Analysis of cell-free DNA (cfDNA) in men with elevated PSA levels.
Research type
Research Study
Full title
A multi-centre prospective study to analyse cancer derived cell-free DNA (cfDNA) in men with elevated PSA levels.
IRAS ID
197827
Contact name
Hashim Ahmed
Contact email
Sponsor organisation
Chronix Biomedical Corporation
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The prostate is the most common site of cancer in men with 47,000 new cases diagnosed annually in the United Kingdom with approximately 10,000 yearly deaths. Screening of potential prostate cancer usually relies on digital rectal exam (DRE) and prostate specific antigen (PSA) levels. The PSA test is a blood test, and is widely available to the general population. It is limited however due to its low sensitivity and low specificity, and its inability to distinguish between low-grade and high-grade tissue damage (called lesions). The DRE is also widely available; however there is some discomfort for the patient and a risk of slight bleeding.
The purpose of this study is to test a potential new method for detecting prostate cancer in men. This new method will be tested by analyzing a small blood sample from men, taken before they undergo their planned biopsy (removal of a piece of tissue to examine for the presence of prostate cancer). Researchers in the United States, Germany and Canada have developed a new method for detecting cell-free tumor DNA in the bloodstream. In a previous study, they analyzed blood samples from more than 400 men, and compared the blood test results with PSA levels and prostate tissue biopsy gradings (called the Gleason score). They showed that it was possible to detect tumor DNA in the bloodstream, and that it could distinguish between men who have prostate cancer and those who don’t, and between men who have cancer and those who have an enlarged or inflamed prostate (known as benign hyperplasia or prostatitis, respectively). The aim of this study is to show simlilar results but in a much larger population of men.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1252
Date of REC Opinion
11 Aug 2016
REC opinion
Further Information Favourable Opinion