Trial results for the NeuroSAFE procedure, an intervention for Prostate Cancer, were posted on ClinicalTrials.gov on 2025-09-04. The study reported a statistically significant mean difference of 3.18 units (95% CI: 1.62, 4.75) in erectile function favoring the NeuroSAFE procedure compared to control (p=0.0001).
Background
Prostate cancer is a prevalent malignancy, and radical prostatectomy is a common surgical treatment. A significant concern with this procedure is its potential impact on patients' quality of life, particularly regarding functional outcomes such as erectile function and urinary continence. The NeuroSAFE technique, which involves frozen section technology, aims to mitigate these side effects by improving surgical precision while maintaining oncological effectiveness.
Trial design
This study, titled "Evaluating the Effects of Frozen Section Technology on Oncological and Functional Outcomes at Radical Prostatectomy," enrolled a total of 407 participants. The trial phase was not specified in the provided data. The study focused on patients with Prostate Cancer. The intervention group received the NeuroSAFE Procedure, while the comparator group served as a control. Primary outcomes were not specified in the provided data.
Key results
The trial reported several key measurements and analyses:
- Erectile Function:
- Participants undergoing the NeuroSAFE Procedure had a mean erectile function score of 12.7 units on a scale (Standard Deviation 8.0).
- The Control group had a mean erectile function score of 9.7 units on a scale (Standard Deviation 7.5).
- Functional Outcome - Urinary Continence:
- For the NeuroSAFE Procedure group, the mean urinary continence score was 5.8 units on a scale (Standard Deviation 4.1).
- For the Control group, the mean urinary continence score was 7.4 units on a scale (Standard Deviation 5.2).
- Functional Outcome - Urinary Continence at 6 Months:
- The NeuroSAFE Procedure group showed a mean score of 4.5 units on a scale (Standard Deviation 4.2).
- The Control group showed a mean score of 5.1 units on a scale (Standard Deviation 4.7).
- Oncological Outcome (Count of Participants):
- In one measurement, 7 participants in the NeuroSAFE Procedure group and 5 in the Control group were reported.
- In another measurement, 10 participants in the NeuroSAFE Procedure group and 7 in the Control group were reported.
- In a third measurement, 8 participants in the NeuroSAFE Procedure group and 2 in the Control group were reported.
Key analyses revealed the following:
- For erectile function, a linear regression model adjusted for recruitment site, participant's age, and baseline IIEF-5 showed a mean difference (final values) of 3.18 (95% CI: 1.62, 4.75) with a p-value of 0.0001, favoring the NeuroSAFE Procedure.
- For urinary continence, a linear regression analysis showed a mean difference (final values) of -1.41 (95% CI: -2.42, -0.41) with a p-value of 0.006.
What this means
The results suggest that the NeuroSAFE procedure significantly improves erectile function outcomes for prostate cancer patients undergoing radical prostatectomy, as evidenced by the statistically significant mean difference of 3.18 units (p=0.0001). While the trial also reported a statistically significant mean difference of -1.41 units (p=0.006) for urinary continence, the clinical interpretation of this negative difference depends on the specific scoring scale, which was not detailed. The oncological outcome data, presented as participant counts, lacks statistical analysis in the provided data, precluding definitive conclusions on this aspect.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03317990, titled "Evaluating the Effects of Frozen Section Technology on Oncological and Functional Outcomes at Radical Prostatectomy," were posted on 2025-09-04 on clinicaltrials.gov.