BACKGROUND: Retrospective analyses of randomized trials suggest that Black men with metastatic castration-resistant prostate cancer (mCRPC) have longer survival than White men. The authors conducted a prospective study of abiraterone acetate plus prednisone to explore outcomes by race. METHODS: This race-stratified, multicenter study estimated radiographic progression-free survival (rPFS) in Black and White men with mCRPC. Secondary end points included prostate-specific antigen (PSA) kinetics, overall survival (OS), and safety. Exploratory analysis included genome-wide genotyping to identify single nucleotide polymorphisms associated with progression in a model incorporating genetic ancestry. One hundred patients self-identified as White (n = 50) or Black (n = 50) were enrolled. Eligibility criteria were modified to facilitate the enrollment of individual Black patients. RESULTS: The median rPFS for Black and White patients was 16.6 and 16.8 months, respectively; their times to PSA progression (TTP) were 16.6 and 11.5 months, respectively; and their OS was 35.9 and 35.7 months, respectively. Estimated rates of PSA decline by ≥50% in Black and White patients were 74% and 66%, respectively; and PSA declines to <0.2 ng/mL were 26% and 10%, respectively. Rates of grade 3 and 4 hypertension, hypokalemia, and hyperglycemia were higher in Black men. CONCLUSIONS: Multicenter prospective studies by race are feasible in men with mCRPC but require less restrictive eligibility. Despite higher comorbidity rates, Black patients demonstrated rPFS and OS similar to those of White patients and trended toward greater TTP and PSA declines, consistent with retrospective reports. Importantly, Black men may have higher side-effect rates than White men. This exploratory genome-wide analysis of TTP identified a possible candidate marker of ancestry-dependent treatment outcomes.

This study compared traditional short peripheral catheter (SPC) insertion methods with 2 vein visualization equipment models among a general patient population on a surgical step-down unit based on first-attempt success rates and the time required to achieve catheter insertion. The experiences of clinical nurses using the ultrasound and vein visualization equipment were also explored. No significant statistical differences were found between the insertion methods, based on 90 unique SPC insertion attempts. However, nurses reported that using the vein visualization equipment informed patient care, facilitated communication among members of the health care team, and facilitated second SPC insertion attempts. Nursing staff also used the equipment more often after the study concluded.

5015 Background: Abi Race was the first prospective parallel cohort study of abiraterone acetate plus prednisone (AAP) in Black and White men with metastatic castrate-resistant prostate cancer (mCRPC) and demonstrated greater prostate-specific antigen (PSA) response, time to PSA progression (TTP) and toxicity rates among Black patients (pts). We designed the PANTHER trial to estimate clinical outcomes among Black and White pts with mCRPC treated with apalutamide, abiraterone, plus prednisone. Methods: This parallel cohort multicenter study treated androgen receptor pathway inhibitor naïve mCRPC pts with oral apalutamide (240 mg/d), abiraterone (1000 mg/d) and prednisone (10 mg/d) (AAAP) continuously until disease progression, unacceptable toxicity or 2 years. The primary endpoint was radiographic progression free survival (rPFS); secondary endpoints were to estimate TTP, overall survival (OS) and best PSA response, among Black and White pts, separately. Exploratory endpoints included safety and correlative biomarkers of outcome by race and ancestry. Results: Between July 2017 and January 2021, we enrolled 43 Black and 50 White pts from 8 sites. Baseline prognostic characteristics were largely similar with some differences. We report an interim analysis as the pts are still followed for OS. At the time of the abstract submission, there were 18 and 36 rPFS events and 15 and 30 deaths in Black and White pts, respectively. We present the time to event endpoint rates at 12 and 24 mos and PSA declines for Black and White pts. Conclusions: We hypothesize that treatment with the combination of AAAP may result in clinical efficacy in Black men with mCRPC. Black pts were underrepresented in the phase III ACIS trial which compared AAP to AAAP and demonstrated longer rPFS but not OS. Further studies of AAAP combination therapy among Black men with advanced prostate cancer are needed to determine potential clinical benefits in this understudied population. Clinical trial information: NCT03098836 . [Table: see text]

11 Background: Combined external beam radiotherapy (RT) and androgen deprivation therapy (ADT) improves survival over RT alone for high risk prostate cancer (PC). Long-term ADT use, currently recommended for high risk PC, also increases toxicity. Recent data suggests synergistic efficacy with the addition of abiraterone acetate plus prednisone (AAP) to RT/ADT. Potent androgen blockade may provide biochemical control with short-term ADT course in men with aggressive but localized PC. Methods: This was a two center prospective phase 2 single arm clinical trial within the Department of Defense PCCTC (NCT01717053). Eligibility included 2+ intermediate or 1 high NCCN risk factors and no metastatic disease. Men received 6 months of ADT concurrently with 1000mg AA/5mg P daily and 78 Gy RT to prostate/SV. Primary endpoint was PSA < 0.1 ng/ml at 1 year. Secondary objectives included BPFS, PSA nadir, testosterone recovery, toxicity, and patient-reported QOL. Results: We enrolled 37 men (82% white, 18% black) with intermediate to high risk localized PC; 33 completed course of treatment (4 patients halted early for personal preference (N = 2), planned prostatectomy, or renal artery stenosis). Median age was 66 years; 46% Gleason 8-10, 40% Gleason 4+3 = 7, 62% T1c. Median follow-up is 23 months. Regimen was well tolerated with 12 (32%) G3 toxicities (10 hypertension, 2 hyperglycemia, 1 hypokalemia); no G4-5 or unexpected toxicities were observed. At 12 months from enrollment, PSA remained at undetectable levels in 52% of men. Testosterone recovery to normal lab value occurred in 12 (62%) at 12 months. In those patients, 20 (95%) and 21 (100%) remained with PSA under 0.5 and 1.0 ng/ml, respectively. No patient has failed by Phoenix definition to date. 1 year EPIC QOL had median summary scores above 90 for incontinence, urinary, bowel, hormonal, and satisfaction. Sexual summary score fell from median of 46 at baseline to 26 at 1 year. Conclusions: In men with high risk intermediate or limited high risk PC, utilizing short-term ADT/AAP with definitive RT shows 1) high rate of testosterone recovery and good quality of life and 2) excellent PSA control at 1 and 2 years. Clinical trial information: NCT01717053.

No abstract