{"id":"https://openalex.org/W1980738720","doi":"https://doi.org/10.1016/s0022-5347(06)00284-9","title":"The Prostate Cancer Prevention Trial: Design, Biases and Interpretation of Study Results","display_name":"The Prostate Cancer Prevention Trial: Design, Biases and Interpretation of Study Results","publication_year":2006,"publication_date":"2006-05-12","ids":{"openalex":"https://openalex.org/W1980738720","doi":"https://doi.org/10.1016/s0022-5347(06)00284-9","mag":"1980738720","pmid":"https://pubmed.ncbi.nlm.nih.gov/16697846"},"language":"en","primary_location":{"id":"doi:10.1016/s0022-5347(06)00284-9","doi":"https://doi.org/10.1016/s0022-5347(06)00284-9","is_oa":false,"landing_page_url":"https://doi.org/10.1016/s0022-5347(06)00284-9","pdf_url":null,"source":{"id":"https://openalex.org/S30525748","display_name":"The Journal of Urology","issn_l":"0022-5347","issn":["0022-5347","1527-3792"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Urology","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5001359178","display_name":"Phyllis J. Goodman","orcid":"https://orcid.org/0000-0001-9660-7074","observed_orcids":["https://orcid.org/0000-0001-9660-7074"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Phyllis J. Goodman","raw_affiliation_strings":["Southwest Oncology Group Statistical Center, Seattle, Washington"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Southwest Oncology Group Statistical Center, Seattle, Washington","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5015887484","display_name":"Ian Murchie Thompson","orcid":"https://orcid.org/0000-0003-0833-952X","observed_orcids":["https://orcid.org/0000-0003-0833-952X"]},"institutions":[{"id":"https://openalex.org/I165951966","display_name":"The University of Texas at San Antonio Health Science Center","ror":"https://ror.org/02f6dcw23","country_code":"US","type":"education","lineage":["https://openalex.org/I165951966","https://openalex.org/I45438204"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Ian M. Thompson","raw_affiliation_strings":["University of Texas Health Science Center, San Antonio, Texas"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Texas Health Science Center, San Antonio, Texas","institution_ids":["https://openalex.org/I165951966"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5026563364","display_name":"Catherine M. Tangen","orcid":"https://orcid.org/0000-0001-8825-8660","observed_orcids":["https://orcid.org/0000-0001-8825-8660"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Catherine M. Tangen","raw_affiliation_strings":["Southwest Oncology Group Statistical Center, Seattle, Washington"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Southwest Oncology Group Statistical Center, Seattle, Washington","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5103408877","display_name":"John J. Crowley","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"John J. Crowley","raw_affiliation_strings":["Southwest Oncology Group Statistical Center, Seattle, Washington"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Southwest Oncology Group Statistical Center, Seattle, Washington","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5049889117","display_name":"Leslie G. Ford","orcid":"https://orcid.org/0000-0003-2412-8028","observed_orcids":["https://orcid.org/0000-0003-2412-8028"]},"institutions":[{"id":"https://openalex.org/I1299303238","display_name":"National Institutes of Health","ror":"https://ror.org/01cwqze88","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1299303238"]},{"id":"https://openalex.org/I4210140884","display_name":"National Cancer Institute","ror":"https://ror.org/040gcmg81","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1299303238","https://openalex.org/I4210140884"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Leslie G. Ford","raw_affiliation_strings":["National Cancer Institute, Bethesda, Maryland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"National Cancer Institute, Bethesda, Maryland","institution_ids":["https://openalex.org/I1299303238","https://openalex.org/I4210140884"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5080175936","display_name":"Charles A. Coltman","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210165553","display_name":"SWOG Cancer Research Network","ror":"https://ror.org/05n6zrm60","country_code":"US","type":"facility","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1299303238","https://openalex.org/I4210140884","https://openalex.org/I4210165553"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Charles A. Coltman","raw_affiliation_strings":["Southwest Oncology Group Operations Office, San Antonio, Texas"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Southwest Oncology Group Operations Office, San Antonio, Texas","institution_ids":["https://openalex.org/I4210165553"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":4,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":{"value":3000,"currency":"USD","value_usd":3000},"apc_paid":null,"fwci":3.6751,"has_fulltext":false,"cited_by_count":44,"citation_normalized_percentile":{"value":0.91808571,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":88,"max":98},"biblio":{"volume":"175","issue":"6","first_page":"2234","last_page":"2242"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10124","display_name":"Prostate Cancer Diagnosis and Treatment","score":0.888700008392334,"subfield":{"id":"https://openalex.org/subfields/2748","display_name":"Urology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10124","display_name":"Prostate Cancer Diagnosis and Treatment","score":0.888700008392334,"subfield":{"id":"https://openalex.org/subfields/2748","display_name":"Urology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10543","display_name":"Prostate Cancer Treatment and Research","score":0.05530000105500221,"subfield":{"id":"https://openalex.org/subfields/1306","display_name":"Cancer Research"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.019899999722838402,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/prostate-cancer-prevention-trial","display_name":"Prostate Cancer Prevention Trial","score":0.9980000257492065},{"id":"https://openalex.org/keywords/finasteride","display_name":"finasteride","score":0.9909999966621399},{"id":"https://openalex.org/keywords/prostate-cancer-prevention","display_name":"prostate cancer prevention","score":0.9760000109672546},{"id":"https://openalex.org/keywords/trial-design-bias","display_name":"trial design bias","score":0.7200000286102295},{"id":"https://openalex.org/keywords/prostate-specific-antigen","display_name":"prostate-specific antigen","score":0.6570000052452087},{"id":"https://openalex.org/keywords/digital-rectal-examination","display_name":"digital rectal examination","score":0.9490000009536743},{"id":"https://openalex.org/keywords/prostate-biopsy","display_name":"prostate biopsy","score":0.7770000100135803},{"id":"https://openalex.org/keywords/medication-non-adherence","display_name":"medication non-adherence","score":0.7820000052452087},{"id":"https://openalex.org/keywords/contamination","display_name":"contamination","score":0.7459999918937683},{"id":"https://openalex.org/keywords/transurethral-resection","display_name":"transurethral resection","score":0.8410000205039978}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9500417113304138},{"id":"https://openalex.org/C2780192828","wikidata":"https://www.wikidata.org/wiki/Q181257","display_name":"Prostate cancer","level":3,"score":0.6121758818626404},{"id":"https://openalex.org/C527412718","wikidata":"https://www.wikidata.org/wiki/Q855395","display_name":"Interpretation (philosophy)","level":2,"score":0.6065475940704346},{"id":"https://openalex.org/C2776235491","wikidata":"https://www.wikidata.org/wiki/Q9625","display_name":"Prostate","level":3,"score":0.544903576374054},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.49246105551719666},{"id":"https://openalex.org/C121608353","wikidata":"https://www.wikidata.org/wiki/Q12078","display_name":"Cancer","level":2,"score":0.42898663878440857},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.4255021810531616},{"id":"https://openalex.org/C29456083","wikidata":"https://www.wikidata.org/wiki/Q1221899","display_name":"Gynecology","level":1,"score":0.4083021283149719},{"id":"https://openalex.org/C143998085","wikidata":"https://www.wikidata.org/wiki/Q162555","display_name":"Oncology","level":1,"score":0.3817283511161804},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.23855316638946533},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.0},{"id":"https://openalex.org/C199360897","wikidata":"https://www.wikidata.org/wiki/Q9143","display_name":"Programming language","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D001706","descriptor_name":"Biopsy","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000706","qualifier_name":"statistics & numerical data","is_major_topic":true},{"descriptor_ui":"D003627","descriptor_name":"Data Interpretation, Statistical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008297","descriptor_name":"Male","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011471","descriptor_name":"Prostatic Neoplasms","qualifier_ui":"Q000097","qualifier_name":"blood","is_major_topic":false},{"descriptor_ui":"D011471","descriptor_name":"Prostatic Neoplasms","qualifier_ui":"Q000175","qualifier_name":"diagnosis","is_major_topic":false},{"descriptor_ui":"D011471","descriptor_name":"Prostatic Neoplasms","qualifier_ui":"Q000517","qualifier_name":"prevention & control","is_major_topic":true},{"descriptor_ui":"D012107","descriptor_name":"Research Design","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D012107","descriptor_name":"Research Design","qualifier_ui":"Q000706","qualifier_name":"statistics & numerical data","is_major_topic":true},{"descriptor_ui":"D015982","descriptor_name":"Bias","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017430","descriptor_name":"Prostate-Specific Antigen","qualifier_ui":"Q000097","qualifier_name":"blood","is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.1016/s0022-5347(06)00284-9","doi":"https://doi.org/10.1016/s0022-5347(06)00284-9","is_oa":false,"landing_page_url":"https://doi.org/10.1016/s0022-5347(06)00284-9","pdf_url":null,"source":{"id":"https://openalex.org/S30525748","display_name":"The Journal of Urology","issn_l":"0022-5347","issn":["0022-5347","1527-3792"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Urology","raw_type":"journal-article"},{"id":"pmid:16697846","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/16697846","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"The Journal of urology","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.9537000060081482}],"study_designs":[],"awards":[{"id":"https://openalex.org/G7747134535","display_name":"SWOG Community Clinical Oncology Program Research Base","funder_award_id":"U10CA037429","funder_id":"https://openalex.org/F4320337351","funder_display_name":"National Cancer Institute"}],"funders":[{"id":"https://openalex.org/F4320337351","display_name":"National Cancer Institute","ror":"https://ror.org/040gcmg81"}],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":16,"referenced_works":["https://openalex.org/W1990337681","https://openalex.org/W2020094909","https://openalex.org/W2044646650","https://openalex.org/W2055488232","https://openalex.org/W2059472885","https://openalex.org/W2072760602","https://openalex.org/W2078573596","https://openalex.org/W2089030366","https://openalex.org/W2133929387","https://openalex.org/W2154925732","https://openalex.org/W2154963879","https://openalex.org/W2415293293","https://openalex.org/W3135529189","https://openalex.org/W4235484368","https://openalex.org/W4285719527","https://openalex.org/W4320801172"],"related_works":["https://openalex.org/W1984855386","https://openalex.org/W2041714234","https://openalex.org/W9722579","https://openalex.org/W2030849098","https://openalex.org/W2060403748","https://openalex.org/W2065005241","https://openalex.org/W2129302529","https://openalex.org/W4243023173","https://openalex.org/W3135529189","https://openalex.org/W2062034861"],"abstract_inverted_index":{"PURPOSE:":[0],"We":[1],"describe":[2],"the":[3,6,10,16,26,33,41,79,82,89,111,130,146,152,164,173,181,188,205,208,217,222],"complexities":[4],"of":[5,9,25,44,52,84,98,110,140,167,175,180,207,225],"study":[7,64,85,141,165,228],"design":[8,113,199],"PCPT":[11,34,182],"and":[12,23,39,67,69,100,106,114,162,190,200,214,221],"how":[13],"they":[14],"influenced":[15],"end":[17,83,133,139,229],"point":[18,134],"chosen,":[19],"trial":[20,46,90,112,209],"implementation,":[21],"analysis":[22],"interpretation":[24],"results.":[27],"MATERIALS":[28],"AND":[29],"METHODS:":[30],"Data":[31,189],"from":[32],"are":[35,73],"provided":[36],"to":[37,87,155,194],"evaluate":[38,88],"quantify":[40],"potential":[42,50,101],"biases":[43,76,102],"this":[45],"design.":[47],"RESULTS:":[48],"Six":[49],"sources":[51],"bias,":[53],"including":[54,212],"prostate":[55,61,71,176],"specific":[56],"antigen,":[57],"digital":[58],"rectal":[59],"examination,":[60],"biopsy":[62,86,122,142,201,219],"technique,":[63],"medication":[65],"nonadherence":[66],"contamination,":[68],"transurethral":[70],"resection":[72],"presented.":[74],"These":[75],"resulted":[77],"in":[78],"need":[80],"for":[81,105],"objectives.":[91],"CONCLUSIONS:":[92],"There":[93],"were":[94,210],"a":[95],"large":[96],"number":[97],"known":[99],"that":[103,120,135],"worked":[104],"against":[107],"finasteride.":[108],"Because":[109],"inherent":[115],"biases,":[116],"it":[117,150],"is":[118],"imperative":[119],"interim":[121],"results":[123],"should":[124],"be":[125],"interpreted":[126],"with":[127,227],"caution.":[128],"While":[129],"period":[131],"prevalence":[132],"relied":[136],"on":[137,184],"an":[138],"was":[143,151],"perhaps":[144],"not":[145],"most":[147],"clinically":[148],"relevant,":[149],"only":[153],"way":[154],"remove":[156],"as":[157,160],"much":[158],"bias":[159],"possible":[161],"meet":[163],"objective":[166],"determining":[168],"if":[169],"finasteride":[170],"could":[171],"decrease":[172],"risk":[174],"cancer.":[177],"The":[178,198],"success":[179],"depended":[183],"constant":[185],"scrutiny":[186],"by":[187],"Safety":[191],"Monitoring":[192],"Committee":[193],"monitor":[195],"these":[196],"biases.":[197],"assumptions":[202],"outlined":[203],"at":[204],"inception":[206],"met,":[211],"adherence":[213],"contamination":[215],"rates,":[216],"for-cause":[218],"rate":[220],"final":[223],"percent":[224],"men":[226],"points.":[230]},"counts_by_year":[{"year":2026,"cited_by_count":2},{"year":2023,"cited_by_count":2},{"year":2021,"cited_by_count":2},{"year":2020,"cited_by_count":1},{"year":2019,"cited_by_count":1},{"year":2018,"cited_by_count":2},{"year":2017,"cited_by_count":2},{"year":2016,"cited_by_count":3},{"year":2015,"cited_by_count":2},{"year":2013,"cited_by_count":2},{"year":2012,"cited_by_count":5}],"updated_date":"2026-11-06T12:05:46.655746","created_date":"2016-06-24T00:00:00"}
