Intraprostatic PRX302 injection to treat localised prostate cancer
Research type
Research Study
Full title
A single centre, open label, phase IIa study, evaluating the safety and tolerability of targeted intraprostatic administration of PRX302 to treat men with histologically proven, clinically significant, localised, low to intermediate risk prostate cancer that is associated with an MRI lesion.
IRAS ID
163001
Contact name
Mr Hashim Uddin Ahmed
Contact email
Eudract number
2014-003386-22
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Current treatments for early prostate cancer use radiation or surgery to treat the whole prostate. This causes damage to surrounding structures that control erections and urine flow and can also damage the back passage. This leads to leakage of urine, poor sexual function and back passage diarrhoea, bleeding and discomfort.
The direct intraprostatic injection of PRX302 appears to have been shown to be systemically safe with a low incidence of genitourinary side effects. The data collected to date in prostate cancer studies have not been robust on cancer control and this protocol represents the first stage in evaluating whether PRX302 injected directly into a cancer lesion is effective in the short term sufficient to justify a larger multicentre, randomised controlled trial (RCT) evaluating medium term efficacy against a comparator control arm.
This new type of treatment might be more precise and better-controlled for prostate treatment than others we have used. However, we must test these characteristics properly within a clinical trial. If it is found to be of value, this treatment could reduce the burden of side effects that men currently face, in the future.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/0008
Date of REC Opinion
19 Jan 2015
REC opinion
Favourable Opinion