bluuebunny/crossref_metadata_2025_split huggingface dataset:
A brief mind-body intervention to reduce pain and anxiety during prostate needle biopsy: A randomized, controlled trial with two-staged consent.
Authors: Gaffney Christopher , Vertosick Emily E. , Carlsson Sigrid V. , Lin Xin , Wolchasty Natalie , Hardbattle Robin , Vickers Andrew , Ehdaie Behfar 
Published: June 2023

e17092 Background: Prostate biopsy is among the most common oncologic procedures performed annually. A substantial proportion of patients experience significant morbidity related to biopsy, including pain, anxiety, and discomfort which may discourage follow-up biopsy crucial for identifying progression or discourage enrollment in active surveillance programs that require serial biopsy. Guided meditation significantly reduces pain and anxiety during breast biopsy. We developed a brief mind-body intervention that could easily integrate into general practice for patients during prostate biopsy and compared patient-reported outcomes after biopsy with and without this intervention. Methods: We conducted a clinically-integrated randomized controlled trial (MSK IRB 18-089) of a brief mind-body intervention during prostate biopsy compared to usual care. All adult patients offered biopsy were eligible. Patients randomized to the intervention were offered both a pre-biopsy mind-body exercise and guided mindfulness meditation during biopsy via headphones. The primary outcome of interest was any severe patient-reported pain, anxiety, discomfort, or tolerability on a visual-analog scale (0-10). We compared the proportion of men in each arm reporting a severe score (7-10) on any of the four scales using Fisher’s exact test. The pre-specified clinically relevant improvement justifying integration into clinical practice was 15%. We compared means separately using ANCOVA with randomization stratum (first vs. prior biopsy) as a covariate. Results: 238 patients (119 per arm) enrolled. 102 in the intervention arm and 94 in the usual care arm proceeded to biopsy and completed the questionnaire. A total of 37/94 (39%) and 38/102 (37%) patients in the usual care and the intervention arms, respectively, reported severe scores in any of the four domains, a difference of 2.1% (95% confidence interval -13, 17%, p = 0.8). The upper bound of the confidence interval includes the pre-specified clinically relevant difference. There was no evidence of a difference in mean post-biopsy anxiety (p = 0.3), discomfort (p = 0.09), pain (p = 0.4) or tolerability scores (p = 0.2), Table. Conclusions: There was no difference in patient reported outcomes between a mind-body intervention and usual care for prostate biopsy. Though the upper bound of the 95% confidence interval included the clinically relevant difference in severe scores, the difference in means for each outcome suggests a clinically meaningful benefit for this brief mindfulness intervention is unlikely. [Table: see text]
Comparison of generic and specific anxiety in patients treated with apalutamide plus active surveillance vs active surveillance alone for low and intermediate risk prostate cancer.
Authors: Gravis Gwenaelle , Touzani Rajae , Walz Jochen , Ploussard Guillaume , Savoie Pierre-Henri , Durand Matthieu , Poinas Gregoire , Beauval Jean-Baptiste , Mathieu Romain , Ahallal Youness , Vincendeau Sebastien , Guerin Mathilde , Boudin Laurys , Crouzet Sebastien , Salem Naji , Vicier Cecile , Heux Pauline , Sfumato Patrick , Pignot Geraldine , Marino Patricia 
Published: June 2023

e17093 Background: Active surveillance (AS) is a standard of care for low-risk prostate cancer (PCa). However, it is not yet clear whether AS may be a source of anxiety in patients (pts) compared to pts receiving treatment. The objective of this study is to compare anxiety in pts receiving apalutamide monotherapy plus AS versus AS alone in pts with low and intermediate-risk PCa. Methods: The study was conducted, in pts enrolled in a multicenter randomized phase 2 trial comparing AS with apalutamide (240 mg) 6 months versus AS alone. Participants completed questionnaires at baseline, 3, 6, and 12 months after diagnosis. We assessed anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) and prostate-specific anxiety using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC). Results: Patients were randomized to AS alone (n = 40) or AS + apalutamide (n = 51). Anxiety questionnaire, response rates, were 98%, 88%, 92%, and 82%, respectively, at baseline, 3 months, 6 months, and 12 months. HADS scores were similar between treatment groups (p > 0.05 at each assessment point) and did not change significantly over time (p > 0.05 for each comparison over time). By analyzing the general MAX-PC anxiety score, we observed that for pts on treatment, anxiety decreased significantly at 3 months compared to baseline (p = 0.01), then remained stable between 3 and 6 months. For pts on AS, anxiety remained stable during the first 3 months and decreased significantly after 3 months (p = 0.018). At the end of treatment (6 months), anxiety increased significantly in pts in the apalutamide arm (p = 0.05) while it remained stable for pts on AS alone. One year after inclusion, the MAX-PC general anxiety levels returned to baseline for both groups of pts. However, for the prostate cancer anxiety subscale, scores decreased significantly from baseline to 12 months in the AS alone group (p = 0.031). Conclusions: Anxiety was reduced in the apalutamide arm after the start of treatment, but this effect was transient and disappeared at the end of treatment. The decrease in anxiety appears to be delayed over time for AS patients, but after a few months, these patients experience a decrease in anxiety levels, suggesting that patients have become accustomed to not being treated. Better detection of PCa specific anxiety was observed, with disease-specific tools such as MAX-PC compared with generic anxiety detection with HADS. Clinical trial information: NCT03088124 .
Maintenance of castration with concomitant relugolix and apalutamide (Apa) in patients with high-risk localized prostate cancer (HR-LPC): 1 year update.
Authors: Brown Gordon , Belkoff Laurence , Hafron Jason , Aggarwal Pankaj , Potdar Rushikesh , Bhaumik Amitabha , Phillips Jennifer , McGowan Tracy , Shore Neal D. 
Published: June 2023

e17094 Background: Androgen deprivation therapy (ADT) is a mainstay in the management of prostate cancer (PC). We assessed the efficacy of achieving and maintaining castrate testosterone (T) levels when combining relugolix, an oral gonadotropin-releasing hormone antagonist, concomitantly with Apa, an androgen receptor inhibitor. The single-arm, open-label, multicenter, phase 2 Apa-RP study evaluates the biochemical recurrence-free rate in patients with HR-LPC following radical prostatectomy (RP) who received 12 months of adjuvant Apa and ADT (main study). A substudy was added to assess whether the approved maintenance dose of relugolix with concomitant Apa maintained castration. Study results of the 28-day coadministration of relugolix + Apa showed that all evaluable patients achieved and maintained castration at standard relugolix dose and were transitioned into the main study (Brown et al. Target Oncol. 2022). Herein, we report longer term data of T levels and safety findings in the substudy patients who received relugolix + Apa for 1 year. Methods: Patients (n = 12) with HR-LPC (PSA ≥20 ng/mL or Gleason score ≥8) received a loading dose of relugolix (360 mg) at substudy initiation (Day -14) followed by the standard, approved relugolix dose (120 mg/d) for 13 days. Starting on Day 1, patients received relugolix + Apa (240 mg/d) for 28 days, with substudy completion on Day 28. These patients transitioned to the main study and received relugolix + Apa for a total of 1 year. T levels (castrate level defined as < 50 ng/dL) were measured at baseline (Day -14), Day 1, Day 28, and then every 3 months. Results: Of the 12 patients who continued onto the main study, 1 withdrew and another was noncompliant with therapy and subsequently withdrew but maintained castration while on therapy. Of the 10 patients who successfully completed therapy, 100% maintained castration during 1 year of concomitant therapy with relugolix + Apa . No patient required dose modification of relugolix. Median T level was 10.0 ng/dL after 1 year of treatment. One month after treatment discontinuation, 8/10 (80%) patients saw recovery of their T (T ≥50 ng/dL). Treatment-emergent adverse events (TEAEs) occurred in all 12 patients (100%). TEAEs were consistent with known safety profiles for each drug administered separately. Conclusions: During the 12 months of concomitant relugolix + Apa administration, all patients who completed therapy maintained castrate T levels without relugolix dose modification. All but 2 patients had T recovery within 30 days of therapy discontinuation. These data support long-term T suppression with relugolix + Apa at standard doses. Subsequent T levels will be reported upon final analysis of the main study. Clinical trial information: NCT04523207 .
A novel, AI-generated morphologic biomarker to predict prostate cancer recurrence in patients with intermediate risk of progression.
Authors: Nair Sujit , Muhammad Hassan , Jain Parag , Xie Chensu , Pavlova Ina , Brody Rachel , Huang Wei , Nakadar Maria , Zhang Xiangfu , Basu Hirak S , Wilding George , Chakravarty Dimple , Roy Rajat , Tewari Ashutosh K. 
Published: June 2023

e17097 Background: About half of the prostate cancer (PCa) patients within an intermediate-risk group return to the clinic with disease progression after the first line of therapy. While these patients can be stratified into Gleason Grades (GG) 3+4 and 4+3, studies indicate that high-risk patients can still be found in both groups. Using our AI platform, we have developed a morphometric biomarker by analyzing digitized H&E slide images (WSIs), which can accurately predict early biochemical recurrence (within 36 months post-surgery) and the risk of metastatic disease more accurately than GG, TNM staging, and genomic tools. Methods: 125 intermediate-risk (n = 67, 3+4; n = 58, 4+3) samples were collected from the Icahn School of Medicine at Mount Sinai (ISSMS) to form a held-out test set. Seventy-eight patients within the test set had an associated genomic score. A series of deep learning models trained using data from ISMMS, the University of Wisconsin-Madison, and TCGA generated a high dimensional vector for each WSI to provide a numerical representation of observed morphologies, which is then converted into a single score to predict biochemical recurrence within 36 months (BCR) and rank risk of metastasis (MET). Area-under-the-receiver operating characteristic (AROC) was used to measure the accuracy of BCR, and the concordance index (CI) was used to measure the performance of MET. The high and low-risk groups' hazard ratios (HR) for patients within grades 3+4 and 4+3 show that our model can further stratify GG. Results: Our method was significantly better at predicting BCR (AROC: 0.801) and ranking MET (CI: 0.764) relative to GG, TNM, and genomic tool (Table 1). We further sub-stratified the patients into GG 3+4 and 4+3 and identified high-risk patients within each GG. Patients in GG 3+4 with high PATHOMIQ scores had a significantly higher risk of BCR (HR 3.3; 95% CI 1.44 – 7.56; p < 0.005) compared to the low PATHOMIQ score patients. A similar trend was seen in the GG 4+3 group (HR 3.0; 95% CI 1.32 – 6.83; p < 0.01). Conclusions: Our histopathology-based prognostic biomarker significantly improves over standard clinical markers in stratifying patients with intermediate-risk PCa for BCR and MET. Our method overcomes several limitations of genomic testing: We only need digitized WSIs. Our method is non-destructive and preserves the tissue for further interrogation. Moreover, our turn-around time is a few hours. Thus, the PATHOMIQ scoring method may strongly impact the management of intermediate-risk PCa patients and clinical trial patient selection for the successful development of new therapies for early-stage PCa. [Table: see text]
Validation of AI-based postoperative nomograms for biochemical recurrence in prostate adenocarcinoma.
Authors: Lee JaeHeon , Kwak Tae-Yeong , Cho Joonyoung , Kim Sun Woo , Chang Hyeyoon , Ha Hong Koo 
Published: June 2023

e17104 Background: After radical prostatectomy (RP), a steep increase in PSA level is an early sign of the disease progression in prostate cancer, which is known as biochemical recurrence (BCR). The risk of BCR can be evaluated based on a combination of clinicopathological factors, and the patient’s Gleason score plays a significant role. However, this scoring system may have lower consistency due to interobserver reproducibility in classifying Gleason Patterns (GP) as well as in quantifying the amount of each GP. We developed AI-based nomograms, with the aim of investigating their prognostic efficacy. Methods: In this study, digitized whole-slide images (WSIs) of H&E-stained prostatectomy specimens and clinical follow-up information were obtained from two sources: Pusan National University Hospital (PNUH, n = 967, event = 342) from 2010 to 2021 with the median follow-up being 3.7 years, and The Cancer Genome Atlas (TCGA, n = 352, event = 79) from 2000 to 2013 with the median follow-up 2.6 years. We used the DeepDx Prostate - RP, an AI-based prostate cancer Gleason grading model, to compute a pixel-wise probability map of each GP in WSIs. Then, a weighted sum of the probabilities and GPs was calculated for each pixel. The proposed slide-level score (AI score) was then determined by averaging them across all pixels in WSI, resulting in a value ranging from 3 to 5. Also, patients were divided into five groups using AI score thresholds (3.1, 3.5, 3.9, and 4.1), and five binary variables (AI score group 1-5) were generated, where a value of 1 indicates a patient’s categorization into a group. To evaluate predictability we created new nomograms incorporating AI scores based on existing nomograms: MSKCC and CAPRA-S. Unlike the original nomograms, the proposed nomograms do not include the Grade Group (GG) made by pathologists. Then, we fitted a Cox regression model on one of two datasets using the original and newly formed nomograms, and validated on the other dataset reporting the concordance index (c-index). Confidence intervals for the c-index were generated via the non-parametric bootstrap resampling with 9,999 samples. Results: The table shows the prognostic performance of sets of clinicopathological factors and demonstrates that the proposed AI score improved the predictive power. The nomograms with AI score group 1-5 outperformed the original nomograms, as shown in (d). Conclusions: In conclusion, we developed the AI-based nomograms which can improve the accuracy of predicting the biochemical recurrence in prostate cancer compared to the existing nomograms. [Table: see text]
Impact of obesity on admissions for COVID-19 with concurrent prostate cancer.
Authors: Verma Renuka , Ramphul Kamleshun , Dandwani Mehndi , Sharma Shivani , Chennapragada Suma Sri , Pagidipally Alekhya , Sombans Shaheen , Sanikommu Sailaja , Ramphul Yogeshwaree , Mejias Stephanie G , Pekyi-Boateng Prince Kwabla , Arti Fnu , Dhillon Balkiranjit Kaur , Kumar Vijay , Lohana Petras 
Published: June 2023

e17110 Background: Obesity is a significant risk factor for prostate cancer and its associated mortality. Recent studies have shown that a five-point rise in BMI can lead to a 10% rise in death among these patients. Since the pandemic of COVID-19, obesity has also been associated with poorer outcomes among the general population. As there is a paucity of data on the impact of obesity among prostate cancer admissions with COVID-19, we conducted a retrospective study to provide a novel perspective. Methods: Patients with a diagnosis of COVID-19 were used for our study from the 2020 National Inpatient Sample. We included cases between April 2020 to December 2020. Hospitalization records with prostate cancer and obesity were also identified via their respective ICD-10 codes. The differences in outcomes, including non-invasive ventilation, use of mechanical ventilation, pulmonary embolism, events of Acute Kidney Injury(AKI) and in-hospital mortality were compared between obese and non-obese patients with a history of prostate cancer, admitted for COVID-19. We also compared the mean lengths of stay, mean ages between the two groups, and their overall mean hospitalization charge. Results: A total of 7165 prostate cancer patients were hospitalized with COVID-19 between 1st April 2020 to 31st December 2020 in the United States. 1065 (14.9%) were obese. Prostate cancer patients admitted with COVID-19 who were obese were also younger (mean age 71.75 years) than those who were not obese (77.50 years) and recorded a more extended stay (mean LOS 9.68 days vs. 7.93 days). Obese patients also recorded a higher adjusted odds ratio for needing non-invasive ventilation (aOR 1.736, 95% CI 1.331-2.263, p < 0.01), mechanical ventilation (aOR 1.894, 95% CI 1.533-2.340, p < 0.01), events of acute kidney injury (aOR 1.328, 95% CI 1.137-1.550, p < 0.01), and in-hospital mortality (aOR 1.246, 95% CI 1.033-1.502, p = 0.021). While more patients with obesity developed pulmonary embolism (4.2% vs. 3.6%) after adjusting for confounders, the result was not statistically significant (aOR 1.258, 95% CI 0.879-1.800, p = 0.209). Obese patients also recorded a higher mean hospital charge compared to non-obese cases ($117200.50 vs. $81028.15). Conclusions: Obesity in prostate cancer patients admitted with COVID-19 is linked with several poor outcomes and complications, including AKI, mechanical ventilation, non-invasive ventilation, and mortality. Thus, physicians must identify such cases as higher-risk and encourage closer monitoring during their hospitalizations.
Late-stage prostate cancer and associated socioeconomic and demographic factors: A National Cancer Database Study.
Authors: Abodunrin Faith , Adeoye Oluwatayo , Masih Durva , Nelson Nick , Silberstein Peter T. , Tupper Connor 
Published: June 2023

e17115 Background: Prostate cancer accounts for 29% of all cancer diagnoses in men in the United States. A 3% annual increase in the incidence of prostate cancer was reported between 2014 to 2019. The stage at initial presentation significantly impacts the overall mortality of prostate cancer. Current 5-year survival estimates ranged from 99% in early-stage disease to <31% in distant disease. Given this enormous difference in survival rates, we studied the socioeconomic and demographic factors impacting the stage of prostate cancer at diagnosis. We also explored the time trends in the staging of prostate cancer. Methods: Using the National Cancer Database, we identified 1,880,352 patients diagnosed with prostate cancer between 2004 and 2019. We used variables including age at diagnosis, race, insurance status, and year of diagnosis. We used Chi-square tests to determine the association of a variable with staging at diagnosis. Multivariable logistic regression analyses determined the impact of our selected variables on the likelihood of early or late staging at diagnosis. All statistical analyses were performed using SPSS. All tests were performed with a significance level of a = 0.05. Results: In this study, we found that the relative percentage of late-stage diagnoses for blacks 21.5%, Hispanics 24.6% and Asians 25.3% were greater than for Whites 20.7%. Hispanics (OR 1.016) and Asians (OR 1.137) in particular, were more likely to be diagnosed at late stage compared to their white counterparts. Blacks were less likely to be diagnosed at a late stage compared to whites (OR 0.947). Men older than 70 years were more likely to be diagnosed at a late stage than men younger than 60 years (OR 1.149). Insurance status showed the greatest number of late-stage diagnoses in the uninsured 32.4% and Medicaid 31.6% populations while private 19.2% and Medicare 21.9% coverage had lower percentage of late-stage diagnoses. Finally, the year of diagnosis showed large differences in relative percentage of late-stage diagnoses with the 2004-2007 group diagnosing of cases 13.8% at late stage while the 2016-2019 group diagnosed 31.0% at late stage. The probability of having a late-stage diagnosis was higher between 2016-2019 than 2004-2007 (OR 2.724). These results were statistically significant (p<0.001). Conclusions: Old age is associated with late-stage diagnosis. This might be explained by the change in guidelines regarding screening against routine PSA screening in men older than 70 years of age. Since the change in 2008, we have seen a steady increase in the number of late diagnoses. In blacks, there have been some positive strides in late-stage diagnoses as they are less likely to be diagnosed later than whites. However, it is crucial to also pay attention to other groups like Hispanics and Asians that are not considered at increased risk for prostate cancer and hence typically screened less frequently.
Difference in management of patients with prostate cancer and spinal cord compression in teaching vs non-teaching hospitals in the United States.
Authors: Yazdanpanah Omid , Sharma Aditi , Rezazadeh Arash 
Published: June 2023

e17116 Background: Spinal Cord Compression (SCC) secondary to metastatic prostate cancer is a complication that can lead to irreversible loss of neurologic function. Many factors including age, comorbidities, severity of the compression, and neurological deficit can affect the treatment from conservative management to radiation and surgery. We aimed to study the difference in practice patterns and their outcomes in teaching hospitals (TH) vs non-teaching hospitals (NTH) in the United States. Methods: Utilizing the National Inpatient Sample Database (NIS), we conducted a retrospective cohort study on hospitalizations with prostate cancer and SCC between 2016 and 2020 across the US. Patients were divided into two groups of TH and NTH. Demographics, comorbidities, treatment modality, length of hospitalization, costs, and mortality were compared between the two groups. We also studied patients’ characteristics and outcomes in TH and NTH according to their treatment strategy. Results: We identified 11,380 metastatic prostate cancer patients with SCC admitted to the hospitals with a 7-day median length of stay. While 27.4% underwent surgical procedure and 11.5% received inpatient radiation, 61.2% were treated conservatively. The median cost of hospitalization was $21,922 in TH and $15,141 in NTH ( P< 0.001). Although the median age and Charlson Comorbidity Index did not differ between two groups ( P =0.12 & 0.66 respectively), patients in TH were more likely to receive intervention (either radiation or surgery) compared to NTH (Surgery: 28.2% in TH vs 23.0% in NTH; P <0.01 & Radiation: 12.1% in TH vs 8.2% in NTH; P <0.01). Mortality rate was lower in TH than NTH (4.5% vs 7.9%; P < 0.01). In both TH and NTH, patients with private insurance were more likely to undergo surgery (TH: Surgery 25.1% vs Radiation 18.8%; P< 0.05 & NTH: Surgery 27.0% vs 6.9% P< 0.05). Among different races, black patients were more likely to receive radiation than surgery in TH (34.2% vs 26.8%; P <0.05). With no difference in comorbidities between surgery and radiation group in TH ( P =0.16), all-cause mortality was higher for those who received radiation than for surgery (4.4% vs 1.9%; P <0.05) . Conclusions: This study indicated that practice pattern for the management of SCC in prostate cancer is different in teaching and non-teaching hospitals. In addition to more surgery being performed in teaching hospitals, the mortality rate was also lower. There was an association between race and insurance type with different treatment modalities. We also revealed that all-cause mortality was higher with radiation therapy compared to surgery in teaching hospitals.