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International"],"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the feasibility of performing national, randomized trials of dietary interventions for localized prostate cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The Men's Eating and Living (\n                      <jats:styled-content style=\"fixed-case\">MEAL<\/jats:styled-content>\n                      ) study (\n                      <jats:styled-content style=\"fixed-case\">CALGB<\/jats:styled-content>\n                      70807 [Alliance]) is a phase\n                      <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content>\n                      clinical trial testing the efficacy of a high\u2010vegetable diet to prevent progression in patients with prostate cancer on active surveillance (\n                      <jats:styled-content style=\"fixed-case\">AS<\/jats:styled-content>\n                      ). Participants were randomized to a validated diet counselling intervention or to a control condition. Chi\u2010squared and Kruskal\u2013Wallis analyses were used to assess between\u2010group differences at baseline.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Between 2011 and 2015, 478 (103%) of a targeted 464 patients were randomized at 91 study sites. At baseline, the mean (\n                      <jats:sc>sd<\/jats:sc>\n                      ) age was 64 (6) years and mean (\n                      <jats:sc>sd<\/jats:sc>\n                      )\n                      <jats:styled-content style=\"fixed-case\">PSA<\/jats:styled-content>\n                      concentration was 4.9 (2.1)\u00a0ng\/mL. Fifty\u2010six (12%) participants were African\u2010American, 17 (4%) were Hispanic\/Latino, and 16 (3%) were Asian\u2010American. There were no significant between\u2010group differences for age (\n                      <jats:italic>P<\/jats:italic>\n                      = 0.98), race\/ethnicity (\n                      <jats:italic>P<\/jats:italic>\n                      = 0.52), geographic region (\n                      <jats:italic>P<\/jats:italic>\n                      = 0.60), time since prostate cancer diagnosis (\n                      <jats:italic>P<\/jats:italic>\n                      = 0.85),\n                      <jats:styled-content style=\"fixed-case\">PSA<\/jats:styled-content>\n                      concentration (\n                      <jats:italic>P<\/jats:italic>\n                      = 0.96), clinical stage (T1c or T2a;\n                      <jats:italic>P<\/jats:italic>\n                      = 0.27), or Gleason sum (Gleason 6 or 3+4 = 7;\n                      <jats:italic>P<\/jats:italic>\n                      = 0.76). In a pre\u2010planned analysis, the baseline prostate biopsy samples of the first 50 participants underwent central pathology review to confirm eligibility, with an expectation that &lt;10% would become ineligible. One of 50 participants (2%) became ineligible.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      The\n                      <jats:styled-content style=\"fixed-case\">MEAL<\/jats:styled-content>\n                      study shows the feasibility of implementing national, multi\u2010institutional phase\n                      <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content>\n                      clinical trials of diet for prostate cancer and of testing interventions to prevent disease progression in\n                      <jats:styled-content style=\"fixed-case\">AS<\/jats:styled-content>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.13890","type":"journal-article","created":{"date-parts":[[2017,4,24]],"date-time":"2017-04-24T08:55:31Z","timestamp":1493024131000},"page":"534-539","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Men's Eating and Living (\n                    <scp>MEAL<\/scp>\n                    ) study (\n                    <scp>CALGB<\/scp>\n                    70807 [Alliance]): recruitment feasibility and baseline demographics of a randomized trial of diet in men on active surveillance for prostate cancer"],"prefix":"10.1111","volume":"121","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3676-9730","authenticated-orcid":false,"given":"J. 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University Columbus OH USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sin\u2010Ho","family":"Jung","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Center Duke University Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J.","family":"Morris","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Small","sequence":"additional","affiliation":[{"name":"UCSF Helen Diller Family Comprehensive Cancer Center San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olwen","family":"Hahn","sequence":"additional","affiliation":[{"name":"Alliance Central Protocol Operations University of Chicago Chicago IL 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