MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer

Study Overview
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Brief Summary
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Primary purpose : Evaluation of the efficiency and safety of an alternative global prostate treatment in localized prostate cancer. Primary Objective: Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up. Secondary Objectives: Biochemical response Presence of any CSC on biopsy at 1- and 2-year follow-up Radical treatment free survival Adverse events, clinical tolerance Urinary continence Erectile function Quality of life

Official Title
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Evaluation of an Alternative Treatment of Localized Prostate Cancer by Guided MRI Transurtral Ultrasound With 1-year Control of the Absence of Cancer

Conditions
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MRI Guided Transurethral Ultrasound Ablation, Localized Prostate Cancer, Ablation Therapy

Intervention / Treatment
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* Procedure: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patient ≥ 50 years old Histologically confirmed adenocarcinoma of the prostate Gleason ≤ 7 (3 + 4) ; Grade group ≤ 2 according to Epstein Clinically <T3, N0, M0 PSA < 15 ng/mL Prostate volume <100g Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Life expectancy higher than 12 months in the judgement of the investigator Radiological TNM (prostate MRI) T ≤ 2 (absence of extra-capsular extension, absence of seminal vesicle invasion), N = 0, M = 0 First line of treatment or relapse after initial radiotherapy Willing to give signed, informed consent freely Able to adhere to the follow-up schedule and other protocol requirements. Exclusion Criteria: Contraindication to MRI Contraindication to general anesthesia Presence or history of any other malignancy except for non-melanoma skin cancer adequately treated at least 2 years before study entry Unreversible haemostasis disorder

Ages Eligible for Study
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Minimum Age: 80 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: MRI Guided Transurethral Ultrasound<br>Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue | Procedure: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue<br>* Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up. | Clinically significant cancer (CSC) defined by at least one of the following criteria: Gleason score ≥ 7 cancer core length > 3 mm regardless of Gleason score > 2 positive cores. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical response | PSA | Month 3 | 
| Biochemical response | PSA | Month 6 | 
| Biochemical response | PSA | Month 12 | 
| Presence of any CSC on biopsy at 1-year follow-up | Pathology analysis of the biopsy | at 1-year follow-up | 
| Radical treatment free survival | Evaluation of the complication according to Dindo-Clavien | at 1-year follow-up | 
| Adverse events, clinical tolerance |  | at 1-year follow-up | 
| Urinary continence | Urinary continence evaluation by using the USP scale | Month 3 | 
| Urinary continence | Urinary continence evaluation by using the USP scale | Month 6 | 
| Urinary continence | Urinary continence evaluation by using the USP scale | Month 12 | 
| Erectile function | Erectile function evaluated by using the IIEF15 scale | Month 3 | 
| Erectile function | Erectile function evaluated by using the IIEF15 scale | Month 6 | 
| Erectile function | Erectile function evaluated by using the IIEF15 scale | Month 12 | 
| Quality of life EORTC QLQ-C30 scale. | EORTC QLQ-C30 scale. | Month 3 | 
| Quality of life EORTC QLQ-C30 scale. | EORTC QLQ-C30 scale. | Month 6 | 
| Quality of life EORTC QLQ-C30 scale. | EORTC QLQ-C30 scale. | Month 12 |