Heinsberg

This research aims to evaluate the effects and safety of ASP5541, a new form of abiraterone acetate given as a muscle injection, in men with advanced prostate cancer. The study focuses on men with metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC), including Japanese men. It compares ASP5541, with or without the steroid prednisone/prednisolone, to the standard oral abiraterone acetate with prednisone/prednisolone. The goal is to see how well ASP5541 works and its safety profile compared to current treatments. Participants are divided into three groups. Group 1 includes men with mCRPC not previously treated with androgen receptor pathway inhibitors (ARPIs), receiving either ASP5541 with prednisone/prednisolone or abiraterone acetate with prednisone/prednisolone. Group 2 includes men with mHSPC not previously treated with ARPIs, receiving either ASP5541 alone or abiraterone acetate with prednisone/prednisolone. Group 3 includes Japanese men with mCRPC or mHSPC who may have prior ARPI treatment, receiving ASP5541 with prednisone/prednisolone. ASP5541 is given as an injection every 12 weeks, prednisone/prednisolone is taken orally once or twice daily depending on cancer type, and abiraterone acetate is taken as daily tablets. All groups continue standard androgen deprivation therapy. During the study, men will visit clinics regularly for health checks, cancer scans, and safety monitoring. Some men in Group 2 will monitor blood pressure weekly at home. Researchers will track prostate specific antigen (PSA) levels, adverse events, vital signs, and lab tests for up to 37 months. The study evaluates how well ASP5541 lowers PSA compared to abiraterone acetate and monitors for side effects and overall health status throughout treatment and follow-up.

Researchers are evaluating the real-world clinical use and outcomes of men with metastatic castration-resistant prostate cancer (mCRPC) who are treated with a combination of olaparib and abiraterone. The study focuses on patients who have either not previously received next-generation hormonal agents (NHA-naive) or who have been exposed to NHAs before starting this combined treatment. This prospective observational study aims to describe patient demographics, clinical characteristics, and treatments before and after olaparib plus abiraterone therapy. The study will enroll patients who have started treatment with olaparib plus abiraterone after the study site became active. It will follow patients for up to 2 years to collect data on their treatment experience. No experimental interventions are administered as part of the study; instead, it observes patients receiving standard treatment in routine clinical settings. Participants will be monitored from the start of olaparib treatment until one year after the last patient enrolls. Researchers will collect clinical data to assess treatment discontinuation times and overall outcomes during this period. The study will capture information on patients’ clinical progress and any subsequent therapies, providing insights into the real-world effectiveness and use of this treatment combination.

Ulcerative colitis (UC) is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. This research evaluates the effectiveness of upadacitinib (RINVOQ), an approved treatment for UC, in adults with active moderate to severe UC. The study aims to understand the early therapeutic response and predict the long-term effectiveness of this medication. Upadacitinib will be given according to the approved local label and prescribed by the participant's physician as part of routine care. About 400 adult participants from Germany, Austria, and Switzerland who are starting upadacitinib treatment will be enrolled. Treatment decisions are made by the investigator independently of the study. Participants will be followed for up to two years, with no extra procedures beyond their standard care. During the study, participants will attend regular hospital or clinic visits where routine data will be collected and used for the study. Researchers will monitor the percentage of participants achieving symptomatic remission based on clinical response and intestinal ultrasound at week 8, with follow-up assessments at week 52. The study focuses on real-world treatment outcomes without adding extra burden to participants.