A novel technique designed to improve the precision of prostate cancer surgery could preserve erectile function in nearly twice as many men compared with standard surgery, according to new findings presented by Almeida-Magana et al at the European Association of Urology (EAU) Congress 2025 (Abstract GC9) and simultaneously published by Dinneen et al in The Lancet Oncology.
The findings may raise the prospect of major quality-of-life improvements in men undergoing surgery for prostate cancer.
Background
Prostate cancer surgery can often result in erectile dysfunction and urinary incontinence. Robotic surgery technology has recently made it possible to preserve the nerves that are situated in the prostate’s outermost layers and provides surgeons with the precision required to peel off and retain these layers of the prostate. During standard surgery, however, it can be difficult to determine whether retaining these outer layers risks leaving some cancerous cells behind. In many cases, especially where the tumor is most advanced, surgeons will err on the side of caution and forgo nerve sparing to ensure that all of the patient’s cancer cells are removed.
Study Methods and Results
In the NeuroSAFE PROOF trial, researchers evaluated the NeuroSAFE surgical method—which is capable of sparing prostate cancer nerves during prostate removal by checking to determine whether further tissue removal is required. The method involves an additional test to ensure that all of the cancerous cells are removed so that preserving the nerves doesn’t risk the procedure’s success. In the technique, the surgeon extracts the prostate gland and preserves the maximum amount of nerve tissue around it as possible. The prostate is then flash frozen, and samples of it are examined by a pathologist while the operation is still underway. If cancer is found at the edges of the prostate around where key nerves are situated, the surgeon can then remove additional tissue, sacrificing the nerves but achieving a complete removal of the tumor. If no cancer is found, the surgery is complete.
The researchers randomly assigned 344 men diagnosed with prostate cancer who were scheduled to undergo prostatectomy and who had no prior issues with erectile dysfunction to receive the NeuroSAFE technique during their surgeries or to undergo standard surgery.
The researchers discovered that 1 year postsurgery, 39% of the men in the NeuroSAFE group had no or mild erectile dysfunction and just 38% of them had severe erectile dysfunction, compared with a respective 23% and 56% of those in the standard surgery group.
“Our results show that, by using NeuroSAFE, nearly twice as many men don’t have to face potentially life-changing loss of erectile function after prostate surgery. It is an involved procedure that requires expertise, but it isn’t expensive, particularly given the benefits it offers for patients, and most importantly, [it] doesn’t jeopardize cancer control,” detailed senior study author Greg Shaw, MD, of the University College London (UCL) Surgery & Interventional Science and a consultant urologist at UCL Hospitals. “NeuroSAFE wouldn’t be appropriate for all patients, as many can safely have nerve-sparing surgery using standard robotic techniques. [However], for younger patients and those who wouldn’t normally be seen as eligible for nerve-sparing surgery, it offers them a greater chance to hold onto their quality of life,” he added.
The technique was not found to increase the overall proportion of patients who eventually returned to being fully continent at 12 months. However, the patients who received the NeuroSAFE technique who recovered their urinary control did so quicker compared with the patients who underwent standard surgery.
Conclusions
“NeuroSAFE offers surgeons a real-time evaluation of the safety of the procedure. In standard robotic surgery, surgeons determine whether to choose nerve sparing based on [magnetic resonance imaging] scans, on digital rectal examinations, and on biopsy results prior to surgery,” stated co–study author Ricardo Almeida-Magana, MD, of the UCL Surgery & Interventional Science. “[Where] those methods can provide guidance, NeuroSAFE provides certainty, [a]nd that opens up the option of nerve-sparing surgery for many more men without compromising on the chances of controlling the cancer,” he highlighted.
The additional step to rapidly examine the prostate could allow more patients to benefit from nerve sparing while still ensuring that all of their cancer cells will be removed.
“We use NeuroSAFE for most of the 2,500 [patients with] prostate cancer we treat each year, and it’s great to see the technique assessed in a randomized controlled trial for the first time. The results are as we would expect: NeuroSAFE allows more patients to have nerve sparing, and that results in better recovery of erectile function. Postsurgical penile rehabilitation for patients can affect erectile function as well, so that is an aspect that also needs to be considered,” underscored Derya Tilki, MD, Professor of Urology at the Martini Klinik Prostate Cancer Center in Hamburg, Germany and a member of the EAU Scientific Congress Office. “This trial wasn’t designed to look at longer-term cancer outcomes but based on the data we have from using the technique for over 20 years, NeuroSAFE does not appear to affect these. It would be really valuable to have that confirmed in another randomized trial,” she concluded.
Disclosure: The research in this study was funded by the National Institute for Health and Care Research for Patient Benefit program, The Rosetrees Foundation, St Peter’s Charitable Trust, and the Jon Moulton Charity Trust. For full disclosures of the study authors, visit urosource.uroweb.org and thelancet.com.
