Summary

Summary

  • The technology described in this briefing is trublood-prostate. It is for triaging and helping with the diagnosis of people with symptoms of prostate cancer.

  • The innovative aspects are that trublood-prostate uses immunocytochemistry (ICC) profiling to characterise prostate adenocarcinoma-specific circulating tumour cells (CTCs) that have been isolated from patients' blood.

  • The intended place in therapy would be either to triage people with suspected prostate cancer before having a conventional invasive prostate biopsy, or to make a diagnosis in people with suspected prostate cancer who are not well enough to have a prostate biopsy. The test would be used in secondary care after multi-parametric MRI to guide subsequent care.

  • The main points from the evidence summarised in this briefing are from 2 observational studies including 1,208 people with suspected prostate cancer in India. They show that trublood-prostate has over 90% CTCs detection rate and over 90% sensitivity for detecting malignant prostate cancer.

  • Key uncertainties around the evidence or technology are that the evidence is limited in quantity and quality. There is currently no evidence assessing the effect of the test on clinical decision making and long-term clinical outcomes in the NHS.

  • The cost of trublood-prostate is £750 per test (excluding VAT). This will be in addition to standard care.