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

University Hospital, Strasbourg, France

Status: Completed

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

Treatments: Procedure: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

Study type: Interventional

Funder types: Other

Identifiers

NCT03996005

7429

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: Male

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

MRI Guided Transurethral Ultrasound

Experimental group

Description:

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

Treatment:

Procedure: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue