MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-24

Study Completion Date

2023-07-25

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:

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

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Detailed Description

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Conditions

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MRI Guided Transurethral Ultrasound Ablation Localized Prostate Cancer Ablation Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MRI Guided Transurethral Ultrasound

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

Group Type EXPERIMENTAL

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

Intervention Type PROCEDURE

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

Interventions

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Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

Intervention Type PROCEDURE

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

Minimum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No