Mp35-01 baseline Prevalence and Magnitude of Spatial Deviations in a Simulator From the Transrectal Ultrasound Prostate Biopsy Template

Abstract

nmCRPC, demonstrated that APA added to androgen deprivation therapy (ADT) prolonged metastasis-free survival (MFS) by > 2 yrs (median 40.5 vs 16.2 mo; HR, 0.28; p < 0.0001) and provided a 55% reduction in the risk of symptomatic progression (HR, 0.45; 95% CI, 0.32-0.63; p < 0.0001) (Smith et al. N Engl J Med 2018). We examined whether treatment with APA, a next-generation androgen receptor inhibitor, provided the same benefit and safety profile in pts with or without prior RP and/or XRT (RP/XRT).METHODS: Pts with nmCRPC and a high risk of developing metastasis (prostate-specific antigen doubling time [PSADT] 10 mo) were randomized 2:1 to APA (240 mg QD) þ ADT or PBO þ ADT. Pt outcomes were evaluated based on any RP/XRT prior to the study. Cox proportional hazard analysis was used to estimate the HR and 95% CI for MFS.RESULTS: 41% of pts in each arm (334/806 APA; 166/401 PBO) had prior RP/XRT. Pts with prior RP/XRT were younger with longer time since diagnosis, had lower PSA values, lower ECOG and Gleason scores, and were less likely to have renal impairment. Despite these baseline advantages in the PBO group, pts with prior RP/XRT had poorer outcomes. MFS was significantly shorter for PBO pts with vs without prior local therapy (HR, 1.73; p [ 0.0002). This negative prognosis for pts with prior RP/XRT was overcome with APA (HR, 0.80; p [ 0.13), which delayed development of metastases by 68%-84% vs PBO (Table ). The relative magnitude of improvement with APA vs PBO was highest in pts with prior local therapy. No impact of prior local therapy was observed on incidence of grade 3/4 treatment-emergent adverse events with APA and PBO. Incidence of falls, fractures, hypothyroidism, seizures, and skin rash was similar in pts with or without prior RP/XRT. CONCLUSIONS: Regardless of prior local therapy, pts received highly significant MFS benefit from treatment with APA. Prior therapy did not have an impact on tolerability of APA.

Attitude is everything: keep probe pitch neutral during side‐fire prostate biopsy. A simulator study

“…Comparison of experts using the simulator against trainees was beyond the scope of this study; however, in a prior preliminary study, a small sample (n = 3) of experts (faculty instructors) evaluated on our simulator had similar baseline sPBx template deviation to that of 15 trainees; neither faculty nor trainees achieved a template deviation ≤5.0 mm at the baseline sPBx set [12]. Based on self-reported experience, study participants were placed in two groups: experienced vs non-experienced.…”

“…Without standardized training curricula and techniques, acquisition and maintenance of freehand sPBx skills can be haphazard and non-uniform, which can significantly impact the accuracy and diagnostic value of prostate tissue biopsies [12]. The literature on a teachable, methodical technique for freehand, side-fire TRUS sPBx according to a template or schema is limited.…”