NeroSAFE May Increase Erectile Function After Prostate Cancer Surgery

Use of the NeuroSAFE technique during prostate cancer surgery nearly doubled the number of patients who had no or mild erectile dysfunction approximately a year later, researchers have found.

Findings from the NeuroSAFE PROOF phase 3 trial, which was conducted at five National Health Service Hospitals in the United Kingdom, were published in The Lancet Oncology and presented at the 2025 European Association of Urology Congress in Madrid, with researchers reporting on the use of NeuroSAFE to guide nerve sparing during robot-assisted radical prostatectomy (RARP).

In 344 patients who underwent radical prostatectomy, or the surgical removal of the prostate (173 patients in the NeuroSAFE group and 171 in the standard RARP group) at a median follow-up of 12.3 months, 39% and 23% of patients, respectively, had no or mild erectile dysfunction.

CURE spoke with NeuroSAFE PROOF researcher Dr. Greg Shaw about the study and its findings. Shaw is the lead for robotic urology for University College London Hospitals and a professor of urology at University College London.

CURE: What do you hope is the big takeaway from these findings?

Shaw: The trial that we presented in Madrid, that coincided with the Lancet Oncology paper, is definitive evidence that the new technique that we trialed, the NeuroSAFE technique, allows us to help more men get back to potency after radical prostatectomy. Radical prostatectomy, some of you will probably be aware, is an operation used to cure prostate cancer. It's really good for curing prostate cancer, but many men are left with side effects, urinary incontinence and erectile problems. And using this technique, we doubled the number of men who were able to get normal erections after the procedure compared to our standard approach.

How does the NeuroSAFE technique supplement or how is it different than the current standard of care?

It's an additional step to the operation, and it's performed during the operation whilst the patients asleep. It's designed because when we do a prostatectomy, we want to take away all the cancer and leave behind all of the important structures that surround the prostate, but they're really closely approximated. So, the prostate is a bit like an onion. It's got concentric layers running around it, and within the outer layers are the very small, microscopic nerves that send the signals for men to get erections. So where we can we peel those layers off, we leave them inside the patient, so they remain functional. And that's OK if the tumor is away from where the nerves are, but if it's close to the edge, and as it stands, we don't have a way of accurately telling us, even MRI scanning doesn't tell us exactly where the cancer finishes and the nerves are, so to a certain extent, we err on the side of caution. And sometimes we find we've taken a prostate out with the outer coverings, not done nerve sparing, whereas actually we could have done nerve sparing, and that's due to the lack of resolution on the MRI scans, it doesn't give you that sub-millimeter measure of how close you might or how far you might be from the nerves.

So this technique is designed to deal with that problem. It gives the surgeon feedback during the operation. So the approach is you do a full nerve spare, regardless of what the MRI scan looks like, and then when the prostate is removed from its attachments, it can be brought out from the inside of the patient and analyzed, and we look at the edge of it, and there's quite an involved process. It's called frozen section. We freeze the tissue, slice it super thin, and then stain it so that it can be examined by a pathologist. And if the pathologist tells you that there's cancer at the edge here, that's not good. OK, we we now need to take the nerves away, and we do that at the same sitting during the same operation. So it adds about an hour on to the patient's surgery. The patient is asleep during that time, but it allows us this control, this extra bit of information, [to determine] has nerve sparing been safe in this patient or not.

Did anything in these results surprise you and your colleagues?

I think we were optimistic that we were going to see an effect, but perhaps surprised to see that the effect was quite so marked: twice as many men a year after surgery, either with no erectile dysfunction or mild erectile dysfunction. And that's quite important, because we treat many, many men with prostate cancer. Some of them are young. The age at which we start worrying about prostate cancer is 50 in Caucasian men, 45 in patients who have relatives with prostate cancer or Afro Caribbean men.

So some of these patients are young, and it's one thing saying to a 70-year-old man who's not particularly sexually active, "You're not going to get erections again." But you tell that to someone who's 45 years old, who's maybe not in a stable relationship, that's life changing, and they've got the rest of their life to live with that. So this is really important for younger patients, sexually active patients, but particularly patients who were the conventional methods are used, MRI scanning, looking at the biopsy results, where it's felt they can't have nerve sparing, because there's a question about whether it would be safe or not,

How should these findings inform conversations that patients have with their doctors?

I think patients should be asking their doctors if they offer NeuroSAFE and discussing the relative merits of it. There are technical issues with running it. It takes a lot of coordination. It takes a team of people to prepare the slides. You've got to have a pathologist available to make the interpretation, make the call that the surgeon acts on. So I think we will see this being taken up by more centers with time. Some centers can't do it either because of geography, maybe the pathologist is not in the same building as the as the surgery. That becomes a real issue when you're talking about transferring tissue samples. But there's some new technology out there that's quite exciting. There's something called a confocal laser microscope, which gives it a similar readout. It scans the whole surface of the prostate, and that image can then be beamed to a pathologist. They might be miles away. They might be around the other side of the world. The Internet is so quick now, and the pathologist can make a call on that image.

So, I think this calls for an increase in our performing an examination of the prostate to guide nerve sparing during surgery. The practicalities of that will vary by hospital, by geography, but I think many more surgeons will be making an effort to gather this extra bit of information that clearly makes a difference to patients.

Reference:

“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” by Eoin Dinneen et al., The Lancet Oncology.

Transcript has been edited for clarity and conciseness.

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