C2I 2022 Medical & Healthcare winner - ProstaPalp

Category: Medical & Healthcare

Headline sponsor: Babcock International Group

Project: ProstaPalp

Partners:  IntelliPalp, Heriot-Watt University, University of Edinburgh, EPSRC, MRC, Western General Hospital (Edinburgh), CENSIS. Support from Scottish Enterprise and the Urology Fund

It is estimated that one man dies every 45 minutes from prostate cancer, yet over three quarters of men who agree to a biopsy will not have the disease.

This can be problematic, with risks that include bleeding, infection and erectile disfunction. It can also be expensive, with the UK accounting for 220,000 prostate biopsies annually at a cost of £355 per procedure. In Europe, 1.3 million biopsies are carried out at €2,392 per biopsy, and in the USA one million biopsies occur at a cost of $2,300 per biopsy.

According to Professor Alan McNeill, Chief Medical Officer and co-founder of Intellipalp Dx, winners of C2I’s Medical & Healthcare category, there is also an environmental penalty to biopsies that return negative results.

“MRIs, the gold standard for prostate cancer diagnosis, require specialists to both operate and interpret the results while the technique consumes as much energy as 50 UK homes - over 13 operational hours - a significant environmental impact given the percentage of unnecessary MRIs delivered daily,” he said.

Then there are the very real costs in terms of lost lives, with 11,500 men dying from prostate cancer from the more than 47,500 who test positive for it.

The problem is further exacerbated by a shortfall of healthcare professionals and the backlog of cancer diagnoses and treatment arising from the pandemic.

“In June 2022, analysis by the Royal College of Radiologists found that Scotland has 103 fewer consultant radiologists than required to meet demand - a 23 per cent shortfall,” said McNeill. “Projected to increase to a 30 per cent shortfall by 2026, this will severely impact the record numbers of patients on waiting lists for CT scans, MRIs and diagnostic ultrasounds.”

Now, after a decade’s collaboration among clinicians, academics, engineers, scientists, and biologists, Intellipalp Dx’s ProstaPalp device looks set to save the NHS millions of pounds whilst simultaneously improving patient care.

ProstaPalp is worn under the glove during DREs (digital rectal examinations) and makes an independent assessment by oscillating against the prostate's surface, determining its firmness. Measuring 12 points to create a map of cancerous nodules, it conforms to the human finger and activates at specific frequencies, using an algorithm to determine cancer risk.

“The unique technology comprises a base unit - a microprocessor with embedded software, display and data collection functions and a linked mini-hydraulic actuator - connected to a small, disposable, 10-use probe fitted to a clinician's finger. During a DRE examination, a sophisticated algorithm identifies whether the patient has a low, intermediate, or high risk of significant prostate cancer,” said Bob Reuben, Chief Technical Officer and co-founder of Intellipalp Dx, a university spin-out based at Heriot-Watt University in Edinburgh. “The operating principle is not like ultrasound, which is based on launching a sound wave into the tissue and recording echoes. As such, ultrasound only ‘sees’ the interface between areas of static stiffness contrast. The palpation method is a whole-body movement, so the probe tests the entire column of tissue underneath the probe point.”

Reuben continued: “The ability to change the frequency of oscillation, the indentation depth [mean contact force] and the amplitude of oscillation, leads to a probe which can be used in a much more exploratory way than any other device. The incorporation of model-based interpretation also allows the probe to be used in an intelligent way, giving the user instructions on how to improve the measurement during a test.”

To date, a prototype ProstaPalp has been used successfully on 25 patients undergoing radical prostatectomy in vivo and ex vivo, which was followed by the first clinical trial with over 400 men.

Funded by The Urology Foundation, the study showed Intellipalp Dx that its stiffness maps correlated well with the presence or absence of significant prostate cancer. It also identified issues regarding calibration and data processing, issues that the company has made ‘significant steps to resolve and will be addressed fully as part of engineering developments in this project.’

Intellipalp Dx said it is now partnering with CENSIS - Scotland's Innovation Centre for sensing, imaging and Internet of Things (IoT) technologies - to make the device available for trials of an optical sensing technology to reduce surgical margins during robotic cancer operations.

Focusing on developing the design and manufacture of the probe along with the signal processing algorithm to deliver more user-friendly, reproducible and reliable results, this work will also lay the foundation for integrating ‘mechanical intelligence’ into the company’s algorithms.

Future versions of Intellipalp Dx’s products will be equipped with an element of machine learning. The sensor development will help it manufacture enough probes to undertake a further clinical evaluation with the urology team at Bristol University. After this clinical evaluation, the company believes commercial sales of the device for use in clinical practice will begin.

Intellipalp Dx finds itself uniquely positioned in that no comparable technology is available yet. McNeill said other groups are seeking alternative blood and urine tests to identify men with the most significant prostate cancer, but these tests will not be available at the point of care and have associated laboratory costs.

“A few other research groups are working on mechanical probes for prostate cancer identification but none of these are deployable - or yet demonstrated - in vivo and are more suited to open surgery,” added Reuben. “They don't use dynamic palpation, so don't assess the viscous behaviour of the tissue. Our team has a global lead in its understanding of in vivo measurements and the understanding of the relationship between the structure of soft tissue and its mechanical properties.”

With an initial grant award of £2m from EPSRC and MRC, the researchers first began by measuring prostates transurethrally. Reuben explained that by using the excised material from men having transurethral resections and radical prostatectomies, they found a measure that was indicative of both cancer and benign disease.

“We identified the need to take measurements with the prostate in situ. This insight led to ProstaPalp,” he said. “By forging an initial academic/clinical partnership at the start of the project, we were able to overcome many of the challenges other medical innovations face when translating research from lab to clinical use.”

Reuben continued: “We've overcome multiple challenges including the medical regulatory process. As we ran patient studies early in our research, we were locked into using early-stage designs due to strict protocols governing trials. We've worked through this with input from the medical physics team at the Royal Infirmary of Edinburgh and Western General Hospital and are now applying for further funding to refine the device.”

Prof McNeill concluded by saying that routine use of the ProstaPalp device in community settings will present a huge opportunity that could reduce the existing and enormous burden on secondary care.

“Only those at risk of having significant prostate cancer would be referred to hospitals for further investigation, with all others would be reassured immediately,” he said.