bluuebunny/crossref_metadata_2025 huggingface dataset:
Association of multiparametric magnetic resonance imaging findings with oncologic outcomes in non-palpable localized prostate cancer.
Authors: Kumar Abhishek , LaBella Dominic , Acklin-Wehnert Scarlett , Gupta Rajan T. , Salama Joseph Kamel , Boyer Matthew J
Published: January 2024

281

Background: Multiparametric magnetic resonance imaging (mpMRI) is becoming increasingly integrated into the evaluation and medical decision making for localized prostate cancer. However, mpMRI findings have not been correlated with prostate cancer outcomes and therefore are not currently included in staging. The purpose of this study was to test the association between mpMRI detected extraprostatic extension with oncologic outcomes in patients with non-palpable prostate cancer. Methods: We used the Veterans Affairs Prostate Data Core to identify patients diagnosed with cT1N0M0 prostate cancer between 2000-2021 with an mpMRI prior to definitive treatment. We reviewed MRI reports to identify presence of extracapsular extension (MRI-T3a), seminal vesicle invasion (MRI-T3b), and adjacent organ invasion (MRI-T4). We assessed the impact of mpMRI findings on metastasis free survival with multivariable Fine-Gray competing-risks regression. Results: Overall, 3,142 veterans with cT1N0M0 prostate cancer were included. There were 1,411 (45%) Black patients. By clinical staging, 904 (29%) had low risk, 1,626 (52%) had intermediate risk, and 612 (19%) had high risk disease. The majority of patients were treated with radiation (N=2,267; 72%). There were 217 (7%) patients with MRI-T3a disease, 87 (3%) patients with MRI-T3b disease, and 26 (1%) patients with MRI-T4 disease. The median follow-up time was 5.4 years (90% CI, 1-13 years). The 5-year cumulative incidence of metastases for patients with low, intermediate, and high risk prostate cancer were 3% (95% CI, 2-4%), 7% (95% CI, 6-8%), and 15% (95% CI, 12-18%). The 5-year cumulative incidence of metastases for patients with MRI-T3a, MRI-T3b, and MRI-T4 disease were 15% (95% CI, 10-20%), 29% (95% CI, 29-39%), and 40% (95% CI, 13-66%). After controlling for age, race, risk stratification (which includes prostate specific antigen (PSA) and grade group), local therapy, and co-morbidities, the presence of MRI-T3a (HR 1.58, 95% CI 1.09-2.29, p=0.02), MRI-T3b (HR 3.38, 95% CI 2.31-4.95, p<0.0001), and MRI-T4 disease (HR 4.47, 95% CI 2.32-8.62, p<0.0001) were independently associated with worse metastasis free survival. Similar results were obtained with PSA and grade group as individual variables. Conclusions: Extraprostatic extension observed on mpMRI is independently prognostic of metastasis free survival in patients with non-palpable prostate cancer. mpMRI is a critical imaging modality that should be widely available for patients with prostate cancer, and studies are ongoing to define its role as a standard staging modality.
Interim analyses from the PROSPET-BX trial: [G8Ga]PSMA PET/CT vs. mpMRI in patients with suspicion of prostate cancer and previous negative biopsy.
Authors: Lopci Egesta , Lazzeri Massimo , Disconzi Luca , Colombo Piergiuseppe , Saita Alberto , Peschechera Roberto , Fasulo Vittorio , Maffei Davide , Zanca Roberta , Casale Paolo , Rodari Marcello , Guazzoni Giorgio Ferruccio , Balzarini Luca , Buffi Nicolo' , Lughezzani Giovanni
Published: January 2024

282

Background: Herein we present the results of the interim analyses of our prospective trial (Identifier: NCT05297162), designed to compare [68Ga]PSMA PET/CT with mpMRI in men with a high suspicion of prostate cancer (PCa) after at least one previous negative biopsy. Methods: From April 2022 until September 2023, overall, 94 patients were screened, 78 were enrolled and 64 completed all study investigations. Inclusion criteria: PSA>4.0ng/ml; free-to-total PSA ratio <20%; progressive rise of PSA levels in two consecutive samples; at least one previous negative biopsy; negative digital rectal examination. [68Ga]PSMA PET/CT and 3T mpMRI were performed within one month, followed by TRUS-fusion prostate biopsy. Target lesions were defined based on PI-RADS v2.1 for mpMRI and Primary Score, SUVmax and SUVratio for [68Ga]PSMA PET/CT, then correlated to pathology findings. Results: Median age was 64 years (range 51-83) and median PSA 10.4 ng/ml (range 4.3-25,9). Most patients (76.6%) had one previous negative biopsy. According to re-biopsy results, 10 patients presented with clinically significant PCa (csPCa), 4 with GS 6, while the majority had a negative biopsy (78%). mpMRI results were: 40 patients with PI-RADS 2 (62.5%), 3 with PI-RADS 3 (4.7%), 15 with PI-RADS 4 (23.4%), and 6 with PI-RADS 5 (9.4%). Primary scores were: 45 score 1-2 (70%), and 19 score 3-5. PI-RADS and Primary scores were significantly correlated (P=0.0006). Median SUVmax and SUVratio were 3.7 and 1.35 for benign versus 8.9 and 3 for malignancy, respectively (P<0.001). ROC analyses identified optimal cut-off points for csPCA, with SUVmax>7.48 (AUC 0.756; 95%CI 0.633-0.855) and SUVratio>2.79 (AUC 0.748; 95%CI 0.624-0.848). PI-RADS, Primary score, SUVmax and SUVratio proved significantly associated to biopsy results. When combining [68Ga]PSMA PET/CT with mpMRI data, the detection rate was 90% for csPCa, and the combination of both modalities could spare 87.5% of unnecessary re-biopsies. Conclusions: In these interim results, [68Ga]PSMA PET/CT parameters predict biopsy results as mpMRI in patients who are candidates to re-biopsy; the combination of both modalities can spare most unnecessary re-biopsies, by granting a 90% detection rate for csPCa. Clinical trial information: NCT05297162 .
Detection and delineation of intraprostatic lesions (IPLs) using multiparametric magnetic resonance imaging (mpMRI) and prostate specific membrane antigen positron emission tomography (PSMA PET) for patients with prostate cancer: A systematic review and meta-analysis.
Authors: Dhar Aneesh , Mendez Lucas , Cendejas-Gomez Jose de Jesus , Boldt Gabriel , McArthur Eric , Zamboglou Constantinos , Bauman Glenn
Published: January 2024

287

Background: External beam radiation therapy (EBRT) is a common treatment used for patients with prostate cancer, however, isolated local failures (ILFs) can occur in up to 13% of patients receiving EBRT. Most ILFs occur at the location of the previously known intraprostatic lesions (IPLs). The FLAME trial has shown improved cancer outcomes for patients treated with EBRT who receive a focal radiation boost to their IPL. Both mpMRI and PSMA PET can be used to localize IPL for these patients. Methods: A systematic review and meta-analysis was conducted for the use of mpMRI and PSMA PET for the detection and delineation of IPLs for patients with localized prostate cancer. Trials were included if patients received either mpMRI, PSMA PET, or both, prior to radical prostatectomy (RP). IPLs on RP specimens were used as the reference standard. The quality of the co-registration between imaging and histopathology was assessed as high or low for each study included in the systematic review. Outcomes that were recorded include sensitivity and specificity, among others. A meta-analysis was conducted using a bivariate model to determine the sensitivity, specificity, and area under the receiver operating curve (AUROC) of mpMRI, PSMA PET, and their combination. This systematic review was registered through PROSPERO (CRD42023389092). Results: After exclusions, 20 studies were incorporated into the bivariate meta-analysis. In total, there were 13 studies using mpMRI (n = 541 patients), 12 studies that used PSMA PET (n = 327), and 5 studies that used a combination (n = 180). The pooled sensitivity (95% CI), specificity (95% CI) and AUROC for mpMRI were 64.7% (50.2% – 76.9%), 86.4% (79.7% - 91.1%), and 0.852; the pooled outcomes for PSMA PET were 75.7% (64.0% - 84.5%), 87.1% (80.2% - 91.9%), and 0.889; for their combination, the pooled outcomes were 70.3% (64.1% - 75.9%), 81.9% (71.9% - 88.8%), and 0.796. When reviewing studies with a high-quality co-registration between imaging and histopathology, IPL delineation recommendations included using a 1-2 mm margin when delineating on mpMRI, using a SUV max threshold of 20-30% for PSMA PET, and using the union of mpMRI and PSMA PET when using both modalities. Conclusions: In this study, we conducted a meta-analysis of studies that used mpMRI, PSMA PET or their combination prior to RP for patients with localized prostate cancer. The pooled sensitivity and specificity for each modality had overlapping 95% confidence intervals, suggesting the modalities have similar accuracy in detecting IPLs on RP specimens. There were different delineation recommendations based on the imaging modalities used in studies with a high-quality co-registration of imaging and histopathology.
Imaging predictive biomarkers of response in patients with prostate cancer undergoing high-intensity focused ultrasound (HIFU) focal therapy.
Authors: Lopci Egesta , Lughezzani Giovanni , Fasulo Vittorio , Maffei Davide , Saita Alberto , Casale Paolo , Peschechera Roberto , Hurle Rodolfo , Benetti Alessio , Pasini Luisa , Zandegiacomo Silvia , Rodari Marcello , Zanca Roberta , Balzarini Luca , Guazzoni Giorgio Ferruccio , Buffi Nicolo' , Lazzeri Massimo
Published: January 2024

288

Background: The current study is designed to evaluate the role of PSMA PET/CT for response prediction in prostate cancer (PCa) patients who are candidates for High-Intensity Focused Ultrasound (HIFU) focal therapy (FT). Methods: BetweenOctober 2020 and June 2023, overall 65 patients have been enrolled in our prospective, single-center study. Inclusion criteria were: PSA<20ng/mL, radiological stage ≤T2bN0M0, ISUP grade 1-3, PSMA PET/CT at baseline and at response evaluation 6-12 months post-treatment. Follow up included: PSA at 3, 6 and 12 months. Post-treatment biopsies were scheduled per-protocol at 12 months or earlier if imaging suspicious. Biochemical response and treatment failure were correlated to mpMRI and PSMA PET data, comprising PI-RADS, Primary score, SUVmax, SUVratio, and their variations after HIFU FT. Results: Median age was 67 years (range 53-80), initial PSA (iPSA) was 6.56ng/mL (range 2.25-13.25) and prostate volume was 45mL (range 20-160). The majority of the patients presented with ISUP 1 (66%). mpMRI results were: 14 patients with PI-RADS 1-2 (21.5%) and 51 with PI-RADS 3-4. Baseline Primary scores were: 30 score 1-2 (45%), and 35 score 3-5. Median baseline SUVmax and SUVratio resulted 5.4 (range 1.5-33.2) and 1.43 (range 0.86-9.39), respectively. At 3 months post-HIFU, 23% of the patients obtained a PSA response ≥50%; whereas at 6 months and 12 months, PSA responses were 26% and 45%, respectively. Post-treatment PSMA PET/CT was available in 40 patients. Median SUVmax and SUVratio post-treatment resulted 3.4 (range 1.4-28.4) and 1.1 (range 0.64-10), respectively, with a median ΔSUVmax of 39% and ΔSUVratio of 42%. There was a moderate negative correlation between post-treatment SUVmax and SUVratio with PSA response at 12 months (rho=-0.504, p=0.0280, and rho=-0.521, p=0.0231, respectively), while a positive moderate correlation was confirmed for ΔSUVmax (rho=0.475, p=0.0383). PET parameters were also statistically significantly correlated to treatment failure at 12months (p=0.020, p=0.048 and p=0,04, respectively for SUVmax, SUVratio and Primary), with Primary scores confirmed as predictive on logistic regression (OR=10.5; 95%CI 1.12-98.9). Conclusions: PSMA PET/CT provides useful information for treatment monitoring in PCa patients undergoing HIFU FT. Baseline and post-treatment SUV parameters and Primary score can predict biochemical response and treatment failure at 12 months post-completion.
Association of aggressive prostate cancer features on whole-mount histopathology and quantitative measures on PSMA PET.
Authors: Sonni Ida , Kim Daniel Hyeong Seok , Ter-Pogosyan Arthur , Grogan Tristan , Barroso Nashla , Ahuja Preeti , Soin Priti , Calais Jeremie , Reiter Robert Evan , Hsu William , Czernin Johannes , Sisk Anthony E , Raman Steven
Published: January 2024

289

Background: The intraductal carcinoma (IDC) and the large cribriform growth pattern (LCP) are two architectural patterns of prostate cancer (PC) associated to more aggressive disease, high Gleason scores, advanced tumor stage, biochemical relapse, and distant metastasis. Predicting the presence of these pathology features could be of significant help in case whole-mount pathology (WMHP) is not available. The goal of this analysis was to assess the distribution of quantitative parameters from 68Ga-PSMA-11 PET/CT (PSMA PET) in lesions with and without LCP/IDC patterns on WMHP. We assessed the ability of pre-surgical PSMA PET imaging to predict the presence of aggressive pathology features. Methods: With IRB approval and HIPAA compliance, we derived a study cohort of PC patients who underwent PSMA PET prior to robotic radical prostatectomy (RALP). WMHP analysis described presence/absence of LCP and IDC patterns in each identified PC lesion. Board-certified physicians contoured all PC lesions on PSMA PET. Only lesions matching with WMHP were included in the analysis. PSMA PET metrics (SUVmax, SUVmean and PSMA-volume) were extracted. All lesions were categorized in sub-cohorts as LCP+/IDC+, LCP+/IDC-, LCP-/IDC-, and LCP-/IDC+. One way-ANOVA assessed significant differences among the imaging parameters in the sub-cohorts. The area under the curve (AUC) from ROC analysis was used to assess the ability of imaging metrics to predict the presence of aggressive PC features on WMHP. Results: The final cohort comprised 155 patients and 177 lesions. The median (IQR) PSA at time of RALP was 9.2 (5.55-15.05). 73/177 lesions (41.2%) were categorized as LCP+/IDC+, 63/177 (35.6%) as LCP-/IDC-, 37/177 (20.9%) as LCP+/IDC-, and 4 (2.3%) as LCP-/IDC-. SUVmax (p=0.007), SUVmean (p=0.048) and lesion size on PSMA PET (p=0.003) were significantly higher in lesions showing LCP, whereas only lesion size was significantly higher in lesions showing IDC (p=0.003). Lesions showing LCP+/IDC- had significantly higher SUVmax (p=0.002) and SUVmean (p=0.001) than lesions showing LCP-/IDC-. SUVmean was significantly higher in LCP+/IDC- than in LCP+/IDC+ (0.043). SUVmax and SUVmean were not significantly different among other sub-cohorts. Lesion size on PSMA PET was significantly higher in LCP+/IDC+ than in LCP-/IDC- (0.009). A logistic regression model analysis showed that PSMA PET quantitative measures predict the presence of LCP and/or IDC with moderate accuracy (AUC= 0.69; p=0.001). Conclusions: Higher SUVmax and SUVmean are found in lesions showing LCP, but not in those showing IDC. A linear regression model including SUVmax, SUVmean and PSMA PET lesion volume was able to predict with moderate accuracy the presence of pathology features of aggressive prostate cancer (AUC: 0.69).
Prospective evaluation of the Kaiser Permanente prostate cancer risk calculator in biopsy-naïve men with mild PSA elevations.
Authors: Presti Joseph , Horton Brandon , Alexeeff Stacey , Prausnitz Stephanie , Avins Andrew
Published: January 2024

290

Background: To assess the impact on biopsy outcomes in biopsy-naïve men with mild PSA elevations (<10 ng/ml) when provided risk estimates using a novel prostate cancer risk calculator. Methods: This prospective study was conducted in urology departments in Kaiser Permanente Northern California in men with PSA elevations that were <10 ng/ml between March 2021 and March 2023. Patient variables (age, race, family history of prostate cancer, body mass index, and PSA level) were entered into our validated calculator. Risk estimates for high-grade cancer (Gleason score ≥7) and overall cancer were shared with the patient who accepted or declined the biopsy. We compared age, race, family history for prostate cancer, BMI, PSA level, predicted high-grade and overall cancer risks between those that accepted and those that declined biopsy. The outcomes of those who underwent biopsy were compared to historical data of biopsy-naïve men with PSA elevations <10 ng/ml who underwent biopsy in the three years prior to the Covid pandemic between January 2016 and December 2019 (n=5141). Results: After 24 months, the calculator was used to estimate risk for 1962 biopsy-naïve men with mild PSA elevations. 1455 (74%) accepted the biopsy. Those with a family history for prostate cancer were slightly more likely to accept biopsy. Age (continuous and categorical), and BMI (continuous and categorical) were not associated with decision for biopsy. Similarly, race/ethnicity when analyzed as four categories (White, Black, Asian, Hispanic) or as two categories (Black vs. all others) was not associated with decision for biopsy. The men who accepted the biopsy had higher predicted median high-grade cancer risks (24% [IQR 17-31%] vs. 20% [IQR 14-29%]; p<0.0001) and higher predicted median overall cancer risks (48% [IQR 40-56%] vs 45% [IQR 37-53%], respectively; p<0.0001) than those who declined the biopsy. Compared to the historical group, use of the risk calculator resulted in a biopsy population enriched with high-grade cancer: 29% vs 25%; similar rates of low-grade cancer: 24% vs 24%; and fewer negative biopsies: 47% vs. 51%, respectively; overall p=0.013. Conclusions: In biopsy-naïve men with mild PSA elevations, use of our risk calculator resulted in a biopsy population that had more high-grade cancer and fewer negative biopsies compared to a historical group. Only family history and higher predicted cancer risks by the calculator were associated with biopsy acceptance.
The risk of prostate cancer diagnosis in men with an elevated PSA but low IsoPSA.
Authors: Abdallah Nour , Benidir Tarik , Wood Andrew , Lone Zaeem M , Campbell Rebecca , Zhang Ao , Ergun Onuralp , Curry Caleb , Liao Ross , Michael Patrick , Haywood Samuel , Schwen Zeyad , Olivares Ruben , Kaouk Jihad , Abouassaly Robert , Klein Eric A. , Weight Christopher
Published: January 2024

292

Background: IsoPSA is a structure-based serum assay. Initial studies demonstrated that it outperformed total and percent-free PSA in detecting clinically significant prostate cancer (csPCa) (i.e., grade group (GG) ≥2) on biopsy. This led to an overall reduction in invasive testing and magnetic resonance imaging (MRI). We sought to compare the risk of csPCa in patients with an initially normal or high IsoPSA, thus assessing IsoPSA’s prospective predictive ability of csPCa. Methods: We performed a single-center retrospective review of patients (n=1578) who underwent IsoPSA testing from November 2016 to August 2022. Data was dichotomized into patients with normal (≤6) and high IsoPSA (>6). We collected the outcomes of any follow-up IsoPSA, prostate biopsy, MRI, and diagnosis of prostate cancer. In the case of multiple follow-up tests, the most recent one was recorded. Results: The median follow-up time of 1578 patients who underwent IsoPSA testing was 24 months (IQR 16-29). Among 541 patients with an initial normal IsoPSA, 60 (11.1%) had a subsequent high IsoPSA, 23 (4.3%) had csPCa on a subsequent biopsy, and 48 (8.9%) had suspicious lesions on MRI (PI-RADS 4-5). Among 1037 patients with an initial high IsoPSA, 366 (35.3%) had csPCa on a subsequent biopsy and 342 (33%) had suspicious lesions on MRI. The sensitivity of IsoPSA to predict csPCa was 94.1%, and its negative predictive value was 89.3%. Conclusions: With 24-month follow-up, 4.3% of patients with normal IsoPSA developed csPCa, suggesting that a low baseline IsoPSA provides durable information about the 2-year risk of csPCa.[Table: see text]
Burnout among GU oncologists and associated factors: BUCARE survey.
Authors: Kahharov Alisher , Tsimafeyeu Ilya , Shatkovskaya Oxana , Kaidarova Dilyara , Polatova Jamila , Guliyev Fuad , Ongarbayev Bakytzhan , Mitin Timur
Published: January 2024

293

Background: The growing number of patients with genitourinary (GU) cancers coupled with complexity of their treatments could create an increasing burden on GU oncologists. The Bureau for Cancer Research (BUCARE) assessed the prevalence of burnout among GU oncologists. Methods: This is a cross-sectional survey study conducted online among practicing surgical, medical and radiation oncologists from Kazakhstan, Russia, Uzbekistan, Azerbaijan, Georgia, Kyrgyzstan, Tajikistan, and Israel. The primary outcome is burnout experience assessed through the Maslach Burnout Inventory. Association between respondents’ characteristics and presence of burnout was tested using X-test. Results: From April to August 2023,a total of 674 GU oncologists completed the questionnaire. The characteristics of respondents are 50% female, 45% medical oncologists, 35% surgeons, 15% radiation oncologists, working in outpatient (35%) and inpatient (65%) departments. Ninety-two percent of responders are interested in their daily work and 83.7% have a great interest in further professional development. However, 71.5% (482 of 674) had symptoms of burnout (high emotional exhaustion and/or depersonalization scores) and 60.8% of respondents describe readiness to seek psychological support. 172 (25.5%) and 401 (59.5%) participants reported that they do not have enough time to communicate with their family at all or partially, respectively. Significant drivers of burnout identified in multivariable regression modeling include ≥20 patients per day (odds ratio [OR] = 15.1; P<0.001) and ≥10 working hours per day (OR=10.4; P<0.001). Male gender (OR=0.1; P<0.001) and specialization in radiation oncology (OR=0.19; P<0.01) are associated with lower odds of burnout. Conclusions: Two-thirds of surveyed GU oncologists met predefined standardized criteria for burnout. Expanding the staff of GU oncologists and reducing the daily workload may improve the emotional state of these physicians. Special attention must be paid to the work environment of female providers as well as surgical and medical oncologists to decrease the rate of burnout.
Contemporary management and pathologic outcomes of men with low- and very low-risk prostate cancer.
Authors: Ho Austin Y. , Li Eric , Bennett Richard , Aguiar Jonathan , Kumar Sai , Neill Clayton , Schaeffer Edward M. , Patel Hiten Dilip , Ross Ashley
Published: January 2024

297

Background: The very-low risk (VLR) substratification of prostate cancer has been called into question with the 2022 American Urological Association (AUA) guidelines dropping this designation. Historical data suggested men with VLR disease have a reduced risk of disease progression compared to other low risk (LR) men. In this study, we evaluate contemporary initial management, disease progression, and predictors of upgrading for VLR and LR patients in a multi-centered hospital system. Methods: We retrospectively identified men diagnosed with VLR or LR prostate cancer across our eleven-hospital system (January 2018-September 2022). Active surveillance (AS) was defined as no treatment within 1 year of diagnosis. Adverse pathology at surgery was defined as Gleason Grade (GG) 3-5 or pT3b. Clinical variables were compared with appropriate statistical tests (Wilcoxon rank sum, Chi square, Fisher’s exact). A multivariable logistic regression model evaluated predictors of upgrading (≥GG2). Results: 566 patients (305 VLR, 261 LR) were included. AS was the initial management for 85% and 78% of VLR and LR patients, respectively (p=0.029). With a median follow up time of 26 months, VLR patients were less likely receive treatment versus LR patients (24% vs. 38%, p<0.001) or be reclassified to GG2-5 disease (24% vs. 39%, p<0.001). VLR patients had less volume of disease at diagnosis by percentage of positive cores (7% vs. 16%, p<0.001) and maximum core positivity (7% vs. 20%, p<0.001). On multivariable regression analysis, only pre-biopsy PI-RADS (OR 1.88 for PI-RADS 4 (p=0.030); OR 4.53 for PI-RADS 5 (p<0.001)) and percentage of positive cores (OR 1.02, p=0.039) were significant predictors of upgrading. Of men who receiving surgery, adverse pathology rates were similar for VLR and LR patients (14% vs. 19%, p=0.5). Conclusions: Men with VLR prostate cancer have lower treatment and upgrading rates than LR patients. VLR patients were more likely to be initially managed with AS and forgo definitive treatment, but rates of adverse pathology at surgery were similar. The findings support the AUA decision to drop the VLR substratification, but attention to high MRI PI-RADS and percentage of positive cores at diagnosis should be considered when evaluating risk of disease progression for men with GG1 prostate cancer.[Table: see text]
Real-world treatment patterns for patients with high-risk biochemically recurrent nonmetastatic castration-sensitive prostate cancer.
Authors: Freedland Stephen J. , Ribbands Amanda , Butcher Jake , Brown Tom , Russell David , Bland Christopher S , Touya Maelys , Ivanova Jasmina I.
Published: January 2024

299

Background: Patients with biochemically recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC) who are identified as high-risk of developing metastases may benefit from earlier treatment. This study analyzed treatment patterns in these patients. Methods: The Adelphi Real World nmCSPC retrospective survey was completed by urologists and radiation oncologists in the US. For this analysis, data from medical charts for patients diagnosed with high-risk BCR nmCSPC from Jan 2021–Jul 2023 were extracted; physicians completed a chart for their last 6–8 patients. Data were analyzed descriptively for first line (1L) treatment received (regardless of time) since high-risk BCR diagnosis for the total patient sample and subgroups of interest. Physicians documented those with no treatment as on observation. Results: Aggregated data were analyzed for 376 patients with high-risk BCR nmCSPC; 252 (67%) had prostate-specific antigen doubling time (PSADT) ≤9 months after BCR and initial definitive therapy of radiotherapy (RT) and/or radical prostatectomy (RP). Overall, 84% were treated by urologists and 16% by radiation oncologists. Median age was 70 years; 64% were White, 31% were Black/African American. Median PSA at high-risk BCR diagnosis was 5 ng/mL. Median follow-up after high-risk BCR diagnosis was 249 days. Median time between high-risk BCR diagnosis and initiation of 1L treatment was 17 days. Most common 1L treatments were androgen deprivation therapy (ADT) alone, salvage RT, novel hormonal therapy (NHT) + ADT, and observation alone. For patients on observation alone, median follow-up after high-risk BCR diagnosis was 181 days. Few numerical differences were seen in treatment patterns depending on how patients were determined as high-risk (Table). Patients treated by urologists rather than radiation oncologists had numerically higher proportions of 1L treatment with NHT + ADT (21% / 2%) and observation alone (17% / 8%), and numerically lower proportions of ADT alone (27% / 34%) and salvage RT (12% / 44%). Conclusions: First line treatments were typically initiated rapidly following high-risk BCR nmCSPC diagnosis, with only 15% of patients receiving observation alone during available follow-up. [Table: see text]
Endocrine and metabolic diseases among survivors of prostate cancer in a population-based cohort.
Authors: Hu Siqi , Chang Chun-Pin , Dodson Mark W. , Deshmukh Vikrant , Newman Michael , Date Ankita , Sanchez Alejandro , Lloyd Shane , ONeil Brock , Hashibe Mia
Published: January 2024

306

Background: Prostate cancer treatment has been widely associated with developing and/or worsening metabolic syndrome. While numerous studies have explored the interplay between prostate cancer and metabolism, there have been very few studies investigating endocrine and metabolic disease diagnoses among prostate cancer survivors with long term follow up. The aim of this study is to examine the incidence of endocrine and metabolic disease among prostate cancer survivors compared to a general population cohort. A secondary aim is to investigate risk factors for endocrine and metabolic disease among prostate cancer survivors. Methods: Cohorts of 18,134 cancer patients with prostate adenocarcinomas diagnosed between 2004 and 2017 and 73,470 men without cancer matched by age, birth state and follow up time from the general population were identified. Incidental endocrine and metabolic diseases diagnoses were identified from electronic medical records and statewide healthcare facilities data. Cox proportional hazard models were used to estimate hazard ratios (HRs). Results: Prostate cancer patients had increased risks of endocrine and metabolic diseases for the overall 16-year follow-up after cancer diagnosis (1-5 years: HR=1.26, 99%CI=1.22-1.31; 5-10 years: HR=1.21, 99%CI=1.16-1.26; 10-16 years: HR=1.20, 99%CI=1.12-1.28) compared to the general population. Elevated risks of thyroid disorder among prostate cancer patients were observed across follow-up periods (1-5 years: HR=1.19, 99%CI=1.11-1.28; 5-10 years: HR=1.12, 99%CI=1.03-1.22; 10-16 years: HR=1.17, 99%CI=1.02-1.35). Similarly, disorders of lipid metabolism risks were higher for all follow-up periods (1-5 years: HR=1.53, 99%CI=1.41-1.66; 5-10 years: HR=1.21, 99%CI=1.15-1.26; 10-16 years: HR=1.20, 99%CI=1.11-1.29). The risks of obesity and diabetes mellitus were also increased within 1-10 years and 1-5 years, respectively. Risk factors for endocrine and metabolic diseases among prostate cancer survivors included non-Hispanic ethnicity, unhealthy BMI, CCI≥1, family history of cancer, older age at diagnosis, and higher cancer stage throughout the overall follow-up periods after prostate cancer diagnosis. Significant risk factors for endocrine and metabolic diseases within 1-10 years after prostate cancer diagnosis included family history of prostate cancer, single marital status, government health insurance, high socioeconomic level, and high household incomes. Moreover, prostate cancer survivors with a diagnosis of endocrine and metabolic diseases faced a 13% increased risk of death. Conclusions: This study highlights a heightened risk of endocrine and metabolic diseases among prostate cancer survivors throughout the entire follow-up period after cancer diagnosis. It underscores the importance of multidisciplinary care to monitor and manage endocrine and metabolic diseases in this population of survivors.
Prostate Cancer Supportive Care (PCSC) Program: A model for meeting an unmet need for patients with PC.
Authors: Higano Celestia S. , Sundar Monita , Zarowski Christine , Lui Meghan , Pratap Nicholas , Egilson Joy , Holmes Andrea , Ivanov Nikita , Dayan Marcy , Hudon-Kaide Anna , Griggs Paul , Maurice-Dror Corinne , Ho Rosalie , Sare Daniella , Hwang Angela , Flannigan Ryan
Published: January 2024

308

Background: Prostate cancer (PC) patients (pts) face treatment-related sequelae that affect their quality of life. The PCSC Program was created in 2013 and is located in the Vancouver Prostate Centre’s urology clinic. It is a clinical, educational, and evidence-based program that addresses challenges experienced by PC pts from the time of diagnosis onward. The program consists of 8 “modules,” each designed to support a specific concern. Methods: We describe the operational details of the PCSC Program and its metrics. Results: The program consists of a Medical Director and Program Manager who articulate the mission, oversee the day-to-day operations, and hire and manage the allied health clinicians and administrative staff. Clinicians include two sexual health RNs (1.4 FTE), two pelvic floor physiotherapists, a nurse practitioner, a registered dietitian, two clinical exercise physiologists, and two clinical counselors (all 0.2 FTE). A sexual health urologist is in the clinic, and a medical oncologist delivers the metastatic disease module. As of 09/2023, 3562 pts registered for this no-cost program (Table). Pts choose modules relevant to their interests and needs. The program supports free language interpretation services to non-English speaking pts. Translation of education session recordings is currently underway. In 4/2020, in response to the COVID-19 pandemic, the real-time group education sessions and clinic appointments transitioned from in-person to hybrid delivery, with virtual options enabling the participation of pts from throughout British Columbia. PCSC maintains high patient satisfaction, as indicated by responses to patient satisfaction questionnaires. Conclusions: The need for PC supportive care is well recognized but may be challenging when the services are fragmented, costly, and time-consuming to orchestrate. All modules offered by the PCSC Program can be accessed with one registration and are conveniently housed in one location, which also facilitates clinician communications across disciplines. We attribute the success of our program and high patient satisfaction to this model and our team approach to the individual patient’s needs. [Table: see text]
Transperineal prostate biopsies without routine administration of perioperative antibiotics: A single-institution retrospective analysis.
Authors: Lichtbroun Benjamin , Patel Mann , Khizir Labeeqa , Said Munisa , Consalvo Alexis , Chien Austin , Chua Kevin J. , Srivastava Arnav , Pfail John , Elsamra Sammy , Jang Thomas L. , Ghodoussipour Saum
Published: January 2024

310

Background: Infections are the most feared complication of transrectal prostate biopsy. Unfortunately, these complications are not infrequent. With antibiotic resistance becoming increasingly common, our institution has transitioned to a transperineal approach without use of perioperative antibiotics or bowel preparation. Given this significant change in practice pattern, we retrospectively analyzed these patients for rates of post-operative complications, 30-day hospital readmissions, and detection of prostate cancer. Methods: We retrospectively analyzed 146 patients who underwent a transperineal prostate biopsy at our institution in 2022. We recorded rates of complications including UTIs, sepsis, hematuria, and 30-day hospital readmissions. We also analyzed the percentage of patients found to have prostate cancer. Results: Of the 146 patients analyzed, 8 patients received peri-operative antibiotics (5.47%) - this was at the discretion of the surgeon performing the procedure. The reason 8 patients received peri-operative antibiotics was due to a prior infectious complication following a previous transrectal prostate biopsy. No patient received bowel preparation. Pre-procedure MRI was performed in 134 patients who had a MRI-ultrasound fusion biopsy. Hematuria was reported in 12 patients (8.21%) and there were zero infectious complications (UTI or sepsis). There were no 30-day readmissions amongst this cohort. Median procedure time was 24 minutes (Table). 86 patients were found to have adenocarcinoma (58.90) while 48 patients had benign pathology (32.87%). Conclusions: Despite a small percentage of patients receiving perioperative antibiotics, we had zero patients develop sepsis or an UTI. Our 30-day readmission rate was also 0%. With the high reported rates of infectious complications after transrectal prostate biopsy and antibiotic resistance becoming increasingly common, our data supports the notion that transperineal prostate biopsies are safe and can largely be done without the use of perioperative antibiotics.[Table: see text]
De novo financial toxicity in patients with prostate cancer following radical prostatectomy and its impact on health-related quality of life.
Authors: Westhofen Thilo , Buchner Alexander , Eismann Lennert , Rodler Severin , Becker Armin , Stief Christian G. , Kretschmer Alexander
Published: January 2024

318

Background: Financial toxicity (FT), a patient-reported outcome measure (PROM) is defined as the detrimental impact of financial burden caused by a cancer diagnosis on a patient’s well-being. FT is common among cancer patients, yet little is known about FT following radical prostatectomy (RP) for prostate cancer in countries with universal health coverage. We aimed to assess de novo FT and its impact on health-related quality of life (HRQOL) in a large prospective cohort of patients undergoing RP with a systematic follow-up of up to 10 yrs. Methods: 2254 consecutive patients who underwent RP at a large tertiary care center were analyzed. PROMs were prospectively assessed preoperatively, postoperatively at 3mo, then annually until a maximum follow-up of 120mo, applying the validated EORTC QLQ-C30- and the prostate cancer-specific QLQ-PR25 questionnaires. FT was assessed by the “financial toxicity subscale” (FTS) of the EORTC QLQ-C30. Based on previous reports, meaningful FT was defined as FTS ≥ 17. Multivariable regression analysis was used to identify predictors for the development of de novo FT. Separate modeling of longitudinal HRQOL was performed for patients with de novo FT (FT-cohort) and without FT (no-FT-cohort). General HRQOL was assessed by the global health status domain (GHS) of the EORTC QLQ-C30. Results: 298 patients reporting FT prior RP were excluded from further analysis. 20.3% (n=397) of the included patients reported de novo FT within 12 months after RP with a mean FTS-score of 47.3 (SD 21.9). Baseline clinicopathological characteristics did not differ between the FT-cohort and the no-FT-cohort (p-range .060-.173). Multivariable logistic regression analysis revealed subsequent therapies following RP (OR 1.981, 95%CI 1.11-3.53, p=.020), low preoperative emotional functioning (OR 0.990, 95%CI 0.92-0.99, p=.031) and low preoperative social functioning (OR 0.990, 95%CI 0.98-0.99, p=.035) to independently predict development of de novo FT after RP. In longitudinal analysis, significantly worse general HRQOL was observed for patients with de novo FT postoperatively and up to 48mo after RP (p-value each < .001). In the longer term, both cohorts reported no significant difference in general HRQOL up to 10yrs post RP (p-range: .90 - .91). Conclusions: The current study provides prospective data from a unique contemporary patient cohort, which reveals independent predictors for de novo FT in prostate cancer patients following RP. Furthermore, it displays the natural course of general HRQOL for patients who develop de novo FT.
Assessing the clinical utility of rapid post-therapy whole-body digital SPECT/CT in evaluating early treatment response of 177Lu-PSMA-617 treatment.
Authors: Song Hong , Leonio Maria Isabel , Ferri Valentina , Duan Heying , Shah Jagruti , Moradi Farshad , Mari Aparici Carina , Franc Benjamin Lewis , Davidzon Guido , Bergstrom Colin P , Fan Alice C. , Shah Sumit , Khaki Ali Raza , Srinivas Sandy , Iagaru Andrei
Published: January 2024

32

Background: Multi-detector cadmium-zinc-telluride (CZT) based whole-body digital SPECT/CT is a new generation of imaging system. We aim to assess the clinical utility of rapid post-therapy whole-body SPECT/CT scan in evaluating early treatment response of 177Lu-PSMA-617 treatment. Methods: We retrospectively reviewed patients with progressive metastatic castration resistant prostate cancer (mCRPC) who were treated with at least two cycles of 177Lu-PSMA-617 at our institution from June 2022 to June 2023. Post-therapy whole-body digital SPECT/CT (GE StarGuide) was performed from vertex to mid-thigh at 1-2 hours after 177Lu-PSMA-617 infusion. Post-therapy SPECT/CT images were quantified with MIM software. Lu177-PSMA positive lesions were delineated with liver parenchyma uptake as cut-off. Lu-PSMA positive total tumor volume (Lu-TTV), tumor SUVmax and SUVmean were obtained. Post-therapy SPECT/CT image after cycle 1 was used as baseline for comparison with SPECT/CT after cycle 2 and 3. Overall survival, PSA progression free survival (PSA-PFS) as defined by PCWG3 and PSA decline > 50% from baseline (PSA50) at any time after treatment were measured. Changes in post-therapy SPECT/CT were correlated with clinical outcomes to assess quantitative SPECT/CT as a tool for early treatment response. Analyses were performed with SPSS. Results: A total of 56 patients (76±8, mean ± SD, range 60-93 years old) who were imaged with at least 2 post-therapy SPECT/CT were included in the analysis. Post-therapy whole body SPECT/CT was acquired in ~12 mins. All scanned patients tolerated the rapid whole-body SPECT/CT very well. With median follow up of 10 months, median PSA-PFS was 5.0 months (range 1.0-15 months), 33 of 56 patients (58.9%) achieved PSA50 at any time after treatment, and 42 of 56 patients (75%) were alive at data cutoff. Quantitative analysis of SPECT/CT images showed that 36 of 56 patients (64%) had a >30% decrease in Lu-TTV on early follow-up post-therapy SPECT/CT after cycle 2 or 3. Kaplan-Meier survival analysis showed that a >30% decrease in Lu-TTV was associated with longer overall survival (median not reached vs 6 months, P = 0.008) and longer PSA-PFS (6 months vs 1 months, P < 0.001). Decrease in SUVmax or SUVmean, however, was not associated with PSA-PFS or overall survival. Conclusions: Rapid post-therapy whole-body digital SPECT/CT was well tolerated in post-therapy SPECT/CT imaging following 177Lu-PSMA-617 treatment. Quantitation of post-therapy SPECT/CT may be useful in evaluating early treatment response of 177Lu-PSMA-617. Prospective validation and larger patient cohorts are needed to further elucidate the role of post-therapy SPECT/CT imaging in guiding patient management in 177Lu-PSMA-617 therapy.
Long-term outcomes of a multicenter prospective observational study of active surveillance for early-stage prostate cancer: The PRIAS-JAPAN study.
Authors: Kato Takuma , Matsumoto Ryuji , Yokomizo Akira , Tohi Yoichiro , Mori Keiichiro , Fujii Yoichi , Fukuhara Hiroshi , Sato Takuma , Inokuchi Junichi , Hashine Katsuyoshi , Sakamoto Shinichi , Sugimoto Mikio , Kakehi Yoshiyuki ,   the PRIAS-JAPAN study group
Published: January 2024

322

Background: Japan is participating in the Prostate cancer Research International: Active Surveillance (PRIAS) study as PRIAS-JAPAN since 2010. This study’s aim is to report the long-term outcomes of the PRIAS-JAPAN study initiated in 2010. Methods: Basic patient eligibility criteria were clinical stage ≤T2, PSA ≤10, PSA density (PSAD) <0.2, number of positive cores ≤2, and Gleason score (GS) ≤6. Those have been revised progressively since then, and since January 2021, for patients who underwent MRI fusion biopsy at the time of initiation or follow-up biopsy, PSA ≤ 20, PSAD < 0.25, and the number of positive cores ≤ 2 for GS3+3, and ≤ 6 for GS3+4. For the number of positive cores, the eligibility criteria were expanded to no limit for GS3+3 and no more than half of the total number of cores for GS3+4. PSA test every 3 months, rectal examination every 6 months, biopsy at 1, 4, 7, and 10 years, and every 5 years thereafter, and recommendation for secondary treatment after confirming pathological deterioration. Reevaluation of MRI within 3 months after diagnosis and targeted biopsy of the same site if there is a lesion suspicious for cancer, and recommends annual MRI when PSA-DT < 10 years and annual systematic biopsy if MRI cannot be performed. Results: As of the end of February 2023, 1204 patients were enrolled. The eligibility criteria were met in 1173 patients. The median age, PSA, PSAD, and number of positive cores were 69 years, 5.3, 0.15, 1, 844, and 309, respectively, and the clinical stage was T1c in 1,019 and T2 in 154 patients. The acceptance rates of re-biopsy at 1, 4, 7, and 10 years were 83.0%, 63.5%, 39.0%, and 20.3%, respectively, and the pathological deterioration rate at each re-biopsy was 29.4%, 29.7%, and 35.6%, respectively. The pathological deterioration rate at the time of each biopsy was 29.4%, 29.7%, 35.6%, and 18.1%, respectively.467 patients selected subsequent therapy and prostatectomy was the most frequently chosen treatment option. Conclusions: Pathological deterioration was observed in about 30% of patients at the time of biopsy, but the rate of biopsy decreased over time. Adherence to biopsy was considered necessary for the safe implementation of active surveillance. Clinical trial information: 2021-211.[Table: see text]
A systematic review: Are the findings of indirect treatment comparisons (ITCs) in metastatic hormone-sensitive prostate cancer (mHSPC) consistent?
Authors: Shore Neal D. , Morgans Alicia K. , Paracha Noman , Hodgkinson Sarah , Eichinger Christian , Millar Craig , Chen Stephanie , Boegemann Martin
Published: January 2024

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Background: Multiple treatment options exist for mHSPC, including androgen receptor-axis-targeted (ARAT) therapies with or without docetaxel (DOC). Many ITCs have been published that compare efficacy and safety of treatment alternatives in mHSPC that have not been directly compared in head-to-head clinical trials. We assessed the methodology and findings of previously published ITCs, focusing on outcomes related to triple therapy with darolutamide (DARO) + androgen deprivation therapy (ADT) + DOC from the ARASENS clinical trial. Methods: We performed systematic literature review searches in MEDLINE, Embase and Cochrane databases to identify ITCs published from 1946 to May 2023 (PROSPERO, CRD42023429478). We focused on reporting ITCs that included ARASENS trial data and treatment versus treatment comparisons. Results: We included 12 ITCs across 17 publications. There was variation across the ITCs in the number of trials included (range: 2–10), and the statistical method used (frequentist or Bayesian network meta-analyses, random or fixed effects). Furthermore, reporting of treatment effect modifiers, network inconsistency/heterogeneity, and subgroup analysis was inconsistent across studies. Despite methodological differences, ITCs were consistent in showing a significant benefit in overall survival (OS) with DARO triple therapy compared with ADT (4 ITCs), and with DOC+ADT (7 ITCs; in line with ARASENS trial results). DARO triple therapy demonstrated a numerical benefit in OS compared with doublet (ARAT+ADT) and with other triple therapies (abiraterone acetate+prednisone [AAP] or enzalutamide [ENZ]+DOC+ADT) (Table 1). DARO triple therapy was consistently ranked highest, above other ARAT double and triple therapies, on OS across 9 ITCs. The risk of grade ≥3 adverse events (AEs) were numerically greater with DARO triplet therapy compared with ARAT doublets (6 ITCs). Available ITC evidence comparing AEs across triple therapies showed numerically fewer AEs for DARO compared with AAP (2 ITCs). Conclusions: Despite variability in their methodology, ITCs were consistent in showing OS benefit and highest ranking with DARO triple therapy, above the other ARAT therapies, and in reporting fewer AEs for DARO compared with AAP. As the number of mHSPC publications grows, so too does the need for standardizing ITC methodology to ensure robustness of findings and to optimize treatment decision-making. [Table: see text]