Siracusa

Researchers are conducting a Phase III international trial to study the effects and safety of androgen deprivation therapy ADT with or without darolutamide in men newly diagnosed with metastatic prostate cancer who have vulnerable functional abilities. This study specifically includes patients who have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The goal is to evaluate how these treatments impact disease progression and patient health over time. Participants will be randomly assigned to one of two groups one receiving ADT plus darolutamide 600 mg taken orally twice daily, and the other receiving ADT plus a placebo taken with the same schedule. Treatment will continue until imaging shows disease progression or until the patient or doctor decides to stop for reasons such as side effects or other health issues. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, further treatments, and any ongoing or new side effects. During the study, participants will undergo regular assessments including imaging scans to check for cancer progression, blood tests, evaluations of urinary symptoms, and quality of life questionnaires. Researchers will track outcomes like progression-free survival, overall survival, symptom changes, and adverse events. Monitoring visits will occur periodically both during treatment and follow-up to gather comprehensive data on health status and treatment effects.

Researchers are evaluating the use of HIV pre-exposure prophylaxis PrEP in Italy to prevent new HIV infections. The study aims to understand how effective and tolerable PrEP is, how well people stick with it, and what barriers exist to its long-term use. It is an observational study coordinated by Fondazione ICONA, including about 5,000 HIV-negative adults who are either starting or continuing PrEP. Participants are followed in 49 hospital and university infectious disease clinics and 4 community-based checkpoints across Italy. They attend routine clinical visits every 3 to 5 months, where they undergo HIV and STI testing, safety laboratory tests, and complete electronic questionnaires via a mobile app. The study collects data on demographics, clinical status, behavior, and quality of life to monitor HIV seroconversion rates and other outcomes. During the study, participants will be monitored for new HIV infections, side effects related to PrEP, adherence to treatment, and behavioral factors affecting persistence in care. Data are securely collected and managed in an electronic case report form. The study will run for at least 10 years, with regular follow-up visits to ensure ongoing assessment of PrEPs real-world use and impact.