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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI Guided Transurethral Ultrasound | Experimental | Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue | Procedure | Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 1 year |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thibault TRICARD, MD | University Hospital, Strasbourg, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de strasbourg | Strasbourg | 67000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40441432 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MRI Guided Transurethral Ultrasound | Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2020 |
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| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MRI Guided Transurethral Ultrasound | Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Clinically significant cancer (CSC) on biopsy | 1 patient was deemed unfit for biopsy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Posted | Count of Participants | Participants | 1 year |
|
|
|
1 year
old study, no possibility of MedDRA coding for non-serious AE
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MRI Guided Transurethral Ultrasound | Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue | 1 | 25 | 3 | 25 | 0 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr TRICARD Thibault | Hôpitaux Universitaires de Strasbourg | 03 69 55 04 61 | thibault.tricard@chru-strasbourg.fr |
| Dec 15, 2025 |
| Prot_SAP_000.pdf |