Validation of a metastatic biology subtype in prostate cancer
Research type
Research Study
Full title
The validation of a metastatic biology subtype in an independent collection of primary prostate cancer samples from multiple sites.
IRAS ID
154794
Contact name
Richard Kennedy
Contact email
Sponsor organisation
Almac Group
Clinicaltrials.gov Identifier
NA, NA
Research summary
Prostate cancer is diagnosed in approximately 40,000 patients per year in the UK of which the majority present with potentially curable disease. Curable patients can either be treated with radical resection of the prostate or radical radiotherapy. Despite this 20% of patients receiving radical therapies develop disease recurrence and may benefit from additional adjuvant treatment such as more extensive radiotherapy or adjuvant hormonal therapy. In addition, there is a population of prostate cancer patients whose primary disease will remain indolent and may not require radical treatment.
We have previously identified a novel subtype of primary prostate tumours which have a metastatic biology at the time of presentation, these tumours demonstrate increased rates of biochemical recurrence and worse overall survival. We have developed a gene expressed based signature which can prospectively assign a tumour sample as metastatic biology or not.
The overall aim of this study is to validate the performance of the multi-gene metastatic prostate sub-group signature in an independent cohort of clinical samples with associated clinical information. The samples are to be provided from multiple centres. The primary endpoint is the prediction of risk of disease recurrence following surgery with curative intent. Disease recurrence is defined/measured by biochemical failure, i.e. a Prostate Specific Antigen (PSA) level of 0.4 ng/ml followed by another increase. The use of this definition of recurrence status best explains the development of distant metastasis and disease recurrence among 10 candidate definitions (Stephenson et al., 2006), furthermore PSA defined recurrence is widely used for reporting the outcome of radical prostatectomy.
We would also like to correlate mutations and translocations to the metastatic subgroup to better understand the genetic profile that underlies this subgroup. This process will better inform the biology underpinning this molecular group and help identify novel drug targets for new therapeutic development.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1066
Date of REC Opinion
21 Jul 2014
REC opinion
Favourable Opinion