VARIANT
Research type
Research Study
Full title
The Prostate Cancer Androgen Receptor Splice Variant 7 Biomarker Trial - A multicentre feasibility study of biomarker-guided personalised treatment in advanced prostate cancer.
IRAS ID
232962
Contact name
Rakesh Heer
Contact email
Sponsor organisation
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
Patients with advanced metastatic prostate cancer are initially treated with hormone treatment either alone or in combination with chemotherapy. Eventually most patients stop responding to initial hormone therapy. At this point treatment is usually with next generation hormonal treatment or non-hormonal treatment such as chemotherapy or radiotherapy. There is no clear guidance for which of these two treatments a patient should receive, however, it is known that only 30-50% of patients will respond well to next generation hormone treatment.
The AR-V7 (Androgen Receptor Splice Variant 7) biomarker (a biological substance) is found in the blood of some patients who have received initial hormone treatment. Studies suggest that patients with AR-V7 in their blood may be less likely to respond well to further hormone therapy. Therefore, although AR-V7 biomarker testing is not performed as part of standard practice it may be a useful test to guide choice of treatments in patients who have stopped responding to initial hormone treatment.The VARIANT study will look at whether doctors and patients are willing to use the results of an AR-V7 blood test to decide on a treatment option. This is an initial feasibility study, the results of which will be used to plan a future randomised controlled trial to find out if AR-V7 biomarker testing should be used in standard practice.
VARIANT aims to recruit 70 men with advanced metastatic prostate cancer over the period of 1 year. Participants will be randomised (1:1) to receive either standard care not guided by the AR-V7 blood result (control arm), or personalised standard treatment guided by the AR-V7 blood result (intervention arm). Participants will be followed up with 12 weekly blood tests and periodic completion of a quality of life questionnaire for up to 24 weeks.
Three centres across England, Scotland and Wales will take part in the VARIANT study.REC name
Wales REC 2
REC reference
18/WA/0419
Date of REC Opinion
2 Jan 2019
REC opinion
Further Information Favourable Opinion