No safety measures spared to restart prostate cancer surgery study
Giving patients the opportunity to use online methods to tell doctors about their health and making sure the site was COVID safe were key achievements in getting a surgical prostate cancer trial back up and running again.
NeuroSAFE PROOF, led by University College London, is a randomised controlled trial which compares two different approaches in prostate cancer surgery.
For cancer which has not spread from the prostate to form metastases, surgeons remove the prostate. This often leads, however, to a loss of erections and urinary incontinence due to nerve damage.
During the operation the surgeons can opt to perform nerve sparing surgery, where the outer layers of the prostate are removed, which can increase postoperative potency, but may increase the risk of cancer being left behind and the need for radiotherapy, which renders the men impotent, even if they had nerve sparing surgery.
A new technique called NeuroSAFE has been developed to promote nerve sparing without compromising cancer control. With the NeuroSAFE technique, during surgery, a pathologist examines the prostate near the nerves to check for exposed cancer. If cancer is found, the nerve tissue is removed so the recurrence risk is similar to when cancer cells are not exposed.
The trial compares the NeuroSAFE technique with standard NHS care.
“We do our surgery in north London which is a ‘cold’ site. This means there aren’t any COVID-19 affected inpatients, which minimises the risk of surgical patients getting unwell with COVID-19” explained Mr Greg Shaw, trial CI for NeuroSAFE and Urology Specialty Lead for CRN North Thames. “We had to ensure that we did everything we could to keep staff and patients safe.”
The trial was suspended due to coronavirus in April, but study patients started to return in July.
Mr Shaw explained: “We worked with the University College London Hospitals NHS Foundation Trust research and development department on how best to restart the study. The overarching principle was always to maintain patient safety.
“We checked on the health of our staff and patients regularly, but we also had to ensure we weren’t bringing patients in unnecessarily. So we had to do things a bit differently.”
To do this, the study team embraced the use of online technologies. Patients on the study were able to give their consent electronically, instead of in person, and a website was used to give patients the opportunity to tell the study team how they were faring after surgery and to collect the patient reported outcomes, necessary for the study endpoints. The study team is also working on an app to allow patient-reported outcomes to be fed back too.
Patients were also engaged during a virtual patient and public involvement meeting during which the study team told them of plans to restart surgery.
Now they have restarted, those working on the trial are keen to press ahead with recruitment. “We’ve got 152 patients enrolled so far and we’re very keen now to get on” explained Mr Shaw. “We want to try to reach 400 people in total over the next 18 months.
“We’re excited about the possibilities of this study and we hope that, in the future, removal of the prostate gland will be less frequently associated with problematic side effects like impotence.”