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Prostate Imaging Compared to Transperineal Ultrasound-guided biopsy for significant prostate cancer Risk Evaluation (PICTURE): a prospective cohort validating study assessing Prostate HistoScanning

Prostate Cancer and Prostatic Diseases volume 22, pages 261–267 (2019)Cite this article

Subjects

Abstract

Background:

Men with negative prostate biopsies or those diagnosed with low-risk or low-volume intermediate-risk prostate cancers often require a second prostate biopsy prior to a treatment decision. Prostate HistoScanning (PHS) is an ultrasound imaging test that might inform prostate biopsy in such men.

Methods:

PICTURE was a prospective, paired-cohort validating trial to assess the diagnostic accuracy of imaging in men requiring a further biopsy (clinicaltrials.gov, NCT01492270) (11 January 2012–29 January 2014). We enrolled 330 men who had undergone a prior TRUS biopsy but where diagnostic uncertainty remained. All eligible men underwent PHS and transperineal template prostate mapping (TTPM) biopsy (reference standard). Men were blinded to the imaging results until after undergoing TTPM biopsies. We primarily assessed the ability of PHS to rule out clinically significant prostate (negative predictive value [NPV] and sensitivity) for a target histological condition of Gleason ≥4+3 and/or a cancer core length (MCCL) ≥6 mm. We also assessed the role of visually estimated PHS-targeted biopsies.

Results:

Of the 330 men enrolled, 249 underwent both PHS and TTPM biopsy. Mean (SD) age was 62 (7) years, median (IQR) PSA 6.8 (4.98–9.50) ng/ml, median (IQR) number of previous biopsies 1 (1–2) and mean (SD) gland size 37 (15.5) ml. One hundred and forty six (59%) had no clinically significant cancer. PHS classified 174 (70%) as suspicious. Sensitivity was 70.3% (95% CI 59.8–79.5) and NPV 41.3% (95% CI 27.0–56.8). Specificity and positive predictive value (PPV) were 14.7% (95% CI 9.1–22.0) and 36.8% (95% CI 29.6–44.4), respectively. In all, 213/220 had PHS suspicious areas targeted with targeting sensitivity 13.6% (95% CI 7.3–22.6), specificity 97.6% (95% CI 93.1–99.5), NPV 61.6% (95% CI 54.5–68.4) and PPV 80.0% (95% CI 51.9–95.7).

Conclusions:

PHS is not a useful test in men seeking risk stratification following initial prostate biopsy.

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Acknowledgements

We would like to thank the men who participated in this study.

Funding

PICTURE received funding from the US National Institute of Health (primary award 1R01CA135089; sub-award via Riverside Research Institute NYO.G00351P.011741.12) and an unrestricted research grant from Advanced Medical Diagnostics SA.

Author contributions

Study concept and initial design: LAMS, CMM, ME, HUA. Study design and statistical analysis: HUA, Moore, ME, SCC, JvdM. Acquisition of data and data analysis and interpretation: MA, HUA, TB, SCC, ME, AF, JG, CJ, AK, NM, CMM, LAMS, JvdM. Guarantor of data: HUA.

Author information

Author notes

  1. These authors contributed equally: Lucy A. M. Simmons, Abi Kanthabalan.

  2. These authors jointly supervised this work: Mark Emberton, Hashim U. Ahmed.

Authors and Affiliations

  1. Division of Surgery and Interventional Science, University College London, Faculty of Medical Sciences, London, UK

    Lucy A. M. Simmons, Abi Kanthabalan, Neil McCartan, Caroline M. Moore, Mark Emberton & Hashim U. Ahmed

  2. Department of Urology, UCLH NHS Foundation Trust, London, UK

    Lucy A. M. Simmons, Abi Kanthabalan, Manit Arya, Neil McCartan, Caroline M. Moore, Mark Emberton & Hashim U. Ahmed

  3. Department of Urology, The Royal Free London NHS Foundation Trust, London, UK

    Tim Briggs & James Gelister

  4. Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK

    Susan C. Charman & Jan van der Muelen

  5. Clinical Effectiveness Unit, The Royal College of Surgeons of England, London, UK

    Susan C. Charman & Jan van der Muelen

  6. Department of Pathology, UCLH NHS Foundation Trust, London, UK

    Alex Freeman & Charles Jameson

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  1. Lucy A. M. Simmons
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Corresponding author

Correspondence to Hashim U. Ahmed.

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Conflict of interest

ME’s research is supported by core funding from the NIHR UCH/UCL Biomedical Research Centre. He is an NIHR Senior Investigator. HUA receives funding from the Wellcome Trust, MRC and Prostate Cancer UK. HUA’s research is supported by core funding from the NIHR UCH/UCL Biomedical Research Centre. HUA receives funding from Sonacare Medical, Sophiris and Trod Medical for other trials. Travel allowance was previously provided from Sonacare Inc. He is a paid consultant to Sophiris for trial-related work. ME has stock interest in Nuada Medical Ltd. He is also a consultant to Steba Biotech and GSK. He receives travel funding from Sanofi Aventis, Astellas, GSK and Sonacare. He previously received trial funding or resources from GSK, Steba Biotech and Angiodynamics and currently receives funding for trials from Sonacare Inc, Sophiris Inc and Trod Medical. AF has stock interest in Nuada Medical Ltd. All the other authors declare no conflict of interest.

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Simmons, L.A.M., Kanthabalan, A., Arya, M. et al. Prostate Imaging Compared to Transperineal Ultrasound-guided biopsy for significant prostate cancer Risk Evaluation (PICTURE): a prospective cohort validating study assessing Prostate HistoScanning. Prostate Cancer Prostatic Dis 22, 261–267 (2019). https://doi.org/10.1038/s41391-018-0094-1

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