Phase III Study of 18F-PSMA-1007 PETCT Imaging in Adult Men with Prostate Cancer Including Post-Treatment and High-Risk Cases

What this Trial Is About

Researchers are evaluating the use of 18F-PSMA-1007 PETCT imaging in adult men with prostate cancer, particularly those with a history of radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy, or who have high-risk features for metastatic disease. This phase III study aims to assess the safety of the 18F-PSMA-1007 tracer and to analyze non-specific bone lesions detected during imaging. Participants include men aged 18 and older with specific PSA levels or clinical features related to prostate cancer. Participants will receive a single intravenous injection of 18F-PSMA-1007 at a dose of 4 MBqkg up to a maximum of 400 MBq. The study involves imaging with PETCT following tracer injection to observe the distribution and activity of the tracer. The safety of the tracer will be monitored immediately after injection, after the scan approximately 2.5 hours later, and for delayed adverse events up to 7 days post-injection. Researchers will also follow non-specific bone lesions identified during the scan for at least one year to determine their nature. During the study, participants will be screened for adverse effects at multiple time points, including immediately post-injection and post-scan. They will receive information to self-report any delayed side effects occurring within one week after injection. The study will record and evaluate up to five non-specific bone lesions per participant, tracking their size and location. Safety assessments continue for up to a year after the scan to better understand the clinical relevance of these lesions. Participation duration varies depending on follow-up assessments.

18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028