Association between Endogenous Testosterone (T), Prostate Symptoms, and Prostate-Specific Antigen (PSA) Levels in Hypogonadal Men

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SAT 554-583-Male Reproductive Endocrinology & Case Reports
Saturday, June 15, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SAT-579
Andre B. Araujo*1, Adrian S. Dobs2, Frederick C. W. Wu3, Claus G. Roehrborn4, Fritz H. Schröder5, Teresa M. Curto6, Julia F. Martha6 and Raymond C. Rosen6
1New England Research Institutes, Watertown, MA, 2Johns Hopkins University School of Medicine, Baltimore, MD, 3Central Manchester University Hospitals NHS Foundation Trust, Manchester, United Kingdom, 4UT Southwestern Medical Center, Dallas, TX, 5Erasmus Medical Center, Rotterdam, Netherlands, 6New England Research Institutes, Inc., Watertown, MA
Introduction: Hypogonadism (HG) and lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) are common disorders in the aging male. While T is required for the normal development and function of the male urogenital tract and prostate gland, current epidemiologic data are in conflict regarding the association between T and LUTS/BPH. Our objective was to examine the relations between endogenous T, LUTS/BPH, and PSA levels in a registry of hypogonadal men.

Methods: RHYME is a multi-center registry of 999 men with clinically-diagnosed HG (naïve to androgen treatment) from 25 sites in 6 European countries (DE/ES/IT/NL/SE/UK). Overall LUTS and voiding and storage symptoms were assessed by the American Urological Association Symptom Index. Clinical BPH and BPH medication use [5-alpha-reductase inhibitors (5ARIs) and alpha-blockers (AB)] were assessed via medical record. PSA (immunometric assay) and T (mass spectrometry) were measured centrally. Differences in geometric mean T in relation to LUTS, clinical BPH, and PSA were assessed via multivariable linear regression models controlling for age, BMI, HG duration, smoking, exercise, self-rated health, number of comorbidities, blood draw time, country, and 5ARI/AB use.

Results: Mean age, T, and PSA were 59y, 9.5±1.6nmol/L and 0.73±2.8ng/mL, respectively. Prevalence of clinical BPH was 18.0% and LUTS was 40.0%, with 8.8% reporting severe LUTS, 31.6% voiding LUTS, and 49.3% storage LUTS. 21.6% had PSA≥1.5ng/mL. Use of 5ARIs was less frequent than use of ABs for BPH (2.8% vs. 9.7%). The prevalence of overall LUTS, voiding and storage symptoms, clinical BPH, and PSA all significantly increased with age (all p<.001), whereas T was not associated with age (p=.06). Mean PSA levels were significantly (p<.001) higher in men with (0.87ng/mL) vs. without (0.67ng/mL) LUTS, with similar findings for voiding/storage LUTS. In unadjusted or adjusted models, overall, voiding, and storage LUTS were not associated with T levels. Clinical BPH was not associated with T levels once confounders were controlled. In contrast, higher PSA levels were associated (p<.001) with higher T in a multivariable model.

Conclusions: Prevalence of LUTS, clinical BPH, and PSA elevations (≥1.5ng/mL) are relatively high in hypogonadal men. Differences in endogenous T levels among these hypogonadal men is not related to patient-reported prostate symptoms or clinical BPH, while PSA is strongly and consistently associated with endogenous T. Future analyses from RHYME will be critical to understanding whether T therapy impacts the presentation of prostate symptoms in hypogonadal men.

Disclosure: ABA: Consultant, Eli Lilly & Company, Principal Investigator, GlaxoSmithKline, Principal Investigator, Abbott Laboratories. ASD: Advisory Group Member, Endo Pharmaceuticals, Speaker Bureau Member, Endo Pharmaceuticals, Investigator, Endo Pharmaceuticals, Investigator, Clarus, Investigator, Takeda, Investigator, NIH. FCWW: Consultant, Eli Lilly & Company, Consultant, Galapagos ( Mechelen, Belgium), Consultant, Ligand Pharmaceuticals Inc (San Diego, CA), Consultant, Novartis Pharmaceuticals, Speaker, Bayer Schering Pharma, Speaker, Eli Lilly & Company. CGR: Consultant, Eli Lilly & Company, Researcher, Neotract, Consultant, Neotract, Consultant, NxThera, Consultant, GlaxoSmithKline, , RHYME, Consultant, Sophiris. RCR: Principal Investigator, Bayer Health Care, Consultant, Eli Lilly & Company, Consultant, Ferring Pharmaceuticals. Nothing to Disclose: FHS, TMC, JFM

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Sources of Research Support: Bayer Pharma AG