Table 3.
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.