TABLE 2.

Primary and Secondary Endpoints Results

Outcome measure	Overall (n = 43)	6.0 GBq (n = 14)	7.4 GBq (n = 29)	Hazard ratio (95% CI)	P
Primary endpoint
PSA response after 2 cycles
No. of evaluable patients	40	13	27
PSA decline ≥ 50% after 2 cycles	11 (28%, 95% CI 15–44)	6 (46%, 95% CI 19–75)	5 (19%, 95% CI 6–38)	—	0.12*
Secondary endpoint
Best PSA response
No. of evaluable patients	43	14	29
Best PSA response ≥ 50%	16 (37%, 95% CI 23–53)	7 (50%, 95% CI 23–77)	9 (31%, 95% CI 15–51)	—	0.31*
Pain response
No. of evaluable patients	18	7	11
Patients with pain improvement (n)	12 (67%)	6 (86%)	6 (55%)	—	0.31*
Pain PFS
Median (mo)	8.2 (95% CI 3.9–12.5)	5.4 (not reached)	8.2 (95% CI 2.3–14.1)	0.96 (0.35–2.66)	0.94
Post hoc analysis
OS
Median (mo)	14.0 (95% CI 10.1–17.9)	15.8 (95% CI 11.8–19.4)	13.5 (95% CI 10.0–17.0)	0.94 (0.46–1.92)	0.87

^*P values compare the 6.0- and 7.4-GBq treatment arms using exact Fisher test.