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Serum complexed and free prostate-specific antigen (PSA) for the diagnosis of the polycystic ovarian syndrome (PCOS)

  • Eleftherios P. Diamandis EMAIL logo , Frank Z. Stanczyk , Sarah Wheeler , Anu Mathew , Martin Stengelin , Galina Nikolenko , Eli N. Glezer , Marshall D. Brown , Yingye Zheng , Yen-Hao Chen , Hsiao-Li Wu and Ricardo Azziz
Published/Copyright: March 31, 2017

Abstract

Background:

Polycystic ovarian syndrome (PCOS) is a common cause of reproductive and metabolic dysfunction. We hypothesized that serum prostate-specific antigen (PSA) may constitute a new biomarker for hyperandrogenism in PCOS.

Methods:

We conducted a cross-sectional study of 45 women with PCOS and 40 controls. Serum from these women was analyzed for androgenic steroids and for complexed PSA (cPSA) and free PSA (fPSA) with a novel fifth- generation assay with a sensitivity of ~10 fg/mL for cPSA and 140 fg/mL for fPSA.

Results:

cPSA and fPSA levels were about three times higher in PCOS compared to controls. However, in PCOS, cPSA and fPSA did not differ according to waist-to-hip ratio, Ferriman-Gallwey score, or degree of hyperandrogenemia or oligo-ovulation. In PCOS and control women, serum cPSA and fPSA levels were highly correlated with each other, and with free and total testosterone levels, but not with other hormones. Adjusting for age, body mass index (BMI) and race, cPSA was significantly associated with PCOS, with an odds ratio (OR) of 5.67 (95% confidence interval [CI]: 1.86, 22.0). The OR of PCOS for fPSA was 7.04 (95% CI: 1.65, 40.4). A multivariate model that included age, BMI, race and cPSA yielded an area-under-the-receiver-operating-characteristic curve of 0.89.

Conclusions:

Serum cPSA and fPSA are novel biomarkers for hyperandrogenism in PCOS and may have value for disease diagnosis.


Corresponding author: Eleftherios P. Diamandis, MD, PhD, FRCP(C), FRSC, Head of Clinical Biochemistry, Mount Sinai Hospital and University Health Network, 60 Murray St. Box 32, Floor 6, Rm L6-201, Toronto, ON, M5T 3L9, Canada, Phone: +(416) 586-8443

  1. Author contributions: EPD conceived and designed the study and wrote the manuscript with help from all the co-authors. FZS participated in patient selection. SW, AM, MS, EG and GN participated in PSA sample analysis. MDB and YZ performed the statistical analysis and YHC; HW and RA participated in patient selection. All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: This research was supported by the Partnership for Clean Competition.

  3. Employment or leadership: RA is on the advisory board of Global PET and a consultant to KinDex Pharmaceuticals; SH, AM, MS, GN and ENG are employees of Meso Scale; the remaining authors have no conflicts of interest to declare.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Supplemental Material:

The online version of this article (DOI: 10.1515/cclm-2016-1124) offers supplementary material, available to authorized users.


Received: 2016-12-9
Accepted: 2017-2-21
Published Online: 2017-3-31
Published in Print: 2017-10-26

©2017 Walter de Gruyter GmbH, Berlin/Boston

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