MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer

University Hospital, Strasbourg, France25 enrolled

Overview

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: 1. Biochemical response 2. Presence of any CSC on biopsy at 1- and 2-year follow-up 3. Radical treatment free survival 4. Adverse events, clinical tolerance 5. Urinary continence 6. Erectile function 7. Quality of life

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

MRI Guided Transurethral Ultrasound Ablation Localized Prostate Cancer Ablation Therapy

Interventions

Eligibility

Sex: MALEMin age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 year