Application of the PRECISION Trial Biopsy Strategy to a Contemporary Magnetic Resonance Imaging-Targeted Biopsy Cohort-How Many Clinically Significant Prostate Cancers are Missed?

PURPOSE: To demonstrate the generalizability of PRECISION findings and apply the PRECISION biopsy strategy to a contemporary cohort to characterize cancers missed by employing this strategy. MATERIALS AND METHODS: A total of 629 men biopsied between February 2015 and September 2018 met PRECISION inclusion criteria. Men with PI-RADS™ 1-2 magnetic resonance imaging were only biopsied if high clinical suspicion for cancer. Missed cancers were defined as prostate cancer identified uniquely on systematic biopsy in men with PI-RADS 3-5 magnetic resonance imaging, or on either systematic biopsy or magnetic resonance imaging-targeted prostate biopsy in men with PI-RADS 1-2 magnetic resonance imaging. Outcomes included 1) clinically significant prostate cancer, Gleason grade group 2 or greater, detection rate, 2) missed clinically significant prostate cancer rate upon application of PRECISION biopsy strategy, 3) Gleason grade group distribution, core size, spatial orientation and oncologic risk among missed cancers. RESULTS: Application of the PRECISION biopsy strategy to the study cohort resulted in avoidance of biopsy in 28%, similar magnetic resonance imaging-targeted prostate biopsy detection rate to PRECISION, reduction of Gleason grade group 1 detection rate by 60% and reduction of clinically significant prostate cancer detection rate by 19%. Missed clinically significant prostate cancers were often smaller than 6 mm (54.5%), Gleason grade group 2 (67.3%) and low risk by clinical nomogram (74.6%). Gleason grade group 1 cancers identified uniquely on systematic biopsy were often contralateral to magnetic resonance imaging target (46.4%), while missed clinically significant prostate cancer was predominantly ipsilateral (81%). Limitations include biopsy of only men with high risk clinical features among PI-RADS 1-2 magnetic resonance imaging, potentially overestimating the clinically significant prostate cancer detection rate. CONCLUSIONS: The study cohort demonstrated generalizability of PRECISION findings. Applying the PRECISION biopsy strategy greatly reduces Gleason grade group 1 detection rate, while missing a small number of clinically significant prostate cancer, typically small volume, low risk, and Gleason grade group 2. Missed clinically significant prostate cancer is predominantly ipsilateral to magnetic resonance imaging target, possibly representing targeting error.

National assessment of recommendations from healthcare providers for smoking cessation among adults with cancer.

Cancer survivors benefit from evidence-based smoking cessation treatment. A crucial first step in this process is a clinician recommending that the patient quit smoking. However, contemporary delivery of advice to quit among patients with cancer is not well known. In a cross-sectional analysis of all adult smokers included in a prospective population-representative study of US adults, we analyzed the frequency that patients reported receiving advice to quit smoking from a healthcare professional according to reported cancer history (no cancer, tobacco-related cancer, non-tobacco related cancer history). Among an estimated 28.3 million smokers, 9.3% reported a history of cancer, 48.8% of which were tobacco-related cancers. In general, advice to quit was reported by more (67.8%) cancer survivors than those adults without any cancer (56.0%). After adjustment for sociodemographic factors, smokers with a non tobacco-related cancer (0.51, 95% CI 0.32-0.83) and those without any cancer history (0.43, 95% CI 0.30-0.63) were both less likely to report being advised to quit smoking than patients with a tobacco-related cancer history.

Systematic review of smoking relapse rates among cancer survivors who quit at the time of cancer diagnosis.

BACKGROUND: Tobacco cessation, at the time of cancer diagnosis, has been associated with better oncologic outcomes. Cancer diagnosis has been shown to serves as a "teachable moment," inspiring tobacco cessation. However, the sustainability of abstinence from smoking is understudied. Similarly, there is a paucity of data regarding the utility of behavioral/pharmacologic intervention to support continued smoking cessation. METHODS: A systematic literature review was conducted in August 2021 with no date limits. Relevant studies that reported tobacco smoking relapse rates for patients who quit at the time of cancer diagnosis were included. Our literature search identified 1620 articles and 29 met inclusion criteria. The primary endpoint of the study was smoking relapse rate. Secondary outcome was a descriptive assessment of behavioral and pharmacologic interventions to promote continued cessation. Exploratory outcomes included a regression analysis to examine associations between study factors and relapse rates. RESULTS: There were 3021 smokers who quit at the time of cancer diagnosis. Weighted overall relapse rate for the study population was 44 % (range 5-57 %). Interventions to support smoking cessation were employed in 17 of the 29 included studies and protocols were heterogenous, including behavioral, pharmacologic, or mixed intervention strategies. Exploratory analysis demonstrated no association between relapse rates and publication year, gender, or study type. Relapse rates were indirectly associated with age (p = .003), suggesting that younger patients were more likely to relapse. CONCLUSION: The sustainability of smoking cessation after a cancer diagnosis is understudied, and existing literature is difficult to interpret due to heterogeneity. Relapse rates remain significant and, although many studies have included the employment of an intervention to promote continued cessation, few studies have measured the effect of a protocolized intervention to support abstinence.

Non-oncology clinical trial engagement in a nationally representative sample: Identification of motivators and barriers.

BACKGROUND: Enrollment in non-oncology clinical trials is often challenging and social determinants that may serve as motivators or barriers to clinical trial enrollment are largely unexplored. We sought to assess engagement in non-oncology clinical trials with a focus on social determinants of health as barriers or motivators toward participation. METHODS: A cross-sectional analysis of non-cancer respondents was conducted using the Health Information National Trends Survey (HINTS) administered in 2020. Our analytic cohort was comprised of respondents with no reported history of cancer. Our primary outcome of interest was trial engagement defined as receiving an invitation to participate in a clinical trial. Secondary outcomes included participation in a clinical trial and reported motivators and barriers to clinical trial participation. RESULTS: A total of 3113 respondents with no reported history of cancer were included. Overall, 8.1% of respondents reported being invited to participate in a clinical trial. Amongst those invited to participate, 47.7% reported participating in a clinical trial. Respondents reported that clinical trial participation was motivated "somewhat" or "a lot" by "wanting to get better" (80.5%), "helping other people" (61.4%), "physician encouragement" (60.6%), "getting a chance to try new care" (60.2%), "family friend encouragement" (54.2%), or "getting paid" (50.0%). Overall, 82.5% of all respondents "don't know anything" or have "a little knowledge" about clinical trials. Reported barriers to clinical trial participation including getting transportation, childcare or paid time off work (48.4%) and standard of care not covered by insurance (62.0%) influenced the decision to participate "somewhat" or "a lot." CONCLUSION: Amongst a nationally representative sample, non-oncology clinical trial invitation is low, but participation amongst those invited is nearly 50%. This highlights the need for clinician engagement in clinical trials. Identifying modifiable social determinants of non-oncologic clinical trial participation may help promote improved engagement.

Persistent deficiencies in the measurement and reporting of tobacco use in contemporary genitourinary oncology clinical trials.

Smoking is a causal or contributory factor for nearly all genitourinary cancers and exerts significant influence on treatment, quality of life, and survival outcomes. In order to understand the influence smoking has on the outcomes of contemporary therapies, pertinent smoking-related data must be systematically collected and report. We sought to determine how often and how rigorously smoking status is collected and reported in publications of clinical trials in genitourinary cancers by conducting a systematic review. Our initial search yielded 622 articles, 354 of which met criteria. The vast majority of included studies (91.8%) did not report any details about trial participants' smoking status. When included, 96.3% of studies reported baseline status qualitatively. No studies used a validated measurement instrument or reported change in participants' smoking status over the study period. Absence of the collection and reporting of smoking-related data precludes further study of how smoking impacts outcomes and highlights an important deficiency in GU oncology clinical trial design.

A Population-Level Assessment of Smoking Cessation following a Diagnosis of Tobacco- or Nontobacco-Related Cancer among United States Adults.

INTRODUCTION: Smoking cessation after a cancer diagnosis can significantly improve treatment outcomes and reduce the risk of cancer recurrence and all-cause mortality. AIM: We sought to measure the association between cancer diagnosis and subsequent smoking cessation. METHODS: Data was sourced from the Population Assessment of Health and Tobacco (PATH) study, a representative population-based sample of United States adults. Our analytic sample included all adult smokers at Wave I, our baseline. The exposure of interest was either a tobacco-related cancer diagnosis, nontobacco-related cancer diagnosis, or no cancer diagnosis (the referent) reported at Wave II or III. The primary outcome was smoking cessation after diagnosis, at Wave IV. Results/Findings. Our sample was composed of 7,286 adult smokers at the baseline representing an estimated 40.9 million persons. Smoking cessation rates after a diagnosis differed after a tobacco-related cancer (25.9%), a nontobacco-related cancer (8.9%), and no cancer diagnosis (17.9%). After adjustment, diagnosis with a tobacco-related cancer was associated with a higher odds of smoking cessation (OR 1.83, 95% CI 1.00-3.33) compared to no cancer diagnosis. Diagnosis with a nontobacco-related cancer was not significantly linked to smoking cessation (OR 0.52, 95% CI 0.48-1.45). CONCLUSION: Diagnosis with a tobacco-related cancer is associated with greater odds of subsequent smoking cessation compared to no cancer diagnosis, suggesting that significant behavioral change may occur in this setting.

Randomized trial of community health worker-led decision coaching to promote shared decision-making for prostate cancer screening among Black male patients and their providers.

BACKGROUND: Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the USA. The United States Preventive Services Task Force (USPSTF) encourages prostate-specific antigen (PSA) testing decisions to be based on shared decision-making (SDM) clinician professional judgment, and patient preferences. However, evidence suggests that SDM is underutilized in clinical practice, especially among the most vulnerable patients. The purpose of this study is to evaluate the efficacy of a community health worker (CHW)-led decision-coaching program to facilitate SDM for prostate cancer screening among Black men in the primary care setting, with the ultimate aim of improving/optimizing decision quality. METHODS: We proposed a CHW-led decision-coaching program to facilitate SDM for prostate cancer screening discussions in Black men at a primary care FQHC. This study enrolled Black men who were patients at the participating clinical site and up to 15 providers who cared for them. We estimated to recruit 228 participants, ages 40-69 to be randomized to either (1) a decision aid along with decision coaching on PSA screening from a CHW or (2) receiving a decision aid along with CHW-led interaction on modifying dietary and lifestyle to serve as an attention control. The independent randomization process was implemented within each provider and we controlled for age by dividing patients into two strata: 40-54 years and 55-69 years. This sample size sufficiently powered the detection differences in the primary study outcomes: knowledge, indicative of decision quality, and differences in PSA screening rates. Primary outcome measures for patients will be decision quality and decision regarding whether to undergo PSA screening. Primary outcome measures for providers will be acceptability and feasibility of the intervention. We will examine how decision coaching about prostate cancer screening impact patient-provider communication. These outcomes will be analyzed quantitatively through objective, validated scales and qualitatively through semi-structured, in-depth interviews, and thematic analysis of clinical encounters. Through a conceptual model combining elements of the Preventative Health Care Model (PHM) and Informed Decision-Making Model, we hypothesize that the prostate cancer screening decision coaching intervention will result in a preference-congruent decision and decisional satisfaction. We also hypothesize that this intervention will improve physician satisfaction with counseling patients about prostate cancer screening. DISCUSSION: Decision coaching is an evidence-based approach to improve decision quality in many clinical contexts, but its efficacy is incompletely explored for PSA screening among Black men in primary care. Our proposal to evaluate a CHW-led decision-coaching program for PSA screening has high potential for scalability and public health impact. Our results will determine the efficacy, cost-effectiveness, and sustainability of a CHW intervention in a community clinic setting in order to inform subsequent widespread dissemination, a critical research area highlighted by USPSTF. TRIAL REGISTRATION: The trial was registered prospectively with the National Institute of Health registry ( www.clinicaltrials.gov ), registration number NCT03726320 , on October 31, 2018.

In vivo degradation rate of alginate-chitosan hydrogels influences tissue repair following physeal injury.

The physis is a cartilaginous tissue in children's long bones that is responsible for bone elongation. Physeal injuries can heal with bony repair tissue known as a "bony bar," and this can cause growth deformities. Current treatments involve surgical resection of the bony bar and insertion of inert materials in hopes of preventing bony bar re-formation and preserving bone elongation. However, these materials frequently fail and the bony bar commonly returns. This study investigated alginate-chitosan hydrogels as interpositional materials to block bony bar formation in a rat model of physeal injury. Further, biomaterial properties such as substrate stiffness, permeability, and degradation rate were studied. Different ratio alginate:chitosan hydrogels with or without calcium cross-linking were tested for their inhibition of bony bar formation and restoration of the injured physis. Alginate:chitosan were mixed (a) 90:10 with calcium (90:10 + Ca); (b) 50:50 with calcium (50:50 + Ca); (c) 50:50 without calcium (50:50 - Ca); and (d) 50:50 made with irradiated alginate (IA) and without calcium. We found that repair tissue was determined primarily by the in vivo degradation rate of alginate-chitosan hydrogels. 90:10 + Ca had a slow degradation rate, prevented cellular infiltration, and produced the most bony bar tissue while having softer, more permeable material properties. IA had the fastest degradation, showed high cellular infiltration, and produced the most cartilage-like tissue while having stiffer, less permeable material properties. Our results suggest that the in vivo biomaterial degradation rate is a dynamic property that can be optimized to influence cell fate and tissue repair in physeal injuries.

High Grade Mucinous Urothelial Carcinoma of the Renal Collecting System: A Case Report.

High grade mucinous urothelial carcinoma is a rare pathological variant. There is still controversy as to its nomenclature and classification. We report the case of a 64 year old female with history of pelvic pain who was incidentally discovered to have a left upper pole renal mass. Left nephroureterectomy was performed and histopathological examination revealed high grade mucinous urothelial carcinoma. Accurate diagnosis of this distinct pathological entity will allow for better understanding of phenotypic behavior and inform best treatment strategies.