MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer (MRI-TULSAP)

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

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 Overview

• Status: Completed
• Conditions: Localized Prostate Cancer; MRI Guided Transurethral Ultrasound Ablation; Ablation Therapy
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI Guided Transurethral Ultrasound; Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue	Procedure: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue; Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Thibault TRICARD, MD, University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 24, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 7429

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No