Evaluation of PSA and PSA Density in a Multiparametric Magnetic Resonance Imaging-Directed Diagnostic Pathway for Suspected Prostate Cancer: The INNOVATE Trial

Hayley Pye; Saurabh Singh; Joseph M. Norris; Lina M. Carmona Echeverria; Vasilis Stavrinides; Alistair Grey; Eoin Dinneen; Elly Pilavachi; Joey Clemente; Susan Heavey; Urszula Stopka-Farooqui; Benjamin S. Simpson; Elisenda Bonet-Carne; Dominic Patel; Peter Barker; Keith Burling; Nicola Stevens; Tony Ng; Eleftheria Panagiotaki; David Hawkes; Daniel C. Alexander; Manuel Rodriguez-Justo; Aiman Haider; Alex Freeman; Alex Kirkham; David Atkinson; Clare Allen; Greg Shaw; Teresita Beeston; Mrishta Brizmohun Appayya; Arash Latifoltojar; Edward W. Johnston; Mark Emberton; Caroline M. Moore; Hashim U. Ahmed; Shonit Punwani; Hayley C. Whitaker

doi:10.3390/cancers13081985

Cancers (Apr 2021)

Evaluation of PSA and PSA Density in a Multiparametric Magnetic Resonance Imaging-Directed Diagnostic Pathway for Suspected Prostate Cancer: The INNOVATE Trial

Hayley Pye,
Saurabh Singh,
Joseph M. Norris,
Lina M. Carmona Echeverria,
Vasilis Stavrinides,
Alistair Grey,
Eoin Dinneen,
Elly Pilavachi,
Joey Clemente,
Susan Heavey,
Urszula Stopka-Farooqui,
Benjamin S. Simpson,
Elisenda Bonet-Carne,
Dominic Patel,
Peter Barker,
Keith Burling,
Nicola Stevens,
Tony Ng,
Eleftheria Panagiotaki,
David Hawkes,
Daniel C. Alexander,
Manuel Rodriguez-Justo,
Aiman Haider,
Alex Freeman,
Alex Kirkham,
David Atkinson,
Clare Allen,
Greg Shaw,
Teresita Beeston,
Mrishta Brizmohun Appayya,
Arash Latifoltojar,
Edward W. Johnston,
Mark Emberton,
Caroline M. Moore,
Hashim U. Ahmed,
Shonit Punwani,
Hayley C. Whitaker

Affiliations

Hayley Pye: Division of Surgery & Interventional Science, University College London, London WC1E 6BT, UK
Saurabh Singh: Centre for Medical Imaging, University College London, London WC1E 6BT, UK
Joseph M. Norris: Division of Surgery & Interventional Science, University College London, London WC1E 6BT, UK
Lina M. Carmona Echeverria: Division of Surgery & Interventional Science, University College London, London WC1E 6BT, UK
Vasilis Stavrinides: Division of Surgery & Interventional Science, University College London, London WC1E 6BT, UK
Alistair Grey: Department of Urology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK
Eoin Dinneen: Department of Urology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK
Elly Pilavachi: Centre for Medical Imaging, University College London, London WC1E 6BT, UK
Joey Clemente: Centre for Medical Imaging, University College London, London WC1E 6BT, UK
Susan Heavey: Division of Surgery & Interventional Science, University College London, London WC1E 6BT, UK
Urszula Stopka-Farooqui: Division of Surgery & Interventional Science, University College London, London WC1E 6BT, UK
Benjamin S. Simpson: Division of Surgery & Interventional Science, University College London, London WC1E 6BT, UK
Elisenda Bonet-Carne: Centre for Medical Image Computing, Department of Computer Science, University College London, London WC1E 6BT, UK
Dominic Patel: Department of Pathology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK
Peter Barker: Department of Clinical Biochemistry, Addenbrookes Hospital NHS Foundation Trust, Cambridge CB2 0QQ, UK
Keith Burling: Department of Clinical Biochemistry, Addenbrookes Hospital NHS Foundation Trust, Cambridge CB2 0QQ, UK
Nicola Stevens: Centre for Medical Imaging, University College London, London WC1E 6BT, UK
Tony Ng: Molecular Oncology Group, University College London, London WC1E 6BT, UK
Eleftheria Panagiotaki: Centre for Medical Image Computing, Department of Computer Science, University College London, London WC1E 6BT, UK
David Hawkes: Department of Medical Physics and Bioengineering, University College London, London WC1E 6BT, UK
Daniel C. Alexander: Centre for Medical Image Computing, Department of Computer Science, University College London, London WC1E 6BT, UK
Manuel Rodriguez-Justo: Department of Pathology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK
Aiman Haider: Department of Pathology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK
Alex Freeman: Department of Pathology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK
Alex Kirkham: Department of Radiology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK
David Atkinson: Centre for Medical Imaging, University College London, London WC1E 6BT, UK
Clare Allen: Department of Radiology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK
Greg Shaw: Department of Urology, University College London Hospitals NHS Foundation Trust, London WC1H 8NJ, UK
Teresita Beeston: Centre for Medical Imaging, University College London, London WC1E 6BT, UK
Mrishta Brizmohun Appayya: Centre for Medical Imaging, University College London, London WC1E 6BT, UK
Arash Latifoltojar: Centre for Medical Imaging, University College London, London WC1E 6BT, UK
Edward W. Johnston: Centre for Medical Imaging, University College London, London WC1E 6BT, UK
Mark Emberton: Division of Surgery & Interventional Science, University College London, London WC1E 6BT, UK
Caroline M. Moore: Division of Surgery & Interventional Science, University College London, London WC1E 6BT, UK
Hashim U. Ahmed: Imperial Urology, Imperial College Healthcare NHS Trust, London W2 1NY, UK
Shonit Punwani: Centre for Medical Imaging, University College London, London WC1E 6BT, UK
Hayley C. Whitaker: Division of Surgery & Interventional Science, University College London, London WC1E 6BT, UK

DOI: https://doi.org/10.3390/cancers13081985
Journal volume & issue: Vol. 13, no. 8
p. 1985

Abstract

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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–Reporting 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 ≥ 3 + 4 of any length OR maximum cancer core length (MCCL) ≥4 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 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.

Published in Cancers

ISSN: 2072-6694 (Online)
Publisher: MDPI AG
Country of publisher: Switzerland
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.mdpi.com/journal/cancers/

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