Intraprostatic PRX302 injection to treat localised prostate cancer /2b
Research type
Research Study
Full title
A Multi-Centre, Open Label, Phase IIb Study, Evaluating the Safety, Tolerability and Efficacy 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
219354
Contact name
Hashim Ahmed
Contact email
Sponsor organisation
Sophiris Bio Corp.
Eudract number
2016-004694-41
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Current treatments for early prostate cancer (men with clinically significant, localized, low to intermediate risk) use radiation or surgery to treat the whole prostate. This may cause 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 be systemically safe with a low incidence of genitourinary side effects. Data from a recent proof of concept Phase 2a study in 18 men with clinically important localized prostate cancer showed that PRX302 caused very few immediate side-effects and no long-term side-effects on erections and urine function. It also showed that PRX302 is able to kill prostate cancer cells in about half the men but the response was not consistent. The data indicated that higher doses and a different way to deliver the drug were needed and addressing both those areas might improve the cancer destruction. That is why the Sponsor wants to do this study.
PRX302 might provide a more precise and better controlled treatment for clinically important prostate cancer while reducing the burden of side effects that men currently face.
The study will be conducted at urology sites in both the US and the UK. The participants will be involved for approximately 6-12 months. If a man still has some clinically important cancer remaining 6 months after the initial treatment with PRX302, they may be offered a second administration of PRX302 providing they have not experienced any clinically significant side effects. If a man receives a second treatment of PRX302 they will be followed up for a further 6 months so their total participation would be approximately 12 months.REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/2148
Date of REC Opinion
3 Feb 2017
REC opinion
Further Information Favourable Opinion