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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MRI Guided Transurethral Ultrasound Ablation

Eligibility Criteria

80 Years - undefined (Older Adult)MaleDoes not accept 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

Sites / Locations

  • Hôpitaux Universitaires de strasbourg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI Guided Transurethral Ultrasound

Arm Description

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Biochemical response
PSA
Biochemical response
PSA
Biochemical response
PSA
Presence of any CSC on biopsy at 1-year follow-up
Pathology analysis of the biopsy
Radical treatment free survival
Evaluation of the complication according to Dindo-Clavien
Adverse events, clinical tolerance
Urinary continence
Urinary continence evaluation by using the USP scale
Urinary continence
Urinary continence evaluation by using the USP scale
Urinary continence
Urinary continence evaluation by using the USP scale
Erectile function
Erectile function evaluated by using the IIEF15 scale
Erectile function
Erectile function evaluated by using the IIEF15 scale
Erectile function
Erectile function evaluated by using the IIEF15 scale
Quality of life EORTC QLQ-C30 scale.
EORTC QLQ-C30 scale.
Quality of life EORTC QLQ-C30 scale.
EORTC QLQ-C30 scale.
Quality of life EORTC QLQ-C30 scale.
EORTC QLQ-C30 scale.

Full Information

First Posted
June 19, 2019
Last Updated
August 28, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT03996005
Brief Title
MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer
Acronym
MRI-TULSAP
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MRI Guided Transurethral Ultrasound Ablation, Localized Prostate Cancer, Ablation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI Guided Transurethral Ultrasound
Arm Type
Experimental
Arm Description
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Intervention Description
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Primary Outcome Measure Information:
Title
Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Biochemical response
Description
PSA
Time Frame
Month 3
Title
Biochemical response
Description
PSA
Time Frame
Month 6
Title
Biochemical response
Description
PSA
Time Frame
Month 12
Title
Presence of any CSC on biopsy at 1-year follow-up
Description
Pathology analysis of the biopsy
Time Frame
at 1-year follow-up
Title
Radical treatment free survival
Description
Evaluation of the complication according to Dindo-Clavien
Time Frame
at 1-year follow-up
Title
Adverse events, clinical tolerance
Time Frame
at 1-year follow-up
Title
Urinary continence
Description
Urinary continence evaluation by using the USP scale
Time Frame
Month 3
Title
Urinary continence
Description
Urinary continence evaluation by using the USP scale
Time Frame
Month 6
Title
Urinary continence
Description
Urinary continence evaluation by using the USP scale
Time Frame
Month 12
Title
Erectile function
Description
Erectile function evaluated by using the IIEF15 scale
Time Frame
Month 3
Title
Erectile function
Description
Erectile function evaluated by using the IIEF15 scale
Time Frame
Month 6
Title
Erectile function
Description
Erectile function evaluated by using the IIEF15 scale
Time Frame
Month 12
Title
Quality of life EORTC QLQ-C30 scale.
Description
EORTC QLQ-C30 scale.
Time Frame
Month 3
Title
Quality of life EORTC QLQ-C30 scale.
Description
EORTC QLQ-C30 scale.
Time Frame
Month 6
Title
Quality of life EORTC QLQ-C30 scale.
Description
EORTC QLQ-C30 scale.
Time Frame
Month 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thibault TRICARD, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires de strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

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MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer

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