Advice
Expert comments
Expert comments
Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
Four experts contributed to the development of this briefing. None of the experts had used the technology and only 2 were familiar with the technology. All experts noted that the technology is not currently used in the NHS. Two of the experts have done bibliographic research on the technology.
Intended setting
Views from experts varied around the most appropriate setting for Stockholm3. One expert stated that, considering the tests will be done in a reference laboratory, the test is best done by a urologist in a secondary care setting after the referral. In this case, they noted that about 50% of people who have a prostate-specific antigen (PSA) test would likely have a significantly raised PSA level and would go on to need the Stockholm3 blood test. Other experts stated the most appropriate point of introducing the technology would be at primary care at the outset of referral, recognising that it could be a useful screening tool but this would depend on initiative towards prostate cancer screening in the UK. One expert stated in addition to being used upfront in primary care, it could equally or perhaps more beneficially be used to follow up of people having investigations for suspected prostate cancer and being discharged back to primary care with normal MRI or negative biopsies. The expert stated that the technology can then help to find an optimal point for people to be re-referred to secondary care for further investigations. Another expert stated they did not think it would gain use in primary care, but it would be used in secondary care in helping decision making for whether to biopsy after MRI for risk scores of 3 or below. This expert considered it unlikely to replace MRI as the primary screening tool.
Level of innovation
Two experts noted that there are a couple of blood-test tumour markers that have been published which include: the 4Kscore test; a prebiopsy test that incorporates 4 prostate proteins along with clinical information and the Prostate Health Index (PHI); a formula that combines all 3 forms of PSA. Prostate cancer antigen 3 (PCA3) is another urinary test that measures the concentration of PCA3 molecules in urine. Another expert noted that the PCA3, free or total PSA has been tried before but not routinely used.
Potential patient impact
Three experts said that the main patient benefit would be a possible reduction in unnecessary MRIs and biopsies in people with suspected prostate cancer. Avoiding the unnecessary invasive tests subsequently avoids the accompanying complications. One expert highlighted that the technology would mainly benefit all those aged above 50, particularly people over 70 and people with a family history of prostate cancer. Another expert said the technology is likely to benefit 2 groups of people who are normally disadvantaged by PSA testing alone. One of the groups in the 15% that present with normal PSA levels but may have prostate cancer, and a second group in the 2% that present with normal PSA levels but may have a fast‑growing cancer. The other expert mentioned that younger people with smaller prostates who have harder to interpret MRIs were likely to benefit from the technology.
Potential system impact
One expert said the technology would lead to a small reduction in biopsies but would be unlikely to replace the use of MRIs. Another expert said the cost of the new technology would likely balance out against reduced diagnostic and treatment interventions, hospital visits, capacity and staffing in the NHS. Furthermore, the expert said the technology would likely be cheaper and beneficial in the long run. Another expert suggested the resource impact of adopting the technology would likely be less or the same as the current standard of care. Several experts commented that there will be additional financial costs to providing equipment, staff and potential training for doing the Stockholm3 blood test which will be borne by the reference laboratory. One expert said that there would need to be a reference laboratory (United Kingdom Accreditation Service [UKAS] and International Organisation for Standardisation [ISO] accredited) with all the appropriate CE accredited tests both plasma proteins and molecular testing. Another expert said there would be no change in facilities except for additional logistics to get test and results communicated.
Safety
One expert said there was no potential harm of using the technology while another expert said that potential harms of the technology are similar to the harms of using PSA testing which would be underdiagnosis or overdiagnosis of prostate cancer.
Evidence
All experts recommended some additional research. One expert felt that there was a need for long term (over 15 years) longitudinal follow-up data in people who had testing with the technology and who did not have an MRI or biopsy. Another expert noted the need for research to see how the technology works in Black, Asian and minority ethnic populations. The expert also acknowledged there is an ongoing study in the US which might address this issue. One other expert recommended that additional research in the UK setting was needed and stated that the issue which would prevent adoption of the technology would be the additional expense and unclear benefits in the NHS setting. One expert mentioned the need for more clarity on cut-off levels.