Barueri

Researchers are conducting two related studies called RADICAL PC1 and RADICAL PC2 focused on men diagnosed with prostate cancer. RADICAL PC1 follows men within one year of their prostate cancer diagnosis or who have recently started androgen deprivation therapy (ADT). The goal is to understand factors linked to developing cardiovascular disease in these men, especially related to ADT. RADICAL PC2 is a randomized controlled trial within RADICAL PC1 that tests a systematic approach to improving heart health and lifestyle risk factors in this population. The treatments studied include behavioral advice on healthy nutrition, exercise including strength and resistance training, and smoking cessation support if needed. Drug treatments include prescriptions of low to moderate dose statins and ACE inhibitors or angiotensin receptor blockers for controlling blood pressure above 130 mmHg. The intervention targets men newly diagnosed or recently starting ADT, and treatment is personalized based on cardiovascular risk. Participants engage in assessments to monitor heart-related outcomes such as death, heart attacks, strokes, heart failure, or arterial revascularization over 3 to 5 years. The study tracks cardiovascular health and lifestyle factors throughout this period to evaluate the effectiveness of the interventions. Safety and progress are closely monitored to understand impacts on long-term outcomes in men with prostate cancer undergoing ADT.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are studying how well lebrikizumab works for adolescents and adults with moderate atopic dermatitis (eczema) who have a high level of itchiness and limited areas affected on the body. The study focuses on participants who have had eczema for at least one year and aims to measure improvements in skin condition and itch severity. This is a Phase 4, open-label, single-arm trial involving individuals aged 12 and older. Participants will receive lebrikizumab through subcutaneous injections. The treatment period lasts for 24 weeks (6 months), during which the medication is administered as per the study protocol. The entire participation, including screening and follow-up, spans approximately 38 weeks (9 and a half months). During the study, participants will undergo regular assessments including skin evaluations and itch severity ratings to track changes from baseline. Researchers will measure the percentage of participants achieving at least a 75% improvement in eczema severity or a 4-point reduction in itch intensity by week 16. Safety and adherence to treatment will also be monitored throughout the study duration.