Functional imaging guided stereotactic ablative body radiotherapy (SABR) with focal dose escalation and bladder trigone sparing for intermediate and high-risk prostate cancer: study protocol for phase II safo trial.

BACKGROUND: Stereotactic ablative body radiotherapy (SABR) is an emerging treatment alternative for patients with localized low and intermediate risk prostate cancer patients. As already explored by some authors in the context of conventional moderate hypofractionated radiotherapy, focal boost of the index lesion defined by magnetic resonance imaging (MRI) is associated with an improved biochemical outcome. The objective of this phase II trial is to determine the effectiveness (in terms of biochemical, morphological and functional control), the safety and impact on quality of life, of prostate SABR with MRI guided focal dose intensification in males with intermediate and high-risk localized prostate cancer. METHODS: Patients with intermediate and high-risk prostate cancer according to NCCN definition will be treated with SABR 36.25 Gy in 5 fractions to the whole prostate gland with MRI guided simultaneous integrated focal boost (SIB) to the index lesion (IL) up to 50 Gy in 5 fractions, using a protocol of bladder trigone and urethra sparing. Intra-fractional motion will be monitored with daily cone beam computed tomography (CBCT) and intra-fractional tracking with intraprostatic gold fiducials. Androgen deprivation therapy (ADT) will be allowed. The primary endpoint will be efficacy in terms of biochemical and local control assessed by Phoenix criteria and post-treatment MRI respectively. The secondary endpoints will encompass acute and late toxicity, quality of life (QoL) and progression-free survival. Finally, the subgroup of high-risk patients will be involved in a prospective study focused on immuno-phenotyping. DISCUSSION: To the best of our knowledge, this is the first trial to evaluate the impact of post-treatment MRI on local control among patients with intermediate and high-risk prostate cancer undergoing SABR and MRI guided focal intensification. The results of this trial will enhance our understanding of treatment focal intensification through the employment of the SABR technique within this specific patient subgroup, particularly among those with high-risk disease, and will help to clarify the significance of MRI in monitoring local responses. Hopefully will also help to design more personalized biomarker-based phase III trials in this specific context. Additionally, this trial is expected to be incorporated into a prospective radiomics study focused on localized prostate cancer treated with radiotherapy. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT05919524; Registered 17 July 2023. TRIAL SPONSOR: IRAD/SEOR (Instituto de Investigación de Oncología Radioterápica / Sociedad Española de Oncología Radioterápica). STUDY SETTING: Clinicaltrials.gov identifier: NCT05919524; Registered 17 July 2023. TRIAL STATUS: Protocol version number and date: v. 5/ 17 May-2023. Date of recruitment start: August 8, 2023. Date of recruitment completion: July 1, 2024.

Complementary and alternative medicine in HIV care: frequency of consumption, risks and interactions with antiretroviral therapy.

OBJECTIVES: People living with HIV (PLWH) are common users of complementary and alternative medicine (CAM). The main objective of this study was to study the frequency and patterns of CAM natural products use in a large cohort of PLWH and to identify potential drug-drug interactions (DDIs) and the impact on their antiretroviral treatment (ART) adherence and efficacy. METHODS: This was a cross-sectional multicenter survey including 420 PLWH from different Spanish hospitals. Participants completed a face-to-face questionnaire on CAM consumption and different sociodemographic and clinical data were collected. DDIs between CAM and ART were identified and classified according to the Liverpool University Database and patient factors related to CAM consumption were assessed. RESULTS: 420 participants were included (82.6% male, mean age 47 years); 209 patients (49.8%) were taking at least one CAM. The most consumed CAM were green, black and red tea (n=146, 25.4%), ginger (n=26, 4.5%), fish oil (n=25, 4.4%) and cannabis (n=24, 4.2%). An ART based on integrase inhibitors was the only factor independently associated with CAM consumption (OR 1.54, 95% CI 1.04 to 2.26). 50 potential CAM-ART interactions in 43 (20.6%) patients taking CAM were identified, being clinically significant in 80% of the cases. CAM products most frequently involved with a potential significant DDI were supplements containing divalent cations (n=11) and garlic (n=7). No differences in ART efficacy and adherence were observed between patients with and without CAM consumption. CONCLUSIONS: Almost 50% of patients were taking at least one CAM product and its use was associated with an integrase inhibitor based ART. One out of every six patients was at risk of presenting with an interaction between a CAM and their ART, confirming the need to review continuously the use of CAM as part of the medication review process.

Obesity in Childhood and Adolescence: The Role of Motivation for Physical Activity, Self-Esteem, Implicit and Explicit Attitudes toward Obesity and Physical Activity.

The purpose of the present study was to compare attitudes toward body weight and physical activity in both regular-weight and overweight/obese children and adolescents, and assessing relations between attitudes and self-esteem, motivation for physical activity, life satisfaction and level of physical activity. A total of 126 children (Mage = 12.2, SD = 3.4), divided into two subsamples (i.e., overweight/obese, N = 44, and regular-weight), voluntarily participated in the study. A series of univariate analyses of variance was conducted to examine the differences in the study variables across the subsamples. Correlational analyses were conducted to examine the relationships among the variables. The results indicated that obese/overweight participants expressed a more positive implicit attitude toward the thin category than regular-weight participants. Furthermore, among overweight/obese participants, implicit attitude toward physical activity was significantly negatively correlated with explicit attitude toward physical activity and general self-esteem. Significant differences between obese/overweight and regular-weight participants indicated that the status in terms of weight played a key role in attitudes toward the explored constructs.

Neural empathic response to disability: An ERP study of prejudice.

While social neuroscience has already provided evidence for a deficit of affective empathy in racial prejudice, little is known about other less visible social categories when considered as an outgroup. We studied the process of empathy through event-related brain potentials (ERPs). We focused on the group "people with disabilities" as they are the target of a large amount of prejudice. Twenty-six participants performed a pain decision task. The mean amplitudes of N1, P2, N2-N3 and P3 components were recorded. Our results are consistent with previous work on prejudice, showing that the pain detection is modulated by group membership (with disabilities vs. without disabilities) on N2-N3, suggesting a better neural decoding of pain vs. non-pain in the without-disability condition. Critically, no effect of early sensory components (N1, P2) was found, and P3 was not moderated by disability. These findings indicate a different time course of empathic responses depending on the condition, suggesting that people with disabilities trigger specific empathic responses. Our results contribute to disentangling perceptual processes from affective empathy reactions.

Removing the academic framing in student evaluations improves achievement in children with dyslexia: The mediating role of self-judgement of competence.

Self-judgement is known to play a crucial role in academic achievement, and as such, may be expected to have an impact on students with dyslexia. Their self-judgements may reflect the negative stereotype of low competence that targets people with disabilities. Their repeated academic failures may lead to a negative association between "school" and "failure". The aim of the present study was to investigate how such factors contribute to academic failure in students with dyslexia. Participants were 183 French middle school students. We assessed students' self-judgement and manipulated the framing of performance tasks so that students completed literacy tasks in both academic and non-academic forms. We expected a detrimental impact of dyslexia on performance in academic but not in non-academic tasks. We also expected self-judgement to account for this difference. Students with dyslexia perceive themselves as less competent than students without dyslexia. Significantly, structural equation modeling revealed that students with dyslexia performed poorly in academic tasks, compared to students without dyslexia. This difference no longer appeared in non-academic tasks. Self-judgement of competence is a predictor of the performance of students with and without dyslexia at school and their impact is related to how the academic features of the tasks are emphasized.

MRI-guided focal boost to dominant intraprostatic lesion using volumetric modulated arc therapy in prostate cancer. Results of a phase II trial.

OBJECTIVE: To determine morphological and biological control as well as toxicity and quality of life (QoL) of men with localized prostate cancer (PCa) treated with MRI-guided focal boost radiotherapy. MATERIAL AND METHODS: 30 patients with PCa and a visible dominant intraprostatic lesion (DIL) identified on mpMRI were included in a prospective Phase II trial. Matching point registration of planning CT and T2W, diffusion-weighted and a gradient-recalled echo (GRE) MRI images made in treatment position was used for prostate and tumour delineation. Treatment consisted on 35 daily fractions of 2.17 Gy with a concomitant focal boost to the DIL of 2.43 Gy using volumetric modulated arc therapy (VMAT) and image-guided radiation therapy (IGRT) with intraprostatic fiducial markers. Biochemical failure was analysed using PSA nadir +2 ng/mL criteria and local control using mpMRI evaluation at 6-9 months following RT. Acute and late toxicity were defined according to CTCAE v.4.0 and RTOG/EORTC scales and QoL was assessed using IPSS, EPIC short-form and UCLA-PCI questionnaires. RESULTS: The median radiation dose to the prostate was 77.6 Gy (IQR 77.3-78.1), and to the DIL was 85.5 Gy (IQR 85.0-86.0). With a median follow up of 30.0 months (IQR 25.5-40.27), all patients remain free of biochemical relapse. An mpMRI complete response was observed in 25 patients during the first post-treatment evaluation at 6 months. The remaining five patients achieved a complete disappearance of the DIL both on T2 and DWI on the second mpMRI performed at 9 months following treatment. Six out of 30 (20%) patients presented acute Grade 2 urinary toxicity with no Grade 3 acute complications. Acute rectal toxicity was only found in 2 (6.6%) patients (both Grade 1). Only late Grade 1 urinary and rectal complications were observed in 3/30 patients, respectively, with no Grade 2 or more late toxicity. The urinary, bowel and sexual bother EPIC scores were slightly and insignificantly increased in the first 3 months post-treatment, returning to normal afterwards. CONCLUSIONS: mpMRI-guided focal boost using VMAT hypofractionated technique is associated with an excellent morphological and functional response control and a safe toxicity profile. ADVANCES IN KNOWLEDGE: In the present trial, we examined the potential role of mpMRI for radiological assessment (functional and morphological) of treatment response in high-risk prostate cancer patients treated with MRI-guided focal radiotherapy dose intensification to dominant Intraprostatic lesion.

Neuropsychological functioning and academic abilities in patients with juvenile idiopathic arthritis.

BACKGROUND: The involvement of the central nervous system is not rare in rheumatoid diseases. Even though children with juvenile idiopathic arthritis (JIA) may face academic difficulties until adulthood, very few studies have evaluated potential cognitive disorders in these patients. The present research aims to thoroughly investigate the cognitive and neuropsychological functioning of these patients. METHODS: We measured the cognitive profile of JIA patients via their neuropsychological profile, implicit memory and social cognition skills, and estimated their academic performance using reading and mathematics tests. We recruited 21 children with JIA aged 6 to 17 years-old (M = 11.01, SD = 3.30) and 21 healthy children matched in age, gender, academic level (same school class) and socioeconomic status. RESULTS: Our results showed that the cognitive profile and estimated academic ability of JIA patients are similar to those of their peers. These results support the hypothesis that children with JIA have the same cognitive predispositions to succeed at school as any other pupil. CONCLUSION: Comparing our results with the existing literature, we propose complementary hypotheses for further research. Longitudinal studies seem to be necessary to understand the psychosocial and cognitive processes involved in the development of children with JIA.