Clinical trials

The LDR BURST trial will compare the side effects of two radiotherapy treatments for men with localised prostate cancer. The first treatment is 4D low dose rate brachytherapy where small radioactive seeds are inserted into the prostate gland under ultrasound guidance. A computerised tomography scan is subsequently performed to check seed positioning. Patients usually return home the same day. The seeds emit their radiation over several months before losing their activity. Stereotactic radiotherapy, an alternative treatment, is a form of external radiation using precise high energy x-rays to target the prostate gland. It is delivered in 5 treatment sessions on alternate days; the full treatment course is completed within 2 weeks. Stereotactic radiotherapy has recently been approved by the National Health Service following successful results in international trials demonstrating it is safe and effective to give external radiotherapy in five treatment sessions. Delivering a higher dose in each treatment fraction is known as 'ultra-hypofractionation'. Before the treatment, men will undergo a minor procedure, typically under local anaesthetic, to have metallic markers inserted into the prostate to improve visibility of the prostate gland when planning and delivering the treatment. The side effects of both the radiation treatments are similar. Common side effects include bladder issues, such as needing to urinate more often and having a slower urine flow. Patients might also experience more frequent and looser bowel movements, occasionally with a little blood. Symptoms usually improve over time. Additionally, some men might have trouble achieving or maintaining an erection after radiation treatment, this can often be managed with medications. Both of the treatments use ionising radiation to destroy the prostate cancer cells which may cause cancer many years or decades after exposure. The chances of this happening are the same whether taking part in this trial or not. A protective gel, called Barrigel, will be inserted into the space between the prostate gland and the rectum increasing the distance between them. This significantly reduces the dose of radiation to the rectum. The gel can be inserted at the same time as the brachytherapy seed or fiducial marker insertion. The gel is slowly reabsorbed following treatment over the next 3 to 6 months. The trial will randomly assign 110 men to each radiation treatment to compare their side effects. There is a 50% chance the patient will be assigned to brachytherapy and 50% chance of stereotactic radiotherapy. Patients will be asked to complete four questionnaires prior to starting treatment and at regular time points following treatment. They will be telephoned every 4 weeks for the first 2 months to check on side effects, followed by a face-to-face appointment at 3 months, and a PSA blood test, and then followed up at regular intervals for 5 years.

Adnexal masses are growths that can form in the ovaries or fallopian tubes for different reasons, such as hormonal changes, infection, or cancer. These masses may cause pelvic discomfort, pain, constipation, or no symptoms at all. When adnexal masses are found on scans, they are described in a certain way to indicate if they could represent early-stage cancer, and the word "complex" is used to refer to these masses. Surgery is often recommended, where the mass is removed and examined under the microscope during surgery in a process called (frozen section analysis); to determine its true nature. It is still difficult to confirm cancer before surgery, and many of these masses turn out to be benign (not cancerous) or borderline (slow-growing tumours). Currently, doctors use open surgery with a cut from at least the belly button to the pubic bone to remove these masses. Patients with a cancer diagnosis will then have more surgical steps including assessment and sampling of various areas inside the abdomen (known as staging surgery) to see how far the cancer has spread. Recovery after open surgery can be long and painful, with a slow return to normal daily activities. The trial investigators know from practice that robotic surgery has replaced open surgery for most benign adnexal diseases and other types of women's cancers, such as womb cancer. Recovery is quicker, with less pain and blood loss, allowing for a faster return to daily activities. This study, MIRRORS-FROZEN (pilot), compares robotic versus the standard open surgery in managing women with complex adnexal masses of eight centimetres or less. The hope is to decrease the need for open surgery in patients with benign or borderline disease and to assess if robotic surgery has similar, worse, or better outcomes for patients with cancer. MIRRORS-FROZEN is funded by Intuitive Foundation and GRACE Charity. The investigators will establish the feasibility of conducting a large multicentre randomized controlled trial in the future comparing certain cancer outcomes between robotic and open surgery.

The goal of this observational study is to characterise changes in gene expression in endothelial cells in patients with either sepsis or post major abdominal surgery. The main question we plan to answer is: 'What molecular pathways are differentially expressed during inflammatory pathologies?'

To determine the quality of life following the radical excision of recto-vaginal endometriosis.