{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T18:56:48Z","timestamp":1790535408509,"version":"4.1.0"},"reference-count":47,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T00:00:00Z","timestamp":1790467200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T00:00:00Z","timestamp":1790467200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100004239","name":"Politechnika Pozna\u0144ska","doi-asserted-by":"publisher","award":["NCI P30 CA046934"],"award-info":[{"award-number":["NCI P30 CA046934"]}],"id":[{"id":"10.13039\/501100004239","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009141","name":"Cancer League of Colorado","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009141","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Molecular Carcinogenesis"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Prostate cancer (PCa) is a major cause of cancer\u2010related death among American men. While androgen deprivation therapy (ADT) is commonly used in the treatment of rising prostate\u2010specific antigen (PSA) levels after primary therapy, its adverse systemic side effects support exploring low\u2010impact treatment options during the observation period of nonmetastatic PSA\u2010only progression. Grape seed extract (GSE) is a nontoxic phytochemical that has shown anti\u2010PCa efficacy in preclinical studies. Herein, we report the results of a completed Phase II clinical trial (CT.gov\u2010NCT03087903) which investigated the effect of GSE in patients with PSA\u2010only recurrence after maximum local therapy for PCa. Study endpoints included PSA response (defined as a\u2009\u2265\u200930% increase in model\u2010estimated PSA\u2010DT) and change in PSA velocity. Forty\u2010one patients were given 150\u2009mg of GSE orally twice daily (Leucoselect\u2010Phytosome formulation with increased bioavailability) for 12 months or until PSA\u2010DT\u2009\u2264\u20093 months. Mixed\u2010effects spline modeling of longitudinal PSA demonstrated a modest increase in PSA\u2010DT following treatment initiation. Most patients experienced some degree of increase in model\u2010estimated PSA\u2010DT, with 37% of those patients meeting the primary endpoint of \u2265\u200930% increase in PSA\u2010DT. GSE demonstrated a favorable safety profile. Although further validation is warranted, the observed changes in PSA\u2010DT indicate that GSE may contribute to delaying PCa progression. The therapeutic effect appeared to be more pronounced among patients with higher baseline PSA and testosterone levels, suggesting that these factors may influence responsiveness to treatment. These promising findings support further investigation to identify patient populations most likely to benefit from GSE intervention.<\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial Registration:<\/jats:bold>\n                    ClinicalTrials.gov site (CT.gov\u2010NCT03087903).\n                  <\/jats:p>","DOI":"10.1002\/mc.70183","type":"journal-article","created":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T18:18:51Z","timestamp":1790533131000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Phase II Trial Using Grape Seed Extract for Prostate Cancer Patients With Nonmetastatic Prostate\u2010Specific Antigen Progression After Local Therapy"],"prefix":"10.1002","author":[{"given":"Paul","family":"Maroni","sequence":"first","affiliation":[{"name":"Department of Surgery, Division of Urology University of Colorado Anschutz Medical Campus Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tad A.","family":"Manalo","sequence":"additional","affiliation":[{"name":"Department of Surgery, Division of Urology University of Colorado Anschutz Medical Campus Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Baker","sequence":"additional","affiliation":[{"name":"Department of Surgery, Division of Urology University of Colorado Anschutz Medical Campus Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth R.","family":"Kessler","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Medical Oncology University of Colorado Anschutz Medical Campus Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7769-1175","authenticated-orcid":false,"given":"Andrew","family":"Nicklawsky","sequence":"additional","affiliation":[{"name":"University of Colorado Cancer Center University of Colorado Anschutz Medical Campus Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor","family":"Trevisanut","sequence":"additional","affiliation":[{"name":"University of Colorado Cancer Center University of Colorado Anschutz Medical Campus Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas W.","family":"Flaig","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Medical Oncology University of Colorado Anschutz Medical Campus Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elaine T.","family":"Lam","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Medical Oncology University of Colorado Anschutz Medical Campus Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James C.","family":"Moore","sequence":"additional","affiliation":[{"name":"UCHealth Cancer Care and Hematology Clinic \u2013 Harmony Campus Fort Collins Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3920-7060","authenticated-orcid":false,"given":"Dexiang","family":"Gao","sequence":"additional","affiliation":[{"name":"University of Colorado Cancer Center University of Colorado Anschutz Medical Campus Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0371-1070","authenticated-orcid":false,"given":"Komal","family":"Raina","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences University of Colorado Anschutz Medical Campus Aurora Colorado USA"},{"name":"Department of Pharmaceutical Sciences South Dakota State University Brookings South Dakota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9455-0235","authenticated-orcid":false,"given":"Rajesh","family":"Agarwal","sequence":"additional","affiliation":[{"name":"University of Colorado Cancer Center University of Colorado Anschutz Medical Campus Aurora Colorado USA"},{"name":"Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences University of Colorado Anschutz Medical Campus Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,27]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"crossref","first-page":"302","DOI":"10.1016\/j.eururo.2024.11.013","article-title":"Recent Patterns and Trends in Global Prostate Cancer Incidence and Mortality: An Update","volume":"87","author":"Schafer E. 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H. H.","year":"2011","journal-title":"Journal of the American Dietetic Association"},{"key":"e_1_2_13_11_1","first-page":"227","article-title":"Effects of Niacin\u2010Bound Chromium and Grape Seed Proanthocyanidin Extract on the Lipid Profile of Hypercholesterolemic Subjects: A Pilot Study","volume":"31","author":"Preuss H. G.","year":"2000","journal-title":"Journal of Medicine"},{"key":"e_1_2_13_12_1","doi-asserted-by":"crossref","first-page":"255","DOI":"10.1089\/jmf.2012.2408","article-title":"Red Grape Seed Extract Improves Lipid Profiles and Decreases Oxidized Low\u2010Density Lipoprotein in Patients With Mild Hyperlipidemia","volume":"16","author":"Razavi S. 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T.","year":"2016","journal-title":"Journal of Nutritional Biochemistry"},{"key":"e_1_2_13_32_1","doi-asserted-by":"crossref","first-page":"15579","DOI":"10.18632\/oncotarget.24528","article-title":"Grape Seed Procyanidin Extract Against Lung Cancer: The Role of microrna\u2010106b, Bioavailability, and Bioactivity","volume":"9","author":"Xue B.","year":"2018","journal-title":"Oncotarget"},{"key":"e_1_2_13_33_1","doi-asserted-by":"crossref","first-page":"1869","DOI":"10.1093\/carcin\/23.11.1869","article-title":"Grape Seed Extract Induces Apoptotic Death of Human Prostate Carcinoma DU145 Cells via Caspases Activation Accompanied by Dissipation of Mitochondrial Membrane Potential and Cytochrome c Release","volume":"23","author":"Agarwal C.","year":"2002","journal-title":"Carcinogenesis"},{"key":"e_1_2_13_34_1","first-page":"721","article-title":"Inhibition of Nf\u2010\u03baB Pathway in Grape Seed Extract\u2010Induced Apoptotic Death of Human Prostate Carcinoma DU145 Cells","volume":"23","author":"Dhanalakshmi S.","year":"2003","journal-title":"International Journal of Oncology"},{"key":"e_1_2_13_35_1","doi-asserted-by":"crossref","first-page":"1265","DOI":"10.1158\/1535-7163.MCT-06-0014","article-title":"Grape Seed Extract Induces Anoikis and Caspase\u2010Mediated Apoptosis in Human Prostate Carcinoma LNCaP Cells: Possible Role of Ataxia Telangiectasia Mutated\u2010p53 Activation","volume":"5","author":"Kaur M.","year":"2006","journal-title":"Molecular Cancer Therapeutics"},{"key":"e_1_2_13_36_1","doi-asserted-by":"crossref","first-page":"733","DOI":"10.1002\/ijc.11620","article-title":"Grape Seed Extract Inhibits Advanced Human Prostate Tumor Growth and Angiogenesis and Upregulates Insulin\u2010Like Growth Factor Binding Protein\u20103","volume":"108","author":"Singh R. 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