Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial
IMPORTANCE: Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data. OBJECTIVE: To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression...
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| Veröffentlicht in: | JAMA : the journal of the American Medical Association 2020-01, Vol.323 (2), p.140-148 |
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| creator | Parsons, J. Kellogg Zahrieh, David Mohler, James L Paskett, Electra Hansel, Donna E Kibel, Adam S Liu, Heshan Seisler, Drew K Natarajan, Loki White, Martha Hahn, Olwen Taylor, John Hartman, Sheri J Stroup, Sean P Van Veldhuizen, Peter Hall, Lannis Small, Eric J Morris, Michael J Pierce, John P Marshall, James |
| description | IMPORTANCE: Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data. OBJECTIVE: To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: The Men’s Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those |
| doi_str_mv | 10.1001/jama.2019.20207 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6990696</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><ama_id>2758598</ama_id><sourcerecordid>2338054594</sourcerecordid><originalsourceid>FETCH-LOGICAL-a353t-d3c0d148c1616ef71f3708fe6b0bc56ff455a24f1b3b31605abc7b232b639c8f3</originalsourceid><addsrcrecordid>eNpdklGL1DAQx4so3nr6LPggAV986V3SNGnrg7Auqx7soeiqjyFNJ90sbbIm2YXzI_kpTW_3DjWEDMn8ZpiZ_LPsOcEXBGNyuZWjvCgwadJR4OpBNiOM1jllTf0wm2Hc1HlV1uVZ9iSELU6L0OpxdkZJQxku-Cz7vdQaVEROI4newUYejPNyQFc2gj-AjcZZFF26Kw8yAPoOPUTZDoAWzob9uLsl0l5Iq8Cjz971HkKYXuejsz26Bot-mLhBS-mHm_xrlD1MWIgywinsDVpvAF0v5yv0RdrOjeYXdGgxGGtUqmbtjRyeZo-0HAI8O9nz7Nv75XrxMV99-nC1mK9ySRmNeUcV7khZK8IJB10RTStca-AtbhXjWpeMyaLUpKUtJRwz2aqqLWjRctqoWtPz7O0x727fjtCpNIQ0EbHzZpT-RjhpxL8eazaidwfBmwbzhqcEr08JvPu5hxDFaIKCYZAW3D6IgtIas5I1ZUJf_Ydu3d7b1F6iSsrr1MNEXR4plaYWPOj7YggWkw7EpAMx6UDc6iBFvPy7h3v-7uMT8OIITIF33qJidVIO_QP-Erlz</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2343686164</pqid></control><display><type>article</type><title>Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial</title><source>MEDLINE</source><source>American Medical Association Journals</source><creator>Parsons, J. Kellogg ; Zahrieh, David ; Mohler, James L ; Paskett, Electra ; Hansel, Donna E ; Kibel, Adam S ; Liu, Heshan ; Seisler, Drew K ; Natarajan, Loki ; White, Martha ; Hahn, Olwen ; Taylor, John ; Hartman, Sheri J ; Stroup, Sean P ; Van Veldhuizen, Peter ; Hall, Lannis ; Small, Eric J ; Morris, Michael J ; Pierce, John P ; Marshall, James</creator><creatorcontrib>Parsons, J. Kellogg ; Zahrieh, David ; Mohler, James L ; Paskett, Electra ; Hansel, Donna E ; Kibel, Adam S ; Liu, Heshan ; Seisler, Drew K ; Natarajan, Loki ; White, Martha ; Hahn, Olwen ; Taylor, John ; Hartman, Sheri J ; Stroup, Sean P ; Van Veldhuizen, Peter ; Hall, Lannis ; Small, Eric J ; Morris, Michael J ; Pierce, John P ; Marshall, James</creatorcontrib><description>IMPORTANCE: Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data. OBJECTIVE: To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: The Men’s Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017. INTERVENTIONS: Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241). MAIN OUTCOMES AND MEASURES: The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy. RESULTS: Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, −8.1% to 12.2%]). CONCLUSIONS AND RELEVANCE: Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01238172</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.2019.20207</identifier><identifier>PMID: 31935026</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Adenocarcinoma ; Aged ; Aged, 80 and over ; Antigens ; Behavior modification ; Biopsy ; Clinical trials ; Consumption ; Counseling ; Diet ; Disease Progression ; Health risks ; Humans ; Intervention ; Male ; Middle Aged ; Neoplasm Staging ; Oncology ; Original Investigation ; Patients ; Population studies ; Prostate cancer ; Prostate-specific antigen ; Prostate-Specific Antigen - blood ; Prostatic Neoplasms - diet therapy ; Prostatic Neoplasms - pathology ; Prostatic Neoplasms - therapy ; Telephone ; Urology ; Vegetables ; Watchful Waiting</subject><ispartof>JAMA : the journal of the American Medical Association, 2020-01, Vol.323 (2), p.140-148</ispartof><rights>Copyright American Medical Association Jan 14, 2020</rights><rights>Copyright 2020 American Medical Association. All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-a353t-d3c0d148c1616ef71f3708fe6b0bc56ff455a24f1b3b31605abc7b232b639c8f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.2019.20207$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2019.20207$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,230,314,776,780,881,3327,27901,27902,76232,76235</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31935026$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Parsons, J. Kellogg</creatorcontrib><creatorcontrib>Zahrieh, David</creatorcontrib><creatorcontrib>Mohler, James L</creatorcontrib><creatorcontrib>Paskett, Electra</creatorcontrib><creatorcontrib>Hansel, Donna E</creatorcontrib><creatorcontrib>Kibel, Adam S</creatorcontrib><creatorcontrib>Liu, Heshan</creatorcontrib><creatorcontrib>Seisler, Drew K</creatorcontrib><creatorcontrib>Natarajan, Loki</creatorcontrib><creatorcontrib>White, Martha</creatorcontrib><creatorcontrib>Hahn, Olwen</creatorcontrib><creatorcontrib>Taylor, John</creatorcontrib><creatorcontrib>Hartman, Sheri J</creatorcontrib><creatorcontrib>Stroup, Sean P</creatorcontrib><creatorcontrib>Van Veldhuizen, Peter</creatorcontrib><creatorcontrib>Hall, Lannis</creatorcontrib><creatorcontrib>Small, Eric J</creatorcontrib><creatorcontrib>Morris, Michael J</creatorcontrib><creatorcontrib>Pierce, John P</creatorcontrib><creatorcontrib>Marshall, James</creatorcontrib><title>Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>IMPORTANCE: Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data. OBJECTIVE: To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: The Men’s Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017. INTERVENTIONS: Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241). MAIN OUTCOMES AND MEASURES: The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy. RESULTS: Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, −8.1% to 12.2%]). CONCLUSIONS AND RELEVANCE: Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01238172</description><subject>Adenocarcinoma</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antigens</subject><subject>Behavior modification</subject><subject>Biopsy</subject><subject>Clinical trials</subject><subject>Consumption</subject><subject>Counseling</subject><subject>Diet</subject><subject>Disease Progression</subject><subject>Health risks</subject><subject>Humans</subject><subject>Intervention</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Oncology</subject><subject>Original Investigation</subject><subject>Patients</subject><subject>Population studies</subject><subject>Prostate cancer</subject><subject>Prostate-specific antigen</subject><subject>Prostate-Specific Antigen - blood</subject><subject>Prostatic Neoplasms - diet therapy</subject><subject>Prostatic Neoplasms - pathology</subject><subject>Prostatic Neoplasms - therapy</subject><subject>Telephone</subject><subject>Urology</subject><subject>Vegetables</subject><subject>Watchful Waiting</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdklGL1DAQx4so3nr6LPggAV986V3SNGnrg7Auqx7soeiqjyFNJ90sbbIm2YXzI_kpTW_3DjWEDMn8ZpiZ_LPsOcEXBGNyuZWjvCgwadJR4OpBNiOM1jllTf0wm2Hc1HlV1uVZ9iSELU6L0OpxdkZJQxku-Cz7vdQaVEROI4newUYejPNyQFc2gj-AjcZZFF26Kw8yAPoOPUTZDoAWzob9uLsl0l5Iq8Cjz971HkKYXuejsz26Bot-mLhBS-mHm_xrlD1MWIgywinsDVpvAF0v5yv0RdrOjeYXdGgxGGtUqmbtjRyeZo-0HAI8O9nz7Nv75XrxMV99-nC1mK9ySRmNeUcV7khZK8IJB10RTStca-AtbhXjWpeMyaLUpKUtJRwz2aqqLWjRctqoWtPz7O0x727fjtCpNIQ0EbHzZpT-RjhpxL8eazaidwfBmwbzhqcEr08JvPu5hxDFaIKCYZAW3D6IgtIas5I1ZUJf_Ydu3d7b1F6iSsrr1MNEXR4plaYWPOj7YggWkw7EpAMx6UDc6iBFvPy7h3v-7uMT8OIITIF33qJidVIO_QP-Erlz</recordid><startdate>20200114</startdate><enddate>20200114</enddate><creator>Parsons, J. Kellogg</creator><creator>Zahrieh, David</creator><creator>Mohler, James L</creator><creator>Paskett, Electra</creator><creator>Hansel, Donna E</creator><creator>Kibel, Adam S</creator><creator>Liu, Heshan</creator><creator>Seisler, Drew K</creator><creator>Natarajan, Loki</creator><creator>White, Martha</creator><creator>Hahn, Olwen</creator><creator>Taylor, John</creator><creator>Hartman, Sheri J</creator><creator>Stroup, Sean P</creator><creator>Van Veldhuizen, Peter</creator><creator>Hall, Lannis</creator><creator>Small, Eric J</creator><creator>Morris, Michael J</creator><creator>Pierce, John P</creator><creator>Marshall, James</creator><general>American Medical Association</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>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20200114</creationdate><title>Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial</title><author>Parsons, J. Kellogg ; Zahrieh, David ; Mohler, James L ; Paskett, Electra ; Hansel, Donna E ; Kibel, Adam S ; Liu, Heshan ; Seisler, Drew K ; Natarajan, Loki ; White, Martha ; Hahn, Olwen ; Taylor, John ; Hartman, Sheri J ; Stroup, Sean P ; Van Veldhuizen, Peter ; Hall, Lannis ; Small, Eric J ; Morris, Michael J ; Pierce, John P ; Marshall, James</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a353t-d3c0d148c1616ef71f3708fe6b0bc56ff455a24f1b3b31605abc7b232b639c8f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adenocarcinoma</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antigens</topic><topic>Behavior modification</topic><topic>Biopsy</topic><topic>Clinical trials</topic><topic>Consumption</topic><topic>Counseling</topic><topic>Diet</topic><topic>Disease Progression</topic><topic>Health risks</topic><topic>Humans</topic><topic>Intervention</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Oncology</topic><topic>Original Investigation</topic><topic>Patients</topic><topic>Population studies</topic><topic>Prostate cancer</topic><topic>Prostate-specific antigen</topic><topic>Prostate-Specific Antigen - blood</topic><topic>Prostatic Neoplasms - diet therapy</topic><topic>Prostatic Neoplasms - pathology</topic><topic>Prostatic Neoplasms - therapy</topic><topic>Telephone</topic><topic>Urology</topic><topic>Vegetables</topic><topic>Watchful Waiting</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Parsons, J. 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Kellogg</au><au>Zahrieh, David</au><au>Mohler, James L</au><au>Paskett, Electra</au><au>Hansel, Donna E</au><au>Kibel, Adam S</au><au>Liu, Heshan</au><au>Seisler, Drew K</au><au>Natarajan, Loki</au><au>White, Martha</au><au>Hahn, Olwen</au><au>Taylor, John</au><au>Hartman, Sheri J</au><au>Stroup, Sean P</au><au>Van Veldhuizen, Peter</au><au>Hall, Lannis</au><au>Small, Eric J</au><au>Morris, Michael J</au><au>Pierce, John P</au><au>Marshall, James</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2020-01-14</date><risdate>2020</risdate><volume>323</volume><issue>2</issue><spage>140</spage><epage>148</epage><pages>140-148</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><abstract>IMPORTANCE: Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data. OBJECTIVE: To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: The Men’s Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017. INTERVENTIONS: Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241). MAIN OUTCOMES AND MEASURES: The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy. RESULTS: Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, −8.1% to 12.2%]). CONCLUSIONS AND RELEVANCE: Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01238172</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>31935026</pmid><doi>10.1001/jama.2019.20207</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | JAMA : the journal of the American Medical Association, 2020-01, Vol.323 (2), p.140-148 |
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| subjects | Adenocarcinoma Aged Aged, 80 and over Antigens Behavior modification Biopsy Clinical trials Consumption Counseling Diet Disease Progression Health risks Humans Intervention Male Middle Aged Neoplasm Staging Oncology Original Investigation Patients Population studies Prostate cancer Prostate-specific antigen Prostate-Specific Antigen - blood Prostatic Neoplasms - diet therapy Prostatic Neoplasms - pathology Prostatic Neoplasms - therapy Telephone Urology Vegetables Watchful Waiting |
| title | Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial |
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