NeuroSAFE Improves Erectile Function, Urinary Continence in Prostate Cancer

NeuroSAFE technique v. Standard RARP:

  1. A side-by-side comparison of standard RARP versus the NeuroSAFE technique, showing how NeuroSAFE preserves the critical nerve bundles that are often sacrificed in standard procedures
  2. The key clinical trial results from the Lancet Oncology study, visualizing:
    • Improved erectile function scores (IIEF-5) at 12 months
    • Higher percentage of patients with no/mild erectile dysfunction
    • Better urinary continence at 3 months (lower ICIQ scores)

The color coding helps distinguish between the standard approach (red) and the NeuroSAFE technique (blue),.

Breakthrough in Prostate Cancer Surgery Offers Better Quality of Life

NeuroSAFE Technique Shows Significant Improvements in Erectile Function and Urinary Continence

A clinical trial has confirmed that a specialized surgical technique for prostate cancer patients can dramatically improve quality of life without compromising cancer control. The NeuroSAFE PROOF study, recently published in The Lancet Oncology, shows that men who undergo NeuroSAFE-guided robot-assisted radical prostatectomy (RARP) experience significantly better erectile function and early urinary continence than those receiving standard RARP.


What Is NeuroSAFE?

NeuroSAFE (Neurovascular Structure Adjacent Frozen Section Examination) is an innovative approach that allows surgeons to preserve the delicate nerves responsible for erectile function and urinary control that run within the outer coverings of the prostate. During standard RARP procedures, surgeons must wait days for the final pathology report after removing the prostate, creating a significant time lag between the operation and confirmation of cancer clearance.

With NeuroSAFE, the prostate is flash frozen during surgery and immediately examined by a pathologist while the operation is still underway. If cancer is found at the edges near crucial nerves, surgeons can remove additional tissue. If no cancer is detected, the operation is completed with the nerves preserved.

The Evidence: Better Outcomes for Patients

The multicenter, randomized, controlled phase 3 trial included 381 patients across five UK hospitals. At 12 months post-surgery:

  • The mean IIEF-5 score (measuring erectile function) was 12.7 in the NeuroSAFE group versus 9.7 in the standard RARP group
  • 39% of NeuroSAFE patients had no or mild erectile dysfunction compared to only 23% in the standard group
  • Urinary continence was significantly better at 3 months in the NeuroSAFE group

Importantly, there was no difference in serious adverse events between the groups, with comparable safety profiles. The cancer control metrics also remained similar between the two approaches.

What This Means for Patients Facing Treatment Decisions

For men newly diagnosed with prostate cancer and weighing treatment options, this research provides valuable information:

  1. Surgical Advancements: The NeuroSAFE technique opens up the option of nerve-sparing surgery for many more men, without compromising cancer control. This addresses one of the primary concerns about radical prostatectomy.

  2. Quality of Life Impact: Nerve sparing during prostate removal significantly increases post-operative potency but traditionally increased the risk of leaving cancer behind. The NeuroSAFE technique helps balance both concerns.

  3. Decision Framework: When considering surgery versus radiation, men can now factor in that surgery with NeuroSAFE might provide better erectile function preservation than previously possible, potentially influencing their treatment choice.

Patient Experience

Danny Schogger, a patient who underwent NeuroSAFE-guided surgery, reported that his urinary leakage stopped within 6-7 weeks and sexual function returned sooner than expected. "Within 6-8 weeks it was proven to me the nerves had been spared," he shared.

Similar experiences were reported by other trial participants who underwent the NeuroSAFE procedure.

Availability and Future Directions

While this technique has been available for over a decade in Germany and some private healthcare settings, it is not yet widely used outside these areas. The promising results from this study may help change that, making NeuroSAFE more accessible to prostate cancer patients globally.

Dr. Matthew Hobbs, Director of Research at Prostate Cancer UK, notes that the study is promising and provides evidence that innovative surgery can reduce erectile dysfunction, though more research is needed to confirm long-term cancer control.

For IPCSG members considering surgical treatment for prostate cancer, asking your urologist about the availability of NeuroSAFE-guided RARP could be an important part of your treatment discussion. As with any treatment decision, discussing the potential benefits and limitations with your healthcare team remains essential.

Here's a formal list of the source citations with links:

Primary Sources

  1. Dinneen E, Almeida-Magana R, Al-Hammouri T, et al. 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. Lancet Oncol. 2025 Mar 18:S1470-2045(25)00091-9. doi: 10.1016/S1470-2045(25)00091-9. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00091-9/fulltext

  2. Fabbricatore R. NeuroSAFE Improves Erectile Function, Urinary Continence in Prostate Cancer. Cancer Network. March 24, 2025. https://www.cancernetwork.com/view/neurosafe-improves-erectile-function-urinary-continence-in-prostate-cancer

Additional Sources

  1. Santis Health. NeuroSAFE: better nerve preservation and cancer control. October 2, 2023. https://www.santishealth.org/prostate-cancer-information-centre/neurosafe-better-nerve-preservation-and-cancer-control/

  2. NCITA. NeuroSAFE PROOF Study. January 30, 2023. https://ncita.org.uk/neurosafe-proof-study/

  3. Health Research Authority. NeuroSAFE proof. https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/neurosafe-proof/

  4. The London Clinic. Nerve sparing technique for robotic prostate surgery. https://www.thelondonclinic.co.uk/media-hub/features/nerve-sparing-technique-robotic-prostate-surgery

  5. Hamdy FC, Donovan JL, Lane JA, et al. Different Nerve-Sparing Techniques during Radical Prostatectomy and Their Impact on Functional Outcomes. PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC8996922/

  6. Mount Sinai. A Pioneering Clinician and Researcher Produces Innovations in Nerve Sparing Techniques to Tailor a Unique Approach for Each Patient. https://reports.mountsinai.org/article/uro2022-02-a-pioneering-clinician-and-researcher-produces-innovations

  7. North Bristol NHS Trust. BUI Current Clinical Research | NEUROSAFE PROOF. https://www.nbt.nhs.uk/bristol-urological-institute/bui-research/bui-clinical-research/bui-current-clinical-research

  8. van der Slot MA, et al. Nerve-sparing radical prostatectomy using the neurovascular structure-adjacent frozen-section examination (NeuroSAFE): results after 20 years of experience. Prostate Cancer and Prostatic Diseases. 2024. https://www.nature.com/articles/s41391-024-00851-x

  9. Palayoor ST, et al. Nerve-sparing robot-assisted radical prostatectomy: Current perspectives. ScienceDirect. https://www.sciencedirect.com/science/article/pii/S2214388220300382

  10. University College London. Twice as many men recover erectile function after improved prostate cancer surgery. UCL News. March 26, 2025. https://www.ucl.ac.uk/news/2025/mar/twice-many-men-recover-erectile-function-after-improved-prostate-cancer-surgery

 

NeuroSAFE Improves Erectile Function, Urinary Continence in Prostate Cancer

cancernetwork.com

Roman Fabbricatore

The adverse effect profile was similar among patients with prostate cancer using NeuroSAFE-assisted RARP vs standard RARP.

“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,” Matthew Hobbs, MD, director of Research at Prostate Cancer UK, said in a news release.

NeuroSAFE-guided nerve sparing during robot-assisted radical prostatectomy (RARP) improved patient-reported 12-month International Index of Erectile Function (IIEF)–5 scores and short-term urinary continence, according to results from the phase 3 NeuroSAFE PROOF (NCT03317990) trial published in The Lancet Oncology.1

At a median follow-up of 12.3 months (IQR, 11.8-12.7), efficacy data from the trial revealed that the mean IIEF-5 scores were significantly higher in patients undergoing surgery with NeuroSAFE at 12.7 (SD, 8.0) vs 9.7 (SD, 7.5) in those who underwent standard RARP (adjusted mean difference, 3.18; 95% CI, 1.62-4.75; P <.0001). Additionally, a similar benefit was seen in IIEF-6 scores: 15.3 (SD, 9.7) vs 11.5 (SD, 9.0) in each respective population (adjusted mean difference, 3.92; 95% CI, 2.01-5.83; P <.0001).

Patients in the NeuroSAFE group saw significant decreases in International Consultation on Incontinence Questionnaire (ICIQ) scores. The 3-month ICIQ scores among the NeuroSAFE and standard RARP groups were 5.8 (SD, 4.1) and 7.4 (SD, 5.2), respectively (adjusted mean difference, –1.41; 95% CI, –2.42 to –0.41; P = .006). Additionally, at 6 months, scores were 4.5 (SD, 4.2) and 5.1 (SD, 4.7) in the respective groups (adjusted mean difference, –0.37; 95% CI, –1.35 to 0.62; P = .46).

“Prostate cancer surgery is a life-saving option for lots of [patients], but it’s a major procedure that can cause [adverse] effects [AEs, such as] erection problems,” Matthew Hobbs, MD, director of Research at Prostate Cancer UK, said in a news release.2 “A major challenge we face is how to cure [patients] but also ensure they can live life to the [fullest] afterwards. This study is promising and provides evidence that innovative types of surgery can reduce erectile dysfunction in some [patients]. However, more research is needed to prove whether NeuroSAFE is as effective as traditional techniques at delivering a complete cure.”

Patients with non-metastatic prostate cancer eligible for RARP were randomly assigned to receive NeuroSAFE-based RARP (n = 204) or standard RARP (n = 203). Standard RARP was performed by an experienced RARP surgeon using the DaVinci surgical system per NHS standard-of-care protocol.

Patients receiving NeuroSAFE-based RARP underwent initial postero-lateral dissection followed by prostate extraction. Then, segments from the dissection were snap frozen, sectioned, and stained with hematoxylin and eosin before examination by a consultant genitourinary histopathologist. The margins were considered negative if the sides of a section were free of prostate cancer cells.

In the event of positive margins, a secondary resection was recommended if: more than 1 section was positive; there was a prostate cancer Gleason grade 4 pattern or higher; or more than 2 mm of Gleason grade 3 pattern was observed in a single section of an inked margin. Secondary resections encompassed a full excision of the entire ipsilateral neuro-vascular bundle.

The primary end point of the study was erectile function at 12 months assessed by IIEF-5. Secondary end points included the difference in ICIQ scores at 3 and 6 months, and the difference in IIEF-6 scores. Exploratory end points included time from surgery to erectile function recovery, time to urinary continence recovery, and positive surgical margin rates.

The 12-month rates of IIEF-5 scores of 21 or greater were 20% in the NeuroSAFE group vs 14% in the standard RARP group. Additionally, 39% vs 23% of the respective groups had no or mild erectile dysfunction at 12 months. Furthermore, small positive margins were observed in 21% vs 13%, respectively, and large or multifocal positive margins were observed in 14% vs 16%.

A total of 4% of patients in the NeuroSAFE group and 3% of the standard RARP group experienced prostate-specific antigen (PSA) persistence. In the respective groups, 6% and 4% experienced biochemical recurrence, and 4% and 1% underwent adjuvant treatment.

There were 20 AEs and 6 serious AEs observed in the NeuroSAFE group (n = 182) and 25 AEs and 5 serious AEs in the standard RARP group (n = 188). In the standard RARP group, 1 patient experienced 2 serious AEs. A total of 4 patients died within 12 months of surgery: 2 in the NeuroSAFE group due to myocardial infarction and co-occurring cancer and 2 in the standard RARP group due to co-occurring cancer and an unknown cause, with none considered related to prostate cancer or surgery.

References

  1. Dinneen E, Almeida-Magana R, Al-Hammouri T, et al. 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. Lancet Oncol. Published online March 24, 2025. doi:10.1016/S1470-2045(25)00091-9
  2. Sample I. Prostate cancer surgery breakthrough offers hope for erectile function. News release. The Guardian. March 24, 2025. Accessed March 24, 2025. https://tinyurl.com/3us729ha

 

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