Prostate cancer androgen receptor splice variant 7 biomarker study - a multicentre randomised feasibility trial of biomarker-guided personalised treatment in patients with advanced prostate cancer (the VARIANT trial) study protocol

What is it about?

Background to VARIANT study:
Prostate cancer is the commonest male cancer and a quarter of men affected progress to non curable metastatic disease. Initial treatments include hormonal approaches or chemotherapy. However, responses are temporary and thereafter, management options lie between (1) additional chemotherapy and drug based internal radiotherapy (radium-223) or (2) further hormone manipulation. Presently, there is no clear rationale for choosing between these mechanistically different treatment approaches. As many patients can be insensitive to either treatment approach, there are considerable costs from ill-guided management, both in terms of patient experience and outcomes (side-effects and disease progression) and also economic costs to the NHS (large burden of expensive treatments for the commonest male cancer).

Why the VARIANT study is important:
The development of a biomarker to identify treatment sensitivity is a clinical priority for patients and service providers. The forerunner in the advanced prostate cancer setting, the AR-V7 biomarker, potentially affords a significant opportunity to help personalise treatments. The biomarker could identify those likely to be sensitive to further hormonal treatment and avoid ineffective treatments in those that are predicted to be insensitive.

What will the VARIANT study achieve?
The main outcome of the VARIANT study is to determine if promising, predictive findings of a blood biomarker (AR-V7), has value in routine clinical practice in personalising treatment in men with advanced prostate cancer. Before embarking on a full clinical trial, the VARIANT trial will confirm feasibility i.e. acceptability to both clinicians and patients to randomise to an experimental study where subsequent treatment is defined by a biomarker result.

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