A surgical technique that improves the precision of prostate cancer operations has nearly doubled the number of men who maintain their erectile function post-surgery, according to a landmark UK study published Monday in The Lancet Oncology.
The findings from the NeuroSAFE PROOF trial, presented at the 2025 European Association of Urology Congress in Madrid, signal a potential sea change in quality of life outcomes for thousands of men facing prostate cancer surgery.
Researchers from University College London and University College London Hospitals found that using the NeuroSAFE method during robot-assisted radical prostatectomy (RARP) significantly improved both erectile function and early urinary continence recovery without compromising cancer control.
“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,” said Professor Greg Shaw, the trial lead from UCL Surgery & Interventional Science and Consultant Urologist at UCLH.
The randomized controlled trial involved 344 men across five UK hospitals who had good preoperative erectile function. Participants were randomly assigned to either standard RARP or NeuroSAFE-guided RARP, with researchers tracking outcomes for 12 months following surgery.
How the NeuroSAFE technique works
The NeuroSAFE technique, developed in Germany but not widely used outside its country of origin, allows surgeons to preserve the delicate nerve bundles surrounding the prostate that control erectile function.
During the procedure, surgeons aim to preserve as much nerve tissue as possible while removing the prostate. The extracted gland is then flash-frozen and examined by a pathologist during the operation. If cancer cells are detected at the edges near critical nerves, surgeons can remove additional tissue to ensure complete tumor removal. If no cancer is found, the nerve-sparing approach is confirmed as appropriate.
This real-time evaluation provides certainty that standard preoperative planning methods cannot, enabling nerve-sparing surgery for many more patients without compromising cancer treatment.
“NeuroSAFE offers surgeons a real time evaluation of the safety of the procedure,” explained Dr. Ricardo Almeida-Magana, lead author on the Lancet Oncology paper. “In standard robotic surgery, surgeons determine whether to choose nerve sparing based on MRI scans, on digital rectal examinations and on biopsy results prior to surgery. But whereas those methods can provide guidance, NeuroSAFE provides certainty.”
Dramatic differences in outcomes
The results were striking: 12 months after surgery, 39% of men who underwent the NeuroSAFE procedure had no or mild erectile dysfunction, compared to just 23% in the standard surgery group. Severe erectile dysfunction affected only 38% of NeuroSAFE patients versus 56% of those receiving standard treatment.
At the 12-month mark, the mean International Index of Erectile Function (IIEF-5) score was 12.7 in the NeuroSAFE group versus 9.7 in the standard RARP group, representing a significant improvement.
While both groups eventually achieved similar rates of urinary continence by the one-year mark, those who underwent NeuroSAFE surgery recovered their urinary control more quickly—a meaningful quality of life advantage during the challenging post-surgical period.
The study also found that patients who normally wouldn’t be considered suitable candidates for nerve-sparing based on traditional preoperative assessments benefited most from the NeuroSAFE approach.
“It is an involved procedure that requires expertise, but it isn’t expensive, particularly given the benefits it offers for patients, and most importantly doesn’t jeopardize cancer control,” Professor Shaw noted. “NeuroSAFE wouldn’t be appropriate for all patients, as many can safely have nerve-sparing surgery using standard robotic techniques. But 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.”
From Germany to global practice?
The technique has been used for over a decade at Germany’s Martini Klinik Prostate Cancer Center in Hamburg, where it was first developed, but has not been widely adopted elsewhere despite promising observational studies.
Commenting on the results, Professor Derya Tilki from the Martini Klinik, who was not involved in the trial, said: “We use NeuroSAFE for most of the 2,500 prostate cancer patients 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.”
The trial also addressed concerns about cancer control, showing no significant differences in early oncological outcomes between the groups. While 9% of NeuroSAFE patients experienced PSA persistence or biochemical recurrence after 12 months compared to 6% in the standard group, researchers noted these differences were not statistically significant for determining long-term cancer outcomes.
Implications for practice
Prior to this trial, evidence supporting NeuroSAFE was limited to retrospective studies, many with moderate to serious risk of bias. This randomized controlled trial provides the highest quality evidence to date that the technique improves functional outcomes.
The study authors suggest that prostate cancer care guidelines should be updated to reflect these findings.
The study had notable strengths, including its diverse participant population with a high proportion of Black African and Afro-Caribbean men—groups at higher risk of early-onset prostate cancer who may particularly benefit from function-preserving techniques.
However, researchers acknowledge several limitations. Most procedures were performed at a single center, and the trial’s 12-month follow-up period precludes definitive conclusions about long-term cancer control. Additionally, the NeuroSAFE technique requires specialized personnel and increases surgical times, which could limit widespread adoption in resource-constrained settings.
As prostate cancer remains the most common cancer among men, with radical prostatectomy a standard treatment option, these findings could potentially impact thousands of patients annually. The prospect of maintaining sexual function while successfully treating cancer represents a significant step forward in addressing one of the most feared side effects of prostate cancer treatment.
The study was funded by the National Institute for Health and Care Research, The Rosetrees Foundation, St Peter’s Charitable Trust, and the Jon Moulton Charity Trust.
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