Himanshu Joshi

Background/Objectives: Active surveillance (AS) is the recommended management strategy for localized, early-stage prostate cancer. Despite promising cancer-specific outcomes, up to one-third of men discontinue AS and undergo radical prostatectomy without evidence of disease progression, often because of stress, anxiety, uncertainty, and unmet supportive care needs. Evidence-based psychosocial interventions tailored to men on AS are lacking. We aimed to: (1) adapt the Stress Management and Resilience Training (SMART) program to address the unique psychosocial and supportive care needs of men with prostate cancer on AS (SMART-AS), and (2) evaluate the feasibility and acceptability of SMART-AS. Methods: Following the Assessment, Decision, Adaptation, Production, Topical Experts, Integration, Training, Testing (ADAPT-ITT) framework, we adapted SMART for men with prostate cancer on AS (SMART-AS) informed by our prior qualitative study and expert input. Next, we conducted a single-arm pilot feasibility study at one large urban academic medical center. Participants attended eight weekly 90-minute telehealth group SMART-AS sessions. Feasibility and acceptability were evaluated one-week post-intervention. Results: Based on our prior qualitative study and expert input, core SMART-AS components included content targeting stress, anxiety, communication, and self-management. In total, 30 participants were enrolled in the pilot feasibility study and completed baseline assessments (mean age = 71 years, standard deviation = 8.3); 26/30 (86.7%) completed six out of eight SMART-AS sessions, and 17/30 (56.7%) completed post-intervention assessments. Nearly all (16/17, 94.1%) reported that they would recommend SMART-AS to others. Most agreed that SMART-AS helped them talk to clinicians (13/17, 76.5%), reduced anxiety (13/17, 76.5%), enhanced coping skills for AS challenges (15/17, 88.2%), and supported self-care (15/17, 88.2%). Nearly two-thirds (11/17, 64.7%) reported SMART-AS helped them continue AS as a management strategy. Conclusions: This pilot study provides preliminary evidence supporting the feasibility and acceptability of SMART-AS among men with prostate cancer on AS. Participants reported perceived improvements in anxiety, coping, communication with clinicians, and self-management. Findings support further evaluation in a randomized controlled trial.

The large language models ChatGPT-o1 and Gemini-2.5-Pro, guided with Oncologically Relevant Findings Reporting and Data System (ONCO-RADS) prompts, accurately extracted and classified incidental findings from whole-body imaging reports and outperformed these strategies without ONCO-RADS prompts and the medical named entity recognition model.

Synthetic radiographs, including OpenAI’s ChatGPT-generated ones, are not easily distinguishable from authentic radiographs by either radiologists or large language models; physician training and dedicated tools are crucial to mitigate risks.

PURPOSE: Latin America (LATAM), home to over 650 million people, remains under-represented in global oncology trials despite a growing cancer burden. This study aimed to evaluate the evolution of LATAM participation in phase III oncology trials over the past decade, with a focus on site distribution, cancer types studied, therapeutic classes investigated, and demographic reporting. METHODS: We conducted a cross-sectional analysis of global phase III oncology trials registered on ClinicalTrials.gov between January 1, 2013, and December 31, 2022. Trials were included if they studied anticancer therapies and listed at least one LATAM site. We extracted data on trial geography, cancer type, treatment modality, control group, and Hispanic ethnicity reporting. Trends in proportional regional site representation and therapy class were assessed using the Mann-Kendall trend test. RESULTS: A total of 172 phase III trials with LATAM sites were identified, representing 2,609 of 29,718 global sites (8.8%). Brazil (45.8%), Argentina (18.6%), and Mexico (13.0%) accounted for over 75% of LATAM trial sites. LATAM's proportional site representation increased modestly from 7.1% in 2013 to 9.3% in 2021 (Bonferroni-adjusted P = .040), but no individual country showed a statistically significant increase. The most frequently studied cancers were lung (26.7%), breast (22.1%), and genitourinary (16.3%). Targeted therapies (42.4%) and immunotherapies (33.1%) dominated, whereas hormone therapy declined over time. Hispanic ethnicity was reported in only 61.6% of trials, with no improvement over time. CONCLUSION: Although LATAM's participation in global oncology trials has increased, it remains geographically concentrated and demographically under-reported. Structural and policy efforts are needed to improve trial equity and align research with regional cancer burdens.

A greater proportion of participants undergoing hepatocellular carcinoma screening had excellent MRI scan quality compared with US image quality, but quality was adversely affected by obesity (both modalities at univariate analysis only) and Child-Pugh score (for MRI at univariable and multivariable analysis).

Background: The withdrawal of patients from cancer clinical trials with unspecified rationale introduces selection bias, compromises study validity, and reduces generalizability. Excluding these data can lead to informative censoring, masking treatment toxicity, or inflating efficacy estimates. Whereas regulatory agencies emphasize documenting reasons for withdrawal and retaining data after withdrawal, adherence to these guidelines is unclear, raising concerns about trial integrity. The objectives of this study were to determine the prevalence of withdrawal with unspecified rationale, evaluate retention strategies, and assess data‐retention practices after patient withdrawal in contemporary cancer clinical trials. Methods: This cross‐sectional study included 300 completed phase 3 clinical trials registered on ClinicalTrials.gov between 2014 and 2024 that evaluated systemic or local anticancer therapies with available protocols. The primary outcome was the proportion of patients who withdrew without a specified rationale. Secondary outcomes included the prevalence of protocol‐stated retention strategies and postwithdrawal data‐retention practices. Results: Of 165,674 enrolled patients, 106,915 discontinued participation. Of those, 15.8% ( n = 16,842) withdrew without a specified rationale. Nearly all protocols (99.6%; n = 299) required documenting the reasons for withdrawal; however, the median proportion of withdrawals without a specified rationale per trial was 7.5% (range, 0%–64.4% withdrawals; 25th to 75th percentile, 4.5%–10.5%). Most withdrawals were patient‐initiated (60.1%), retention strategies were absent in 68.0% of trial protocols, and 32.3% of protocols failed to specify retention practices for data collected after withdrawal. Conclusions: A substantial proportion of patients in phase 3 cancer trials withdraw without a specified rationale. Inconsistent withdrawal documentation practices, limited use of a retention strategy, and unclear postwithdrawal data policies highlight the need for standardized approaches to improve trial quality.

Extraprostatic extension (EPE) in prostate cancer (PCa) has implications for nerve-sparing approaches. mpMRI-based nomograms show modest accuracy, highlighting the need for improved predictive models. This study evaluates ¹⁸F-DCFPyL prostate-specific membrane antigen (PSMA) positron emission tomography/ computed tomography (PET/CT) for predicting side-specific EPE using maximum standardized uptake value (SUVmax). This single-center cohort study included patients undergoing RALP by a single surgeon (AKT) from January 2022 to September 2024. Baseline variables included demographics, PSA, biopsy, MRI, and PSMA parameters (SUVmax, EPE, SVI). The primary endpoint was side-specific EPE on final pathology. Univariable and multivariable logistic regression identified significant predictors. A nomogram was built based on this. To evaluate model performance, a 1000-iteration bootstrap approach was used to compare (1) the institutional MRI-only 2018 model, (2) an MRI + PSMA Fixed Model, and (3) a retrained MRI + PSMA Model built on each bootstrap sample. Three hundred fifty-five patients were analyzed. EPE was detected in 18.9% by MRI and 5.4% by PSMA PET. Median intraprostatic SUVmax was 11.30. EPE-positive sides were more likely to have MRI/PSMA-detected EPE (p < 0.001), PIRADS 5 lesions (p < 0.001), aggressive biopsy GGG (p < 0.001), higher positive cores (p < 0.001), and greater percent tumor involvement (p < 0.001). Median SUVmax was significantly higher in the EPE group (9.1 vs. 5.4; p < 0.001). Multivariable analysis identified PSA, MRI-detected EPE, GGG, tumor involvement percentage, and SUVmax ≥13 as significant predictors. The PSMA + MRI Fixed Model outperformed the MRI-only model (median AUC: 0.7542 vs. 0.7350) with p < 0.001. Calibration plots showed strong agreement between predicted and observed probabilities, and decision curve analysis demonstrated greater net clinical benefit across relevant thresholds. We developed a nomogram integrating PSMA PET with MRI and clinicopathological variables, outperforming our institutional model. PSMA uptake strongly predicts side-specific EPE, which can enhance preoperative assessment and improve postoperative functional outcomes.

Purpose: This systematic review and meta-analysis compared the diagnostic performance of MRI, [¹⁸F]FDG-PET/CT, and [¹⁸F]FDG-PET/MRI in detecting focal bone lesions and bone marrow infiltration in the initial staging of patients with multiple myeloma (MM) who underwent both MRI and [¹⁸F]FDG-PET/CT or [¹⁸F]FDG-PET/MRI studies. Patients and Methods: A systematic literature search was conducted across PubMed, Embase, and Cochrane databases, including studies comparing the performance of MRI (WB-MRI or spine/pelvis MRI), [¹⁸F]FDG-PET/CT, and/or [¹⁸F]FDG-PET/MRI in the same patients for MM initial staging. Pooled sensitivities and concordance between imaging modalities were analyzed using R (package META-R). Heterogeneity and bias were assessed with the QUADAS-C tool. Results: Twenty studies (published between 2007 and 2025) using the international MM diagnostic criteria as a reference standard met the inclusion criteria. Of these, 13 (n=742) compared per-patient sensitivity of [¹⁸F]FDG-PET/CT and MRI, and 4 (n=224) compared MRI and [¹⁸F]FDG-PET/MRI. Pooled sensitivities were 0.807 (95% CI: 0.74–0.86) for [¹⁸F]FDG-PET/CT (with significant heterogeneity) versus 0.914 (95% CI: 0.88–0.94) for MRI (0.906 for spine/pelvis MRI and 0.920 for WB-MRI) (P18F]FDG-PET/CT and MRI results, while 14% (101/721) patients had negative [¹⁸F]FDG-PET/CT and positive MRI with significant differences between the 2 techniques for the paired sample analysis (P18F]FDG-PET/MRI was 0.944 (95% CI: 0.88–0.98). Consensus definitions for specificity in MM imaging should be standardized across studies. Conclusions: This systematic review and comparative meta-analysis demonstrates superior sensitivity of WB-MRI compared with [¹⁸F]FDG-PET/CT for initial staging of MM patients. Future international guidelines might prioritize MRI and [¹⁸F]FDG-PET/MRI for staging of MM patients. Registration: PROSPERO CRD42024564937.

Background: Tumor-promoting inflammation and inflammatory cytokines are linked to immune checkpoint blockade (ICB) resistance. Methods: We assessed the associations between pre-treatment Interleukin-6 (IL-6), Interleukin-8 (IL-8) levels and on-treatment changes in IL-6, IL-8 and C-reactive protein (CRP) with ICB trial end points. Results: 27 studies representing 6,719 patients were included. Low pre-treatment IL-6 levels were associated with improved objective response rate (ORR) (odds ratio (OR) = 0.31 [0.18-0.55]) and better progression-free survival (PFS) (hazard ratio (HR) = 0.59 [0.48-0.72]) and overall survival (OS) [95% confidence interval (CI)] (HR = 0.42 [0.35-0.50]). Low pre-treatment IL-8 levels were associated with improved ORR (OR = 0.47 [0.36-0.61]) and better PFS (HR = 0.65 [0.58-0.74]) and OS (HR = 0.44 [0.39-0.51]). On-treatment decline in CRP was associated with improved ORR (OR = 0.18 [0.11-0.20]), PFS (HR = 0.40 [0.31-0.91]) and OS (HR = 0.48 [0.40-0.58]). Conclusion: Peripheral blood cytokines warrant further evaluation as enrichment and pharmacodynamic biomarkers for strategies targeting tumor-promoting inflammation.