MAGNABLATE I
Research type
Research Study
Full title
MAGnetic NAnoparticle thermoaBLATion – Retention and Maintenance in prostatE: A Phase 0 Study in Men (MAGNABLATE I Trial)
IRAS ID
127667
Contact name
Hashim U Ahmed
Contact email
Sponsor organisation
University College London
Research summary
Men with early prostate cancer face a number of options which lie at the extremes of care. Active surveillance involves monitoring the disease or immediate treatment which involves surgery or radiotherapy. The difference between these two strategies in terms of reducing the chance of a man dying from his disease is small.
However, not only is the survival benefit small, surgery or radiotherapy carry significant risk of side-effects. These occur because of damage to surrounding tissue resulting in incontinence of urine (1 in 5), erectile dysfunction (1 in 2) and back-passage bleeding, diarrhoea or discomfort (1 in 10).
The ideal treatment should be given under local anaesthetic, effectively destroy areas of cancer, limit damage to surrounding tissues and be repeatable. We think magnetic thermoablation may be able to deliver on these ideal attributes.
Magnetic thermoablation involves injecting magnetic nanoparticles directly into the cancer. When a magnetic field is applied close to them, these nanoparticles heat up thus killing cells.
We propose a study to find out whether the magnetic nanoparticles stay where they are injected. They could move away from the cancer which means the cancer will not be heated effectively, or they could move to sensitive structures around the prostate, leading to side-effects.
This study will involve approaching men who are having their prostates removed anyway using surgery. If men agree to participate, we will inject their prostate with varying amounts of nanoparticles. We will NOT heat them up. After their surgery, we will look at the pathology specimens to see where the nanoparticles have gone. The nanoparticles are not harmful but the process of injection can carry a small amount of harm.
If the nanoparticles stay where they are injected, we will then be able to run another study in which we treat men who have prostate cancer with magnetic thermoablation.
REC name
London - Stanmore Research Ethics Committee
REC reference
13/LO/1233
Date of REC Opinion
17 Sep 2013
REC opinion
Favourable Opinion