177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High- and Very High-risk Prostate Cancer After Radical Treatment Using Locoregional Teleradiotherapy and Hormone Therapy

What this Trial Is About

Researchers are evaluating the use of lutetium 177Lu vipivotide tetraxetan, administered as a single dose, as a systemic adjuvant treatment for adult men with high or very high risk prostate cancer. This phase 2 clinical trial focuses on patients who have completed radical locoregional teleradiotherapy and hormone therapy and show no signs of cancer spread in recent radiological exams. The study aims to assess treatment effectiveness and progression-free survival over a long follow-up period. Participants are randomly assigned to one of two groups one receiving a single administration of 7.4 GBq of 177Lu-PSMA alongside standard hormone therapy, and the other receiving hormone therapy alone. The intervention phase lasts one day, after which participants enter a five-year observation phase to monitor outcomes and safety. Both groups continue with standard hormone therapy throughout the study. During the study, researchers will conduct regular assessments including biochemical and radiological evaluations to track cancer progression, quality of life measures, and adverse events. The primary outcome is treatment effectiveness measured at two and five years after treatment. Participants will be monitored for up to five years to observe progression-free survival, time to next therapy, and overall health status. The study is sponsored by the Maria Sklodowska-Curie National Research Institute of Oncology.

177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer