Derby

Researchers are studying patients with cirrhosis caused by alcohol-related or metabolic dysfunction-associated steatotic liver disease MASLD. The trial aims to evaluate whether taking capsules containing faecal microbiota from healthy donors can reduce infections and mortality in these patients. This Phase 3 trial follows earlier research that showed faecal microbiota transplantation FMT delivered via endoscopy was safe and feasible, leading to the development of capsules for easier treatment administration. Participants will be randomly assigned to receive either encapsulated FMT or placebo capsules that look identical but contain no active treatment. They will take five capsules every three months over a total period of 21 months or until they develop an infection requiring hospital admission. This double-blind trial means neither participants nor study staff will know which treatment is given. The study will last up to 24 months including follow-up, monitoring effects on infection rates, liver health, immune system function, and antibiotic resistance. Throughout the trial, participants will be regularly assessed for infections, liver disease progression, hospital admissions, quality of life, mental health, alcohol use, and safety of FMT treatment. Laboratory tests will examine immune response and bacterial resistance. The primary outcome is the time until first infection needing hospital care. The study involves detailed monitoring and follow-up visits for up to two years to understand the treatments impact and safety in patients with cirrhosis.

Researchers are evaluating whether less frequent dosing of pembrolizumab after six months of standard treatment is safe and effective for patients with advanced non-small cell lung cancer NSCLC. Pembrolizumab, an immunotherapy targeting the PD-1 receptor, has improved outcomes in NSCLC, but current dosing every six weeks for up to two years may result in overtreatment. This UK phase III trial aims to find if reducing dose frequency can maintain effectiveness while improving quality of life and lowering costs. Participants who have received six months of pembrolizumab, with or without chemotherapy, and plan to continue treatment will be randomized to receive pembrolizumab intravenously every six weeks control or every twelve weeks initially. If the 12-week dosing is found to be not less effective, additional groups receiving doses every nine, fifteen, and eighteen weeks will be included. Patients who experience disease progression while on reduced frequency dosing can return to the standard six-week schedule. Throughout the study, participants will be monitored for overall survival at 18 months from randomization, along with other outcomes such as progression-free survival, response rate, duration of response, and adverse events over two years. The study involves regular hospital visits for treatment and assessments, and the results may lead to safer, more convenient treatment options for NSCLC patients. The total participation time varies depending on individual treatment and follow-up schedules.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the efficacy and safety of opevesostat combined with daily corticosteroids compared to alternative treatments abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with one next-generation hormonal agent NHA. The study aims to determine if opevesostat offers better control of disease progression assessed by radiographic progression-free survival, including participants with and without androgen receptor ligand binding domain mutations. Overall survival has also been included as a secondary outcome measure. Participants are randomly assigned to one of two groups. One group receives opevesostat 5 mg orally twice daily, plus dexamethasone 1.5 mg and fludrocortisone acetate 0.1 mg orally once daily, continuing until disease progression. Hydrocortisone is available as a rescue medication if needed. The other group receives either abiraterone 1000 mg once daily with prednisone 5 mg twice daily or enzalutamide 160 mg once daily, also until disease progression. This open-label, phase 3 study compares these two treatment approaches in a parallel design. During the study, participants undergo regular assessments including imaging scans to measure disease progression, safety monitoring, and evaluations of overall survival and quality of life. Researchers track radiographic progression-free survival for up to 52 months and secondary outcomes such as overall survival, time to new treatments, pain progression, and prostate-specific antigen PSA responses for up to approximately 82 months. Participants are closely monitored for adverse events and treatment tolerability throughout the study duration, which spans several years.

Researchers are evaluating whether combining the investigational drug PF-06821497 with enzalutamide works better than enzalutamide alone in men with metastatic castration-resistant prostate cancer mCRPC who have not yet received certain advanced anti-cancer treatments. This global, multicenter, randomized Phase 3 study focuses on participants who have not been treated with androgen receptor signaling inhibitors like enzalutamide or abiraterone before, except for androgen deprivation therapy or first-generation anti-androgen agents. The study is sponsored by Pfizer and aims to assess treatment effects in this patient population. Participants will be randomly assigned to one of two groups one group will receive PF-06821497 875 mg twice daily combined with enzalutamide 160 mg once daily, while the other will receive a placebo twice daily plus enzalutamide 160 mg once daily. The study includes several phases screening, randomization, treatment, safety follow-up, and long-term follow-up. Treatment continues over a period of up to approximately three years for primary outcomes, with ongoing assessments for up to five years for some secondary outcomes. During the study, participants will undergo various assessments including scans to monitor disease progression, blood tests to measure prostate-specific antigen levels and circulating tumor DNA, patient-reported pain and quality of life questionnaires, and evaluations of adverse events. The primary outcome is radiographic progression-free survival measured from randomization up to about three years. Safety and long-term effects will be monitored through follow-up visits lasting up to five years. Participants will be followed closely throughout the study duration to track treatment impact and side effects.

Researchers are evaluating two types of stereotactic body radiotherapy SBRT in men with high risk localized prostate cancer, where the cancer is confined to the prostate but may grow quickly or spread. The study aims to compare the safety and effectiveness of delivering radiotherapy to the prostate alone versus the prostate plus surrounding lymph nodes, with both treatments given in only 5 sessions. This phase III trial is designed to see if including lymph nodes reduces the chance of cancer returning and to review any side effects that occur. Participants will be randomly assigned to one of two groups. One group will receive SBRT targeting the prostate and seminal vesicles, delivering 36.25Gy in 5 fractions on alternate days with 40Gy to the prostate clinical target volume. The other group will get the same prostate treatment plus 25Gy in 5 fractions to the pelvic lymph nodes on alternate days. Treatments will be provided over approximately two weeks at experienced NHS radiotherapy centers that meet quality standards for these therapies. During the study, participants will be monitored for at least three and a half years to assess time to biochemical or clinical failure, which is the main outcome. Researchers will also track acute and late side effects, cancer relapse, survival rates, patient-reported outcomes, and adherence to treatment protocols for up to five years post-randomization. Regular imaging and assessments will be performed before treatment to confirm eligibility and exclude metastatic disease. Overall, participants can expect close monitoring and follow-up throughout and after their treatment period.

Sarcopenia is the loss of skeletal muscle mass and function often seen in older adults, which can impact physical independence and metabolic health. Researchers are studying how different doses of a new leucine-enriched whey protein supplement, called super-whey, affect muscle building in older adults. This study aims to find the best dose to stimulate muscle protein synthesis, especially since muscle loss is linked to reduced response to protein and exercise in aging. Participants will receive three different low doses of the super-whey protein supplement 5 grams, 10 grams, and 20 grams. These doses will be given as single bolus servings in a randomized crossover manner, meaning each participant will try all doses in a random order. The doses are considered safe and similar to normal protein intake recommendations. The study will measure muscle protein synthesis both at rest and after acute exercise in older adults. During the study, participants will be monitored for muscle protein fractional synthetic rates at 3 and 6 hours after supplement intake. Blood samples will be taken over 7.5 hours to measure amino acid levels. Participants must be physically able to perform resistance exercise and will be assessed under close supervision by the research team. The study will help understand how different protein doses affect muscle building in older adults and will last until October 2026.

Skeletal muscle, making up about 45-55% of body mass, is vital for movement, support, and overall metabolism. As people age, they often experience sarcopenia, which is the loss of muscle mass and function. This condition increases risks like disability, falls, and death. One key factor in sarcopenia is anabolic resistance, where older muscles respond less effectively to nutrition and exercise, especially in terms of muscle protein synthesis MPS. This study aims to explore whether enhancing protein with leucine, an amino acid important for stimulating MPS, can improve muscle health in older adults. Researchers are comparing two types of protein supplements a super-whey SW protein enriched with approximately 40% more leucine and 20% more essential amino acids, against a standard isonitrogenous whey protein WP. Participants will receive 20g of their assigned supplement with controlled meals during study visits. The study will evaluate the effects of these supplements both in a rested state and within 24 hours following exercise, under controlled diet and activity conditions. Participants will undergo a three-day lead-in period with a controlled diet and limited physical activity, followed by two and a half days of study visits. During these visits, researchers will closely monitor muscle protein synthesis responses. The primary measurement is muscle protein synthesis, assessed in both rested and post-exercise states. This trial is randomized and triple-blinded, focusing on healthy male volunteers aged 65 and older, with careful monitoring throughout the study period.

Researchers are evaluating the use of Targeted Sentinel Node Biopsy TSNB in patients with breast cancer who have limited nodal disease and are undergoing primary surgery. The study focuses on patients with T1 or T2 tumors and biopsy-confirmed nodal metastases with up to two abnormal nodes on axillary ultrasound. The goal is to audit surgical outcomes of TSNB and compare them with outcomes from sentinel node biopsy and targeted axillary dissection after chemotherapy, assessing arm lymphoedema and disease progression over time. The intervention involves performing TSNB using either a dual- or single-tracer technique in line with protocols from the ongoing ATNEC trial. The marked biopsy-positive node and at least three nodes are removed during surgery. Node marking techniques may include clips, black dye, magnetic seeds, or reflectors, with the timing of marking either at biopsy or a separate visit. Axillary treatment after TSNB is determined by local multidisciplinary teams based on findings. Participants will be monitored for up to 60 months, with regular assessments including histology to identify nodal macrometastases, identification rates of the marked node, false negative rates of TSNB, and arm lymphoedema. Secondary outcomes include rates of axillary, regional, and local recurrence, disease-free survival, and overall survival. This long-term follow-up will help benchmark TSNB outcomes against previous trials and provide data on surgical morbidity and disease control.

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.