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Licensed Unlicensed Requires Authentication Published by De Gruyter August 2, 2022

Testosterone analysis in castrated prostate cancer patients: suitability of the castration cut-off and analytical accuracy of the present-day clinical immunoassays

  • Lennart Jan van Winden ORCID logo , Eef G.W.M. Lentjes , Ayse Y. Demir , Henk J. Huijgen , Andries Marinus Bergman , Henk G. van der Poel and Huub H. van Rossum EMAIL logo



Testosterone testing is relevant for evaluating castration adequacy and diagnosis of castration-resistant prostate cancer (PCa). However, the recommended testosterone cut-off of 1.7 nmol/L (50 ng/dL) to define adequate castration is based on consensus and not validated for the automated immunoassays (AIA) used in today’s medical laboratories. Furthermore, appropriate population intervals have not been determined by a state-of-the-art assay. We investigated the analytical suitability of this cut-off and the accuracy of the present-day AIAs for testosterone analysis in castrated PCa patients.


Leftover serum from 120 PCa patients castrated with luteinizing hormone-releasing hormone agonists was analysed for testosterone by five methods: Architect i2000 (Abbott), Access (Beckman), Cobas 6000 (Roche), Atellica (Siemens), LC-MS/MS. For all assays, the castration 95th, 97.5th and 99th percentile upper limits were determined. Furthermore, Passing-Bablok regression, mean bias and Spearman’s correlation coefficients were compared to the LC-MS/MS method and total error based on biological variation.


All castration upper limits, ranging from 0.472 nmol/L (LC-MS/MS) to 1.25 nmol/L (Access) (95% percentile), were significantly lower than the current castration cut-off (1.7 nmol/L). Slopes of Passing-Bablok regressions comparing the AIA with the LC-MS/MS method ranged from 1.4 (Cobas and Atellica) to 3.8 (Access). The Architect showed the highest correlation with LC-MS/MS (ρ=0.58). All AIA failed to meet the desirable total error criterion.


These results suggest that a lower general testosterone castration cut-off may be more appropriate in evaluating the adequacy of castration in PCa and that present-day AIA lack analytical accuracy to quantify testosterone levels in castrated PCa.

Corresponding author: Dr. Huub H. van Rossum, EuSpLM, The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Plesmanlaan 121 1066 CX, Amsterdam, The Netherlands, Phone: +31 20 512 2756, E-mail:

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Not applicable.

  5. Ethical approval: Prior to the start of our study, approval of the Institutional Review Board was obtained (IRBd18-145). The study is in accordance with the declaration of Helsinki.


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Supplementary Material

The online version of this article offers supplementary material (

Received: 2022-05-24
Accepted: 2022-07-13
Published Online: 2022-08-02
Published in Print: 2022-09-27

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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