bluuebunny/crossref_metadata_2025_split huggingface dataset:
Contemporary diagnosis of very low risk prostate cancer in a multi-centered hospital system.
Authors: Bennett Richard , Li Eric , Ho Austin Y. , Aguiar Jonathan , Mahenthiran Ashorne Krithiesh , Kumar Sai , Suk-ouichai Chalairat , Neill Clayton , Patel Hiten Dilip , Schaeffer Edward M. , Jawahar Anugayathri , Ross Ashley 
Published: January 2024

274 Background: NCCN very low risk (VLR) prostate cancer is frequently clinically insignificant and thus over-diagnosed. Use of MRI prior to patient selection for prostate biopsy and to inform biopsy targeting can reduce the diagnosis of VLR disease. Indeed, a recent publication has reported no VLR diagnoses since 2018. We sought to better understand the incidence of VLR disease in our multi-hospital institutional cohort. Methods: We retrospectively identified 3197 patients who were newly diagnosed with prostate cancer at our eleven-hospital system from January 2018 – June 2023. Within this cohort, we identified patients who met VLR criteria. Patient clinical, pathological, and imaging characteristics were collected for analysis. Biopsies were considered MRI-informed if MRI was performed within two years prior to prostate biopsy. Biopsies were considered targeted if at least one region of interest was designated on pathology. Patients who had incomplete clinical records (n=2) were excluded from analysis. Active surveillance as initial disease management was defined as no treatment within one year of diagnosis. Welch’s two-sample t-test, Pearson’s chi-squared test, and Fisher’s exact tests were performed to compare clinical characteristics. PSA was log transformed for analysis. Results: In the study period, 11% (351/3195) of men diagnosed with prostate cancer were classified as NCCN very low risk. The incidence of VLR diagnoses was steady from 2018-2023 (p=0.8) despite increased usage of MRI-informed biopsies (p<0.001). Use of MRI-informed biopsy was similar for detection of VLR and higher risk disease (68% vs 72%, p=0.07). Of VLR patients who received a targeted biopsy, 69% (127/184) of disease was found in systematic regions only, 21% (39/184) was found in targeted regions only, and 10% (18/184) was found both systematically and in targeted regions. On multivariable analysis, black race, logPSA, and PIRADS 4 and 5 regions were negatively associated with VLR disease (Table). 86% (304/351) of VLR patients chose active surveillance as their initial disease management. Conclusions: VLR disease comprises a significant minority of prostate cancer diagnoses. The incidence of VLR has remained unchanged despite increased utilization of MRI-informed biopsies in our hospital system. In the majority of cases the diagnosis of VLR is made from the template biopsy (whether MRI-informed or not). Patients should, and frequently do, choose active surveillance to manage their disease. Use of nomograms and limiting biopsy of PI-RADS 3 lesions may decrease the incidence of VLR prostate cancer.[Table: see text]
What criteria do clinicians use to classify men as “high risk” among patients with biochemically recurrent nonmetastatic castration-sensitive prostate cancer?
Authors: Freedland Stephen J. , Ribbands Amanda , Butcher Jake , Walley Maria , Barlow Sophie , Russell David , Bland Christopher S , Touya Maelys , Ivanova Jasmina I. 
Published: January 2024

300 Background: In patients with biochemically recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC), guidelines support the use of clinical factors such as prostate-specific antigen doubling time (PSADT) and Gleason score to identify high-risk patients who are more likely to develop metastases and could benefit from earlier intervention. The current study aimed to understand criteria used by physicians in the real-world to categorize patients with BCR nmCSPC as high-risk. Methods: This analysis used data from the Adelphi Real World nmCSPC retrospective survey, completed by urologists and radiation oncologists in the US. Physicians extracted data from medical charts for their last 6–8 patients diagnosed with high-risk BCR nmCSPC since January 2021 (until July 2023). A physician attitudinal survey was also completed. Data were analyzed descriptively. Results: Overall, 84 physicians provided data (68 urologists; 16 radiation oncologists). When asked in general (not patient specific) to name clinical factors used to determine level of risk, physicians cited using multiple factors, most frequently PSADT (93%), Gleason score (88%), absolute PSA rise following definitive therapy (86%), and clinical stage (85%). PSADT was cited as the single most important clinical factor by nearly 50%, followed by Gleason score, clinical stage, and absolute PSA rise following definitive therapy (Table). For physicians who used PSADT to risk stratify, the median (IQR) threshold for high-risk was 6 (6–9) months. Aggregated patient-level data were analyzed for 352 patients with high-risk BCR nmCSPC, as defined by the physicians. Clinical factors used to classify patients as having high-risk BCR in this study included PSADT (58%), Gleason score (44%), absolute PSA rise after definitive therapy (42%), clinical stage (21%), and pathological findings at radical prostatectomy (15%). Overall, 65% of patients had a PSADT ≤9 months after BCR, and 68% had a PSADT < 12 months (high-risk per the AUA guidelines). Conclusions: Physicians reported using multiple clinical factors to classify patients as having high-risk BCR nmCSPC, with PSADT considered the most important for risk stratification. Appropriate and timely identification of patients as high-risk may help to identify patients for whom earlier intervention could be beneficial.[Table: see text]
Patients with prostate cancer consider clinical trial options significantly earlier in their journey compared to patients with other solid tumors.
Authors: Edry-Botzer Liat , Lapidot Yelena , Katz Hanna , Bader Tzvia , Gaziel Avital 
Published: January 2024

305 Background: A common misconception is that oncology clinical trials (CT) are a last resort for those who have exhausted treatments or are in advanced stages. This is reflected in the patient (pt) population seeking CT and the greater focus on CT tailored to progressive, refractory, or recurrent diseases. Due to effective screening and its natural progression, prostate cancer (PC) is discovered relatively early, compared to other cancers. Effective, sophisticated non-systemic approaches for treatment are also available in the clinical and also within CT for this cancer. In this study, using real-world pt data, we explored whether those differences impact the way PC pts digitally search for CT. Methods: Leal Health, an AI-based platform, matches cancer pts to CT using pt-reported questionnaires to create individual clinical profiles. These profiles include disease status, stage, biomarkers, treatment history, diversity, and demographics. We analyzed a cohort of 35,671 pt profiles, comparing different clinical and non-clinical parameters between PC pts and those with other solid tumors (bladder, CRC, lung, breast). Results: Leal's data revealed a significantly greater proportion of newly diagnosed PC pts who actively pursued CT, in comparison to individuals diagnosed with other solid tumors (49% vs. 32%, p<0.0001). Additionally, there were significantly fewer available PC trials for newly diagnosed pts compared to relapsed/refractory cases (p<0.0001). The increase in matched trials was 1.61-fold for relapsed/refractory PC pts (p<0.0001) and 2.08-fold for pts with other solid tumors (p<0.0001). A stratified analysis showed that male gender is not a dominant driver for the difference. PC pts were often diagnosed at earlier stages with better performance status compared to other cancer types (p<0.001 for both comparisons). 51% of newly diagnosed PC pts were at stage 1, compared to only 35% of other solid tumors cancer types were. Furthermore, 12% of newly diagnosed PC cases had metastatic disease compared to 26% for other solid tumors. Conclusions: Our research highlights a shift in the traditional pt decision-making, with PC pts showing proactive interest in CT much earlier in their journey compared to other cancers. Male gender alone does not account for this significant difference, which is primarily linked to PC type. While more research is needed, immediate implications and opportunities arise. For example, the significant representation of newly diagnosed PC pts in the digital space represents an opportunity to introduce CT options to pts through this channel and invest in research and trial designs for those pt populations who are not adhering to the traditional standard of care approach before exploring CTs.
Prognostic value of FDG, PSMA, and DOTATATE uptake on PET imaging in metastatic castration-resistant prostate cancer (mCRPC).
Authors: Pouliot Frederic , Saad Fred , Rousseau Étienne , Richard Patrick O. , Zamanian Atefeh , Probst Stephan , Levesque Eric , Castonguay Vincent , Marcoux Nicolas , Juneau Daniel , Lodde Michele , Lattouf Jean-Baptiste , Buteau François-Alexandre , Hamilou Zineb , Pavic Michel , Castilloux Jean-François , Bouvet Guillaume , Tetu Amélie , Guérin Brigitte , Beauregard Jean-Mathieu 
Published: January 2024

31 Background: In mCRPC, fluorodeoxyglucose (FDG) and prostate-specific membrane antigen (PSMA) PET/CT are often used in combination for selecting patients for PSMA-radioligand therapy (PSMA-RLT). Few studies have specifically assessed the prognostic value of FDG+/PSMA- lesions, which exclude patients from PSMA-RLT. Also, little is known about the significance of somatostatin receptor expression, a potential biomarker of neuroendocrine differentiation of mCRPC, which can be assessed with DOTATATE-PET/CT. 3TMPO is a prospective study in progressing mCRPC patients who were imaged with up to 3 PET tracers. Here, we report on patient’s overall survival (OS), with respect to the presence of FDG+/PSMA- and DOTATATE+ lesions. Methods: In 3TMPO (NCT04000776, protocol in PMID 34674367), all patients had 68Ga-PSMA-617 and 18F-FDG PET/CT scans. A 68Ga-DOTATATE scan was ordered if an FDG+/PSMA- lesion was found. For all tracers, positivity was defined as lesion SUVpeak being 1.5x higher than liver SUVmean. Kaplan-Meier with log-rank test was used to assess the difference in OS between groups. Cox regression model was used to quantify the effect of factors predictive of OS. Results: The median [95% CI] OS of the 98 enrolled patients was 10.2 [8.5-11.8] mo. At least one FDG+/PSMA- lesion was found in 45 (45.9%) patients and their OS was shorter than that of the others: 5.6 [4.3-6.9] vs. not reached (p=0.0001). Six (16.2%) of 37 patients who underwent 68Ga-DOTATATE-PET had ≥1 DOTATATE+ lesion and their OS was shorter than that of patients without a DOTATATE+ lesion: 3.0 [2.2-3.7] vs. 6.4 [1.6-11.1] mo. (p=0.0004). Characteristics significantly associated with worse OS were ECOG, ISUP grade, number of metastases, number of lines of therapy, presence of visceral metastases, FDG and PSMA molecular tumor volumes (MTV) (p<0.05). In a multivariate analysis adjusted for the number of metastases and of treatment lines, the presence of an FDG+/PSMA- lesion increased the risk of death (HR [95% CI]=2.4 [1.4-4.3], p=0.002), and this was also significant after adjusting for both PSMA and FDG-MTV (HR [95% CI]=2.9 [1.4-5.8], p=0.003). Conclusions: mCRPC patients harboring FDG+/PSMA- lesion(s) had a shorter OS than those who did not, and their prognosis was even poorer if they also had DOTATATE+ lesion(s). Upfront FDG/PSMA-PET followed by DOTATATE-PET might help clinicians to guide patient towards palliative care vs. further systemic therapy, including PSMA-RLT. Clinical trial information: NCT04000776 .
Hierarchical clustering analysis for predicting 30-day readmissions after major surgery for prostate cancer.
Authors: Khosla Atulya Aman , Batra Nitya , Ganiyani Mohammad Arfat , Singh Rohit , Jatwani Karan , Chedella Venkata Lakshmi Prajwala , Roy Mukesh , Ramamoorthy Venkataraghavan , Rubens Muni B. , Saxena Anshul , Jaiyesimi Ishmael A. , Garje Rohan 
Published: January 2024

311 Background: Effective risk assessment techniques and follow-up strategies are scarce for patients with prostate cancer because of the heterogeneity of the population. We aimed to conduct a study for better risk stratification, applying machine learning–based classification to patients with prostate cancer who underwent major surgery. Methods: We identified eligible patients who underwent prostatectomy or surgeries related to excision of the prostate using data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) for the years 2016–2021. Hierarchical clustering was conducted with variables such as age, BMI, smoking status, taking HTN medication, past medical history (diabetes, COPD, and CHF), preoperative labs (Na, BUN, creatinine, WBC count, HCT, and platelet count), operation time in minutes, and major complications. A multivariate logistic regression analysis was also conducted with a 30-day readmission as an outcome. The model accounted for cluster groups (high risk vs. low risk), among other variables. Results: The median [Q1, Q3] age of the sample ( n = 83,776) was 65.0 [59.0, 69.0] years. The participants were divided into two clusters (low-risk cluster, n = 72891; high-risk cluster, n = 10885) by hierarchical clustering, using 31 clinical variables. Patients in the high-risk cluster showed higher median levels of BUN (21 vs. 16 mg/dL), WBC count (7 vs. 6.5 /uL), platelet count (225 vs. 221/μL), and operation time (231 vs. 197 minutes). 30-day readmission rates were higher among the high-risk cluster (12.1% vs. 5.4%; p < 0.001). Similar trends were observed for minor complications (10.7% vs. 5.2%), major complications (8% vs. 2.5%), and reoperation (3.4% vs. 1.3%). Results from logistic regression showed that cases in the high-risk cluster were 1.10 (95% CI: 1.03, 1.17; p < 0.0015) times as likely to return to the hospital within 30 days of discharge as compared to the cases in the low-risk cluster (AUROC: 78.6%). Conclusions: In our study, hierarchical clustering divided prostate cancer cases into subgroups with a higher 30-day readmission risk. Applying machine learning–derived classification to prostate cancer patients undergoing major surgery may contribute to better risk stratification, leading to better prognosis and follow-up strategies.[Table: see text]
EMBARK post hoc analysis of sexual activity (SA) patient-reported outcome (PRO) measures.
Authors: Freedland Stephen J. , Mulhall John , Gleave Martin , De Giorgi Ugo , Saad Fred , Rannikko Antti , Ivanova Jasmina I. , Nasr Anchen , Reisman Arlene , Ganguli Arijit , Kral Pavol , Shore Neal D. 
Published: January 2024

313 Background: In the phase 3 EMBARK trial (NCT02319837), enzalutamide (ENZ) + leuprolide (L) and ENZ monotherapy (mono) delayed metastasis-free survival (MFS) vs placebo (P) + L without impairing global health-related quality of life (HRQoL) in high-risk biochemically recurrent (BCR) nonmetastatic hormone-sensitive prostate cancer (nmHSPC) (PSA doubling time ≤9 months). A prespecified PRO analysis showed that SA (measured as a composite score using European Organization for Research and Treatment of Cancer QoL Questionnaire-Prostate 25 [QLQ-PR25]) was better preserved with ENZ mono vs P + L and no significant difference between ENZ + L vs P + L. A post hoc analysis at the HRQoL item level was conducted to understand the effect on SA in each comparison and enable shared decision-making between physicians and patients. Methods: Men with high-risk BCR nmHSPC were randomized (1:1:1) to ENZ + L (double blind), ENZ mono (open label), and P + L (double blind). HRQoL was assessed at baseline and every 12 weeks until metastasis/death. This post hoc analysis assessed effects on time to confirmed (two consecutive visits) deterioration (TTCD) using predefined thresholds of one category decline from baseline in sexual interest, activity, satisfaction, erectile function, and feeling like a man using QLQ-PR25 item 50; QLQ-PR25 item 51; FACT-P item GS7; FACT-P item BL5; and FACT-P item P5 measures, respectively (Table). Intent-to-treat principle was applied. Results: At baseline, 327–332 men per arm completed the PRO surveys; overall completion rates were ≥85%, except for GS7 (≤36% due to voluntary response). ENZ mono vs P + L : TTCD in items 50 (interest) and 51 (activity), GS7 (satisfaction), and BL5 (erectile function) was delayed with ENZ mono. ENZ + L vs P + L: no significant differences in TTCD were observed, except a shorter TTCD by a median 0.06 months in BL5 (erectile function) with ENZ + L (Table). Conclusions: This post hoc item-level analysis of the EMBARK trial confirmed that SA was better preserved with ENZ mono vs P + L in terms of interest, activity, satisfaction, and maintaining erection. Further, the SA PROs were similar between ENZ + L and P + L, implying there is no further SA burden when adding ENZ to androgen-deprivation therapy. Clinical trial information: NCT02319837 . [Table: see text]
Baseline disease characteristics of participants enrolled on ENZARAD (ANZUP1303) and DASL-HiCaP (ANZUP1801) trials of highly effective androgen receptor antagonists in high-risk localized or locally advanced prostate cancer (PCa).
Authors: Niazi Tamim , Nguyen Paul L. , Williams Scott , Stockler Martin R. , Martin Andrew James , Horvath Lisa , Thomas Hayley , Zebic Danka Sinikovic , Roncolato Felicia , Lim Tee , Jose Chakiath , Martin Jarad , Chung Hans T. , Ebacher Annie , Morgan Scott C. , Hughes Simon , McBride Sean Matthew , Kelly Paul J. , Davis Ian D. , Sweeney Christopher ,   The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
Published: January 2024

328 Background: ENZARAD investigates the addition of enzalutamide or conventional nonsteroidal anti-androgens (NSAA) to radiation therapy (RT) and ADT for high-risk localized PCa. DASL-HiCaP investigates the addition of darolutamide or placebo to RT and androgen deprivation therapy (ADT) using Luteinizing hormone releasing hormone analog (LHRHA) for very-high-risk localized PCa as either primary definitive therapy, or as early salvage treatment after prostatectomy where PSA has persisted or become detectable within 12 months. Methods: The eligibility of DASL-HiCaP differed from ENZARAD by excluding patients solely based on PSA > 20ng/mL and also allowing a very-high risk patient population suitable for salvage radiation post prostatectomy. Participants in DASL-HiCaP were randomized 1:1 to darolutamide 600mg twice daily or placebo plus LHRHA for 96 weeks; all received external beam radiotherapy including mandated pelvic radiation. Participants in ENZARAD were randomized 1:1 to enzalutamide 160mg daily for 24 months or conventional NSAA for 6 months, plus LHRHA for 24 months, and EBRT. Brachytherapy boost was allowed in both trials and pelvic nodal radiation was at investigator’s discretion in ENZARAD. The primary end point for both trials is metastasis-free survival (MFS) (time from randomization to first evidence of metastasis or death from any cause). MFS events are based on conventional imaging with 99mTc bone scan and CT, and/or MRI. Lesions evident only on PSMA PET are not counted as MFS events. Results: The median age for both trials was 71-years. Complete baseline characteristics are summarised in the Table. ENZARAD randomized 802 participants across 8 countries. Half had Gleason score 9 (52%), 45% had cT3 PCa, 42% had cT2, and 11% were cN1. Gleason score 7 was present in up to 11% of ENZARAD population. DASL-HiCaP randomized 1,107 participants across 6 countries. Most had Gleason score 9 (69%), 41% had cT3 PCa, 32% had cT2, and 28% were cN1. Gleason score 7 was present in <5% of the DASL-HiCaP population. Conclusions: ENZARAD and DASL-HiCaP will define the efficacy of more potent hormonal therapy in the adjuvant setting of patients with both high- and very-high-risk disease and in both primary and salvage radiation settings. Clinical trial information: NCT02446444 and NCT04136353 . [Table: see text]
Utilization of genetic counseling and testing for patients with prostate cancer following integration of a genetic counselor into a genitourinary cancer clinic.
Authors: Byrne Lindsey , Lewis Mckenna , Wang Shihua , Clinton Steven K. 
Published: January 2024

343 Background: Individuals with prostate cancer may have a 10-20% chance of harboring genetic markers for inherited risk. It is critical that germline genetic testing (GGT) is integrated into prostate cancer care to improve therapy and promote prevention and early detection for individuals and their families. We hypothesized that embedding a genetic counselor (GC) into a multidisciplinary genitourinary (GU) Cancer Clinic would enhance referrals and subsequent GGT. We created a retrospective and prospective study to evaluate the impact on genetic counseling referrals, genetic risk assessments provided, and GGT frequencies before (2016-2018) and after (2019-2022) GC integration into the GU clinic at The James Cancer Hospital at The Ohio State University. Methods: A chart review of 2,593 individuals with prostate cancer seen in the GU program from 2016 to 2022 was performed. Data was analyzed by the Chi Square test. Results: Only 39 referrals to the cancer genetics program were documented in 2016-2019 with an increase to 367 during 2019-2022, despite the COVID pandemic. During the 2016-2019 period GGT was offered to 28% and completed in 26% of referred individuals, whereas GGT was offered to 77% (P<0.0001) and completed in 64% (P<0.0001) in the subsequent period. Individuals proceeding with genetic counseling and GGT were younger in the initial period and became more broadly based in subsequent years. Black patients represented only 8% of referrals in 2016-2019 but increased to 16% in the subsequent period. Individuals with a family history of prostate cancer (P<0.0001) as well as higher Gleason grade (P<0.0001), stage (P<0.0001), metastatic disease (P<0.0001), and PSA (P=0.0507) were more likely to choose genetic counseling. Conclusions: The integration of a GU focused GC into a multidisciplinary GU Cancer Clinic at an academic program dramatically increased genetic counseling referrals, and a greater proportion of individuals with prostate cancer proceeded with GGT. Future studies will analyze barriers and factors promoting referrals to a GC so that we may continue to offer individuals and their families' evidence-based treatment and prevention options.