N/A N=25 Treatment

MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer

MRI Guided Transurethral Ultrasound Ablation · Localized Prostate Cancer · Ablation Therapy

Bottom Line

View on ClinicalTrials.gov: NCT03996005 ↗

Enrolled (actual)

Serious AEs

12.0%

Results posted

Jan 2026

Primary outcome: Primary: Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up. — 8 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue (Procedure)
Age: Older Adult · 80+ yrs
Sex: Male
Sponsor: University Hospital, Strasbourg, France
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up.	8	—

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03996005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.