NCT03996005

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. 1.Biochemical response
  2. 2.Presence of any CSC on biopsy at 1- and 2-year follow-up
  3. 3.Radical treatment free survival
  4. 4.Adverse events, clinical tolerance
  5. 5.Urinary continence
  6. 6.Erectile function
  7. 7.Quality of life

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 24, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 8, 2026

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

3.8 years

First QC Date

June 19, 2019

Results QC Date

November 18, 2025

Last Update Submit

January 7, 2026

Conditions

MRI Guided Transurethral Ultrasound AblationLocalized Prostate CancerAblation Therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

MRI Guided Transurethral Ultrasound

EXPERIMENTAL

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

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

Interventions

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate TissuePROCEDURE

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

MRI Guided Transurethral Ultrasound

Eligibility Criteria

Age80 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de strasbourg

Strasbourg, 67000, France

Location

Related Publications (1)

  • 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.

    PMID: 40441432RESULT

Results Point of Contact

Title
Dr TRICARD Thibault
Organization
Hôpitaux Universitaires de Strasbourg
thibault.tricard@chru-strasbourg.fr
03 69 55 04 61

Study Officials

  • Thibault TRICARD, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 24, 2019

Study Start

September 24, 2019

Primary Completion

July 25, 2023

Study Completion

July 25, 2023

Last Updated

January 8, 2026

Results First Posted

January 8, 2026

Record last verified: 2025-12

Locations

FR(1)