Newcastle Clinical Trials Unit



The 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

  • Study stage: Closed
  • Sponsor:  The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Funder:  NIHR – Research for Patient Benefit
  • Therapeutic area: Cancer and Neoplasm
  • Type of study:  Non clinical intervention

Aim: To determine the feasibility of a definitive randomised control trial to evaluate the clinical utility of an AR-V7 blood biomarker assay in personalising treatment for men with mCRPC in UK NHS clinical practice.

Primary Outcome:

To establish if it is feasible to conduct a definitive large-scale pragmatic trial comparing AR-V7 biomarker-driven management with the current standard of care in patients with metastatic Castration-Resistant Prostate Cancer.

  • Population: Adult
  • Design: RCT
  • Setting: Secondary Care
  • Planned Sample Size: 70