Abstract
Purpose
5-alpha reductase inhibitor (5ARI) reduces prostate-specific antigen (PSA) by half but its effect on prostate health index (phi) is unknown. This study aims to investigate this effect and to enable accurate interpretation of phi in men with elevated PSA and on 5ARI.
Methods
This is a prospective study evaluating the effect of finasteride on PSA, free PSA (fPSA), [ – 2]proPSA (p2PSA) and phi at 6 and 12 moths in men with PSA 4-20 ng/mL, no prior 5ARI use, and one negative prostate biopsy within 6 months before recruitment. The 5ARI Finasteride (5 mg/day) for 1 year was offered if International Prostatic Symptom Score (IPSS) was ≥ 8 at baseline. 5ARI group included patients taking finasteride, while control group included patients not on finasteride. The blood results were compared with t-test between baseline and different time points in each group and between groups at 1 year.
Results
164 men fit the inclusion criteria and 150 were analyzed. In 5ARI group (n = 100) at 1 year, mean PSA reduced by 51.4% from 8.9(± SD 3.7) to 4.4(± SD 2.8)ng/mL (paired t-test, p < 0.001), fPSA reduced by 52.4% from 1.6(± 0.6) to 0.8(± 0.4)ng/mL (p < 0.001), p2PSA reduced by 55.3% from 18.4(± 8.8) to 8.3(± 5.6)pg/mL (p < 0.001), and phi reduced by 34.2% from 33.7(± 11.9) to 22.4(± 12.5) (p < 0.001). PSA and phi values in the control group remained static over 1 year and significantly higher than those in 5ARI group.
Conclusion
This study demonstrated p2PSA and phi are reduced by about 55% and 34% in men on 5ARI. A conversion factor of division by 0.66 is needed for phi in men on finasteride to allow the interpretation and use of phi in men on 5ARI.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
Data availability statement
The de-identified datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. The data set will be available for 5 years based on the study protocol.
References
Wong MCS, Goggins WB, Wang HHX et al (2016) Global Incidence and mortality for prostate cancer: analysis of temporal patterns and trends in 36 countries. Eur Urol 70:862–874. https://doi.org/10.1016/j.eururo.2016.05.043
Hugosson J, Roobol MJ, Månsson M et al (2019) A 16-yr follow-up of the European randomized study of screening for prostate cancer. Eur Urol 76:43–51. https://doi.org/10.1016/j.eururo.2019.02.009
Loeb S, Vellekoop A, Ahmed HU et al (2013) Systematic review of complications of prostate biopsy. Eur Urol 64:876–892. https://doi.org/10.1016/j.eururo.2013.05.049
Chiu PK-F, Ng C-F, Semjonow A et al (2019) A multicentre evaluation of the role of the prostate health index (PHI) in regions with differing prevalence of prostate cancer: adjustment of phi reference ranges is needed for European and Asian settings. Eur Urol 75:558–561. https://doi.org/10.1016/j.eururo.2018.10.047
FDA approval of prostate health index test (2022). https://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfpma/pma.cfm?id=P090026
Chiu PK-F, Roobol MJ, Teoh JY et al (2018) Routine use of Prostate Health Index (PHI) reduces majority of unnecessary prostatic biopsies in Asian men: a prospective study in 2795 men seen at urology clinics. Eur Urol Suppl 17:e2900–e2901. https://doi.org/10.1016/S1569-9056(18)33762-X
McConnell JD, Roehrborn CG, Bautista OM et al (2003) The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med 349:2387–2398. https://doi.org/10.1056/NEJMoă56
Guess HA, Gormley GJ, Stoner E, Oesterling JE (1996) The effect of finasteride on prostate specific antigen: review of available data. J Urol 155:3–9. https://doi.org/10.1016/S0022-5347(01)66524-8
Pannek J, Marks LS, Pearson JD et al (1998) Influence of finasteride on free and total serum prostate specific antigen levels in men with benign prostatic hyperplasia. J Urol 159:449–453. https://doi.org/10.1016/s0022-5347(01)63946-6
Semjonow A, Köpke T, Eltze E et al (2010) Pre-analytical in-vitro stability of [-2]proPSA in blood and serum. Clin Biochem 43:926–928. https://doi.org/10.1016/j.clinbiochem.2010.04.062
Roehrborn CG, Siami P, Barkin J et al (2010) The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol 57:123–131. https://doi.org/10.1016/j.eururo.2009.09.035
Chiu PK-F, Teoh JY-C, Lee W-M et al (2016) Extended use of prostate health index and percentage of [-2]pro-prostate-specific antigen in Chinese men with prostate specific antigen 10–20 ng/mL and normal digital rectal examination. Investig Clin Urol 57:336–342. https://doi.org/10.4111/icu.2016.57.5.336
Span PN, Völler MC, Smals AG et al (1999) Selectivity of finasteride as an in vivo inhibitor of 5alpha-reductase isozyme enzymatic activity in the human prostate. J Urol 161:332–337. https://doi.org/10.1016/S0022-5347(01)62141-4
Thompson IM, Chi C, Ankerst DP et al (2006) Effect of finasteride on the sensitivity of PSA for detecting prostate cancer. J Natl Cancer Inst 98:1128–1133. https://doi.org/10.1093/jnci/djj307
Liu AQ, Remmers S, Lau S-Y et al (2022) Initial prostate health index (phi) and phi density predicts future risk of clinically significant prostate cancer in men with initial negative prostate biopsy: a 6-year follow-up study. Prostate Cancer Prostatic Dis 25:684–689. https://doi.org/10.1038/s41391-021-00444-y
Acknowledgements
None.
Author information
Authors and Affiliations
Contributions
PK-FC: Conception, Design, Data analysis, Drafting of manuscript. AQL: Revision, Data collection. C-HC: Data collection. S-YL: Data collection, administrative support. C-HL: Data analysis. Y-SC: Data collection. SK-KY: Data collection. C-HY: Design, Critical revision of manuscript. JY-CT: Design. W-LT: Obtaining funding, Supervision, Critical revision of manuscript. W-TP: Administrative support, Supervision. C-FN: Obtaining funding, Supervision, Critical revision of manuscript.
Corresponding authors
Ethics declarations
Conflict of interest
The reagents for the blood tests PSA and PHI were sponsored by Beckman Coulter Hybritech Inc. The sponsor had no role in the study design, data analyses or manuscript preparation or approval. The authors declare no competing interest.
Ethical approval
This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Clinical Research Ethics Committee of the Chinese University of Hong Kong (CREC 2017.491) before the start of the study.
Consent to participate
Informed consent was obtained from all individual participants included in the study.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary Information
Below is the link to the electronic supplementary material.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Chiu, P.KF., Chan, CH., Liu, A.Q. et al. A prospective evaluation of the effect of finasteride on prostate health index (phi). Int Urol Nephrol 55, 1087–1092 (2023). https://doi.org/10.1007/s11255-023-03530-3
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11255-023-03530-3