MRI Guided Transurethral Ultrasound AblationMRI-TULSAPNCT03996005
MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer
A study testing Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in people with MRI Guided Transurethral Ultrasound Ablation and Localized Prostate Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older, men only
- Conditions the study is for
- MRI Guided Transurethral Ultrasound Ablation, Localized Prostate Cancer, Ablation Therapy
- What is being tested?
- Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2019to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Biochemical response
- Presence of any CSC on biopsy at 1- and 2-year follow-up
- Radical treatment free survival
- Adverse events, clinical tolerance
- Urinary continence
- Erectile function
- Quality of life
- Being tested
- Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate TissueProcedure or surgery
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
| Study group | Role | What they receive |
|---|---|---|
| MRI Guided Transurethral Ultrasound | Experimental | Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue Receives: Procedure: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start24 Sep 2019
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MRI Guided Transurethral Ultrasound AblationStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibault TRICARD, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996005
- Sponsor's protocol ID
- 7429
- Acronym
- MRI-TULSAP
- Status last verified
- Dec 2025
- First submitted
- 19 Jun 2019
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tricard T, Cazzato RL, Schroeder A, De Mathelin M, Barhoumi C, Gaillard V, Sauleau E, Gangi A, Lang H. Magnetic Resonance Imaging-guided Transurethral Ultrasound Ablation (TULSA) of Localized Prostate Cancer: A prospective Trial. J Vasc Interv Radiol. 2025 Sep;36(9):1401-1408. doi: 10.1016/j.jvir.2025.05.024. Epub 2025 May 27.
PubMed 40441432
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Alternative Treatment of Localized Prostate Cancer by Guided MRI Transurtral Ultrasound With 1-year Control of the Absence of Cancer
- ClinicalTrials.gov ID
- NCT03996005
- Acronym / sponsor ID
- MRI-TULSAP / 7429
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Posted 8 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Biochemical response
- Presence of any CSC on biopsy at 1- and 2-year follow-up
- Radical treatment free survival
- Adverse events, clinical tolerance
- Urinary continence
- Erectile function
- Quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI Guided Transurethral Ultrasound | Experimental | Procedure: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate TissueMagnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue |
Who may qualify
- Ages
- 80 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate TissueMagnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue | Procedure or surgery | MRI Guided Transurethral Ultrasound |
Primary outcome
Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40441432Tricard T, Cazzato RL, Schroeder A, De Mathelin M, Barhoumi C, Gaillard V, Sauleau E, Gangi A, Lang H. Magnetic Resonance Imaging-guided Transurethral Ultrasound Ablation (TULSA) of Localized Prostate Cancer: A prospective Trial. J Vasc Interv Radiol. 2025 Sep;36(9):1401-1408. doi: 10.1016/j.jvir.2025.05.024. Epub 2025 May 27.
Related trials for MRI Guided Transurethral Ultrasound Ablation
Active, not recruitingPhase 1
Neoadjuvant ADT With TULSA in the Treatment of Intermediate Risk Prostate Cancer
Localized Prostate Carcinoma, Castration-Naive Prostate Cancer
Recruiting
MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer
Prostate Carcinoma, Stage I Prostate Cancer AJCC v8
Active, not recruiting
Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostate Cancer
Localized Prostate Cancer
Active, not recruiting
Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer
Prostate Cancer
Active, not recruiting
A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer
Prostate Cancer, Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thibault TRICARD, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in people with MRI Guided Transurethral Ultrasound Ablation and Localized Prostate Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03996005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.