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Context 1
... modeled rates of positive pelvic lymph nodes for each of the three treatment groups (see Methods) are listed in Table 3. Including predicted lymph node status in the weighted Cox regression model resulted in only trivial changes in the estimated hazard ratios relative to RP and the corresponding 95% CIs (Table 4). ...
Context 2
... estimated hazard ratio of the RT subgroup with $ 7920 cGy was 1.33 (95% CI, 1.05 to 1.68) compared with the RT group and 1.68 (95% CI, 1.37 to 2.06) for the , 79.20 Gy RTsubgroup. Sensitivity analysis that split the RT plus brachytherapy with or without AD cohort-to separate those who received AD from those who did not-showed that both subgroups were not statistically different from RP (Appendix Table A3). Another sensitivity analysis for the assessment of the interaction between comorbidity score and the treatment indicated that there was no statistically significant interaction between comorbidity score and treatment effect (Appendix Table A4). ...
Context 3
... modeled rates of positive pelvic lymph nodes for each of the three treatment groups (see Methods) are listed in Table 3. Including predicted lymph node status in the weighted Cox regression model resulted in only trivial changes in the estimated hazard ratios relative to RP and the corresponding 95% CIs (Table 4). ...
Context 4
... estimated hazard ratio of the RT subgroup with $ 7920 cGy was 1.33 (95% CI, 1.05 to 1.68) compared with the RT group and 1.68 (95% CI, 1.37 to 2.06) for the , 79.20 Gy RTsubgroup. Sensitivity analysis that split the RT plus brachytherapy with or without AD cohort-to separate those who received AD from those who did not-showed that both subgroups were not statistically different from RP (Appendix Table A3). Another sensitivity analysis for the assessment of the interaction between comorbidity score and the treatment indicated that there was no statistically significant interaction between comorbidity score and treatment effect (Appendix Table A4). ...

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Citations

... Several studies have sought to compare the outcomes between RP and EBRT with ADT [36][37][38][39][40][41][42][43]. An analysis of 42,765 men with HRPCa in the NCDB found no difference in overall survival between men who received RP versus EBRT plus brachytherapy with or without ADT. ...
... However, they did note that EBRT with just ADT was associated with a higher risk of mortality than RP (hazard ratio [HR] 1.53, 95% confidence interval [CI]: 1.22-1.92) at a median follow-up of 36.34 months [43]. A separate study examined 13,985 men aged 65 years and younger with HRPCa and found that RP was the more common treatment modality over EBRT plus brachytherapy (88% versus 12%, respectively). ...
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Opinion statement Localized high-risk (HR) prostate cancer (PCa) is a heterogenous disease state with a wide range of presentations and outcomes. Historically, non-surgical management with radiotherapy and androgen deprivation therapy was the treatment option of choice. However, surgical resection with radical prostatectomy (RP) and pelvic lymph node dissection (PLND) is increasingly utilized as a primary treatment modality for patients with HRPCa. Recent studies have demonstrated that surgery is an equivalent treatment option in select patients with the potential to avoid the side effects from androgen deprivation therapy and radiotherapy combined. Advances in imaging techniques and biomarkers have also improved staging and patient selection for surgical resection. Advances in robotic surgical technology grant surgeons various techniques to perform RP, even in patients with HR disease, which can reduce the morbidity of the procedure without sacrificing oncologic outcomes. Clinical trials are not only being performed to assess the safety and oncologic outcomes of these surgical techniques, but to also evaluate the role of surgical resection as a part of a multimodal treatment plan. Further research is needed to determine the ideal role of surgery to potentially provide a more personalized and tailored treatment plan for patients with localized HR PCa.
... The next stage shifted from an institutional lens to a more individual approach to uncovering the underlying needs of cancer patients themselves through visually mapping the emotions inhabited throughout a "patient journey". This visual methodology has been shown to have potential in exploring and processing emotions in people with cancer (Ennis et al., 2018). Next, the participants created a collage of images representing the joint vision of HoP. ...
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Purpose This article aims to examine how users' involvement in value co-creation influences the development and orchestration of well-being ecosystems to help tackle complex societal challenges. This research contributes to the public management literature and answers recent calls to investigate novel public service governances by discussing users' involvement and value co-creation for novel well-being solutions. Design/methodology/approach The authors empirically explore this phenomenon through a case study of a complex ecosystem addressing increased well-being, focussing on the formative evaluation stage of a longitudinal evaluation of Sweden's first support centre for people affected by cancer. Following an abductive reasoning and action research approach, the authors critically discuss the potential of user involvement for the development of well-being ecosystems and outline preconditions for the success of such approaches. Findings The empirical results indicate that resource reconfiguration of multi-actor collaborations provides a platform for value co-creation, innovative health services and availability of resources. Common themes include the need for multi-actor collaborations to reconfigure heterogeneous resources; actors' adaptive change capabilities; the role of governance mechanisms to align the diverse well-being ecosystem components, and the engagement of essential actors. Research limitations/implications Although using a longitudinal case study approach has revealed stimulating insights, additional data collection, multiple cases and quantitative studies are prompted. Also, the authors focus on one country but the characteristics of users' involvement for value co-creation in innovative well-being ecosystems might vary between countries. Practical implications The findings of this study demonstrate the value of cancer-affected individuals, with “lived experiences”, acting as sources for social innovation, and drivers of well-being ecosystem development. The findings also suggest that participating actors in the ecosystem should utilise wider knowledge and experience to tackle complex societal challenges associated with well-being. Social implications Policymakers should encourage the formation of well-being ecosystems with diverse actors and resources that can help patients navigate health challenges. The findings especially show the potential of starting from the user's needs and life situation when the ambition is to integrate and innovate in fragmented systems. Originality/value The proposed model proposes that having a user-led focus on innovating new solutions can play an important role in the development of well-being ecosystems.
... Prognostic comparison following RP-and BT-based treatment is not yet supported by high-quality evidence. Retrospective studies and meta-analysis currently demonstrated conflicting results about overall survival (OS), CSS, and BFS [15][16][17][18] [24]. Our findings differ from those of the studies mentioned above. ...
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Objective We compared the outcome of radical prostatectomy (RP) with seed brachytherapy (BT) in clinically localized prostate cancer (LPCa) using two different biochemical recurrence (BCR) definitions. Methods Clinical data of 1117 patients with non-metastatic prostate cancer (PCa) treated with either RP or BT as the basis of the multimodal therapy from a single tertiary hospital between 2007 and 2021 were retrospectively analyzed. 843 LPCa patients (RP = 737, BT = 106) with at least one prostate-specific antigen (PSA) test after treatment were finally included. The BCR survival was evaluated by direct comparison and one-to-one propensity score matching (PSM) analysis using surgical definition (PSA ≥ 0.2ng/ml) for RP and surgical/Phoenix definition (PSA nadir + 2ng/ml ) for BT. The propensity score (PS) was calculated by multivariable logistic regression based on the clinicopathological parameters. Results Median follow-up was 43 months for RP patients and 45 months for BT patients. Kaplan–Meier analysis did not show any statistically significant differences in terms of BCR-free survival (BFS) between the two groups when using Phoenix definition for BT ( P > 0.05). Similar results were obtained in all D’Amico risk groups when stratified analyses were conducted. However, RP achieved improved BFS compared to BT in the whole cohort and all risk groups with the surgical definition for BT( P < 0.05). After adjusting PS, 192 patients were divided into RP and BT groups (96 each). RP presented a better BFS than BT when using the surgical definition ( P < 0.001), but no significant difference was found when using the Phoenix definition ( P = 0.609). Conclusion Inconsistent BCR-free survival outcomes were acquired using two different BCR definitions for BT patients. RP provided comparable BFS with BT using the Phoenix definition but better BFS using the surgical definition, regardless of whether the PSM was performed. Our findings indicated that an exact BCR definition was critical for prognostic assessment. The corresponding results will assist physicians in pretreatment consultation and treatment selection.
... Although treatment options for high-/very-high-risk PCa include androgen deprivation therapy (ADT) and/or external-beam radiation therapy (EBRT), ADT and/or EBRT and/ or brachytherapy (BT), neoadjuvant/adjuvant therapy and/or surgery, and ADT alone [3,[5][6][7], patients with very-highrisk PCa have extremely poor oncologic outcomes, with a 5 years cancer-specific survival (CSS) rate of 58% and 5 and 10 years overall survival (OS) rates of 29% and 18%, respectively [8,9]. Recent meta-analyses have reported that radical prostatectomy (RP) contributes to improved OS and CSS compared with radiotherapy (RT), and the trend is similar in patients with high-and very-high-risk PCa [10][11][12]. However, the combination of RT and ADT has been associated with improved biochemical recurrence-free survival (BRFS) and metastasis-free survival (MFS), making the long-term administration of ADT mandatory [10][11][12]. ...
... Recent meta-analyses have reported that radical prostatectomy (RP) contributes to improved OS and CSS compared with radiotherapy (RT), and the trend is similar in patients with high-and very-high-risk PCa [10][11][12]. However, the combination of RT and ADT has been associated with improved biochemical recurrence-free survival (BRFS) and metastasis-free survival (MFS), making the long-term administration of ADT mandatory [10][11][12]. However, neoadjuvant therapy has been attempted in patients with high-/ very-high-risk PCa because of the difficulty in cancer control using RP alone [13][14][15][16][17][18]. ...
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Robot-assisted radical prostatectomy (RARP) has become one of the standard radical treatments for prostate cancer (PCa). A retrospective single-center cohort study was conducted on patients with PCa who underwent RARP at Gifu University Hospital between September 2017 and September 2022. In this study, patients were classified into three groups based on the National Comprehensive Cancer Network risk classification: low/intermediate-risk, high-risk, and very-high-risk groups. Patients with high- and very-high-risk PCa who were registered in the study received neoadjuvant chemohormonal therapy prior to RARP. Biochemical recurrence-free survival (BRFS) after RARP in patients with PCa was the primary endpoint of this study. The secondary endpoint was the relationship between biochemical recurrence (BCR) and clinical covariates. We enrolled 230 patients with PCa in our study, with a median follow-up of 17.0 months. When the time of follow-up was over, 19 patients (8.3%) had BCR, and the 2 years BRFS rate for the enrolled patients was 90.9%. Although there was no significant difference in BRFS between the low- and intermediate-risk group and the high/very-high-risk group, the 2 years BRFS rate was 100% in the high-risk group and 68.3% in the very-high-risk group (P = 0.0029). Multivariate analysis showed that positive surgical margins were a significant predictor of BCR in patients with PCa treated with RARP. Multimodal therapies may be necessary to improve the BCR in patients with very-high-risk PCa.
... All included studies (Table 1) were non-randomized studies, comprising of one prospective populationbased cohort study [13], four retrospective populationbased cohort studies [14][15][16][17], 10 single-institution retrospective cohort studies [18][19][20][21][22][23][24][25][26][27], two multicenter retrospective cohort studies [28,29] and two studies in which data for the two treatment groups came from different (institutional) databases [30,31]. Both cohort studies for which data were collected retrospectively from electronic medical records and studies that analyzed data from existing (institutional) databases were considered retrospective. ...
... The percentage of patients treated with ADT in addition to EBRT ranged from 69-100% and exceeded 90% in all but four studies. Three studies reported functional outcomes and/or HRQoL [13,23,25] and all studies reported oncological outcomes [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. ...
... Advanced: 9.2% (n = 6) concluded that surgical and radiation-based treatment are similar with respect to oncological outcomes [13,17,20,23,29,31], or only reported more favorable BCRFS (n = 5) after treatment with EBRT and ADT (no difference in DMFS/PCSS/OS) [18,21,24,26,27]. Four studies reported more favorable results after RP compared to EBRT with ADT [14][15][16]25], although in one of these studies this was no longer the case when RP was compared to EBRT and brachytherapy (with or without ADT) [16]. Two studies reported more favorable results after EBRT with ADT versus RP [19,22]. ...
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Background To summarize recent evidence in terms of health-related quality of life (HRQoL), functional and oncological outcomes following radical prostatectomy (RP) compared to external beam radiotherapy (EBRT) and androgen deprivation therapy (ADT) for high-risk prostate cancer (PCa). Methods We searched Medline, Embase, Cochrane Database of Systematic Reviews, Cochrane Controlled Trial Register and the International Standard Randomized Controlled Trial Number registry on 29 march 2021. Comparative studies, published since 2016, that reported on treatment with RP versus dose-escalated EBRT and ADT for high-risk non-metastatic PCa were included. The Newcastle–Ottawa Scale was used to appraise quality and risk of bias. A qualitative synthesis was performed. Results Nineteen studies, all non-randomized, met the inclusion criteria. Risk of bias assessment indicated low (n = 14) to moderate/high (n = 5) risk of bias. Only three studies reported functional outcomes and/or HRQoL using different measurement instruments and methods. A clinically meaningful difference in HRQoL was not observed. All studies reported oncological outcomes and survival was generally good (5-year survival rates > 90%). In the majority of studies, a statistically significant difference between both treatment groups was not observed, or only differences in biochemical recurrence-free survival were reported. Conclusions Evidence clearly demonstrating superiority in terms of oncological outcomes of either RP or EBRT combined with ADT is lacking. Studies reporting functional outcomes and HRQoL are very scarce and the magnitude of the effect of RP versus dose-escalated EBRT with ADT on HRQoL and functional outcomes remains largely unknown.
... Surgeon and hospital volumes are considered important factors because outcomes after RP are highly dependent on surgical and pathologic features such as positive surgical margins (PSM), extracapsular extension, and seminal vesicle invasion. Several recent studies have reported that RP could improve oncologic outcomes for patients with highrisk PCa, including overall survival (OS) and CSS [4,[12][13][14]. Thus, various neoadjuvant therapies prior to RP aim to improve surgical outcomes prior to RP. ...
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Background: This retrospective single-center cohort study evaluated the efficacy and safety of a combination of neoadjuvant luteinizing hormone-releasing hormone (LHRH) antagonist and tegafur-uracil (UFT) therapy (NCHT) and investigated the medical records of patients with high-risk PCa who underwent robot-assisted radical prostatectomy (RARP). The therapy was followed by RARP for high-risk PCa. Materials and methods: The enrolled patients were divided into two groups: low-intermediate-risk PCa patients who underwent RARP without neoadjuvant therapy (non-high-risk) and those who underwent NCHT followed by RARP (high-risk group). This study enrolled 227 patients (126: non-high-risk and 101: high-risk group). Patients in the high-risk-group had high-grade cancer compared to those in the non-high-risk-group. Results: At the median follow-up period of 12.0 months, there were no PCa deaths; two patients (0.9%) died of other causes. Twenty patients developed biochemical recurrence (BCR); the median time until BCR was 9.9 months after surgery. The 2-year biochemical recurrence-free survival rates were 94.2% and 91.1% in the non-high-risk and high-risk-group, respectively (p = 0.465). Grade ≥3 NCHT-related adverse events developed in nine patients (8.9%). Conclusions: This study indicates that combining neoadjuvant LHRH antagonists and UFT followed by RARP may improve oncological outcomes in patients with high-risk PCa.
... An expansive and representative simulation was conducted following the state-of-the-art guidance [6,10,15] on generating data adhering to the structure of multiple treatments with heterogeneous treatment effects on clustered survival outcomes. We based our simulation procedures on real data from the National Cancer Database (NCDB) [16]. We compared our proposed approach to three current methods popularly used in clinical research: (1) inverse probability of treatment weighting with the random-intercept Cox regression model (IPW-riCox) [9]; (2) doubly robust random-intercept additive hazards model (DR-riAH) [17]; and (3) the random-intercept generalized additive proportional hazards model (riGAPH) [18]. ...
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Personalized medicine requires an understanding of treatment effect heterogeneity. Evolving toward causal evidence for scenarios not studied in randomized trials necessitates a methodology using real-world evidence. Herein, we demonstrate a methodology that generates causal effects, assesses the heterogeneity of the effects and adjusts for the clustered nature of the data. This study uses a state-of-the-art machine learning survival model, riAFT-BART, to draw causal inferences about individual survival treatment effects, while accounting for the variability in institutional effects; further, it proposes a data-driven approach to agnostically (as opposed to a priori hypotheses) ascertain which subgroups exhibit an enhanced treatment effect from which intervention, relative to global evidence—average treatment effects measured at the population level. Comprehensive simulations show the advantages of the proposed method in terms of bias, efficiency and precision in estimating heterogeneous causal effects. The empirically validated method was then used to analyze the National Cancer Database.
... One method that appears particularly effective for increasing the prostate dose is to administer a brachytherapy boost, either by permanent Iodine-125 implants or by high dose rate brachytherapy. This is of interest for patients with an unfavourable intermediate or high risk [214,215]. Three randomised trials compared external beam radiotherapy with or without brachytherapy boost. Two of these trials had an underdosed control arm [216]. ...
... Une des méthodes qui apparaît particulièrement efficace pour accroître la dose prostatique est de réaliser un complément de dose (« boost ») par curiethérapie, soit par implants permanents d'Iode 125 soit par curiethérapie à haut débit de dose. Ceci apparaît intéressant pour les patients de risque intermédiaire défavorables ou à haut risque [214,215]. Trois essais randomisés ont comparé radiothérapie externe avec ou sans boost par curiethérapie ; deux de ces essais avaient un bras contrôle sous-dosé [216]. Un seul essai randomisé (ASCENDE-RT) montre que le boost par curiethérapie LDR améliore le contrôle biochimique (86 vs 75 %, p < 0,001), sans bénéfice en survie sans métastase, par rapport à une irradiation externe, au prix d'une toxicité urinaire accrue [217][218][219]. ...
Article
Objective The objective of the French Urology Association Cancer Committee is to propose an update of the recommendations for the diagnosis and management of prostate cancer (PC). Methods A systematic review of the literature from 2020 to 2022 was conducted by the CCAFU on the diagnosis and therapeutic management of localised PC, while evaluating the references and their levels of evidence. Results The recommendations specify the genetics, epidemiology and means of diagnosing prostate cancer, as well as the notions of screening and early detection. MRI, the gold standard imaging examination for localised cancer, is recommended before prostate biopsies are performed. The transperineal approach reduces the risks of infection. The therapeutic methods are described and recommended according to the clinical context. Active surveillance is the gold standard of treatment for tumours with a low risk for progression. Early salvage radiotherapy is recommended in case of biochemical recurrence after radical prostatectomy. Imaging, particularly molecular imaging, helps to guide the decision-making in the event of biochemical recurrence after local treatment, but should not delay early salvage radiotherapy in the event of biological recurrence after radical prostatectomy. Conclusion This update of the French recommendations should help to improve the management of patients with PC.
... 488 In addition, an analysis of outcomes of almost 43,000 patients with high-risk prostate cancer in the National Cancer Database found that mortality was similar in patients treated with EBRT, brachytherapy, and ADT versus those treated with radical prostatectomy, but was worse in those treated with EBRT and ADT. 489 To address historical trial data concerns for increased toxicity incidence associated with brachytherapy boost, careful patient selection and contemporary planning associated with lesser toxicity, such as use of recognized organ at risk dose constraints, use of high-quality ultrasound and other imaging, and prescription of dose as close as possible to the target without excessive margins should be implemented. ...
... Otherwise, no significant differences existed in cancer-specific mortality among treatments (13). Since then, several studies have evaluated the clinical outcomes of patients with clinical localized prostate cancer who received different treatment modalities (14)(15)(16)(17). ...
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PurposeSince there was no consensus on treatment options for localized prostate cancer, we performed a retrospective study to compare the long-term survival benefit of radiotherapy (RT) versus laparoscopic radical prostatectomy (LRP) in Taiwan.Methods218 patients with clinically localized prostate cancer treated between 2008 and 2017 (64 with LRP and 154 with RT) were enrolled in this study. The outcomes of RT and LRP were assessed after patients were stratified according to Gleason score, stage, and risk group. Crude survival, prostate cancer-specific survival, and metastasis-free survival were evaluated using the log-rank test.ResultsThe 5-year crude survival rate was 93.3% in the LRP group and 59.3% in the RT group. A significant survival benefit was found in the LRP group compared with the RT group (p = 0.004). Furthermore, significant differences were found in disease-specific survival (93.3% vs. 64.7%, p = 0.022) and metastasis-free survival (48% vs. 40.2%, p = 0.045) between the LRP and RT groups.Conclusions Men with localized prostate cancer treated initially with LRP had a lower risk of prostate cancer-specific death and metastases compared with those treated with RT.