Session: SAT 554-583-Male Reproductive Endocrinology & Case Reports
Poster Board SAT-579
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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