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OpenTrials
Completed

NCT Number: NCT03996005

MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate 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

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Key information

Conditions

MRI Guided Transurethral Ultrasound Ablation Ablation Therapy Localized Prostate Cancer

Age range

80 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaires de strasbourg

Strasbourg, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

Procedure

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: MRI-TULSAP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 24, 2019
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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