There were a number of significant prostate cancer-related studies and trials discussed at this year’s European Association of Urology Congress, which took place in Madrid from 21-24 March
Twice as many men recover erectile function fter improved prostate cancer surgery
A technique to improve the precision of prostate cancer surgery means that almost twice as many men preserve their erectile function compared to those undergoing standard surgery, according
to results from a clinical trial led by UK researchers. The results of the NeuroSAFE PROOF trial, presented at the 2025 European Association of Urology (EAU) Congress in Madrid and published in The Lancet Oncology, raise the prospect of major quality-of-life improvements for men undergoing surgery for prostate cancer, which can often result in erectile dysfunction and urinary incontinence.
The trial evaluated a method (called NeuroSAFE) of preserving the nerves that run through the prostate’s outer layers, which are thought to be responsible for producing erections, during prostate removal. The pioneering method includes an additional test to ensure that all of the cancerous cells are removed, so that preserving the nerves does not risk the surgery’s success.
In recent years, preservation of these nerves has been made possible by robotic surgery technology that gives the surgeon the precision required to peel off and retain the outermost layers of the prostate where the nerves are situated, ie, ‘nerve-sparing.’
However, during standard surgery, it can be difficult to determine whether retaining these outer layers risks leaving some cancerous cells behind. In many cases, especially where the tumour is most advanced, surgeons will err on the side of caution and forego nerve-sparing to ensure that all of the patient’s cancer is removed.
NeuroSAFE enables them to check during the operation whether further tissue removal is needed or not.
Prof Greg Shaw, the trial lead, said: “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 doesn’t jeopardise cancer control.
“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.”
NeuroSAFE details
The NeuroSAFE PROOF trial, run across five UK hospitals, is the first randomised, controlled trial to fully evaluate the impact of the NeuroSAFE technique on erectile dysfunction and urinary incontinence – two of the most common side-effects of prostate surgery.
The trial analysed outcomes for 344 men diagnosed with prostate cancer who were due to undergo prostate removal and who had no prior issues with erectile dysfunction. Half were randomised to receive NeuroSAFE during their operation and half had standard surgery.
Twelve months after surgery, 39 per cent of men in the NeuroSAFE arm had no or mild erectile dysfunction. In those men who had standard surgery, this was 23 per cent.
A year after their operation, only 38 per cent of those who had surgery using NeuroSAFE had severe erectile dysfunction, compared to 56 per cent of men who had stand- ard surgery.
The technique did not increase the overall proportion of patients who eventually returned to being fully continent at 12 months. However, NeuroSAFE patients who recovered their urinary control did so faster than patients who under- went standard surgery.
In the NeuroSAFE technique, which has been available for over a decade but is not widely used outside of Germany where it was invented, the surgeon extracts the prostate gland while preserving 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 tumour. If no cancer is found, the operation is complete.
This additional step to rapidly examine the prostate means that more patients are able to benefit from nerve-sparing, while still ensuring that all of the cancer will be removed.
Dr Ricardo Almeida-Magana, lead author on the Lancet Oncology paper, said: “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 MRI scans, digital rectal examinations, and biopsy results before surgery.
Derya Tilki, a member of the EAU Scientific Congress Of- fice and Professor of Urology at the Martini Klinik Prostate Cancer Centre in Hamburg, Germany, where the NeuroSAFE technique was developed, 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 randomised con- trolled trial for the first time. The results are as we would expect: NeuroSAFE allows more patients to have nerve spar- ing and that results in better recovery of erectile function. Post-surgical penile rehabilitation for patients can affect erectile function as well, so that is an aspect that also needs to be considered.”
High resolution ultrasound could enable Bfaster prostate cancer diagnosis
Biopsies guided by high-resolution ultrasound are as effective as those using MRI in diagnosing prostate cancer, the results of the OPTIMUM trial presented at the 2025 European Association of Urology (EAU) Annual Congress in Madrid, and published in JAMA, show.
The technology, micro-ultrasound (microUS), is cheaper and easier to use than MRI, and could significantly speed up diagnosis, reduce the need for multiple hospital visits, and free up MRI for other uses, researchers say.
OPTIMUM is the first randomised trial to compare microUS-guided biopsy with MRI-guided biopsy for prostate cancer. It involves 677 men who underwent biopsy at 19 hospitals across Canada, the US, and Europe. Of these, half underwent MRI-guided biopsy, a third received microUS-guided biopsy followed by MRI-guided biopsy, and the remainder received microUS-guided biopsy alone.
MicroUS was able to identify prostate cancer as effectively as MRI-guided biopsy, with very similar rates of detection across all three arms of the trial. There was little difference even in the group who received both types of biopsies, with the microUS detecting the majority of significant cancers.
Around a million prostate cancer biopsies are carried out each year in Europe, a similar number in the US and around 100,000 in Canada. The majority of biopsies are conducted using MRI images fused onto conventional ultrasound, as this enables urologists to target potential tumours directly, leading to more effective diagnosis. MRI-guided biopsy requires a two-step process (the MRI scan, followed by the ultra sound-guided biopsy), requiring multiple hospital visits and specialist radiological expertise to interpret the MRI images and fuse them onto the ultrasound.
MicroUS has higher frequency than conventional ultrasound, resulting in three times greater resolution images that can capture similar detail to MRI scans for targeted biopsies. Urologists and oncologists can be easily trained to use the technique and interpret the images, especially if they have experience in conventional ultrasound, the researchers note. MicroUS is cheaper to buy and run compared to MRI, and could enable imaging and biopsy to be carried out during one appointment, even outside a hospital setting.
The results of the OPTIMUM trial could have a similar impact to the first introduction of MRI, according to lead re- searcher on the trial, Prof Laurence Klotz, Professor of Surgery, University of Toronto’s Temerty Faculty of Medicine and the Sunnybrook Chair of Prostate Cancer Research.
“When MRI first emerged and you could image prostate cancer accurately for the first time to do targeted biopsies, that was a game-changer,” he recalls. “But MRI isn’t perfect. It’s expensive. It can be challenging to get access to it quickly. It requires a lot of experience to interpret properly. And it uses gadolinium, which has some toxicity. Not all patients can have MRI, if they have replacement hips or pacemakers for example.
“But we now know that microUS can give as good a diagnostic accuracy as MRI and that is also game-changing. It means you can offer a one-stop-shop, where patients are scanned, then biopsied immediately if required. There’s no toxicity. There are no exclusions. It’s much cheaper and more accessible. And it frees up MRIs for hips and knees and all the other things they’re needed for.”
Commenting on the data, Prof Jochen Walz, from the Institut Paoli-Calmettes Cancer Centre, Marseille/France, a lead- ing expert in the field of urological imaging and a member of the EAU Scientific Congress Office, said: “This is a well-conducted and exciting study, which adds a very important tool to the diagnosis of prostate cancer. Using microUS is a more straightforward and simpler process. This also makes it safer, by avoiding the potential errors that can creep in during the transfer of MRI to ultrasound for a fusion biopsy.
“It does require training to spot the patterns and interpret micro-ultrasound images correctly. But once that’s been mastered, then it could enable prostate cancer diagnosis and biopsy to happen at the same appointment. It could also make targeted biopsies more available in less developed healthcare systems where MRI is a very precious resource.
“The ease and cost of micro-ultrasound means it could be an important tool for screening programmes as well, but further research would be needed to understand its potential role in that setting.”
The trial was sponsored by Canadian company Exact Imaging, which has developed the microUS technology.
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