Methodology study of PD markers in prostate cancer(BIOMETHS)
Research type
Research Study
Full title
BIOMETHS Study. A methodology study to determine the feasibility, evaluability and temporal variability in candidate pharmacodynamic markers of drug action in castration resistant prostate cancer.
IRAS ID
134317
Contact name
Tony Elliott
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Research summary
We know that cancer cells possess aberrant or dysfunctional signalling pathways that drive the uncontrolled, uncoordinated growth of the cancer cells. A major pathway in prostate cancer cell signalling is the androgen receptor (AR) pathway. Inhibiting this pathway has produced significant benefit for prostate cancer patients. Clinical studies investigating new and existing drug therapies have shown that overall survival in men with castrate resistant prostate cancer (CRPC) can be extended in some patients to over two years. Despite this, inevitably the disease progresses causing morbidity and death.
The difficulty is that prostate cancer cells use several other signalling pathways to promote their growth, enhance the survival of the cancer cells or overcome treatments designed to block key activities that lead to drug resistance and failure of current therapies.
There is an urgent and constant need to develop other therapies that are both effective in blocking these other key signalling pathways and that are well-tolerated. One such pathway is known as the PI3Kinase/AKT pathway. Understanding how the prostate cancer cells use this and other signalling pathways, how they are coordinated and more importantly how we can modulate them to our advantage is the foundation on which we can develop potential new drugs.
Vital to our understanding and developing our ability to block these pathways is the need to access biopsy material, generously donated by patients with this condition, in properly conducted clinical and scientific studies. This study will address and garner several key pieces of information ranging from the feasibility of taking biopsies, evaluating several key biomarkers, their baseline levels, their variation in levels and how these correlate with the disease in order that we can conduct subsequent clinical studies of compounds in development to treat this disease.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/0044
Date of REC Opinion
24 Apr 2014
REC opinion
Further Information Favourable Opinion