bluuebunny/crossref_metadata_2025_split huggingface dataset:
Overall survival outcomes with the use of adjuvant chemotherapy, radiation therapy and hormone therapy in high-risk, very-high-risk and node-positive prostate cancer post radical prostatectomy: A NCDB analysis.
Authors: Basnet Alina , Formica Margaret K , Ramadas Poornima , Benjamin Sam 
Published: March 2019

118 Background: Phase III trials have not consistently demonstrated overall survival (OS) advantage of adjuvant radiation therapy (ART) in prostate cancer (PC) with high risk/very high risk features after radical prostatectomy (RP). Adjuvant hormone therapy (AHT) in PC after RP improved OS in patients with positive lymph nodes (pLNs). We report an observational study on the impact of AHT to ART in NCCN defined high-risk/very high risk (Group 1), and adjuvant chemotherapy (ACT) to AHT in pLNs (group 2) post RP on OS. Methods: We conducted a retrospective study of PC patients (group 1 and group 2) who underwent RP and/or pelvic lymph node dissection. OS was calculated using Kaplan Meier analysis. Group 1 compared ART+AHT vs ART and Group 2 AHT+ ACT vs AHT within 16 weeks of RP. Multivariate analysis was performed with Cox proportional hazard regression model to adjust for different variables. Results: Out of 1,390,357 PC patients reported in NCDB (2004-2015) 182,653 and 11,972 met our inclusion criteria for Group 1 and Group 2 respectively. 3.37% of Group 1 received ART and/or AHT. 19.81% of Group 2 received AHT and/or ACT. Patients who received ART + AHT were more likely to be older, Non-Hispanic white, more likely to have pT4, and have higher prostate specific antigen (PSA) and Gleason scores (GS). Patients who received AHT+ACT were more likely to be younger, with private insurance, and lower Charlson-Deyo Score (CDCC) score. Five and seven year OS with adjusted hazard ratio (aHR) among Group 1 and Group 2 are depicted in table. Conclusions: No statistically significant difference in OS was seen among respective treatment groups. Limitations that exist with this registry based study include lack of randomization, differences in surgical and radiation techniques, duration and choices of ACT and AHT.[Table: see text]
Conservative management of low-risk prostate cancer among young versus older men in the United States: Trends and outcomes from a novel national database.
Authors: Mahal Amandeep R , Butler Santino , Franco Idalid Ivy , Pike Luke Roy George , Zhao Shuang , Sanford Nina Niu , Dess Robert Timothy , Feng Felix Y , D'Amico Anthony Victor , Spratt Daniel Eidelberg , Yu James B. , Nguyen Paul L. , Rebbeck Timothy , Mahal Brandon Arvin Virgil 
Published: March 2019

12 Background: The optimal management for men age ≤55 with low-risk prostate cancer (PCa) is debated given quality of life implications with definitive treatment versus potential missed opportunity for cure with conservative management. We sought to define rates of conservative management for low-risk PCa and associated short-term outcomes in young versus older men in the United States (U.S.). Methods: The Surveillance, Epidemiology, and End Results (SEER) Prostate with Active Surveillance/Watchful Waiting (AS/WW) Database identified 50,302 men diagnosed with low-risk PCa from 2010-2015. AS/WW rates in the U.S. were stratified by age (≤55 versus ≥56). Prostate cancer-specific mortality (PCSM)and overall mortality were defined by initial management type (AS/WW versus definitive treatment [referent]) and age. This non-public data was released by the SEER custom data group. Results: AS/WW utilization increased from 8.61% in 2010 to 34.56% in 2015 among men age ≤55 (Ptrend< 0.001) and from 15.99% to 43.81% among men age ≥56 (Ptrend< 0.001). Among patients with ≤2 positive biopsy cores, AS/WW rates increased from 12.90% to 48.78% for men age ≤55 and from 21.85% to 58.01% for men age ≥56. Among patients with ≥3 positive biopsy cores, AS/WW rates increased from 3.89% to 22.45% for men age ≤55 and from 10.05% to 28.49% for men age ≥56 (all Ptrend< 0.001). Five-year PCSM rates were below 0.30% across age and initial management type subgroups. Conclusions: AS/WW rates quadrupled for patients age ≤55 from 2010-2015, with favorable short-term outcomes. These findings demonstrate the short-term safety and increasing acceptance of AS/WW for both younger and older patients. However, there are still higher absolute rates of AS/WW in older patients (P < 0.001), suggesting some national ambivalence toward AS/WW in younger patients.
Racial differences in long-term prostate cancer specific mortality following conservative management for low-risk prostate cancer: A population-based study.
Authors: Lu-Yao Grace L. , Nikita Nikita , Keith Scott W , Banks Joshua , Handley Nathan , Rebbeck Timothy , Cullen Jennifer , Domingo-Domenech Josep , Kelly William Kevin 
Published: March 2019

121 Background: It is uncertain whether the same criteria for active surveillance can be applied universally across races. This population-based study was undertaken to quantify racial differences in long-term risk of prostate cancer-specific mortality (PCSM) among patients with low-risk prostate cancer (PCa) receiving conservative management. Methods: We used the Surveillance, Epidemiology, and End Results (SEER) database to identify patients who had low-risk PCa (T1-T2a & Gleason 6 & PSA ≤ 10 ng/mL & N0 & M0) diagnosed in 2004 – 2015 and did not receive radical prostatectomy or radiation therapy within one year of diagnosis. Kaplan-Meier analysis was used to calculate PCSM. The Clopper-Pearson method was used to calculate associated 95% confidence intervals. Hazard ratio of PCSM among those with a high PSA (PSA 4-10) compared to those with a low PSA (PSA < 4) was calculated using Cox proportional hazards models adjusted for covariates (including age, race, marital status, insurance status, U.S. region, year of diagnosis, and AJCC clinical tumor stage). Results: Among 33,740 patients with low-risk PCa, long-term PCSM varied with race and PSA levels at diagnosis. For instance, 10-year PCSM was 2.62% (95% CI: 1.15%-5.05%) among African Americans with PSA 4-10 and 0.98% (95% CI:0.16%-3.12%) among Caucasian patients with PSA < 4. There was no significant statistical interaction between race and PSA level on PCSM (p = 0.81). After adjusting for potential confounders, men with PSA 4-10 experienced 2-fold higher PCSM relative to those with PSA < 4 (HR = 1.96, p = 0.011) and African Americans men experienced a 43% higher PCSM compared to Caucasians (HR = 1.43, p = 0.03). Conclusions: Among men diagnosed with low-risk PCa, long-term PCSM varies by race and PSA at diagnosis. More refined risk stratification may improve PCa management among low-risk PCa patients. [Table: see text]
The validation of the 2014 International Society of Urological Pathology (ISUP) grading system for patients with high-risk prostate cancer: A single-center retrospective study.
Authors: Liu Jiandong 
Published: March 2019

128 Background: Since the new 2014 grading system was recommended by the International Society of Urological Pathology (ISUP), it has been validated in patients with localized prostate cancer (PCa) and has shown excellent prognostic value. However, its predictive power in high-risk PCa remained unclear. Methods: Overall, 420 patients with high-risk PCa who underwent radical prostatectomy (RP) were included. Biochemical recurrence-free survival (BRFS) was set as the endpoint. Results: Biochemical recurrence occurred in 84/420 (20.0%) patients at the end of follow-up. Compared to the three-tier grouping system, the five-tier grouping system could more effectively distinguish the BRFS of patients with higher predictive accuracy (C-index: 0.599 vs 0.646). The BRFS of patients with grade group (GG) 1 and GG 2 was similar (p = 0.593). Also, the prognosis between those in the GG 2 and GG 3 could be clearly distinguished (p = 0.001). Whereas the discrimination capacity between patients with GG 3 and GG 4 was limited (p = 0.681). The high proportion of tertiary Gleason pattern 5 (TGP5) among patients with GG 3 might be an important confounder leading to the overlap of survival between GG 4 and GG 3. Conclusions: This study is the first one to validate the new 2014 ISUP grading system in patients with high-risk PCa who underwent RP. The 2014 system could effectively separate patients into five groups with high predictive accuracy. Notably, the existence of TGP5 needs to be routinely reported in clinical practice, which could help to support the predictive ability of the new grading system.
Management of low-risk prostate cancer in a population-based cohort of Australian men between 2008 and 2016.
Authors: Ong Wee Loon , Foroudi Farshad , Evans Susan M. , Millar Jeremy Laurence 
Published: March 2019

13 Background: The aim of this study is to evaluate the practice pattern of management of NCCN low-risk prostate cancer (LRPC) in a population-based cohort of Australian men. Methods: This is prospective cohort of men captured in Prostate Cancer Outcomes Registry Victoria (PCOR-Vic), who were diagnosed with LRPC between Aug 2008 and Dec 2016. Conservative management was defined as no active treatment (surgery, radiotherapy, or other local therapy) within 12-month of LRPC diagnosis. Chi-squared test for trend was used to evaluate change in practice over time. Multivariate logistics regressions were used to patient-, tumour- and institutional factors influencing the likelihood of conservative management for LRPC. Results: A total of 3238 men with LRPC were identified in the PCOR-Vic database. The median age was 62.6 (range:37-94). The median PSA level was 5.1ng/mL (range: 0.01-9.96). Overall, 1934 (60%) had conservative management, of which 1668 (86%) were documented as being on active surveillance. Of the 1304 (40%) men who active treatment within 12-month of diagnosis, 977 (30%) had surgeries, 289 (9%) had radiotherapy, and 38 (1%) had other local treatment. Overall, there is increasing trend in conservative management for LRPC from 52% in 2009 to 73% in 2016 (P<0.001). In multivariate analyses, age, PSA, clinical stage, institutions and year of diagnosis were all independently associated with conservative management. Men diagnosed in private and regional centres were 26% (95%CI=0.63-0.88, P=0.001) and 40% (95% CI=0.51-0.72, P<0.001) less likely to have conservative management for LRPC. Conclusions: This is the largest Australian series on management of LRPC to date. We observe increasing use of conservative management for LRPC over time, however, there is large institutional variations in care with men diagnosed in private and regional centres more likely to have active local management for LRPC.
Reduced risk of prostate cancer in a cohort of Lithuanian diabetes mellitus patients.
Authors: Patasius Ausvydas , Kincius Marius , Linkeviciute-Ulinskiene Donata , Zabuliene Lina , Smailyte Giedre 
Published: March 2019

130 Background: An inverse association has been shown between diabetes and prostate cancer risk. The aim of this study was to determine whether type 2 diabetes mellitus (T2DM) and metformin is associated with prostate cancer risk. Methods: A retrospective cohort design was used to examine the relationship between diabetes and prostate cancer risk. The cohort was composed of male patients identified with diagnosis of T2DM in the National Health Insurance Fund database during 2000–2016. Cancer cases were identified by record linkage with the Lithuanian Cancer Registry which is a nationwide population-based cancer registry that contains personal and demographic information, as well as information on diagnosis of all people diagnosed with cancer in Lithuania since 1978. We calculated standardized incidence ratios (SIRs) for prostate cancers as a ratio of observed number of cancer case in people with diabetes diagnosis to the expected number of cancer cases in the underlying general population. Results: Overall, 68,449 males were diagnosed with diabetes in Lithuania between 2000 and 2016 were included in final cohort. 2,754 prostate cancers were observed versus 3,111.26 expected within a period of observation entailing an SIR of 0.89 (95% CI: 0.85–0.92). Significantly lower risk of prostate cancer was found in diabetic patients in all age groups, there were no differences in prostate cancer risk by time since diabetes diagnosis. Significantly lower risk of prostate cancer also was found in both metformin users and never-users groups, with higher risk reduction in metformin users (SIR 0.71, 95% CI: 0.68–0.75) than in T2DM patients never-users (SIR 0.88, 95% CI: 0.80–0.96). Conclusions: In the large population-based study we found significantly decreased risk of prostate cancer among men with T2DM. Our study suggests that metformin use in patients with T2DM may be associated with reduced risk of developing prostate cancer.
Genomic findings in adenocarcinoma of the urinary bladder.
Authors: Shapiro Oleg , Kotula Leszek , Byler Timothy , Jacob Joseph , Alexander Brian Michael , Gay Laurie M. , Millis Sherri Z. , Elvin Julia Andrea , Chung Jon , Vergilio Jo-Anne , Ramkissoon Shakti , Severson Eric Allan , Killian Jonathan Keith , Ali Siraj Mahamed , Schrock Alexa Betzig , Miller Vincent A. , de La Roza Gustavo , Ross Jeffrey S. , Bratslavsky Gennady , Liu Nick 
Published: March 2019

132 Background: Prostatic ductal carcinoma (PDC) is an uncommon centrally located prostate with a characteristic tubulopapillary histology. PDC shares some biomarker features with the more common prostatic acinar carcinoma (PAC) including PSA expression. Methods: In this comparative comprehensive genomic profiling (CGP) study, FFPE samples from 61 clinically advanced PDC and 4,132 PAC were profiled for all classes of genomic alterations (GA). Tumor mutational burden (TMB) was determined on 1.1 Mbp of sequenced DNA and microsatellite instability (MSI) was determined on 114 loci. Results: The age, frequency of genomic alterations (GA) per tumor and TP53 GA of PDA and PAC were similar (Table). TMPRSS2:ERG fusions and AR GA were more often identified in PAC than PDC whereas PTEN GA were more common in PDC than PAC. Targetable GA were identified at similar frequencies in both groups focused on BRCA2 (PARP inhibitors), BRAF (BRAF/MEK inhibitors) and PIK3CA (MTOR inhibitors). ATM GA (PARP inhibitors) were more common in PAC than PDC. CDK12 GA potentially associated with immunotherapy (IO) benefit were similar in PDA and PAC as were the frequencies of MSI-High status, median TMB and high TMB levels. Conclusions: The pathologic features of PDC and PAC have been classically maintained as representative of 2 different tumor types with potentially contrasting histogenesis. In the current CGP-based study, PDA and PAC did not display significant differences in genomic signatures. CGP may reveal biomarkers that could direct patients to targeted (PARP, MTOR and BRAF/MEK inhibitors) or immunotherapies ( CDK12 GA, MSI-High or high TMB status) in both PDA and PAC. [Table: see text]
Prostate cancer in young men: Our experience.
Authors: Barreira Joao Vasco , Falcão Gil , Parmanande Anuraj , Spencer Ana Sofia , Simão Diana , Winckler Patricia , Luz Ricardo 
Published: March 2019

133 Background: Prostate cancer (PCa) diagnosis is not uncommon in younger men. The three recognized risk factors for PCa are increasing age, african-american race and a family history (FH). Data about PCa treatment outcomes are controversial, younger men may have more aggressive disease and worse prognosis. On the other hand, more recent studies suggest higher rates of indolent PCa with more favorable outcomes in young men after radical prostatectomy (RP). We aimed to compare younger (G1, ≤ 55 yo) vs. older adults (G2, > 56 yo) who underwent RP for PCa between 2010-2016 in terms of FH, race and tumor aggressiveness. Secondly, to determine if the PCa in G1 is more aggressive when there is a PCa familiar background. Methods: Between 2010-2016, 419 men underwent RP for clinically localized PCa at Central Lisbon Hospitals, of which 49 were aged ≤55 years at the time of RP. Clinical characteristics such as race, FH, PSA level, clinical stage, and biopsy Gleason score (BGS) were recorded before RP. Pathological parameters (pathological stage, GS and PSA) were collected after surgery. Results: In G1, 31% had PCa FH vs. 10% in G2 (p < 0.001). Before RP, the average PSA in G1 was 7.47 vs. 8.08 in G2 (p = 0.371). In BGS, 44,3% had Gleason (G) 6, 37,4% G7, 6.9% G≥8, not significantly different between both groups (p = 0.651). Albeit, G1 had more aggressive tumors after RP: 27% G6, 45% G7 e 29% G≥8 vs. 37%, 53% e 11% respectively in G2 (p = 0.002). The pathological stage (pT) was not significantly different between groups (p = 0.243). Biochemical recurrence (BCR) was higher in G1 20% vs. 9% (p = 0.010). In a multivariate logistic regression model, the G1 had more BCR (p = 0.047) and higher PCa FH incidence (p = 0.002). When comparing african vs. caucasian men, the first group had more aggressive tumor histology (p = 0.021). Conclusions: Our study demonstrated that the youngest had superior pathological grades with higher BCR rates. Also, we found a strong relationship between G1 and FH of PCa. Data regarding pathological findings after RP in young men are still controversial. Recent studies confirm that pathological PCa characteristics in young men are not more aggressive than in older men. The present intends to add to the scientific debate around the impact of patients’ age in PCa aggressiveness and prognosis.
Experience of a single Brazilian center on PSMA-PET in biochemical recurrence in patients with prostate cancer.
Authors: Lages Paulo Sergio , Prado Junior Luciano , Prado Leonardo , Lages Luciana 
Published: March 2019

134 Background: Biochemical recurrence in prostate cancer is a common event, and we have data showing that PSMA-PET may guide therapy when it happens. Objectives: Verify the sensibility of PSMA-PET on biochemically recurrent prostate cancer and correlate it with PSA level and Gleason score. Methods: From October 2015 to August 2018, 547 PSMA-PET (68Ga-PSMA) was performed to evaluate prostate cancer individuals. 276 patients had already been treated from prostate cancer and were in biochemical recurrence. From these patients, 122 had information regarding Gleason Score. Results: From the 276 patients, we found 216 positive exams (78.3%). What we can see, and according to the present data we already have, is that the positivity rises with increasing PSA level. Conclusions: PSMA-PET is a useful strategy for planning treatment in patients with biochemical recurrent prostate cancer. The sensibility varies according to PSA level and Gleason Score. An interest thing observed is that the sensibility for Gleason 3+4 is similar to Gleason 3+3 and the sensibility for Gleason 4+3 is similar to 4+4, showing that the Gleason 7 disease has different behaviors, as previous shown in other trials. This dataset reinforces the importance of incorporating PSMA-PET in clinical practice.[Table: see text][Table: see text][Table: see text]
The effect of urologic oncology fellowship training on type and yield of prostate biopsy.
Authors: DeWitt-Foy Molly Elmer , El-Shafei Ahmed , Coronado Wendy Melissa , Abouassaly Robert 
Published: March 2019

135 Background: Prostate biopsy is a commonly performed procedure done in the evaluation of elevated prostate specific antigen (PSA), abnormal digital rectal exam (DRE), or for patients with a known prostate cancer diagnosis on active surveillance. The diagnostic yield of prostate biopsy is related to patient factors including age and race, but may also be correlated with provider factors, including clinical experience and training. We aim to determine the relationship between urologic oncology fellowship training (UOFT) and years of training with diagnostic yield of prostate biopsy. Methods: A retrospective review was conducted of patients who underwent prostate biopsy across the Cleveland Clinic between 2000 and 2018. Biopsies done by urologists with and without UOFT were detailed via descriptive statistics and with appropriate (chi square, Student t) tests. Logistic regression was performed, adjusting for last PSA, age, race, and type of biopsy. Results: A total of 11,255 biopsies performed by 129 urologists had complete information for review. The average patient age at biopsy was 65 years. The mean number of years in practice was 16 with a range from < 1 to 46 (SD 11.26). Of 129 urologists 16 (12.4%) had completed a urology oncology fellowship. Those with UOFT were more likely to use MRI guidance for biopsy (7.73% v 2.89%). Overall, 35.5% of all biopsies were positive for prostate cancer, with a significantly higher rate of positive biopsy for urologists with UOFT (40.7% v 32.43%, OR 1.4, p < 0.0001). Having completed greater than 5 years of clinical practice was correlated with greater odds of positive biopsy (OR 1.170, p < 0.0001), but significance of this association was lost when adjusting for oncology fellowship. UOFT remained a significant predictor of diagnostic yield even when adjusting for most recent PSA, age and race of patient, provider years in practice, and type of biopsy (MRI v transrectal ultrasound). Conclusions: Urologic oncology fellowship training is associated with a higher diagnostic yield on prostate biopsy, and a higher uptake of MRI guided biopsy. Higher rate of positivity on biopsy may be attributable to more nuanced patient selection for biopsy or to biopsy technique.
Updated analysis of progression-free survival with first subsequent therapy (PFS2) and safety in the SPARTAN study of apalutamide (APA) in patients (pts) with high-risk nonmetastatic castration-resistant prostate cancer (nmCRPC).
Authors: Small Eric Jay , Saad Fred , Chowdhury Simon , Oudard Stephane , Hadaschik Boris A. , Graff Julie Nicole , Olmos David , Mainwaring Paul N. , Lee Ji Youl , Uemura Hiroji , Lopez-Gitlitz Angela , Espina Byron M. , Shu Youyi , Rackoff Wayne R. , Rooney Oliver Brendan , Londhe Anil , Cheng Shinta , Smith Matthew Raymond 
Published: March 2019

144 Background: In the phase 3 SPARTAN study, compared with placebo (PBO), APA, a next-generation androgen receptor inhibitor, decreased the risk of distant metastasis or death by 72% (hazard ratio [HR], 0.28; p < 0.0001) in men with high-risk nmCRPC. After 1 year of additional follow-up, PFS2 and safety were reevaluated to ensure maintenance of benefit against potential harm. Methods: Pts with nmCRPC and prostate-specific antigen doubling time of ≤ 10 mos were randomized 2:1 to APA (240 mg QD) + androgen deprivation therapy (ADT) or PBO + ADT. All pts who developed distant metastasis, determined by blinded independent central review, were eligible to receive subsequent therapy including open-label treatment with abiraterone acetate + prednisone, provided by the sponsor. The exploratory PFS2 end point (time from randomization to disease progression on subsequent anticancer therapy or death) was evaluated, as was incidence of treatment-emergent adverse events (TEAEs). Results: Median treatment duration with APA was 25.7 mos; with PBO, 11.5 mos (original analysis, mos: APA, 19.2; PBO, 11.2). Pts randomized to APA continued to show significant benefit in PFS2 (HR, 0.5; 95% CI, 0.39-0.63; p < 0.0001) vs PBO (APA median time to PFS2 not reached vs PBO 39.3 mos). At a median follow-up of 32 mos, 51.3% of pts receiving APA, 8% of the 75 pts who crossed over from PBO to APA, and 99.7% of remaining PBO pts had discontinued study treatment. Rates of discontinuations due to progressive disease and AEs were 27.3% and 12.7%, respectively, in the APA group and 73.4% and 8.4% in the PBO group. There was no substantial change in the incidence of TEAEs in the APA group at the 1-year update. With regard to drug specific TEAEs, there were no grade 4 or 5 events; grade 3 TEAEs consisted of rash, 5.2%; falls, 2.4%; fractures, 3.1%; hypothyroidism, 0%; and seizures, 0%. Conclusions: APA was previously shown to result in an improvement in metastasis-free survival and symptomatic progression. With a median APA treatment duration of 25.7 mos, APA continues to show significant benefit in PFS2, and its safety profile remains unchanged. Clinical trial information: NCT01946204.