Courtney M.P. Hollowell’s research while affiliated with Cook County Hospital and other places

Purpose: Prostate Imaging Reporting and Data System (PIRADS) v2.1 scoring with multiparametric (mp) MRI has a pooled 90% negative predictive value (NPV). PSA density (PSAD) ≤ 0.15 ng/mL/cm3 has been shown to enhance mpMRI's NPV in non-Black men. Populations with higher disease prevalence are known to have lower NPVs. Given that Black men have higher prostate cancer prevalence, we evaluate sensitivity and NPV of mpMRI in Black vs non-Black men to assess possible mpMRI performance differences. As an exploratory objective, we investigate PSAD thresholds providing ≥ 90% sensitivity in Black men. Materials and methods: We prospectively recruited Black and non-Black men referred to outpatient urology clinics for abnormal PSA or prostate examination in 3 similar biomarker validation studies from 2017 to 2023 before MRI-informed diagnostic prostate biopsy. We combined the research cohorts with a retrospective clinical cohort of clinically similar Black and non-Black men from 1 academic institution who also underwent mpMRIs and MRI-informed biopsies. MRIs were scored using PIRADS version 2.0 or 2.1. Results: Our analysis included 286 Black men and 965 non-Black men with PSA ≤ 15.0 ng/mL. PIRADS < 3 had an NPV of 77.1% vs 87.6% and a sensitivity of 90.7% vs 96.3% for Gleason grade group 2 to 5 prostate cancer in Black vs non-Black men, respectively (both P < .05). Using PSAD ≥ 0.09 for Black men with PIRADS 1 to 2 lesions increased sensitivity to 92.9%. Conclusions: PIRADS < 3 has a lower NPV and sensitivity in Black men. For negative prostate MRIs, PSAD ≥ 0.09 may be a better threshold for safe biopsy deferral in Black men to maintain a ≥ 90% sensitivity.

Background Patient navigation (PN) is a promising yet underused approach to address Hispanic/Latino (H/L) cancer survivors' unmet supportive care needs. The authors conducted a randomized trial to evaluate the effect of a culturally tailored PN program with the LIVESTRONG Foundation's Cancer Navigation Services (PN‐LCNS) on reducing unmet needs in H/L survivors. Methods From 2012 to 2015 at two US sites, 288 H/L survivors diagnosed with breast, prostate, or colorectal cancer were randomized to a PN‐LCNS program or to standard PN. Participants assigned to the PN‐LCNS program received 3‐month PN services; access to phone‐based, bilingual, one‐on‐one support; and additional resources (i.e., guidebook, health journal, and care plan). Participants completed assessments at baseline and at 3, 9, and 15 months post‐baseline. The Supportive Care Needs Survey was used to assess unmet needs across five domains: psychological, health system and information, physical and daily living, patient care and support, and sexuality. Intervention effects were tested by using separate multilevel growth models for women and men. Results Women randomized to the PN‐LCNS program, relative to those who received standard PN, had a statistically significant reduction in unmet needs (i.e., overall and for the health systems and information, physical and daily living, and patient care and support domains). Among men, younger age was associated with greater unmet needs at baseline. Prostate cancer survivors reported greater unmet sexual health needs compared with colorectal cancer survivors. There was no significant change in unmet needs among H/L men. Conclusions A culturally tailored PN program can reduce unmet supportive care needs among H/L women cancer survivors. However, interventions specifically targeting unmet needs in H/L men and sexual health are still necessary (ClinicalTrials.gov identifier NCT02275754). Plain Language Summary Hispanic/Latino (H/L) cancer survivors often report concerns or needs that are not adequately addressed by the health care team, which could be related to psychological, health system and information, patient care and support, physical and daily living, and sexuality issues. In this randomized controlled trial of 288 H/L survivors diagnosed with breast, prostate, or colorectal cancer, women assigned to a culturally tailored patient navigation program experienced a reduction in unmet needs compared with those who received standard patient navigation. H/L men did not experience a change in unmet needs.

Introduction: PIRADS scoring with multiparametric-MRI (MRI) has a pooled 90% negative predictive value (NPV) allowing men to defer biopsy while enhancing Gleason Grade group 2-5 (GG2-5) prostate cancer (PCa) detection. PSA density (PSAD) ≥0.15ng/ml/cm3 has been shown to enhance NPV of the prostate MRI in non-Black men. We assessed the performance of the prostate MRI in Black vs. non-Black men by evaluating sensitivity and NPV, and identified a PSAD threshold providing ≥90% NPV in Black men. Methods: We prospectively recruited Black and non-Black men referred to outpatient urology clinics for abnormal PSA or prostate exam in three similar biomarker validation studies from 2017–23 before MRI-informed diagnostic transrectal or transperineal prostate biopsy. We combined this research cohort with a retrospective clinical cohort of clinically similar Black and non-Black men from one academic institution who also underwent prostate MRIs and MRI-informed biopsies for elevated PSA. Trained radiologists used PIRADS version 2.0 or 2.1 for scoring. Results: Following the combination of the research and clinical cohorts, 286 Black men and 965 non-Black men with PSA<15.0ng/ml were included in the analysis. PIRADS ≥3 had an NPV of 77.1% versus 87.6% and a sensitivity of 90.7% vs. 96.3% for GG2-5 PCa in Black versus non-Black men, respectively (both p<0.05). Using PSAD ≥0.09 for Black men with PIRADS 1-2 lesions increased sensitivity to 92.9%. For PIRADS 1-2, GG2-5 PCa frequency was 5.3% higher in Black versus non-Black men with PSAD<0.15, and 11.0% higher in Black versus non-Black men with PSAD≥0.15. For PIRADS=3, GG2-5 PCa frequency was 9.1% higher in Black men with PSAD<0.15 and 27.9% higher for PSAD≥0.15. For PIRADS=4, GG2-5 PCa frequency was 15.9% higher in Black men with PSAD<0.15, and 9.5% higher for PSAD≥0.15. Conclusion: The PIRADS ≥3 threshold has a lower NPV and sensitivity in Black men. A negative prostate MRI requires a PSAD ≥0.09 threshold for safe biopsy deferral in Black men to maintain a sensitivity ≥90%. Citation Format: Sarah Sandlow, Samuel Carbunaru MD, Zequn Sun PhD, Bernice Ofori MPH, Courtney M. P. Hollowell MD, Patricia Vidal MD, Eric Li MD, Edward M. Schaeffer MD, PhD, Peter Gann MD, ScD, Ashley Ross MD, PhD, Shilajit Kundu MD, Adam B. Murphy MD, MBA, MSCI. Lower negative predictive value of prostate MRI in Black men [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr C014.

Purpose The aim of this study was to characterize the prevalence of cardiometabolic comorbidities (i.e., diabetes, peripheral vascular disease, myocardial infarction, congestive heart failure, cerebrovascular disease) among Hispanic/Latino cancer survivors and examine the impact of cardiometabolic comorbidities on health-related quality of life (HRQoL), unmet supportive care needs, patient-provider communication self-efficacy, satisfaction with cancer care, and increases in healthy behaviors. Methods Hispanics/Latinos diagnosed with breast, prostate, or colorectal cancer (N = 288) were assessed within 15 months of primary treatment completion. Results One-quarter (24.7%) of survivors were diagnosed with diabetes and one-fifth (20.8%) were diagnosed with peripheral vascular disease. Survivors with at least one cardiometabolic comoribidity were older (t(278) = -.3.622, p < .001) and more likely to have a household income of less than $25,000 (X² = 8.369, p = .004). When adjusting for sociodemographic and medical covariates, survivors with cardiometabolic comorbidities demonstrated worse overall HRQoL (B = -4.792, p = .050), emotional (B = -1.479, p = .018) and physical (B = -2.228, p = .005) wellbeing, a higher odds of unmet psychological (OR = 2.095, p = .027) and sexuality (OR = 2.898, p = .004) needs, and greater patient-provider communication self-efficacy (B = .179, p = .045). There were no differences in healthy behavior changes or satisfaction with cancer care. Conclusions Cardiometabolic comorbidities may be highly prevalent among Hispanic/Latino cancer survivors and increase the risk of worse HRQoL and unmet supportive care needs. Targeted interventions are needed to optimize health among Hispanic/Latino cancer survivors with cardiometabolic comorbidities.

Purpose: We sought to develop and validate a prostate biopsy risk calculator for Black men and compare it with the Prostate Cancer Prevention Trial version 2.0, Prostate Biopsy Collaborative Group, and Kaiser Permanente Prostate Cancer Risk Calculators for the detection of Gleason Grade Group (GG) ≥ 2 prostate cancer (PCa). Materials and methods: We prospectively recruited 2 cohorts of men undergoing prostate biopsy from 5 facilities in Chicago. The first cohort was split into development (70%) and internal validation (30%) groups. The second was used for external validation. Iterative logistic regression was used to develop 3 models for predicting GG ≥ 2 PCa. Models were compared for discrimination using the C statistics, calibration curves, and net benefit curves. The frequency of unnecessary biopsies and missed PCas was compared at 10% and 30% risk thresholds. Results: The 2 cohorts included 393 and 292 Black men, respectively. Our first model, Mistry-Sun 1, used serum PSA and prior negative biopsy. Mistry-Sun 2 added abnormal digital rectal exam (DRE) and an interaction term with abnormal DRE and PSA to Mistry-Sun 1. Mistry-Sun 3 added prostate volume, abnormal DRE, and age to Mistry-Sun 1. The C statistics were 0.74, 0.74, and 0.78, respectively, and were similar to or higher than established calculators. At the 10% and 30% risk thresholds our models had the fewest unnecessary biopsies and an appropriate proportion of missed GG ≥ 2 PCas. Conclusions: Tailoring a risk calculator to detect clinically significant PCa in Black men may improve biopsy decision-making and outcomes compared to tools developed in non-Black populations.

Introduction The Oncotype Dx Genomic Prostate Score (GPS) is a 17‐gene relative expression assay that predicts adverse pathology at prostatectomy. We conducted a novel randomized controlled trial to assess the impact of GPS on urologist's treatment preference for favorable risk prostate cancer (PCa): active surveillance versus active treatment (i.e., prostatectomy/radiation). This is a secondary endpoint from the ENACT trial which recruited from three Chicago hospitals from 2016 to 2019. Methods Ten urologists along with men with very low to favorable‐intermediate risk PCa were included in the study. Participants were randomly assigned to standardized counseling with or without GPS assay. The main outcome was urologists' preference for active treatment at Visit 2 by study arm (GPS versus Control). Multivariable best‐fit binary logistic regressions were constructed to identify factors independently associated with urologists' treatment preference. Results Two hundred men (70% Black) were randomly assigned to either the Control (96) or GPS arm (104). At Visit 2, urologists' preference for prostatectomy/radiation almost doubled in the GPS arm to 29.3% (29) compared to 14.1% (13) in the Control arm ( p = 0.01). Randomization to the GPS arm, intermediate NCCN risk level, and lower patient health literacy were predictors for urologists' preference for active treatment. Discussion Limitations included sample size and number of urologists. In this study, we found that GPS testing reduced urologists' likelihood to prefer active surveillance. Conclusions These findings demonstrate how obtaining prognostic biomarkers that predict negative outcomes before treatment decision‐making might influence urologists' preference for recommending aggressive therapy in men eligible for active surveillance.

Purpose We aimed to identify subgroups of Hispanic/Latino (H/L) cancer survivors with distinct health behavior patterns and their associated sociodemographic, medical, and psychosocial characteristics. Methods Baseline data were used from a randomized clinical trial evaluating the efficacy of an enhanced patient navigation intervention in H/L cancer survivors. Participants (n = 278) completed the Lifestyle Behavior Scale and validated questionnaires on health-related quality of life (HRQOL), supportive care needs, distress, and satisfaction with cancer care. Latent class analysis was used to determine the latent classes and associated characteristics. Results Three latent classes emerged: class 1 (survivors who increased health behaviors [e.g., exercising and eating healthy] since diagnosis); class 2 (no changes in health behaviors since diagnosis); and class 3 (a “mixed class,” with a higher or lower engagement across various health behaviors since diagnosis). Participants in class 1 were significantly more educated and less likely to be foreign born. Participants in class 2 were significantly older and more likely to have prostate cancer. H/L cancer survivors in class 3 had a significantly lower income, were less educated, and reported greater unmet supportive care needs, more distress, and poorer HRQOL. Conclusions Survivors who report engaging in health behaviors less frequently since diagnosis may be experiencing psychosocial challenges and health disparities. Implications for Cancer Survivors Hispanic/Latino cancer survivors may benefit from screening for social determinants of health and mental health needs, prompt referral to supportive care services, community resources, and public services, and participating in culturally informed psychosocial interventions to address their unique needs.

Purpose We aimed to identify subgroups of Hispanic/Latino (H/L) cancer survivors with distinct health behavior patterns and their associated sociodemographic, medical, and psychosocial characteristics. Methods Baseline data was used from a randomized clinical trial evaluating the efficacy of an enhanced patient navigation intervention in H/L cancer survivors. Participants (n = 278) completed the Lifestyle Behavior Scale and validated questionnaires on health-related quality of life (HRQOL), supportive care needs, distress, and satisfaction with cancer care. Latent class analysis was used to determine the latent classes and associated characteristics. Results Three latent classes emerged: Class 1 (survivors who increased health behaviors [e.g., exercising and eating healthy] since diagnosis); Class 2 (no changes in health behaviors since diagnosis); and Class 3 (a “mixed class,” with a higher or lower engagement across various health behaviors since diagnosis). Participants in class 1 were significantly more educated and less likely to be foreign born. Participants in class 2 were significantly older and more likely to have prostate cancer. H/L cancer survivors in class 3 had a significantly lower income, were less educated, and reported greater unmet supportive care needs, more distress, and poorer HRQOL. Conclusions Survivors who report engaging in health behaviors less frequently since diagnosis may be experiencing psychosocial challenges and health disparities. Implications for Cancer Survivors Hispanic/Latino cancer survivors may benefit from screening for social determinants of health and mental health needs, prompt referral to supportive care services, community resources and public services, and participating in culturally-informed psychosocial interventions to address their unique needs.

Importance: There are few published studies prospectively assessing pharmacological interventions that may delay prostate cancer progression in patients undergoing active surveillance (AS). Objective: To compare the efficacy and safety of enzalutamide monotherapy plus AS vs AS alone in patients with low-risk or intermediate-risk prostate cancer. Design, setting, and participants: The ENACT study was a phase 2, open-label, randomized clinical trial conducted from June 2016 to August 2020 at 66 US and Canadian sites. Eligible patients were 18 years or older, had received a diagnosis of histologically proven low-risk or intermediate-risk localized prostate cancer within 6 months of screening, and were undergoing AS. Patients were monitored during 1 year of treatment and up to 2 years of follow-up. Data analysis was conducted in February 2021. Interventions: Randomized 1:1 to enzalutamide, 160 mg, monotherapy for 1 year or continued AS, as stratified by cancer risk and follow-up biopsy type. Main outcomes and measures: The primary end point was time to pathological or therapeutic prostate cancer progression (pathological, ≥1 increase in primary or secondary Gleason pattern or ≥15% increased cancer-positive cores; therapeutic, earliest occurrence of primary therapy for prostate cancer). Secondary end points included incidence of a negative biopsy result, percentage of cancer-positive cores, and incidence of a secondary rise in serum prostate-specific antigen (PSA) levels at 1 and 2 years, as well as time to PSA progression. Adverse events were monitored to assess safety. Results: A total of 114 patients were randomized to treatment with enzalutamide plus AS and 113 to AS alone; baseline characteristics were similar between treatment arms (mean [SD] age, 66.1 [7.8] years; 1 Asian individual [0.4%], 21 Black or African American individuals [9.3%], 1 Hispanic individual [0.4%], and 204 White individuals [89.9%]). Enzalutamide significantly reduced the risk of prostate cancer progression by 46% vs AS (hazard ratio, 0.54; 95% CI, 0.33-0.89; P = .02). Compared with AS, odds of a negative biopsy result were 3.5 times higher; there was a significant reduction in the percentage of cancer-positive cores and the odds of a secondary rise in serum PSA levels at 1 year with treatment with enzalutamide; no significant difference was observed at 2 years. Treatment with enzalutamide also significantly delayed PSA progression by 6 months vs AS (hazard ratio, 0.71; 95% CI, 0.53-0.97; P = .03). The most commonly reported adverse events during enzalutamide treatment were fatigue (62 [55.4%]) and gynecomastia (41 [36.6%]). Three patients in the enzalutamide arm died; none were receiving the study drug at the time of death. No deaths were considered treatment-related. Conclusions and relevance: The results of this randomized clinical trial suggest that enzalutamide monotherapy was well-tolerated and demonstrated a significant treatment response in patients with low-risk or intermediate-risk localized prostate cancer. Enzalutamide may provide an alternative treatment option for patients undergoing AS. Trial registration: ClinicalTrials.gov Identifier: NCT02799745.