{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T18:45:20Z","timestamp":1790361920719,"version":"4.1.0"},"reference-count":32,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2021,4,20]],"date-time":"2021-04-20T00:00:00Z","timestamp":1618876800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000771","name":"Prostate Cancer UK","doi-asserted-by":"publisher","award":["58949"],"award-info":[{"award-number":["58949"]}],"id":[{"id":"10.13039\/501100000771","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Objectives: To assess the clinical outcomes of mpMRI before biopsy and evaluate the space remaining for novel biomarkers. Methods: The INNOVATE study was set up to evaluate the validity of novel fluidic biomarkers in men with suspected prostate cancer who undergo pre-biopsy mpMRI. We report the characteristics of this clinical cohort, the distribution of clinical serum biomarkers, PSA and PSA density (PSAD), and compare the mpMRI Likert scoring system to the Prostate Imaging\u2013Reporting and Data System v2.1 (PI-RADS) in men undergoing biopsy. Results: 340 men underwent mpMRI to evaluate suspected prostate cancer. 193\/340 (57%) men had subsequent MRI-targeted prostate biopsy. Clinically significant prostate cancer (csigPCa), i.e., overall Gleason \u2265 3 + 4 of any length OR maximum cancer core length (MCCL) \u22654 mm of any grade including any 3 + 3, was found in 96\/195 (49%) of biopsied patients. Median PSA (and PSAD) was 4.7 (0.20), 8.0 (0.17), and 9.7 (0.31) ng\/mL (ng\/mL\/mL) in mpMRI scored Likert 3,4,5 respectively for men with csigPCa on biopsy. The space for novel biomarkers was shown to be within the group of men with mpMRI scored Likert3 (178\/340) and 4 (70\/350), in whom an additional of 40% (70\/178) men with mpMRI-scored Likert3, and 37% (26\/70) Likert4 could have been spared biopsy. PSAD is already considered clinically in this cohort to risk stratify patients for biopsy, despite this 67% (55\/82) of men with mpMRI-scored Likert3, and 55% (36\/65) Likert4, who underwent prostate biopsy had a PSAD below a clinical threshold of 0.15 (or 0.12 for men aged &lt;50 years). Different thresholds of PSA and PSAD were assessed in mpMRI-scored Likert4 to predict csigPCa on biopsy, to achieve false negative levels of \u22645% the proportion of patients whom who test as above the threshold were unsuitably high at 86 and 92% of patients for PSAD and PSA respectively. When PSA was re tested in a sub cohort of men repeated PSAD showed its poor reproducibility with 43% (41\/95) of patients being reclassified. After PI-RADS rescoring of the biopsied lesions, 66% (54\/82) of the Likert3 lesions received a different PI-RADS score. Conclusions: The addition of simple biochemical and radiological markers (Likert and PSAD) facilitate the streamlining of the mpMRI-diagnostic pathway for suspected prostate cancer but there remains scope for improvement, in the introduction of novel biomarkers for risk assessment in Likert3 and 4 patients, future application of novel biomarkers tested in a Likert cohort would also require re-optimization around Likert3\/PI-RADS2, as well as reproducibility testing.<\/jats:p>","DOI":"10.3390\/cancers13081985","type":"journal-article","created":{"date-parts":[[2021,4,20]],"date-time":"2021-04-20T13:58:04Z","timestamp":1618927084000},"page":"1985","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Evaluation of PSA and PSA Density in a Multiparametric Magnetic Resonance Imaging-Directed Diagnostic Pathway for Suspected Prostate Cancer: The INNOVATE Trial"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7042-5416","authenticated-orcid":false,"given":"Hayley","family":"Pye","sequence":"first","affiliation":[{"name":"Division of Surgery &amp; Interventional Science, University College London, London WC1E 6BT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8730-524X","authenticated-orcid":false,"given":"Saurabh","family":"Singh","sequence":"additional","affiliation":[{"name":"Centre for Medical Imaging, University College London, London WC1E 6BT, UK"},{"name":"Department of Radiology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2294-0303","authenticated-orcid":false,"given":"Joseph M.","family":"Norris","sequence":"additional","affiliation":[{"name":"Division of Surgery &amp; Interventional Science, University College London, London WC1E 6BT, UK"},{"name":"Department of Urology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6546-8980","authenticated-orcid":false,"given":"Lina M.","family":"Carmona Echeverria","sequence":"additional","affiliation":[{"name":"Division of Surgery &amp; Interventional Science, University College London, London WC1E 6BT, UK"},{"name":"Department of Urology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vasilis","family":"Stavrinides","sequence":"additional","affiliation":[{"name":"Division of Surgery &amp; Interventional Science, University College London, London WC1E 6BT, UK"},{"name":"Department of Urology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alistair","family":"Grey","sequence":"additional","affiliation":[{"name":"Department of Urology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"},{"name":"Department of Urology, Barts Health, NHS Foundation Trust, London EC1A 7BE, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eoin","family":"Dinneen","sequence":"additional","affiliation":[{"name":"Department of Urology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"},{"name":"Department of Urology, Barts Health, NHS Foundation Trust, London EC1A 7BE, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elly","family":"Pilavachi","sequence":"additional","affiliation":[{"name":"Centre for Medical Imaging, University College London, London WC1E 6BT, UK"},{"name":"Department of Radiology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joey","family":"Clemente","sequence":"additional","affiliation":[{"name":"Centre for Medical Imaging, University College London, London WC1E 6BT, UK"},{"name":"Department of Radiology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2974-4578","authenticated-orcid":false,"given":"Susan","family":"Heavey","sequence":"additional","affiliation":[{"name":"Division of Surgery &amp; Interventional Science, University College London, London WC1E 6BT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Urszula","family":"Stopka-Farooqui","sequence":"additional","affiliation":[{"name":"Division of Surgery &amp; Interventional Science, University College London, London WC1E 6BT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3685-6110","authenticated-orcid":false,"given":"Benjamin S.","family":"Simpson","sequence":"additional","affiliation":[{"name":"Division of Surgery &amp; Interventional Science, University College London, London WC1E 6BT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0567-6141","authenticated-orcid":false,"given":"Elisenda","family":"Bonet-Carne","sequence":"additional","affiliation":[{"name":"Centre for Medical Image Computing, Department of Computer Science, University College London, London WC1E 6BT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9223-6632","authenticated-orcid":false,"given":"Dominic","family":"Patel","sequence":"additional","affiliation":[{"name":"Department of Pathology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Barker","sequence":"additional","affiliation":[{"name":"Department of Clinical Biochemistry, Addenbrookes Hospital NHS Foundation Trust, Cambridge CB2 0QQ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith","family":"Burling","sequence":"additional","affiliation":[{"name":"Department of Clinical Biochemistry, Addenbrookes Hospital NHS Foundation Trust, Cambridge CB2 0QQ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Stevens","sequence":"additional","affiliation":[{"name":"Centre for Medical Imaging, University College London, London WC1E 6BT, UK"},{"name":"Department of Radiology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tony","family":"Ng","sequence":"additional","affiliation":[{"name":"Molecular Oncology Group, University College London, London WC1E 6BT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleftheria","family":"Panagiotaki","sequence":"additional","affiliation":[{"name":"Centre for Medical Image Computing, Department of Computer Science, University College London, London WC1E 6BT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Hawkes","sequence":"additional","affiliation":[{"name":"Department of Medical Physics and Bioengineering, University College London, London WC1E 6BT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2439-350X","authenticated-orcid":false,"given":"Daniel C.","family":"Alexander","sequence":"additional","affiliation":[{"name":"Centre for Medical Image Computing, Department of Computer Science, University College London, London WC1E 6BT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Rodriguez-Justo","sequence":"additional","affiliation":[{"name":"Department of Pathology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5007-1761","authenticated-orcid":false,"given":"Aiman","family":"Haider","sequence":"additional","affiliation":[{"name":"Department of Pathology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Freeman","sequence":"additional","affiliation":[{"name":"Department of Pathology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Kirkham","sequence":"additional","affiliation":[{"name":"Department of Radiology, University College 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UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0202-7912","authenticated-orcid":false,"given":"Hashim U.","family":"Ahmed","sequence":"additional","affiliation":[{"name":"Imperial Urology, Imperial College Healthcare NHS Trust, London W2 1NY, UK"},{"name":"Imperial Prostate, Division of Surgery, Department of Surgery &amp; Cancer, Faculty of Medicine, Imperial College London, London SW7 2AZ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shonit","family":"Punwani","sequence":"additional","affiliation":[{"name":"Centre for Medical Imaging, University College London, London WC1E 6BT, UK"},{"name":"Department of Radiology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2695-0202","authenticated-orcid":false,"given":"Hayley C.","family":"Whitaker","sequence":"additional","affiliation":[{"name":"Division of Surgery &amp; Interventional Science, University College London, London WC1E 6BT, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,4,20]]},"reference":[{"key":"ref_1","unstructured":"Cancer-Research-UK, and UK Cancer Statistics (2016). 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Cancer"}],"container-title":["Cancers"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2072-6694\/13\/8\/1985\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T05:50:26Z","timestamp":1760161826000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2072-6694\/13\/8\/1985"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4,20]]},"references-count":32,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2021,4]]}},"alternative-id":["cancers13081985"],"URL":"https:\/\/doi.org\/10.3390\/cancers13081985","relation":{},"ISSN":["2072-6694"],"issn-type":[{"value":"2072-6694","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,4,20]]}}}