A trial of gene therapy for early prostate cancer (GDEPT)

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 1/2

This trial was looking at a type of gene therapy for early prostate cancer. It was open to men with early stage cancer, who were going to have surgery to remove the prostate gland (radical prostatectomy).

With this treatment, a specially treated virus is injected directly into the prostate cancer. It carries a gene that can turn a harmless drug called CB1954 into a very active anti cancer drug. The harmless drug travels through the bloodstream. When it reaches the virus infected cancer cells, it is activated by the gene in the virus and kills the cancer.

This trial was trying to find out how good the virus was at getting the genes into the cells in the prostate gland, and to find out about any possible side effects. The aim of this trial was to find the highest dose of the virus that could be given safely. The men who took part in this trial did not have the anti cancer drug.

Summary of results

The researchers found the highest dose of the virus that could be given without causing bad side effects.

The trial recruited 20 men. The first few men had a low dose of the virus and as they didn’t have any bad side effects, the next few had a slightly higher dose. And so on, until the highest safe dose was found. This is called a dose escalation study.

One side effect that 4 of the men did have was a change in the results of tests that show how well the liver is working (liver function tests). But this did not last long and did not need any treatment.

As the men in this trial did not have the anti cancer drug, they all had surgery to completely remove their prostate after having the virus injection. The researchers were able to look at samples of the tissue removed during surgery to learn more about how the genes were working in the prostate gland.

Having found the highest safe dose to give, the researchers went on to use this in a trial for men with prostate cancer that had continued to grow.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.