Advice

Expert comments

Expert comments

Comments on this technology were invited from clinical experts working in the field. The comments received are individual opinions and do not represent NICE's view.

Three experts contributed to the development of this briefing. Two experts were familiar with the technology, and 1 had used this technology before. All experts noted that the technology is not currently used in the NHS.

Level of innovation

All experts agreed that trublood-prostate could become an innovative minimally invasive diagnostic test for detecting prostate cancer. Experts also said that a blood test that could identify people who do need to have a biopsy or could make a diagnosis without biopsy would be a game changer in the current care of prostate cancer. However, 2 experts said that the evidence submitted so far for this technology is not sufficient to justify its routine use in the NHS. One expert said that they have no concerns about its use in the NHS because of the validation of the test in 2 observational studies of 1,208 people with suspected prostate cancer. One expert said that the innovative aspect is the circulating tumour cells (CTCs) enrichment technique and that the 8 days turnaround is a useful feature. All experts are aware of other CTCs biomarkers in development.

Potential patient impact

All experts recognised that having a blood test to avoid a prostate biopsy would be the main advantage for people. Experts felt the test would also be very useful for a small number of people who may not be well enough for a biopsy. One expert said that trublood-prostate could increase the diagnostic precision for people with serum prostate-specific antigen (PSA) values in the intermediate range (that is, between 4 and 10). One expert felt that the test could be used to target all men over 50 years for mass screening. However, 3 experts said that these potential benefits need to be supported by robust validation data. One expert said that there is little evidence that early diagnosis of prostate cancer leads to improved mortality rates, unlike cervical, breast and colorectal cancer.

Potential system impact

One expert said that trublood-prostate is likely to be cost effective in the long term by allowing diagnosis of prostate cancer with high sensitivity and specificity from a blood test. One expert said that there would be a small increase in blood sample collection costs. Another expert reported that further data is needed to show that a test that could avoid a biopsy, like trublood-prostate, reduces the need of hospital visits or surveillance. It might be possible that hospital visits may increase to maintain reassurance that a significant cancer has not been missed.

General comments

All experts agreed that the trublood-prostate could be used in addition to standard care. One expert added that in the future the diagnostic test could be used together with PSA as a precision screening tool for prostate cancer. However, 3 experts agreed that the technology needs further clinical development first. One expert said that the technology would be currently used only in clinical trial settings because CTCs tend to be detected more readily in advanced cancer than at early stage, regardless of enrichment approaches. Another expert suggested using complete genomic sequencing on isolated CTCs to robustly identify the nature of CTCs. Two experts said that the use of this diagnostic test in the NHS is premature. One expert felt that this technology should be encouraged to help develop further validating trials. Research should include well powered prostate-specific controlled prospective trials with cross-site validation of the diagnostic device to address uncertainty about the evidence.