Clinical and technical evidence

Advice

Published evidence
Overall assessment of the evidence
Sustainability
Recent and ongoing studies

Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement for medtech innovation briefings. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

There are 2 observational studies of 1,208 people with suspected prostate cancer summarised in this briefing.

The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.

Overall assessment of the evidence

Overall, the quantity of evidence for the accuracy of trublood-prostate is limited and of low methodological quality. The studies were done in India, not in the NHS setting. The description of prospective, independent, blind comparison with a reference (gold) standard of diagnosis was described only in a subset of the blood samples. The company stated that they have unpublished data on method development, analytical validation and blinded prospective validation of the technology using clinical samples. The published evidence came from 1 conference abstract and 1 paper that reported on multiple cancers but only data for prostate cancer was considered relevant for this briefing. More prospective comparative studies are needed to evaluate the accuracy of trublood-prostate. These should compare trublood-prostate with biopsy in the NHS setting. Those assessing the results of trublood-prostate should be blind to the results of biopsy.

Patil et al. (2020)

Study size, design and location

Observational study of 650 people with confirmed malignant and benign prostate enlargement to test the accuracy of immunocytochemistry (ICC)-based characterisation of circulating tumour cells (CTCs) in malignant prostate cancer in India.

Intervention and comparator

ICC-based characterisation of CTCs in prostate cancer. Gold standard was histopathological examination of biopsied tumour tissues (confirmed by the company because it was not described in the abstract).

Key outcomes

Viable CTCs could be obtained from 58 samples (89.2%) out of 65 confirmed prostate cancer cases. Among the 40 samples that were characterised by deep ICC profiling, all samples (100%) were positive for prostate-specific membrane antigen (PSMA) and AMACR. Among the benign cases, CTCs were seen in 10 samples (1.7%), of which all 10 were positive for PSMA but negative for AMACR. These people are having follow up. The possibility of other cancers is not ruled out in these people.

Strengths and limitations

This study is reported in conference abstract form only so is limited in detail. The reference gold standard and blinding of the test are not mentioned and the study was done retrospectively.

Gaya et al. (2020)

Study size, design and location

Observational study of 558 people with a confirmed diagnosis of either malignant prostate cancer or benign hyperplasia or prostatitis, and people with suspected prostate cancer in India.

Intervention and comparator

CTC detection rates and ICC-based characterisation of CTCs in prostate cancer (confirmed as trublood-prostate test by the company) compared with histological examination of biopsy samples.

Key outcomes

Overall, CTC detection rate was 93.7% prospectively (111 samples) and 97.9% retrospectively (140 samples). The ICC-based characterisation showed a 91.3% prospective sensitivity (154 samples) and 96.3% retrospective sensitivity (54 samples) when detecting malignant prostate cancer from benign conditions.

Strengths and limitations

One of the limitations is that this study reports on multiple cancers and data on prostate cancer for this briefing is a small proportion of the paper results section. The description of independent, blind comparison with a reference (gold) standard of diagnosis was only done in a subset of data.

Sustainability

The company claims that the trublood-prostate test may help reduce the environmental impact by decreasing energy use and travel. There is no published evidence to support these claims.

Recent and ongoing studies

PROSTATE prospective observational open label trial: utility of ProState in distinguishing prostate malignancies from benign prostatic hyperplasia. WHO identifier: CTRI/2019/02/017863. Status: ongoing, interim results published (Patil et al. 2020; Gaya et al. 2020). Indication: prostate malignancy. Device: ProState (liquid biopsy platform). Date: 1 March 2019. Country: India.
TRUEBLOOD prospective observational open-label trial: tissue biopsy replacement with unique evaluation of circulating bio-markers for morphological evaluation and clinically relevant molecular typing of malignancies from blood sample. WHO identifier: CTRI/2019/02/017918. Status: ongoing, interim results published for feasibility of harvesting CTC from cancer malignancies (Akolkar et al. 2019). Indication: cancer malignancies. Device: trublood test for different cancers including trublood-prostate. Date: 1 March 2019. Country: India.