Lee, Daniel W.

Abstract Background: Black men experience the highest burden of prostate cancer (CaP) incidence and mortality in the United States. The reasons documented for the significant burden of CaP in Black communities include health systems, care process, and individual/personal level factors, such as cultural factors, psychosocial factors, decision making/preferences, comprehension, past experience, and perceived behavioral control. The Community Living Lab (CoLLab) Learning Health System (LHS) was established within three American Legion Posts (ALP) in Northeast Florida to address these factors. Study Objective: This clinical trial study evaluated the impact of the CoLLab LHS on the knowledge, attitudes, beliefs, and cues to action of Black men who received Resources, Education, Amenities, and Community Health (REACH) services at the ALPs. Methods: The design was guided by the Intervention Mapping Framework and the Social Ecological Model. CoLLab REACH services were made available to participants through trusted community infrastructures. Services integrated include CaP resources and materials, social determinant of health navigation, healthy grocery distribution, cancer advocacy programs, and research participation. Participants were recruited at three ALPs and were asked to visit their respective CoLLab LHS site at least twice a month and up to 24 times over one year to use any of the services. The impact was measured using baseline and quarterly surveys assessing CaP awareness, knowledge, attitude, health beliefs, perceived control, intentions, and cues to action. Descriptive statistics were used to compare participants' information at baseline and at 3-month follow-up. Results: A total of 173 participants were included in this analysis; 57.9% were ≥ 60 years, and 92.2% were US-born Black men. Prostate cancer knowledge increased from baseline to 3-month follow-up. The median score rose from 4±1.29 at baseline, with the mean increasing to 4.24±1.10. Attitudes towards Cap screening declined marginally from 12.58±2.15 to 12.27±2.40. Health beliefs showed a clear upward shift, with the mean increasing from 22.86±3.0 at baseline to 23.20±2.82 after 3 months of intervention. Additionally, cues to action also improved, with the mean increasing from 2.78±1.67 to 3.25±1.45. Only the cues-to-action index showed a statistically significant difference (p = 0.018), with higher scores observed after 3 months of intervention. Conclusion: Across the four core constructs—prostate cancer knowledge, testing attitudes, health beliefs, and cues to action—outcomes at follow-up demonstrated modest but consistent improvements compared to those of baseline, alongside slightly reduced variability for most domains. Overall, the evaluation showed that CoLLab REACH services improved knowledge, enhanced stronger health beliefs, and significantly increased cues to action, while testing attitudes remained comparatively stable. Citation Format: Folakemi T. Odedina, Opeyemi Oreoluwa Bolajoko, Quincy A. Wimberly, Daniel W. Lee, Floyd B. Willis, Toshiko Moultrie, Wayne Ford, Derry Green, Arnold J. Merriweather, Michelle Fudge. The impact of the Community Living Lab learning health system on the prostate cancer knowledge, attitudes, beliefs, and cues to action of Black men [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(8_Suppl):Abstract nr LB324.

Abstract Introduction: The disproportionate prostate cancer (CaP) burden, which includes high mortality rates, is significantly attributed to the characteristics of the social determinants of the health status of the Black Male population. Designing targeted interventions to address poor health outcomes through a collaborative population-based approach could reduce CaP health disparities. The Community Living Lab (CoLLab) Learning Health System was developed to address ethnically sensitive, targeted approaches that will eliminate CaP health disparities among Black Men. This study assessed demographic factors and Knowledge on prostate cancer screening attitudes and research participation among black men. Method: The collab project employed a social ecological model to design intervention to address barriers to CaP screening and participation in clinical trials. A validated, pretested questionnaire was used to collect information on demographics, CaP knowledge, attitudes, testing, and a history of participation in research and clinical trials. Baseline data were collected from 3 American Legion posts (ALPs). The association between variables was evaluated using the Chi-square test. Results: Participants between 60-69 years were 28.38%, and those aged 40-49 were 12.16%. Most are US-born Black (89.8%), with others identifying as African-born Black (6.76%) and Caribbean-born Black (1.35%). Approximately 43.24% were retired, and 36.49% were working full-time. CaP knowledge was high in 43.9%, moderate in 46.6%, and low in 9.5%. Only 45% of the participants have undergone Prostate-Specific Antigen test, and 24.6% have had a Digital Rectal Examination. Reported past clinical trials and research participation were very low (9.38%). Participants with higher knowledge levels had higher information scores (p < .0001), favored various research settings (p = 0.0008), had favorable attitudes towards CaP testing (p < .0001), and were more likely to participate in research (p = 0.0117). Work status was found to impact CaP Knowledge (p = 0.0117). Participants with stronger beliefs about prostate cancer may have different attitudes toward testing (p = 0.0444). Age did not impact attitudes toward CaP testing (p = 0.4298). Conclusion: The knowledge of CaP was found to impact the attitudes, testing, and disposition of the participants towards research. The baseline data generated from the clinical study will curate insightful evidence that will create innovative approaches to prostate cancer education among males in Black communities. Citation Format: Opeyemi O. Bolajoko, Quincy A. Wimberly, Daniel W. Lee, Collisa Mahin, Michelle Fudge, Shaina E. Flynn, Arnold J. Merriweather, Trevanne R. Matthews Hew, Monica L. Albertie, Dery Greene, Wayne Ford, Toshiko Moultrie, Floyd B. Willis, Folakemi T. Odedina. Influence of demographic factors and knowledge on prostate cancer screening attitude and research participation among Black men [abstract]. In: Proceedings of the 18th AACR Conference on the Science of Cancer Health Disparities; 2025 Sep 18-21; Baltimore, MD. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(9 Suppl):Abstract nr C138.

Abstract Background: Epidemiology studies have linked frequent consumption of well-done cooked red meat with aggressive prostate cancer (CaP) risk, whereas rare intake or consuming medium-cooked meat is not. Providing public information about the impact of well-done cooking and its potential role in CaP risk may foster the adoption of evidence-based lifestyle modification of meat consumption to lower CaP risk. This pilot study aimed to provide preliminary data on the occurrence of CaP and the pattern of consumption of cooked red beef among ethnically diverse males in the US. Methods: The proposed project is an exploratory study focused on the assessment of the consumption of various beef dishes among ethnically diverse males in the United States. The study included 408 ethnically diverse males from Florida, Georgia, and Texas. Participants were recruited primarily from partnering restaurants, pharmacies, barbershops and collaborating community businesses using QR codes on the study flyer. Participants completed the self-administered survey that captured demographics, as well as information on beef consumption patterns, including cooking methods, frequency and degree of cooking, and the occurrence of CaP. The data were analyzed using descriptive statistics (frequency and percentages) to summarize demographics and variables on beef dishes. Chi-square was employed to determine the relationship between beef consumption patterns, demographic variables, and CaP occurrence. Results: The study showed that about half (49.8%) of the participants were between ages 44-63 years and 34.2% were 30-43 years old. The participants were quite diverse, as 51.7%, 16.3%, 13.1%, 11.%, and 2.7% were African American, African immigrants, White, Caribbean immigrants, and Hispanics, respectively. Rural dwellers comprised 34.2%, 26.8% were suburban, and 35.7% lived in urban areas. Educational status showed that 22.7%, 27.8%, and 22.7% were completed high school, college graduates, and associate degrees. The beef consumption pattern shows that 23.6%, 33.3%, 40.1%, and 30.3% regularly had boiled, fried, grilled, and barbequed beef, respectively, but 63, 2% reported never eating boiled beef. Doneness preferences differed among participants; 26%, 43.9%, 49.3, and 45.1% preferred well-done, while 1.7%, 1.5%, 2..9%, and 2.7% preferred rare, and 9%, 14.5%, 17.4%, and 15.7% preferred medium boiled, fried, grilled, and barbeques beef, respectively. Only 4.4% of the participants reported being diagnosed with CaP in the past. The pattern of beef consumption, such as the degree of doneness, was found for boiled (p=0.045), fried (p<0.001), grilled (p<0.001), and barbequed (p<0.001) beef, as well as frequency of consumption of (p<0.001), fried (p<0.001), grilled (p=0.001), and barbequed (p<0.001) to be associated with CaP. Conclusion: Beef consumption pattern was found to be associated with the risk of CaP among participants. Citation Format: Opeyemi Oreoluwa Bolajoko, Daniel W. Lee, Catherine Adebukola Oladoyinbo, Ernie Kaninjing, Samuel O. Antwi, Dee M. Glaser-Boivin, Robert J. Turesky, Folakemi T. Odedina. Pattern of beef consumption and prostate cancer risk among males in the United States [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 7112.

Background: Early data from anti-CD19 chimeric antigen receptor (CAR) T-cell trials suggest that concurrent infection can lead to poor outcomes. 1,2 The relationship between CAR T-cell mediated inflammatory responses and infections is not well-established. With CAR T-cell therapies more readily available, practitioners must identify which patient, disease and CAR T-cell specific parameters are associated with an increased risk of infection to optimize outcomes. We provide a comprehensive analysis of infection risk within the first 30 days after CAR T-cell infusion across multiple types of CAR T-cell trials targeting distinct antigens. Methods: This was a single-center, retrospective study conducted at the National Cancer Institute analyzing infectious complications in subjects who underwent CAR T-cell therapy on one of four phase I clinical trials, targeting CD19, CD22, B-cell maturation antigen (BCMA) or disialoganglioside (GD2) from 2012 though 2018. Baseline characteristics are in Table 1. The primary objective was to establish the incidence of infections between initiation of lymphodepleting (LD) chemotherapy through day 30 after CAR T-cell infusion. The secondary objective was to identify risk factors for infection. Patients were censored at relapse and/or initiation of alternative therapy, including treatment for relapse or consolidative hematopoietic stem cell transplantation (HSCT). Univariate screening methods were used to identify parameters associated with increased risk of infection Results: Amongst 144 subjects, 52 (36.1%) received anti-CD19 CAR T-cells (CAR-T); 53 (36.8%) received anti-CD22 CAR-T, 26 (18.1%) received anti-BCMA CAR-T; and 13 (9%) received anti-GD2 CAR-T. The median age was 18 years (range: 4 to 66). Sixty-one (42.4%) had undergone at least one prior allogeneic hematopoietic stem cell transplant (HSCT) and 24 (16.7%) had at least one prior autologous HSCT. Sixty-eight (47.2%) had a history of a recent infection within 100 days of initiation of LD chemotherapy, of which 17 were a major chronic infection and 9 were considered severe. Fifty-eight (40.3%) subjects experienced a total of 103 infections from initiation of LD chemotherapy through day 30 post CAR T-cell infusion, with the median time to first infection being 6 days post-CAR infusion. Twenty-eight (19.4%) subjects had more than 1 infection; 20 (13.9%) subjects had C. difficile infection. The 103 infections consisted of 47 (45.6%) distinct episodes of focal bacterial infections (e.g., sinusitis, pneumonia, urinary tract infection), 25 (24.2%) episodes of bacteremia, 22 (21.4%) viral infections, and 9 (8.7%) invasive fungal infections. Fourteen infections (13.6%) occurred between initiation of LD chemotherapy and day 0 (prior to CAR T-cell infusion). Fever and neutropenia, without a source, was documented as a distinct entity in 85 patients (59.0%). Using univariate statistical screening methods, we identified 4 parameters that were individually associated with an increased risk of infection: increasing number of prior therapies (p=0.0034), prior history of recent infection within the past 100 days (p=0.0064), age > 18 (p =0.028), or enrollment on the CD22 CAR trial (p=0.0028). Eliminating the trial, since that is not generalizable, and combining these into a multivariable logistic regression model identified age > 18, prior history of infection and prior lines of therapies jointly associated with an increased risk of infection. Using these parameters, a predictive model was developed, which, when applied to the data set used to develop the model, can correctly predict 69 of 86 patients without an infection (80.3%; CI: 70.3-88.0%) as well as 32 of 58 patients with an infection (55.2%; 95% CI: 41.5- 68.3%). Conclusion: In this retrospective analysis, we provide the largest experience to date analyzing infection in the setting of CAR T-cell therapy across multiple CAR constructs. Our study demonstrates that adult age, prior history of infection, increased number of prior therapies and enrollment on a particular CAR T-cell trial, in this case the CD22 CAR-T trial, may lead to a higher risk of infection than in those without these risk factors. Further investigations are underway to evaluate clinical outcomes with infection which occur in the peri CAR T-cell setting and potential strategies to minimize infection risk. Generalizability of this model will be tested in an independent data set. Disclosures Lee: Kite, a Gilead Company: Research Funding; Harpoon Therapeutics: Consultancy; Juno Therapeutics: Other: External Advisory Board; ACI Clinical on behalf of Celgene:: Other: Independent Central Quality Review Committee. Mackall:Obsidian: Research Funding; Lyell: Consultancy, Equity Ownership, Other: Founder, Research Funding; Nektar: Other: Scientific Advisory Board; PACT: Other: Scientific Advisory Board; Bryologyx: Other: Scientific Advisory Board; Vor: Other: Scientific Advisory Board; Roche: Other: Scientific Advisory Board; Adaptimmune LLC: Other: Scientific Advisory Board; Glaxo-Smith-Kline: Other: Scientific Advisory Board; Allogene: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Apricity Health: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Unum Therapeutics: Equity Ownership, Membership on an entity's Board of Directors or advisory committees. Kochenderfer:Kite and Celgene: Research Funding; Bluebird and CRISPR Therapeutics: Other: received royalties on licensing of his inventions. OffLabel Disclosure: Conditioning chemotherapy for CAR T-cell therapy; this is a retrospective study that used different lymphodepletion regimens.