MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer

Not Applicable

Completed

• Conditions: Localized Prostate Cancer; Ablation Therapy; MRI Guided Transurethral Ultrasound Ablation

• Registration Number: NCT03996005
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-24
• Study Start: 2019-09-24
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up.	1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpitaux Universitaires de strasbourg; 🇫🇷 Strasbourg, France