Table 3.

Summary of ²²³Ra Phase 2/3 efficacy and safety data

Name	Phase	Method	Number	Outcomes
BC-10231	2	–Four injections 223Ra of 50 kBq kg−1 (or placebo) at 4-week intervals –vs placebo	N = 33 223Ra N = 31 placebo	–Significant delay in PSA progression and fall in ALP in the 223Ra group –Tendency towards reduced rate of skeletal-related event and improved survival in 223Ra group –Well tolerated
BC-10329	2	–Single injection 223Ra 5, 25, 50 or 100 kBq kg−1	N = 26 at 5 kBq kg−1 N = 25 at 25 kBq kg−1 N = 25 at 50 kBq kg−1 N = 24 at 100 kBq kg−1	–Dose-dependent improvement in pain –Well tolerated all dose levels
BC-10430	2	–Three injections 223Ra per subject at 6-week intervals –Either 25, 50 or 80 kBq kg−1 (no dose escalation within groups)	N = 37 at 25 kBq kg−1 N = 36 at 50 kBq kg−1 N = 39 at 80 kBq kg−1 (These N are those treated per protocol and analysed in efficacy calculations. In each group, respectively, 4, 3 and 3 additional patients received 1 or 2 injections and are analysed as part of the safety population.)	–Dose-dependent fall in PSA and ALP –Well tolerated all dose levels
ALSYMPCA5	3	–Six injections of 223Ra of 50 kBq kg−1 (or placebo) at 4-week intervals –vs placebo –Plus best standard of care	N = 614 223Ra N = 307 placebo	–223Ra associated with significant improvement in overall survival (14.9 vs 11.3 months p < 0.001) –223Ra associated with significant delay to first symptomatic skeletal event (15.6 vs 9.8 months p < 0.001) –Number of patients experiencing adverse events lower in 223Ra group (all grades) –Signal to increased (low-grade) diarrhoea in 223Ra group –Signal to increased (low-grade) myelosuppression in 223Ra group

ALP, alkaline phosphatase; PSA, prostate-specific antigen.