Trial Outcomes & Findings for MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer (NCT NCT03996005)
NCT ID: NCT03996005
Last Updated: 2026-01-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
1 year
Results posted on
2026-01-08
Participant Flow
Participant milestones
| Measure |
MRI Guided Transurethral Ultrasound
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
MRI Guided Transurethral Ultrasound
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MRI Guided Transurethral Ultrasound
n=24 Participants
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
|
|---|---|
|
Age, Continuous
|
72.8 years
STANDARD_DEVIATION 7 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=24 Participants
|
|
Clinically significant cancer (CSC) on biopsy
|
10 Participants
n=23 Participants • 1 patient was deemed unfit for biopsy
|
PRIMARY outcome
Timeframe: 1 yearClinically 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.
Outcome measures
| Measure |
MRI Guided Transurethral Ultrasound
n=23 Participants
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
|
|---|---|
|
Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up.
|
8 Participants
|
Adverse Events
MRI Guided Transurethral Ultrasound
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MRI Guided Transurethral Ultrasound
n=25 participants at risk
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
|
|---|---|
|
Renal and urinary disorders
renal failure
|
4.0%
1/25 • 1 year
old study, no possibility of MedDRA coding for non-serious AE
|
|
Renal and urinary disorders
urinary retention
|
4.0%
1/25 • 1 year
old study, no possibility of MedDRA coding for non-serious AE
|
|
Cardiac disorders
Coronary artery disease
|
4.0%
1/25 • 1 year
old study, no possibility of MedDRA coding for non-serious AE
|
Other adverse events
Adverse event data not reported
Additional Information
Dr TRICARD Thibault
Hôpitaux Universitaires de Strasbourg
Phone: 03 69 55 04 61
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place