A breakthrough surgical technique is offering new hope for men concerned about quality of life after prostate cancer surgery. Results from a phase 3 clinical trial published in The Lancet Oncology demonstrate that the NeuroSAFE technique significantly improves post-surgical erectile function and reduces short-term urinary incontinence compared to standard surgical approaches.
The multicenter, patient-blinded, randomized controlled trial (NeuroSAFE PROOF, NCT03317990) enrolled 407 patients with non-metastatic prostate cancer from five hospitals across the United Kingdom. Participants were randomly assigned to receive either NeuroSAFE-guided robot-assisted radical prostatectomy (RARP) or standard RARP.
Significant Improvements in Erectile Function
At a median follow-up of 12.3 months, patients who underwent the NeuroSAFE procedure demonstrated significantly better erectile function. The mean International Index of Erectile Function (IIEF-5) scores were 12.7 in the NeuroSAFE group compared to 9.7 in the standard RARP group (adjusted mean difference, 3.18; 95% CI, 1.62-4.75; P <.0001).
Additionally, 39% of patients in the NeuroSAFE group reported no or mild erectile dysfunction at 12 months post-surgery, compared to just 23% in the standard RARP group. The rates of IIEF-5 scores of 21 or greater (indicating normal erectile function) were 20% versus 14% respectively.
"This study is promising and provides evidence that innovative types of surgery can reduce erectile dysfunction in some patients," said Matthew Hobbs, MD, Director of Research at Prostate Cancer UK. "A major challenge we face is how to cure patients but also ensure they can live life to the fullest afterwards."
Enhanced Urinary Continence Outcomes
The NeuroSAFE technique also demonstrated benefits for urinary continence, particularly in the early recovery period. At three months post-surgery, patients in the NeuroSAFE group had significantly lower International Consultation on Incontinence Questionnaire (ICIQ) scores of 5.8 compared to 7.4 in the standard RARP group (adjusted mean difference, −1.41; 95% CI, −2.42 to −0.41; P = .006), indicating better continence.
By six months, this difference had normalized between the two groups, suggesting that the NeuroSAFE technique may primarily accelerate early continence recovery rather than affecting long-term outcomes.
How the NeuroSAFE Technique Works
The NeuroSAFE approach represents a significant advancement over standard RARP by incorporating real-time tissue analysis during surgery. While standard RARP relies on preoperative planning to attempt nerve-sparing, NeuroSAFE enables surgeons to make immediate, evidence-based decisions during the procedure.
In the NeuroSAFE procedure, after initial postero-lateral dissection and prostate extraction, segments from the dissection are snap frozen, sectioned, and stained with hematoxylin and eosin. A consultant genitourinary histopathologist then examines these sections to determine if cancer cells are present at the margins.
If margins are negative (free of cancer cells), the surgeon can confidently preserve the periprostatic neurovascular bundles that control erectile function. If positive margins are detected, a secondary resection of the affected nerve bundle may be performed, balancing cancer control with functional preservation.
"Prostate cancer surgery is a life-saving option for lots of patients, but it's a major procedure that can cause adverse effects such as erection problems," explained Dr. Hobbs. The NeuroSAFE technique addresses this challenge by maximizing nerve preservation without compromising oncological outcomes.
Safety and Cancer Control
Importantly, the safety profile of NeuroSAFE-guided RARP was comparable to standard RARP. Serious adverse events occurred in approximately 3% of patients in both groups, underscoring the safety of the new technique.
Regarding cancer control, small positive margins were observed in 21% of the NeuroSAFE group versus 13% in the standard RARP group, while large or multifocal positive margins were observed in 14% versus 16%, respectively. Prostate-specific antigen (PSA) persistence was noted in 4% of NeuroSAFE patients compared to 3% in the standard group, and biochemical recurrence occurred in 6% versus 4%.
Dr. Hobbs noted that "more research is needed to prove whether NeuroSAFE is as effective as traditional techniques at delivering a complete cure," highlighting the importance of long-term follow-up data.
Clinical Implications
The NeuroSAFE PROOF trial provides compelling evidence for the effectiveness of this innovative surgical approach in preserving quality of life for men undergoing prostate cancer surgery. The technique's ability to significantly improve erectile function while maintaining similar safety profiles to standard procedures represents a meaningful advance in prostate cancer care.
For the approximately 175,000 men diagnosed with prostate cancer annually in the United States and the 47,500 diagnosed in the UK, these findings offer new hope that curative treatment need not necessarily come at the cost of sexual function and urinary control.
As robotic surgical techniques continue to evolve, the NeuroSAFE approach demonstrates how technological innovation combined with real-time pathological assessment can enhance surgical precision and improve patient outcomes in prostate cancer treatment.
