11-oxo-Androgens Panel

CPT: 82542

Synonyms

  • 11-Hydroxyandrostenedione
  • 11-Hydroxytestosterone
  • 11-Ketotestosterone

Specimen Requirements


Specimen

Serum (EDTA or heparin plasma may be used.)


Volume

2.0 mL


Minimum Volume

0.6 mL


Container

Serum from red-top tube, EDTA plasma tube, or heparin plasma tube


Collection

Collect into vacutainer and separate within 2 hours. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.


Storage Instructions

Freeze.


Stability Requirements

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

441 days

Freeze/thaw cycles

Stable x6


Causes for Rejection

Gross hemolysis, gross lipemia, incorrect specimen type, SST specimen type


Test Details


Use

11-oxo-androgens are emerging biomarkers for androgen production of adrenal origin. These biomarkers will be useful in disease in men and women and children. Although the presence of androgens with oxygen at the 11 position of the steroid backbone have been known for some time, the clinical utility and prevalence of these androgens have only recently come to light. As has been the case historically, the research has been enhanced with availability of good assay techniques, in this case HPLC MS/MS. 11-ketotestosterone and 11-ketodihydrotestosterone bind the androgen receptor as well as testosterone and DHT.1 The 11-oxo-androgens also follow the same metabolic pathways as androgens without oxygen at 11. Interestingly, the origin of 11-oxo-androgens is entirely adrenal. All of this is important because 11-oxo-androgens appear to play a significant role in some endocrine diseases.

PCOS: Polycystic ovary syndrome (PCOS) is a disease characterized by amenorrhea or oligomenorrhea and excess androgens. Although this syndrome is found in 5-10% of women, the disease is not well understood. 11-ketotestosterone has been shown to be in excess in PCOS patients, and levels in those patients are in fact higher than levels of testosterone.3 This finding significantly points to the adrenal as a source of the excess androgens. This idea is supported by the similarity of the levels found in adult men and women. 11-ketotestosterone may be a better biomarker than testosterone or androstenedione for androgen excess in women with PCOS.

CAH: Congenital adrenal hyperplasia due to 21-hydroxylase deficiency is a genetic disease affecting about 1/10,000 people.4 The enzyme defect that causes the disease causes excess adrenal androgen production driven by ACTH, and the major androgens are 11-oxygenated.2 Therefore, 11-oxoandrogens are important to monitor for control of CAH, especially in children and women. In men, 11-oxo-androgens are proposed to be biomarkers for disease activity because they are of adrenal origin. Although excess androgens are a lesser problem for adult men with CAH, these patients are subject to other sequelae of CAH, especially TARTS (testicular adrenal-rest tumors). Following 11-oxo-androgens is expected to be a uniquely useful biomarker since testosterone is not useful as an adrenal androgen for adult men.6

Puberty: Adrenarche is a stage of development that precedes puberty; clinically it is defined by axillary hair and body odor; biochemically it is defined by a rise in adrenal androgens, such as DHEA-sulfate. Testosterone levels do not rise significantly during adrenarche. Recent academic research shows that during adrenarche both DHEA-sulfate and 11-ketotestosterone rise.7 However, DHEA-sulfate is not an active androgen, while 11-ketotestosterone is fully active. Therefore, 11-ketotestosterone may be measured along with DHEA-sulfate when investigating premature adrenarche and premature puberty.

Prostate Cancer: The goal of GnRH agonist treatment, antiandrogens and 17-hydroxylase blockade is to minimize androgens in prostate cancer. Eliminating adrenal androgens has been helpful in castration-resistant prostate cancer, and it now appears that 11-ketotestosterone is an important adrenal androgen to control in castration-resistant prostate cancer.1,5 11-ketotestosterone may be an effective adrenal androgen biomarker to monitor in castration-resistant prostate cancer.


Limitations

This assay is limited to plasma and serum samples. Serum separator gel barrier samples also cannot be analyzed by this method.


Methodology

LC-MS/MS Analysis


Footnotes

1. Storbeck KH, Bloem LM, Africander D, Schloms L, Swart P, Swart AC. 11β-Hydroxydihydrotestosterone and 11-ketodihydrotestosterone, novel C19 steroids with androgenic activity: a putative role in castration resistant prostate cancer? Mol Cell Endocrinol. 2013 Sep 5;377(1-2):135-146.23856005
2. Turcu AF, Nanba AT, Chomic R, et al. Adrenal-derived 11-oxygenated 19-carbon steroids are the dominant androgens in classic 21-hydroxylase deficiency. Eur J Endocrinol. 2016 May;174(5):601-609.26865584
3. Rodin A, Thakkar H, Taylor N, Clayton R. Hyperandrogenism in polycystic ovary syndrome. Evidence of dysregulation of 11 beta-hydroxysteroid dehydrogenase. N Engl J Med. 1994 Feb 17;330(7):460-465.8289851
4. Speiser PW, White PC. Congenital adrenal hyperplasia. N Engl J Med. 2003 Aug 21;349(8):776-788.12930931
5. Pretorius E, Africander DJ, Vlok M, Perkins MS, Quanson J, Storbeck KH. 11-Ketotestosterone and 11-Ketodihydrotestosterone in Castration Resistant Prostate Cancer: Potent Androgens Which Can No Longer Be Ignored. PLoS One. 2016 Jul 21;11(7):e0159867.27442248
6. Turcu AF, Mallappa A, Elman MS, et al. 11-Oxygenated Androgens are Biomarkers of Adrenal Volume and Testicular Adrenal Rest Tumors in 21-Hydroxylase Deficiency. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2701-2710.28472487
7. Rege J, Turcu AF, Kasa-Vubu JZ, et al. 11-Ketotestosterone Is the Dominant Circulating Bioactive Androgen During Normal and Premature Adrenarche. J Clin Endocrinol Metab. 2018 Dec 1;103(12):4589-4598.30137510

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