Abstracts from the Abstracts from the Mid-Atlantic Section of the AUA 2021

MA-AUA 2021 Abstracts Moderated Poster Session 6: Trauma/Sexual Dysfunction Effects of 2-Years Oral Testosterone Undecanoate (TU) Administration (JATENZO®) onLiver Function andOther SafetyMeasures inHypogonadal Men R. Swerdloff 1 , J. Amory 2 , M. Gittelman 3 , C. Wang 1 , B. Seo 4 , N. Rohowsky 5 , R. Dudley 4 1 Lundquist Institute at Harbor-UCLA, Torrance, CA, USA; 2 University of Washington, Seattle, WA, USA; 3 UroMedix and South Florida Medical Research, Aventura, FL, USA; 4 Clarus Therapeutics, Northbrook, IL, USA; 5 Integrated Data Consultant Services, LaGrange, IL, USA Introduction andObjective: Oral testosterone (T) replacement therapy (TRT) is the preferred choice for many hypogonadal men. Historically, the only oral TRT approved in the US was methyl-T but it is associatedwith hepatotoxicity. Recently, the FDA approved the first, oral TU formulation, JATENZO®. The safety of this novel, oral TU formulation was evaluated in hypogonadal men dosed for up to 2 years. Methods: Two trials were conducted in hypogonadal men (serum T ≤ 300 ng/dL) age 18-75 years. Trial I was 2-arm, 12-month, active-controlled study, while Trial 2 was a 12-month extension. Statistical analyses were conducted with the subjects who completed Trial 1 and continued treatment in Trial 2, thus providing up to 2 full years of data. Results: Overall, up to 81 subjects participated in both studies. T concentration increased from 208.3 ± 102.4 ng/dL (Mean ± SD) at baseline (BL) to 470.1 ± 396.5 ng/dL after 24 Mo with oral TU. There were no serious adverse events. There were no clinically significant changes in liver function tests – ALT (28.0 ± 12.3 to 26.6 ± 12.8 U/L), AST (21.8 ± 6.8 to 22.0 ± 8.2 U/L), and bilirubin (0.58 ± 0.22 to 0.52 ± 0.19 mg/dL. At d270, one subject had an ALT level of 227 U/L, which was > 5x the ULN (ULN for ALT = 45 U/L). Despite continued use of oral TU, his ALT dropped to 87 U/L, <2x ULN, at d290. There were no other LFT elevations. Systolic BP consistently showed a mean increase fromBLbetween 3–6mmHg. Prostate-related andCVmeasures changed initially, then stabilized in all subjects. Conclusions: This oral TU formulation is an effective, long-term therapy for hypogonadal men and has a safety profile consistent with other approved T products. Notably, no evidence of liver toxicity was observed. MP6-01 Contrast-Enhanced 4D Ultrasonography for the Evaluation of Complex Renal Cysts E. Mann 1 , A. Quinn 1 , L. Glick 1 , T. Han 2 , C. Wessner 2 , S. Wang 2 , K. Nam 2 , K. Smentowski 2 , J. Eisenbrey 2 , L. Gomella 1,2 , E. Trabulsi 1,2 , C. Lallas 1 , M. Mann 1 , J. Mark 1,2 , F. Forsberg 2 , A. Lyshchik 2 , E. Halpern 2 , T. Chandrasekar 1,2 1 Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA; 2 Thomas Jefferson University Hospital, Philadelphia, PA, USA Introduction andObjective: Management of complex renal cysts, historically dependent on the Bosniak system, is evolving. The objective of this pilot study was to use novel contrast-enhanced ultrasound (CEUS) technology to evaluate the enhancing/solid components of complex renal cysts and correlate to final pathology. Methods: 14 patients undergoing surgery for Bosniak 2F-4 lesions participated in this IRB-approved pilot study. Ultrasound was performed pre-operatively. Patients underwent imaging of the mass in B-mode and power Doppler. Lumason ultrasound contrast was subsequently injected while imaging in 2D with dual B-mode and nonlinear harmonic imaging during collection of volumetric contrast-enhanced ultrasound. Following surgery, evaluation included pathologic stage and estimation of the lesion’s solid proportion. Slices were selected through the lesion.An internal MATLAB programwas used for selection of regions of interest (ROI), defined on B-mode images to include the entire lesion, while ROI on CEUS images included non-enhancing areas (cystic avascular regions). % enhancing volume was calculated: Fractional Tumor Vascularity = 1 – (Total Non-enhancing area/ Total lesion area). The primary endpoint was the correlation of 3D-derived fractional vascularity with solid estimation and tumor staging. Results: Figure 1 demonstrates the selection of ROI on B-mode and CEUS for Patient 3. The fractional vascularity, pathologic estimation of the solid component, and final stage and grade are shown in Table 1. Conclusions: The fractional vascularitywas lowest in benignmasses, with the exception of Patient 7 whose pathology showed a primarily solid oncocytoma. These preliminary results show CEUS may be a useful adjunct to evaluate the malignancy potential of complex renal masses. MP5-13 39