ABCaP: Anaerobic Bacteria and Prostate cancer.
Research type
Research Study
Full title
ABCaP Study: A Study to Evaluate the Role of Anaerobic Bacteria in Prostatic Inflammation and the Pathogenesis of Prostate Cancer.
IRAS ID
215060
Contact name
Frances Chinegwundoh
Contact email
Sponsor organisation
Joint research Management Office (QMUL and Barts Health NHS Trust)
Clinicaltrials.gov Identifier
internal reference number ( ReDA Ref) , 011605
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Prostate cancer is the most common male cancer and the second leading cause of cancer related deaths in men in the UK and the US. The overall incidence of CaP in the UK has increased from 65-70 per 100,000 males in 1993-1995 to 89-116 per 100,000 males in 2008-2010.
This study aims to assess the role of anaerobic bacteria in prostatic inflammation and prostate cancer
We plan to recruit 60 patients presenting to Barts Health NHS Trust with raised PSA. Currently these patients are investigated with a transrectal ultrasound guided biopsy of the prostate. As part of clinical assesment (in clinic) and as part of this procedure patients undergo a digital rectal examination and are asked to provide a urine sample. We plan to perform a short prostate massage at the time of the digital rectal examination and collect the first 5-10 mls of urine before and after their prostate massage. The patient will not be required to undergo any additional clinic visits or procedure (except short prostate massage). The urine will then be cultured and studied with the MOLDI-TOFF mini-mass spectroscopy machine to identify bacteria.
We will also recruit additional 60 patients who have normal PSA but have Lower Urinary Tract Symptoms. Approximately 3/4 of all patients with LUTS will have a normal PSA as this is due to benign enlargement of the prostate. However these patients require a Digital Rectal Examination as part of their normal assesment. We plan to identify these patients in outpatient clinics and consent them for a short prostate massage which will be done at the time of the digital rectal examination. We will collect 5-10 mls of urine before and after the prostate massage. The urine will be analysed as discussed above.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
17/LO/0109
Date of REC Opinion
16 Feb 2017
REC opinion
Further Information Favourable Opinion