Clinical trial results to watch for in 2025

Nature Medicine editors have listed 11 clinical trials poised to impact medicine in 2025. The list was based on input from researchers, many of whom are involved in the trials. The trials include interventions for a range of conditions, including cancer, prion disease and psychosis. All are expected to produce results in 2025.CancerProstate cancerFindings from a new randomized control trial could bring radioligand therapy to hormone-sensitive prostate cancer patients. The new trial compares lutetium-177 therapy (Pluvicto) with standard care to standard care alone in 1,126 prostate-specific membrane antigen (PSMA)-positive metastatic prostate cancer patients who still respond to hormone treatment. A number of Canadian sites are involved in this phase III trial. The main outcome measured is radiographic progression-free survival.Cervical cancer screeningResearchers in France are testing an AI-based chatbot to see if it increases the number of women participating in HPV detection screening through self-sampling. The multilingual chatbot is designed to answer questions about cervical cancer and HPV testing at home. An HPV self-sampling kit was sent to homes, with one randomized group also getting a letter telling the participant about the chatbot, and with the other group receiving no information about the chatbot. The researchers will measure the number of self-sampling kits returned in each group.Read: BD Canada announces Health Canada approval of self-collected HPV testsBreast cancer screeningA large, global trial with 53,000 participants will help answer if personalized breast cancer screening impacts the incidence of breast cancer after four years. The participants are divided into a group that will follow standard protocols for breast cancer screening and another that will get personalized screening based on genetic risk of breast cancer. The first results from the My Personal Breast Screening trial are due in 2025. Results may potentially show if personalized screening can help reduce unnecessary testing on people at low risk while improving outcomes in people with high risk if the cancer is detected earlier. Read: Breast cancer: Screening from age 50 puts racialized women at a disadvantagePsychiatryPsychosisThe Stratification and Treatment in Early Psychosis (STEP) trials test the effect of a cannabidiol (CBD) product in people with psychosis. Participants are from 30 sites in 11 countries, including Canada. The trials investigate CBD versus placebo in people at different stages of psychosis: those at high risk of psychosis, those with early onset psychosis, and those with treatment-resistant psychosis. In the latter, the trial is assessing if CBD can enhance the response to clozapine. Clinical tools, MRIs and blood test are used to measure outcomes.Learning in children with autism spectrum disorderResearchers are studying if app-based games will improve socialization in children with autism spectrum disorder. The app, called GuessWhat, includes games such as social charades, emotion guessing and a quiz, all designed for caregivers to play them with children aged three to 12 with diagnosed autism spectrum disorder. Caregivers will complete a questionnaire after eight weeks which researchers will use to study changes in various symptoms of autism spectrum disorder. Read: New tool assesses gastrointestinal health of people with autismMental health in adolescentsA study in Kenya is investigating how effective a digital toolkit for adolescents and their parents is on improving youth mental health. The trial is part of a larger project to learn about the root causes of behavioural violence.NutritionPrecision nutritionA large 8,000-participant study is examining how people react to three types of eating patterns picked out for them by algorithms. The trial involves examining people’s regular eating habits, lifestyle, genetics and other biological factors, and assigning them to one of three diets. The idea is to see if personalized dietary recommendations can affect health outcomes. The study, called Nutrition for Precision Health, is tied to the All of Us research program, funded by the U.S. National Institutes for Health. Fighting nutrient loss in cropsClimate change has reduced the levels of nutrients in certain staple crops in Kenya and Burkina Faso, leading to malnutrition in children and adults. Researchers are studying if home gardening and nutrition counselling helps offset this nutrient loss. They are measuring height-for-age score as an indicator of nutritional status. Other conditionsPrion diseasesThere are currently 16 trials for ION-717 around the world. It’s an antisense oligonucleotide designed to inhibit the production of prion protein. One trial is examining the safety and tolerability of intrathecal administration of ION-717 compared to a placebo in people with prion disease. The University of Alberta and the McGill University are participating in the trial.Base-editing for sickle-cell diseaseResearchers in this trial are taking hematopoietic stem cells from people with sickle cell disease and editing them with base edits similar to those in people with hereditary persistence of fetal hemoglobin. The idea is that the base edits will result in increased in hemoglobin levels. Unfortunately, there was a death in the trial. It was not due to the base-editing, but caused by busulfan, a medication used in sickle-cell disease. Heat-related diseaseThis trial involved an intervention on the participants’ housing. Sunlight-reflective roof coverings were installed on roofs in 600 houses in Burkino Faso and residents were followed for two years to see if their health improved. Researchers measures heart rates, blood pressure, body temperature, dehydration and blood glucose. They also recorded mental health and other markers of wellbeing, including gender-based violence, to see if the cool-roof intervention impacted human health.The list of trials were published in Nature Medicine.Read: The 2024 Medical Post Awards winners

Clinical trial results to watch for in 2025

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