Bury Saint Edmunds

Researchers are evaluating the safety and effectiveness of advanced external beam radiotherapy called stereotactic body radiotherapy (SBRT) in men with high risk localized prostate cancer. This cancer is limited to the prostate but has a high chance of growing quickly or spreading. The study compares SBRT given to the prostate alone versus SBRT given to both the prostate and surrounding lymph nodes. It is a Phase III trial involving 1128 participants to see which treatment option is better and safer over at least three and a half years of follow-up. Participants receive radiotherapy in 5 visits over two weeks. Half of the men will have SBRT targeted only to the prostate, while the other half will have it directed to both the prostate and pelvic lymph nodes. The treatments are delivered at NHS radiotherapy centers experienced with SBRT and pelvic node radiotherapy. Quality assurance ensures the treatments are administered properly. During the study, men will undergo scans including multi-parametric MRI and various types of PET-CT or MRI to stage their cancer before treatment. Researchers will monitor side effects and cancer outcomes to assess safety and effectiveness. The main outcome measured is the time until biochemical or clinical failure, with a minimum follow-up of 3.5 years after randomization. Participants will be closely followed for side effects and cancer control throughout the study period.

This research aims to understand the genetic factors that contribute to the risk of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR). GCA is a serious inflammatory disease affecting blood vessels, mainly in people over 50, which can cause severe complications like vision loss or stroke if untreated. PMR causes pain and stiffness in the limbs with signs of inflammation. The study involves both patients recently suspected of having GCA and those with confirmed diagnoses from the past. It seeks to provide new insights into disease causes and improve diagnosis and treatment approaches. Participants are observed in a multi-center study collecting clinical and genetic data. The study includes both prospective patients with suspected GCA and retrospective patients with confirmed GCA or PMR diagnoses. Some retrospective participants receiving tocilizumab for recurring or difficult-to-treat GCA are also included in a safety monitoring registry. Data collected include clinical features, imaging, tissue and blood samples, and advanced genetic testing. The study also follows patients over time to assess disease impact, quality of life, and long-term outcomes. During the study, participants provide medical information, biological samples, and complete questionnaires about their symptoms and quality of life. Researchers monitor disease activity and treatment effects, especially among those starting certain immune-modifying drugs. The main measurements focus on genetic susceptibility at the study start, with ongoing evaluation of diagnosis, prognosis, and disease progression. The study is designed to improve understanding and management of GCA and PMR over time.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating the prevention of venous thromboembolism (VTE), which can be a serious complication after an acute stroke. This study is focused on immobile stroke patients who cannot walk without help and aims to compare two methods to prevent VTE during a 90-day follow-up period. The study compares the current standard treatment, Intermittent Pneumatic Compression (IPC), with a medical device called the geko17; device, which uses neuromuscular electrical stimulation to improve blood flow and potentially reduce VTE risk. Participants will be randomly assigned to receive either the IPC treatment, which involves air-filled cuffs squeezing the lower legs, or the geko17; device stimulating the peroneal nerve. Both treatments will be applied until the patient can walk independently or for up to 30 days. Leg compression Doppler scans will be done at 7 days (optional) and 14 days (mandatory) after randomisation. At 14 days, patients will also complete a questionnaire about device comfort and provide health information. Additional data on symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) will be collected from medical records at 30 days. During the study, participants will be monitored through scans, questionnaires, and medical record reviews to track any occurrences of DVT or PE. A final follow-up call at 90 days will assess the patient's recovery, health status, mobility, and quality of life. The main outcome measured is the frequency of symptomatic or asymptomatic DVT in the leg veins or any PE from randomisation up to 30 days. This comprehensive monitoring aims to provide clear information about which prevention method may better support immobile stroke patients.

Researchers are evaluating whether certain drugs can slow down the progression of motor neuron disease (MND) and improve survival. This study uses a multi-arm adaptive design, meaning several treatments are tested simultaneously and can be changed based on emerging results. The trial initially started with memantine, trazodone, and placebo, later adding amantadine and tacrolimus. Some drugs were removed due to lack of benefit, allowing efficient assessment of multiple treatments over time. The drugs tested are already approved for other conditions and were selected through a thorough review by MND experts, considering safety and previous research quality. Participants receive one of the study medicines or a matched placebo, administered once daily either as oral solutions or capsules, depending on the drug. The current arms include amantadine, liquid placebo matched to amantadine, tacrolimus capsules, and capsule placebo matched to tacrolimus. Participants are randomly assigned to the treatments they are eligible for. The study allows new drugs to be added or ineffective ones dropped based on ongoing results, supporting a flexible and comprehensive evaluation. During the 18-month study period, researchers monitor participants' motor function decline using the ALS Functional Rating Scale and track survival. Participants undergo assessments including questionnaires and clinical evaluations to measure the effects of the treatments. Safety is closely monitored, and participants must follow specific guidelines such as contraception and consent procedures. The adaptive design aims to provide clear evidence about which treatments might benefit people with MND over time.

Researchers are investigating the safety and effectiveness of adding olaparib, a PARP enzyme inhibitor, to platinum-based chemotherapy given before surgery in patients with triple-negative breast cancer (TNBC) and/or those with germline BRCA (gBRCA) mutations. This randomized phase II/III trial aims to see if this combined treatment improves the rate of pathological complete response (pCR) at surgery while monitoring safety outcomes. The study plans to enroll at least 780 patients, including a minimum of 220 with gBRCA mutations. Participants will receive a minimum of 21 weeks of chemotherapy followed by surgery. The treatment includes oral olaparib tablets taken twice daily about 12 hours apart, alongside intravenous paclitaxel and carboplatin given in cycles every three weeks. During the trial, standard supportive care like granulocyte-colony stimulating factor and anthracyclines may also be administered. For those with residual disease after initial treatment, there is an option to join a sub-study involving additional chemotherapy drugs. Throughout the study, patients will undergo screenings including BRCA mutation testing and various tumor marker assessments. Safety will be closely monitored by the trial team and an independent committee. The main outcomes measured are treatment-related side effects, pCR rates after surgery, and long-term efficacy assessed over approximately 5.5 years, with follow-up planned for up to 10 years after surgery.

This research aims to evaluate whether lowering blood phosphate levels in people with end-stage kidney disease (ESKD) who are on dialysis can reduce the risk of death or major heart-related events compared to maintaining higher phosphate levels. The study also looks at whether lowering phosphate improves physical health, fatigue, quality of life, patient satisfaction, and itching, as well as whether it is cost-effective. Hyperphosphatemia, or high phosphate in the blood, is common in ESKD and linked to higher death risk, but there is no strong trial evidence that lowering phosphate improves important patient outcomes. Participants will be randomly assigned to one of two groups: an intensive phosphate target group aiming to keep serum phosphate at or below 1.50 mmol/L using phosphate-lowering medications, or a liberal phosphate target group aiming for a higher phosphate range of 2.0 to 2.5 mmol/L. In the liberal group, all phosphate-lowering drugs at baseline will be stopped and only restarted if phosphate rises above 2.5 mmol/L. Medication choice and doses will be based on physicians' and participants' decisions to meet target levels. The trial is multinational and will include 3600 adults on dialysis. During the study, researchers will track major outcomes including cardiovascular death or serious heart and artery events over 5 years. They will also assess physical health, quality of life using the EQ5D-5L questionnaire, fatigue, itching, and overall survival. The study involves monitoring serum phosphate levels and medication use, and measuring cost-effectiveness of the treatment strategies. Participants will be followed closely to understand the safety and impact of the phosphate targets on their health and well-being.

Researchers are evaluating the use of short-term androgen deprivation therapy with apalutamide (Erleada) in men who are on active surveillance for early prostate cancer. This phase 2, randomized, multicenter, double-blind, placebo-controlled trial aims to study whether apalutamide can affect tumor progression in this patient group. The study focuses on men with prostate cancer who meet specific clinical and imaging criteria and are under active surveillance rather than immediate treatment. Participants will be assigned to receive either apalutamide oral tablets or a matching placebo. Apalutamide is a selective androgen receptor inhibitor that targets the prostate cancer cells by binding to their androgen receptors. Treatment duration and dosing schedules are determined by the study protocol, and participants are monitored closely throughout the trial. The study also includes safety monitoring and follow-up to assess the effects of treatment over time. During the trial, men will undergo regular assessments including MRI scans to measure tumor volume 12 months after the end of treatment. Clinical laboratory tests, prostate imaging, and biopsies are part of the evaluation process. Researchers will collect data on tumor changes, safety, and tolerability of the therapy. The total duration of participation depends on the study timeline including treatment and follow-up periods, with detailed monitoring to support study outcomes and participant safety.

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease that causes scarring, leading to coughing and breathlessness. Many people with IPF also have reflux disease, where stomach acid may enter the lungs and cause damage. This research is evaluating whether using proton pump inhibitors (PPIs), medicines that reduce stomach acid like lansoprazole, can slow the progression of IPF. The study is a phase 3 clinical trial involving 298 IPF patients from about 37 UK hospitals to determine if treating with PPIs affects IPF outcomes and cough, reflux, and sleep symptoms. Participants will be randomly assigned to take either lansoprazole 30 mg capsules or matching placebo capsules twice daily, about 12 hours apart, for 12 months. They will be asked to start weekly home breathing tests using equipment provided, and some with a cough will use a device to count coughs over 24 hours. Questionnaires on cough, breathlessness, sleep, and general health will be completed. A sub-study involves additional cough and sleep monitoring sessions. Participants may reduce the dose if side effects occur. Throughout the study, participants will complete home spirometry assessments weekly, provide blood samples for safety checks at set intervals, and answer questionnaires at 3, 6, 9, and 12 months. Visits may be remote or in person. Researchers will monitor medication adherence, medical history changes, and side effects. The main outcome measured is the change in lung function, specifically forced vital capacity, 12 months after randomization. Additional blood samples may be collected for future research with consent.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.