Nuclear Medicine

Lu-177 PSMA RLT: symptom control with limited durable survival benefit

Lu-177 PSMA radioligand therapy yields high objective response rates and rapid pain palliation in advanced prostate cancer. Randomised data and clinical experience show initial favourable responses but disease recurrence is almost universal. Survival benefit observed in trials is modest, so expectations should be tempered for durable disease control. Future gains likely require imaging-guided adaptive strategies, earlier-line use, combination therapies, or next-generation isotopes. 1

Two-trial paradigm is uncommon and regulatory responses to discrepant phase 3 results vary

Among 9,925 phase 3 trials, only about 5% were duplicated, yielding 246 pairs or triplets. Discrepant statistical conclusions occurred in 35 of 206 pairs with available results (17%), and the FDA sometimes authorised despite discrepancies. Outcome modifications and post-unblinding changes were uncommon but present, highlighting interpretative risk when trials are non-replicated. 2

ALLEVIATE-HF: ICM-guided nurse-managed diuretic protocol was safe but not efficacious

In 711 randomized heart-failure patients, ICM-based high-risk alerts with centrally managed diuretic protocols had very low intervention-related serious adverse events (0.32%). The primary 60-day composite did not improve (win ratio 0.79; P=0.06), and cardiovascular events were numerically higher in the intervention arm. Under the tested implementation, the strategy was safe but yielded a neutral efficacy signal, so it is not practice-changing yet for HF management. 3