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Prevalence of measurable disease in metastatic castration resistant prostate cancer

Abstract Background Given the low historical prevalence of measurable disease in metastatic castration-resistant prostate cancer (mCRPC), phase II trials have employed prostate specific antigen (PSA) and bone scan changes as primary endpoints. Frequent whole body imaging and improved computerized to...

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Published in:Clinical genitourinary cancer 2017-10, Vol.15 (5), p.534-539
Main Authors: Sonpavde, G, Madan, A, Baker, M.K, May, J.E, Naik, G, Bae, S
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creator Sonpavde, G
Madan, A
Baker, M.K
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Bae, S
description Abstract Background Given the low historical prevalence of measurable disease in metastatic castration-resistant prostate cancer (mCRPC), phase II trials have employed prostate specific antigen (PSA) and bone scan changes as primary endpoints. Frequent whole body imaging and improved computerized tomography technology currently identify measurable disease more frequently, warranting consideration of objective response as a major endpoint. Methods Data from reported phase III trials of mCRPC were analyzed. The proportion of patients with measurable disease, setting (pre-docetaxel [D], D-based, post-D), year of starting accrual, PSA, and the requirement for symptoms were collected. Chi-square test was used to evaluate the association of variables with measurable disease rate. Results Twenty phase III trials totaling 19,276 men with mCRPC were evaluable. Three trials (N=1289) started accruing before 2000 and 17 trials (N=17,987) accrued after 2000. The proportion of measurable disease rate for all trials was 47.5%. The measurable disease rate was significantly higher (p
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Frequent whole body imaging and improved computerized tomography technology currently identify measurable disease more frequently, warranting consideration of objective response as a major endpoint. Methods Data from reported phase III trials of mCRPC were analyzed. The proportion of patients with measurable disease, setting (pre-docetaxel [D], D-based, post-D), year of starting accrual, PSA, and the requirement for symptoms were collected. Chi-square test was used to evaluate the association of variables with measurable disease rate. Results Twenty phase III trials totaling 19,276 men with mCRPC were evaluable. Three trials (N=1289) started accruing before 2000 and 17 trials (N=17,987) accrued after 2000. The proportion of measurable disease rate for all trials was 47.5%. The measurable disease rate was significantly higher (p&lt;0.001) in trials accruing after 2000 vs. before 2000 (48.7% vs. 31.1%, p&lt; 0.001), D-based (51.8%) or post-D patients (48.9%) compared to pre-D patients (38.6%) and in trials allowing symptomatic vs. asymptomatic/minimally symptomatic patients (50.1 vs. 40.0%). Conclusions The proportion of men with measurable disease was significantly higher in phase III trials of mCRPC accruing after 2000, in D-based or post-D patients and in trials allowing symptomatic patients. Given the association of objective measurable changes with survival, RECIST changes may warrant consideration as a major endpoint in phase II trials to obtain a firm signal of efficacy before launching phase III trials.</description><identifier>ISSN: 1558-7673</identifier><identifier>EISSN: 1938-0682</identifier><identifier>DOI: 10.1016/j.clgc.2017.04.020</identifier><identifier>PMID: 28526418</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Castration-resistant ; Clinical Trials as Topic ; Hematology, Oncology and Palliative Medicine ; Humans ; Male ; Measurable tumor ; Metastatic ; Neoplasm Metastasis ; Prevalence ; Prostate cancer ; Prostate-Specific Antigen - metabolism ; Prostatic Neoplasms, Castration-Resistant - diagnosis ; Prostatic Neoplasms, Castration-Resistant - epidemiology ; Prostatic Neoplasms, Castration-Resistant - metabolism ; RECIST ; Tomography, X-Ray Computed ; Urology ; Whole Body Imaging - methods</subject><ispartof>Clinical genitourinary cancer, 2017-10, Vol.15 (5), p.534-539</ispartof><rights>Elsevier Inc.</rights><rights>2017 Elsevier Inc.</rights><rights>Copyright © 2017 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c510t-8f3bf32cb49600971cd0524a6c0cca5f3d0d43d53f6b363ef3d87d35f18d5cbd3</citedby><cites>FETCH-LOGICAL-c510t-8f3bf32cb49600971cd0524a6c0cca5f3d0d43d53f6b363ef3d87d35f18d5cbd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28526418$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sonpavde, G</creatorcontrib><creatorcontrib>Madan, A</creatorcontrib><creatorcontrib>Baker, M.K</creatorcontrib><creatorcontrib>May, J.E</creatorcontrib><creatorcontrib>Naik, G</creatorcontrib><creatorcontrib>Bae, S</creatorcontrib><title>Prevalence of measurable disease in metastatic castration resistant prostate cancer</title><title>Clinical genitourinary cancer</title><addtitle>Clin Genitourin Cancer</addtitle><description>Abstract Background Given the low historical prevalence of measurable disease in metastatic castration-resistant prostate cancer (mCRPC), phase II trials have employed prostate specific antigen (PSA) and bone scan changes as primary endpoints. Frequent whole body imaging and improved computerized tomography technology currently identify measurable disease more frequently, warranting consideration of objective response as a major endpoint. Methods Data from reported phase III trials of mCRPC were analyzed. The proportion of patients with measurable disease, setting (pre-docetaxel [D], D-based, post-D), year of starting accrual, PSA, and the requirement for symptoms were collected. Chi-square test was used to evaluate the association of variables with measurable disease rate. Results Twenty phase III trials totaling 19,276 men with mCRPC were evaluable. Three trials (N=1289) started accruing before 2000 and 17 trials (N=17,987) accrued after 2000. The proportion of measurable disease rate for all trials was 47.5%. The measurable disease rate was significantly higher (p&lt;0.001) in trials accruing after 2000 vs. before 2000 (48.7% vs. 31.1%, p&lt; 0.001), D-based (51.8%) or post-D patients (48.9%) compared to pre-D patients (38.6%) and in trials allowing symptomatic vs. asymptomatic/minimally symptomatic patients (50.1 vs. 40.0%). Conclusions The proportion of men with measurable disease was significantly higher in phase III trials of mCRPC accruing after 2000, in D-based or post-D patients and in trials allowing symptomatic patients. Given the association of objective measurable changes with survival, RECIST changes may warrant consideration as a major endpoint in phase II trials to obtain a firm signal of efficacy before launching phase III trials.</description><subject>Castration-resistant</subject><subject>Clinical Trials as Topic</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>Male</subject><subject>Measurable tumor</subject><subject>Metastatic</subject><subject>Neoplasm Metastasis</subject><subject>Prevalence</subject><subject>Prostate cancer</subject><subject>Prostate-Specific Antigen - metabolism</subject><subject>Prostatic Neoplasms, Castration-Resistant - diagnosis</subject><subject>Prostatic Neoplasms, Castration-Resistant - epidemiology</subject><subject>Prostatic Neoplasms, Castration-Resistant - metabolism</subject><subject>RECIST</subject><subject>Tomography, X-Ray Computed</subject><subject>Urology</subject><subject>Whole Body Imaging - methods</subject><issn>1558-7673</issn><issn>1938-0682</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNp9UkuL1EAQDqK4D_0DHiRHLxmrX0kHZEGW1RUWFFbPTae6svaYScbuZGD_vRVmXdSDp66u-uqrx1dF8UrARoCo3243ONzhRoJoNqA3IOFJcSpaZSuorXzKtjG2aupGnRRnOW8BtBENPC9OpDWy1sKeFrdfEh38QCNSOfXljnxeku8GKkPM_KEyjuydfZ79HLFENhJb01gmypG941zu07SGiaPMk14Uz3o_ZHr58J4X3z5cfb28rm4-f_x0-f6mQiNgrmyvul5J7HRbA7SNwABGal8jIHrTqwBBq2BUX3eqVsQO2wRlemGDwS6o8-LiyLtfuh0FpJFbG9w-xZ1P927y0f0dGeN3dzcdnLU8vW6Z4M0DQZp-LpRnt4sZaRj8SNOSnWgBrJK6tQyVRyjyrDlR_1hGgFvVcFu3quFWNRxox2pw0us_G3xM-b1-Brw7AojXdIiUXMa4ahFiIpxdmOL_-S_-ScchjhH98IPuKW-nJY0sgBMuSwfudr2H9RxEo0CABvULVKmzBw</recordid><startdate>20171001</startdate><enddate>20171001</enddate><creator>Sonpavde, G</creator><creator>Madan, A</creator><creator>Baker, M.K</creator><creator>May, J.E</creator><creator>Naik, G</creator><creator>Bae, S</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20171001</creationdate><title>Prevalence of measurable disease in metastatic castration resistant prostate cancer</title><author>Sonpavde, G ; Madan, A ; Baker, M.K ; May, J.E ; Naik, G ; Bae, S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c510t-8f3bf32cb49600971cd0524a6c0cca5f3d0d43d53f6b363ef3d87d35f18d5cbd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Castration-resistant</topic><topic>Clinical Trials as Topic</topic><topic>Hematology, Oncology and Palliative Medicine</topic><topic>Humans</topic><topic>Male</topic><topic>Measurable tumor</topic><topic>Metastatic</topic><topic>Neoplasm Metastasis</topic><topic>Prevalence</topic><topic>Prostate cancer</topic><topic>Prostate-Specific Antigen - metabolism</topic><topic>Prostatic Neoplasms, Castration-Resistant - diagnosis</topic><topic>Prostatic Neoplasms, Castration-Resistant - epidemiology</topic><topic>Prostatic Neoplasms, Castration-Resistant - metabolism</topic><topic>RECIST</topic><topic>Tomography, X-Ray Computed</topic><topic>Urology</topic><topic>Whole Body Imaging - methods</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sonpavde, G</creatorcontrib><creatorcontrib>Madan, A</creatorcontrib><creatorcontrib>Baker, M.K</creatorcontrib><creatorcontrib>May, J.E</creatorcontrib><creatorcontrib>Naik, G</creatorcontrib><creatorcontrib>Bae, S</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical genitourinary cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sonpavde, G</au><au>Madan, A</au><au>Baker, M.K</au><au>May, J.E</au><au>Naik, G</au><au>Bae, S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prevalence of measurable disease in metastatic castration resistant prostate cancer</atitle><jtitle>Clinical genitourinary cancer</jtitle><addtitle>Clin Genitourin Cancer</addtitle><date>2017-10-01</date><risdate>2017</risdate><volume>15</volume><issue>5</issue><spage>534</spage><epage>539</epage><pages>534-539</pages><issn>1558-7673</issn><eissn>1938-0682</eissn><abstract>Abstract Background Given the low historical prevalence of measurable disease in metastatic castration-resistant prostate cancer (mCRPC), phase II trials have employed prostate specific antigen (PSA) and bone scan changes as primary endpoints. Frequent whole body imaging and improved computerized tomography technology currently identify measurable disease more frequently, warranting consideration of objective response as a major endpoint. Methods Data from reported phase III trials of mCRPC were analyzed. The proportion of patients with measurable disease, setting (pre-docetaxel [D], D-based, post-D), year of starting accrual, PSA, and the requirement for symptoms were collected. Chi-square test was used to evaluate the association of variables with measurable disease rate. Results Twenty phase III trials totaling 19,276 men with mCRPC were evaluable. Three trials (N=1289) started accruing before 2000 and 17 trials (N=17,987) accrued after 2000. The proportion of measurable disease rate for all trials was 47.5%. The measurable disease rate was significantly higher (p&lt;0.001) in trials accruing after 2000 vs. before 2000 (48.7% vs. 31.1%, p&lt; 0.001), D-based (51.8%) or post-D patients (48.9%) compared to pre-D patients (38.6%) and in trials allowing symptomatic vs. asymptomatic/minimally symptomatic patients (50.1 vs. 40.0%). Conclusions The proportion of men with measurable disease was significantly higher in phase III trials of mCRPC accruing after 2000, in D-based or post-D patients and in trials allowing symptomatic patients. Given the association of objective measurable changes with survival, RECIST changes may warrant consideration as a major endpoint in phase II trials to obtain a firm signal of efficacy before launching phase III trials.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>28526418</pmid><doi>10.1016/j.clgc.2017.04.020</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record>
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subjects Castration-resistant
Clinical Trials as Topic
Hematology, Oncology and Palliative Medicine
Humans
Male
Measurable tumor
Metastatic
Neoplasm Metastasis
Prevalence
Prostate cancer
Prostate-Specific Antigen - metabolism
Prostatic Neoplasms, Castration-Resistant - diagnosis
Prostatic Neoplasms, Castration-Resistant - epidemiology
Prostatic Neoplasms, Castration-Resistant - metabolism
RECIST
Tomography, X-Ray Computed
Urology
Whole Body Imaging - methods
title Prevalence of measurable disease in metastatic castration resistant prostate cancer
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