End points of clinical trials in metastatic castration-resistant prostate cancer: A systematic review

Table 5 Characteristics of randomized clinical trials including radiologic or serological response measures as the primary end point after first line medical treatment of metastatic castration-resistant prostate cancer

Trial	Arms	No. pts	Publication year	Response-related outcome	Response rate (%)
CALGB 9181[40]	MA 160 mg/die	73	2000	MRR	3%
	MA 640 mg/die	76			3%
INT 0159[36]	SUR 3,1	128	2002	PSA-RR/RRR	24%/9%
	SUR 5,3	124			28%/7%
	SUR 7,6	120			34%/15%
ECOG 3882[34]	DOXO + DES	74	2003	MRR	63%1
	DOXO	76			27%
CALGB 9583[41]	AWD + KET + HDC	128	2004	MRR	27%1
	AWD	132			11%
Belgian Trial[38]	DOC + PDN + ESM	71	2008	PSA-RR	41%
	DOC + PDN	69			25%
NHS Trial[39]	DEX + ASP + DES	136	2011	PSA-RR	64%
	DEX + ASP	133			68%

¹Statistically significant difference. ASP: Aspirin; AWD: Anti-androgen withdrawal; DES: Diethylstilbestrol; DEX: Dexamethasone; DOXO: Doxorubicin; ESM: Estramustine; HDC: Hydrocortisone; KET: Ketoconazole; MA: Medroxyprogesterone acetate; MRR: Mixed response rate; PDN: Prednisone; PSA-RR: Prostate-specific antigen response rate; RRR: Radiologic response rate; SUR: Suramine.