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Neurosafe PROOF trail results

User
Posted 25 Mar 2025 at 13:16

The Neurosafe PROOF trail results were published yesterday in the Lancet.

Effect of NeuroSAFE-guided RARP versus standard RARP on erectile function and urinary continence in patients with localised prostate cancer (NeuroSAFE PROOF): a multicentre, patient-blinded, randomised, controlled phase 3 trial

This trial took men with localised prostate cancer who were eligible for the Neurosafe procedure. They were randomised to have either Neurosafe or standard RALP, but they have never been told which they had. The trial compares how the two arms have done.

Erectile function was significantly better on average in the Neurosafe group at 12 months. Continence was also better at 3 months, but no difference by 6 months. (I haven't read enough of it yet to know if that might be a difference in using Retzius Sparing or not.)

The Neurosafe group had a larger percentage of recurrence and further treatment required although that's not mentioned in the summary for some reason. It should be noted that not enough time has passed for a real judgement on the final percentages of these figures and it could be that over the longer term, the difference might reduce or increase.

The trial hopes to report again in the future too, when more time has passed and further data collected. (Hence the reason the trial has not been unblinded.)

User
Posted 25 Mar 2025 at 13:16

The Neurosafe PROOF trail results were published yesterday in the Lancet.

Effect of NeuroSAFE-guided RARP versus standard RARP on erectile function and urinary continence in patients with localised prostate cancer (NeuroSAFE PROOF): a multicentre, patient-blinded, randomised, controlled phase 3 trial

This trial took men with localised prostate cancer who were eligible for the Neurosafe procedure. They were randomised to have either Neurosafe or standard RALP, but they have never been told which they had. The trial compares how the two arms have done.

Erectile function was significantly better on average in the Neurosafe group at 12 months. Continence was also better at 3 months, but no difference by 6 months. (I haven't read enough of it yet to know if that might be a difference in using Retzius Sparing or not.)

The Neurosafe group had a larger percentage of recurrence and further treatment required although that's not mentioned in the summary for some reason. It should be noted that not enough time has passed for a real judgement on the final percentages of these figures and it could be that over the longer term, the difference might reduce or increase.

The trial hopes to report again in the future too, when more time has passed and further data collected. (Hence the reason the trial has not been unblinded.)

User
Posted 30 Mar 2025 at 09:37

Great paper & thanks for posting. This maybe useful as I asked AI to summarise based on the following query: How does neurosafe affect the probability of cancer returning.

Based on the information in the sources, the effect of NeuroSAFE on the probability of cancer returning is being investigated, and the current data provides some insights but is not definitive for long-term outcomes.

Here's a breakdown of how NeuroSAFE affects the probability of cancer returning according to the NeuroSAFE PROOF trial at 12 months:

  • PSA Persistence or Biochemical Recurrence: At 12 months, PSA persistence or biochemical recurrence occurred in 17 (9%) of 182 participants in the NeuroSAFE group versus 12 (6%) of 188 participants in the standard RARP group. This indicates a slightly higher rate of these early indicators of potential recurrence in the NeuroSAFE group, although the study was not powered to detect a significant difference in oncological outcomes.

  • Positive Surgical Margins:

    • Small positive surgical margins were observed in 40 (21%) of 190 participants in the NeuroSAFE group versus 24 (13%) of 191 participants in the standard RARP group.
    • Large or multifocal positive margins were observed in 26 (14%) of 190 participants in the NeuroSAFE group versus 30 (16%) of 191 participants in the standard RARP group participants.
    • The slightly increased overall positive surgical margin rate in the NeuroSAFE group is linked to the study's protocol for triggering secondary resections based on intra-operative frozen section findings. The protocol permitted small single foci of Gleason grade group 3 (up to 2 mm) on the NeuroSAFE frozen section margin without triggering a secondary resection.
    • The study notes that evidence suggests small positive surgical margins might not be associated with a higher risk of biochemical recurrence or worse oncological outcomes.

  • Adjuvant Treatment: A higher number of participants in the NeuroSAFE group received adjuvant treatment (8 [4%]) compared to the standard RARP group (2 [1%]) at 12 months. This was often triggered by adverse pathological features such as the presence of a positive surgical margin and pT3b tumours detected during the NeuroSAFE procedure, rather than PSA persistence or biochemical recurrence.

  • Long-term Oncological Outcomes: The study explicitly states that oncological outcomes are limited to 12 months, precluding definitive conclusions regarding long-term prostate cancer control, development of metastasis, or prostate cancer-specific death. Longer follow-up of the cohort (5 years) is planned to provide prospective evidence on this issue.

  • Existing Evidence: The discussion mentions that existing long-term data on NeuroSAFE RARP from retrospective cohort studies suggest no significant oncological disadvantage. However, the quality of evidence from these studies was generally low prior to the NeuroSAFE PROOF trial.

In summary, at 12 months, the NeuroSAFE group showed a slightly higher rate of PSA persistence or biochemical recurrence and a higher rate of small positive surgical margins (likely due to the study protocol), but also a higher rate of adjuvant treatment administration based on intra-operative findings. The study acknowledges that longer follow-up is needed to determine the definitive long-term impact of NeuroSAFE on cancer recurrence. Patients considering NeuroSAFE should be counselled on its potential functional benefits and the currently unknown long-term impact on the need for additional treatment.

User
Posted 30 Mar 2025 at 09:42

Here is an AI audio discussion of the paper: https://notebooklm.google.com/notebook/e6785137-3df4-4ae5-b2fc-701ea57b87cb/audio

Interestingly if up to 2mm of Gleason 6 was found in surgical margin they didn’t trigger a further resection. In my case the margins were clear on final histology but potentially positive with NeuroSAFE frozen sections so additional tissue was taken. I would be inclined to ask the surgeon to carry out additional resection even with Gleason 6 cells. For me cancer control was always primary.  

Edited by member 30 Mar 2025 at 09:46  | Reason: Not specified

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User
Posted 30 Mar 2025 at 09:37

Great paper & thanks for posting. This maybe useful as I asked AI to summarise based on the following query: How does neurosafe affect the probability of cancer returning.

Based on the information in the sources, the effect of NeuroSAFE on the probability of cancer returning is being investigated, and the current data provides some insights but is not definitive for long-term outcomes.

Here's a breakdown of how NeuroSAFE affects the probability of cancer returning according to the NeuroSAFE PROOF trial at 12 months:

  • PSA Persistence or Biochemical Recurrence: At 12 months, PSA persistence or biochemical recurrence occurred in 17 (9%) of 182 participants in the NeuroSAFE group versus 12 (6%) of 188 participants in the standard RARP group. This indicates a slightly higher rate of these early indicators of potential recurrence in the NeuroSAFE group, although the study was not powered to detect a significant difference in oncological outcomes.

  • Positive Surgical Margins:

    • Small positive surgical margins were observed in 40 (21%) of 190 participants in the NeuroSAFE group versus 24 (13%) of 191 participants in the standard RARP group.
    • Large or multifocal positive margins were observed in 26 (14%) of 190 participants in the NeuroSAFE group versus 30 (16%) of 191 participants in the standard RARP group participants.
    • The slightly increased overall positive surgical margin rate in the NeuroSAFE group is linked to the study's protocol for triggering secondary resections based on intra-operative frozen section findings. The protocol permitted small single foci of Gleason grade group 3 (up to 2 mm) on the NeuroSAFE frozen section margin without triggering a secondary resection.
    • The study notes that evidence suggests small positive surgical margins might not be associated with a higher risk of biochemical recurrence or worse oncological outcomes.

  • Adjuvant Treatment: A higher number of participants in the NeuroSAFE group received adjuvant treatment (8 [4%]) compared to the standard RARP group (2 [1%]) at 12 months. This was often triggered by adverse pathological features such as the presence of a positive surgical margin and pT3b tumours detected during the NeuroSAFE procedure, rather than PSA persistence or biochemical recurrence.

  • Long-term Oncological Outcomes: The study explicitly states that oncological outcomes are limited to 12 months, precluding definitive conclusions regarding long-term prostate cancer control, development of metastasis, or prostate cancer-specific death. Longer follow-up of the cohort (5 years) is planned to provide prospective evidence on this issue.

  • Existing Evidence: The discussion mentions that existing long-term data on NeuroSAFE RARP from retrospective cohort studies suggest no significant oncological disadvantage. However, the quality of evidence from these studies was generally low prior to the NeuroSAFE PROOF trial.

In summary, at 12 months, the NeuroSAFE group showed a slightly higher rate of PSA persistence or biochemical recurrence and a higher rate of small positive surgical margins (likely due to the study protocol), but also a higher rate of adjuvant treatment administration based on intra-operative findings. The study acknowledges that longer follow-up is needed to determine the definitive long-term impact of NeuroSAFE on cancer recurrence. Patients considering NeuroSAFE should be counselled on its potential functional benefits and the currently unknown long-term impact on the need for additional treatment.

User
Posted 30 Mar 2025 at 09:42

Here is an AI audio discussion of the paper: https://notebooklm.google.com/notebook/e6785137-3df4-4ae5-b2fc-701ea57b87cb/audio

Interestingly if up to 2mm of Gleason 6 was found in surgical margin they didn’t trigger a further resection. In my case the margins were clear on final histology but potentially positive with NeuroSAFE frozen sections so additional tissue was taken. I would be inclined to ask the surgeon to carry out additional resection even with Gleason 6 cells. For me cancer control was always primary.  

Edited by member 30 Mar 2025 at 09:46  | Reason: Not specified

 
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