Prostate cancer biomarkers
Research type
Research Study
Full title
Prostate cancer biomarkers identification
IRAS ID
170655
Contact name
Esther Baena
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
4 years, 5 months, 30 days
Research summary
In developed Western Countries, Prostate Cancer (PCa) represents the second highest cause of cancer-related death. The standard therapies for high-risk localized prostate cancer are radical prostatectomy (RP) and radiotherapy (RT). Despite significant advance in surgical procedures, the incidence of biochemical recurrence after RP/RT remains high (˜30%) and increasing levels of prostate specific-antigen (PSA) indicate the presence of viable cancer cells. Androgen-deprivation therapy (ADT) is the first-line therapy for recurrent and metastatic patients. While initially effective in controlling disease spread, progression to a castration-resistant state (CRPC) is inevitable. Up to now, docetaxel-based chemotherapy represents the standard treatment for these incurable forms of PCa, but it is merely palliative. In recent years, novel hormonal agents, such as Abiraterone acetate (de Bono 2012) and Enzalutamide (Scher 2012), the immunotherapeutic agent Sipuleucel-T (Kantoff 2010) and the radiopharmaceutical radium-223 (Parker 2013), have been approved for prostate cancer treatment showing a significant benefit in patients’ overall survival.
This study is proposed to use pre-existing PCa samples. This is a retrospective, non-randomized, non-interventional, translational research study in which genomic alterations, RNA and protein expression profiles will be evaluated in a cohort of patient samples. FFPE and frozen tissues from patients with different clinical parameters and different follow-up will be collected for high-throughput screening. In particular gene and protein expression profiles will be analysed in order to find significant differences between the subgroups of patients. Genes of interest will be further evaluated in vitro and in vivo to define their functional role in PCa. This approach will allow us to identify specific molecules involved in disease progression which are suitable for targeted-therapy. Stored blood samples will be analysed in parallel to validate new biomarkers predictive of disease progression. In particular, we will focus on microRNA profiling since these RNAs are highly stable in body fluids and mirror the molecular phenotype of the tumour of origin.
REC name
London - South East Research Ethics Committee
REC reference
15/LO/0396
Date of REC Opinion
26 Feb 2015
REC opinion
Favourable Opinion