Reference, study phase, and patient number Efficacy results PFS*, OS+ Comparator PSA levels/PSA RR# Docetaxel Tannock et al. [13 ] Phase III; 1006 pts Prolongation of median survival, decrease in serum PSA level, predefined reductions in pain and improvements of quality of life Mitoxantrone Reduced Cabazitaxel Bono et al. [65 ] Phase III; 755 pts Improved OS (95% CI: 0.59–0.83,
) and median PFS (HR: 0· 74, 0.64–0.86,
) Mitoxantrone Reduced Abiraterone acetate De Bono et al. [26 ] Phase III; 1195 pts Prolongation of OS, time to PSA progression (10.2 versus 6.6 months;
), progression-free survival (5.6 months versus 3.6 months;
), and PSA response rate (29% versus 6%,
) Placebo Reduced (>29%) Bicalutamide Kucuk et al. [22 ] Phase II; 52 pts Decreases pain and improves symptom status Baseline after 1st line Reduced (≥50% in 20% pts) Lodde et al. [23 ] Prospective trial; 38 pts PSA response rate Baseline after antiandrogen manipulation Reduced (44.7% pts) DES Smith et al. [25 ] Phase II; 21 pts PSA response rate Baseline after 1st line hormonal therapy Reduced (43% RR) Sipuleucel-T Kantoff et al. [15 ] Phase III, 512 pts Relative reduction of 22% in the risk of death as compared with the placebo group (hazard ratio, 0.78; 95% confidence interval (CI), 0.61 to 0.98;
) Placebo Reduced (≥50% in 2.6%) MDV3100 Scher et al. [34 ] Phase I-II Phase III results not available NA NA NA Patupilone Beardsley et al. [63 ] Phase II, 83 pts Prolongation of PFS, PSA declines, and pain response (decline) Docetaxel Reduced (≥50% in 46%) Eribulin Bono et al. [65 ] Phase II, 108 pts PSA response rate Baseline (stratified by prior taxane exposure) Reduced PROSTVAC-VF Kantoff et al. [72 ] Phase II; 125 pts 44% reduction in the death rate and an 8.5-month improvement in median OS Control empty vectors plus saline injections NA Atrasentan (plus Docetaxel) Carducci et al. [75 ] Phase III; 809 pts Alkaline phosphatase and PSA levels were significantly lower in the treatment arm Docetaxel and placebo Reduced Bevacizumab (plus Docetaxel) Kelly et al. [76 ] Phase III; 1050 pts Improvement in PFS, measurable disease response, and posttherapy PSA decline Placebo Reduced (≥50% in 69.5%) Ipilimumab NCT01057810 [77 ] Phase III ongoing NA Placebo NA Sunitinib Sonpavde et al. [78 ] Phase II; 36 pts PFS, PSA decline, pain control NA Reduced (≥50% in 12,1%)