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

doi:10.5662/wjm.v4.i2.123

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World Journal of Methodology

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2222-0682

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World J Methodol. Jun 26, 2014; 4(2): 123-132
Published online Jun 26, 2014. doi: 10.5662/wjm.v4.i2.123

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%
CALGB 9181[40]	MA 640 mg/die	76	2000	MRR	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
ECOG 3882[34]	DOXO	76	2003	MRR	27%
CALGB 9583[41]	AWD + KET + HDC	128	2004	MRR	27%¹
CALGB 9583[41]	AWD	132	2004	MRR	11%
Belgian Trial[38]	DOC + PDN + ESM	71	2008	PSA-RR	41%
Belgian Trial[38]	DOC + PDN	69	2008	PSA-RR	25%
NHS Trial[39]	DEX + ASP + DES	136	2011	PSA-RR	64%
NHS Trial[39]	DEX + ASP	133	2011	PSA-RR	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.

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Citation: Colloca G, Venturino A, Governato I. End points of clinical trials in metastatic castration-resistant prostate cancer: A systematic review. World J Methodol 2014; 4(2): 123-132
URL: https://www.wjgnet.com/2222-0682/full/v4/i2/123.htm
DOI: https://dx.doi.org/10.5662/wjm.v4.i2.123

Colloca G, Venturino A, Governato I. End points of clinical trials in metastatic castration-resistant prostate cancer: A systematic review. World J Methodol 2014; 4(2): 123-132 [PMID: 25332911 DOI: 10.5662/wjm.v4.i2.123]

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