patients diagnosed with urothelial cancer contraindications for MRI Multifocal prostate cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPLA in patients with prostate cancer<br>Patients diagnosed with low- and intermediate risk unifocal prostate cancer undergo to focal laser ablation therapy. | Procedure: Soractelite Echolaser Transperineal focal laser ablation<br>* US/MRI fusion laser ablation of low- and intermediate risk prostate cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological outcomes MRI | Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by multiparametric prostate MRI. Specifically, 1. complete ablation, 2. partial ablation or 3. persistence of cancer will be identified. | 3 months after treatment | 
| Oncological outcomes MRI | Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by multiparametric prostate MRI. Specifically, 1. complete ablation, 2. partial ablation or 3. persistence of cancer will be identified. | 12 months after treatment | 
| Oncological outcomes PSA | Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA. | 3 months after treatment. | 
| Oncological outcomes PSA | Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA. | 6 months after treatment. | 
| Oncological outcomes PSA | Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA. | 12 months after treatment. | 
| Oncological outcomes Re-biopsy | Evaluation of histological outcomes after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual negativity for cancer in a re-biopsy. | 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcomes IPSS and IPSS QoL | Evaluation of lower urinary tract symptoms and quality of life after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the IPSS, International Prostatic Symptoms Score. | 3, 6 and 12 months after treatment. | 
| Quality of life Pain | Evaluation of pain after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the visual analogue scale (VAS). The VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the parameter to be measured (pain) from 0 to 10 orientated from the left (no pain) to the right (unbearable pain). | day after surgery | 
| Functional outcomes Continence | Evaluation of continence rate after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the ICIQ-SF, International Consulation on Incontinence Questionnaire - Short Form. | 3, 6 and 12 months after treatment. | 
| Functional outcomes Erection | Evaluation of erectile function after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the IIEF5, International Index of Erectile Function. | 3, 6 and 12 months after treatment. | 
| Functional outcomes Ejaculation | Evaluation of ejaculatory function after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the MSHQ SF, Male Sexual Health Questionnaire short form. | 3, 6 and 12 months after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, focal therapy, Echolaser, transperineal laser ablation, TPLA