BACKGROUND:Prostate cancer remains one of the most common cancers in men, and while active surveillance using serial prostate-specific antigen (PSA), imaging, and biopsies is the preferred management for low-risk cases, concerns remain about the impact of biopsy-related sexual dysfunction due to proximity to neurovascular bundles. AIM:To evaluate the association in biopsy frequency and sexual function in men on active surveillance (AS) for low-grade prostate cancer. METHODS:We analyzed data from the Miami Active Surveillance Trial (MAST, a prospective, single-arm study of men with Gleason grade ≤2 prostate cancer under AS, managed with annual magnetic resonance imaging-ultrasound fusion-guided transrectal ultrasound (TRUS) biopsies. Sexual and hormonal function was assessed using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire at baseline and 12-, 24-, and 36-month follow-ups. Minimally important differences (MID) were defined as 10-12 points for the sexual domain, and 4-6 points for the hormonal domain. Statistical analysis involved repeated measures analysis of variance (ANOVA) and paired t-tests using distribution of EPIC scores. OUTCOMES:Annual transrectal biopsies were associated with small, statistically, but not clinically significant declines in sexual function, with no meaningful impact on overall quality of life observed. RESULTS:Among 200 men enrolled, the median age was 62 years old, 89.5% were white, and 43% were Hispanic. A total of 52 men completed all follow-up biopsies. The mean baseline sexual function score was 43.7 (SD 13.1). Repeated measures ANOVA indicated a statistically significant decline in sexual function over time (P = .0105). Though statistically significant, this decline did not exceed the MID threshold for the sexual domain and therefore not clinically significant. Hormonal scores remained stable and showed no significant difference across time points (P = .5767). CLINICAL IMPLICATIONS:These findings support annual biopsy usage in AS protocols for clinicians without compromising sexual function. STRENGTHS & LIMITATIONS:The strengths of this study include rigorous annual biopsy protocols and validated EPIC measures to identify clear clinically significant thresholds. Limitations include sample attrition over time due to longer follow-up and single-institution design. CONCLUSION:Increased frequency of TRUS biopsies was associated with a statistically, but not clinically significant decline in sexual function, indicating that annual TRUS fusion biopsies are not likely to significantly impact sexual health and may be confidently recommended for patients on active surveillance.
BACKGROUND:Peyronie's disease (PD) is an acquired connective tissue disorder characterized by fibrous plaque formation within the penile tunica albuginea that may be influenced by androgen status. AIM:To evaluate whether baseline testosterone levels and testosterone therapy (TTh) during collagenase clostridium histolyticum (CCH) treatment affect curvature severity and treatment outcomes in men with PD. METHODS:This multi-center retrospective study included men with PD treated with CCH who had no curvature progression in the preceding three months and documented baseline testosterone levels. Demographics, baseline and post-treatment curvature, pain, plaque calcification, adverse events, TTh use, and surgical conversion were analyzed. Testosterone deficiency was defined as testosterone <300 ng/dL and concurrent signs or symptoms of low testosterone. Multivariable analyzes assessed predictors of curvature improvement. OUTCOMES:Primary outcomes included change in penile curvature following CCH therapy and secondary outcomes included adverse events and surgical conversion rates. RESULTS:Among 790 men, 778 met inclusion criteria (mean age 56.6 ± 9.1 years), with a median of eight CCH injections. Testosterone deficiency was present in 21% (n = 166), of whom 54% (n = 90) received TTh. Baseline curvature was similar among eugonadal men, testosterone deficient men on TTh, and testosterone deficient men not receiving therapy (45° vs. 44° vs. 48°, P = .392), as were pain symptoms and disease duration, though plaque calcification was more common in testosterone deficient men (P = .039). Mean curvature improvement was greatest in eugonadal men (24°), followed by testosterone deficient men on TTh (19°) and testosterone deficient men without therapy (17°). On multivariable analysis adjusting for age, baseline erectile dysfunction, baseline curvature severity, plaque calcification and post procedure modeling, both testosterone deficient groups remained independently associated with less curvature improvement compared with eugonadal men, with no significant difference between testosterone deficient men receiving versus not receiving TTh. Testosterone deficient men experienced higher rates of pain requiring medication (P < .05). Other adverse events and surgical conversion rates were similar across groups. CLINICAL IMPLICATIONS:Baseline androgen status may influence response to CCH therapy and should be considered during counseling and treatment planning. STRENGTHS AND LIMITATIONS:Strengths include a large multi-center cohort and multivariable analysis, while limitations include retrospective design, variability in TTh regimens, and potential unmeasured confounders. CONCLUSION:Testosterone deficiency is associated with reduced curvature improvement following CCH therapy regardless of testosterone treatment, with eugonadal men demonstrating the greatest therapeutic benefit.
Purpose In a prospective trial, we aimed to examine the predictive value of multiparametric MRI (mpMRI) for time to grade progression (GP) and compare the diagnostic yield of targeted vs. systematic biopsies across varying Prostate Imaging Reporting and Data System (PI-RADS) scores in men on active surveillance (AS). Methods The Miami AS Trial is a prospective, single-center study enrolling men with low- to favorable intermediate-risk prostate cancer. All patients underwent a confirmatory biopsy within 12 months of diagnosis, with subsequent biopsies at 12, 24, and 36 months, each guided by preceding mpMRI. Targeted cores were obtained from PI-RADS ≥3 lesions plus a 12-core template. GP was defined as upgrade from grade group (GG) 1 to GG2+ or GG2 to GG3+. Results From 2014 to 2020, 205 patients were enrolled (median age 62; prostate-specific antigen 5 ng/ml). During a median follow-up of 3.8 years, 79 men (38.5%) experienced GP. Targeted biopsy detected 68% of GP cases vs. 64% for systematic, with no significant difference (P = 0.6031). Detection was comparable for PI-RADS 3 to 4, but in PI-RADS 5 lesions, targeted biopsy outperformed systematic biopsy (93.8% vs. 43.8%, P = 0.0028). Progression-free survival was shorter for PI-RADS 4 (28.5 months) and 5 (25.4 months) vs. PI-RADS 3, with no difference between PI-RADS 4 and 5 lesions (P = 0.72). Conclusion Baseline PI-RADS predicts time to progression in AS. Targeted and systematic biopsies offer complementary value, particularly for PI-RADS 3 and 4 lesions, and omission of either risks underdetection of GP. For PI-RADS 5, targeted biopsy identified nearly all cases of GP, missing only one case that was found on systematic biopsy.
OBJECTIVES:To examine the role of multiparametric magnetic resonance imaging (mpMRI) in enhancing prostate cancer (PCa) detection and selecting candidates for active surveillance (AS), given that its utility in monitoring disease progression remains unclear. PATIENTS AND METHODS:The Miami Active Surveillance Trial (MAST) is a prospective trial of men undergoing serial mpMRI and biopsies on AS for PCa. Participants had annual mpMRI with MRI-targeted and systematic biopsies at confirmatory (12-18 months) and subsequent intervals (12, 24, and 36 months). Grade progression was defined as an upgrade from Grade Group (GG) 1 to GG ≥2 or GG 2 to GG ≥3. The performance of MRI was evaluated at baseline (prior to confirmatory biopsy) and on subsequent biopsies for association with grade progression. Fine and Gray competing-risk models evaluated MRI for predicting grade progression after controlling for risk factors. RESULTS:Among 205 men, 79 (38.5%) had grade progression at the conclusion of the trial (36 months), with 40 (19.5%) men having grade progression at confirmatory biopsy, and the remaining 39 (2.0-9.8%/year) progressing on subsequent biopsies. A Prostate Imaging-Reporting And Data System (PI-RADS) score of 4 or 5 (vs no suspicious lesions or PI-RADS 1 and 2) on baseline MRI (prior to confirmatory biopsy) was an independent predictor of grade progression on confirmatory biopsy (Gray's test P < 0.001), with volume progression treated as a competing risk. At 36 months, MRI-only surveillance would have avoided 45% of biopsies but missed 32% of progression events. CONCLUSION:Pre-confirmatory biopsy MRI independently predicted grade progression on confirmatory and subsequent biopsies during AS; however, false positives and negatives still occur highlighting the need for periodic biopsy of the prostate.
OBJECTIVES:To evaluate basal-luminal cell of origin subtyping using Prediction Analysis of Microarray of 50 genes (PAM50) genomic classification profiles for predicting disease progression in men undergoing active surveillance (AS) for prostate cancer (PCa). PATIENTS AND METHODS:In the prospective Miami Active Surveillance Trial (MAST) trial, 205 men undergoing AS received serial multiparametric magnetic resonance imaging (MRI) and biopsies, including MRI-targeted and systematic sampling. The highest-grade core from each biopsy was sent for expression profiling using Decipher, a clinical-grade transcriptome assay (Veracyte Inc., San Diego, CA, USA). Basal-luminal subtyping was evaluated using PAM50 molecular subtype models. PCa grade progression was compared across subtypes, as were gene mutation signatures, prognostic indices, and pathway activities. Kaplan-Meier curves, log-rank test, and multivariable Cox regression were used to assess association between PAM50 and grade progression. Heatmaps and volcano plots were rendered to illustrate potential mechanistical differences between PAM50 subtypes. RESULTS:Of the 205 patients, 128 had transcriptome data for baseline basal-luminal classification. PAM50 identified 46 Luminal A (LA), 26 Luminal B (LB), and 56 Basal subtypes. Decipher scores were lowest in LA, followed by Basal, and highest in LB. Grade progression-free survival was worse in patients with the LB subtype (median 1.7 years) compared to those with LA and Basal subtypes (median 2.9 years; log-rank P = 0.005); LB patients had grade progression-free survival of 34% by 24 months of AS, compared to 63% for Basal or 68% for LA. Transcriptome analysis showed distinct enrichment profiles for each subtype, with LB strongly associated with SPOP and CHD1 mutations. Limitations include small sample size and single-institution setting. CONCLUSION:The PAM50 basal-luminal subtyping shows promise as a molecular classification tool for predicting progression risk in PCa. This is one of the only prospective studies evaluating PAM50 subtyping for predicting cancer progression in a cohort of men undergoing AS for PCa.
Introduction Despite prostate MRI, image-guided biopsies, and other improvements in Active Surveillance, pathologic reclassification still occurs in 11% to 32% of confirmatory biopsies in contemporary series. Therefore, we evaluated if the Decipher Genomic Classifier (GC) and other genomic signatures in biopsy cores with Gleason Group (GG) 1 cancer can predict coexisting higher-grade disease elsewhere in the prostate among participants of the Miami Active Surveillance Trial (MAST). Methods style="margin-bottom: 12pt; text-align: justify; line-height: 150%">MAST enrolled 205 men with low and favorable intermediate-risk prostate cancer undergoing AS. Participants underwent a multiparametric MRI and confirmatory biopsy at enrollment, and annually thereafter for three years. Positive biopsy cores underwent GC version 1.2 profiling, and Genomic Prostate Score (GPS) and Cell Cycle Progression (CCP) signatures were also derived based on the normalized (to a 0.0 to 1.0 scale) expression of the specific target genes included in these tests. The primary objective was to compare GC scores in GG1 cores from prostates with (positive) vs. without (negative) coexisting GG2+ cancer elsewhere. Similar comparisons were made using the derived CCP and GPS. As secondary objectives, the Decipher GC, derived GPS, and derived CCP were also compared regarding 1) coexisting GG3+ cancer elsewhere and 2) the highest-volume GG1 core from each biopsy session. Neither patients, providers, nor investigators had access to genomic data that could affect clinical decisions throughout the trial. Results style="margin-bottom: 12pt; text-align: justify; line-height: 150%">141 men contributed with 324 cores harboring GG1 cancer with successful genomic analysis. Men with coexisting GG2+ in at least one biopsy were older (median 69 vs. 62 years, p=0.003), had higher PSA density (median 0.19 vs. 0.10, p=0.008), and higher baseline 4K scores (median 47.0% vs. 20.5%, p=0.001). There was no significant difference between groups in GC or CCP scores regarding the primary objective, whereas median (IQR) GPS was 0.14 (0.08–0.24) in positive vs. 0.10 (0.07–0.16) in negative groups (p=0.018) – Figure 1. Figure 2 shows genomic scores distribution for each core regarding coexisting GG2 cancer elsewhere in the gland. For coexisting GG3+ elsewhere, GC or CCP scores again showed no difference, while GPS was 0.24 (0.19–0.29) vs. 0.10 (0.07–0.16) in positive and negative groups, respectively (p=0.005). The three tests did not differ when considering only the highest-volume GG1 core for expression profiling. Conclusions In a prospective AS trial, the genomic classifiers – Decipher GC and the derived CCP and GPS signatures – showed no clinically relevant differences between GG1 biopsy cores with and without coexisting higher-grade cancer elsewhere in the prostate. The slightly higher values observed in the GPS signature are insufficient to support any clinical application but merit further investigation. Findings suggest that prostate cancer foci are heterogeneous and genomically independent, and results from any particular core are more reflective of the region sampled, rather than informing on the risk of missed higher-grade cancer elsewhere in the gland
Purpose: To assess the mid- to long-term safety and effectiveness of prostatic artery embolization (PAE) at a single-center cohort of 1,075 patients. Materials and Methods: This institutional review board-approved retrospective study included patients with moderate-to- severe lower urinary tract symptoms (LUTS) or urinary retention who underwent PAE from January 2014 to July 2023. Patients were assessed at 1, 3, 6, and 12 months after PAE and yearly thereafter. The International Prostate Symptom Score (IPSS), quality of life (QoL) score, International Index of Erectile Function-5 (IIEF-5) score, prostate-specific antigen (PSA), prostate volume (PV), postvoid residual, benign prostatic obstruction (BPO) medication usage, urinary catheter status, and further prostatic interventions were assessed. Adverse events were recorded and classified using the Society of Interventional Radiology (SIR) adverse events (AEs) severity classification. Results: The mean follow-up was 458.4 days (SD +/- 559.5). The mean age was 70.4 years (SD +/- 9.0), the median (inter- quartile range) PV was 107 g (76-150 g), and the median preprocedural IPSS, QoL, and IIEF-5 scores and PSA level were 23 (18-28), 5 (4-6), 17 (10-21), and 4.7 ng/mL (2.6-8), respectively. In the LUTS subgroup, at 1-3, 6-12, and 48-60 months, the median IPSS values were 7 (4-12, P < .001), 6 (3-11, P < .001), and 9 (4-15, P < .001), respectively. The QoL scores at the same time points were 2 (1-2, P < .001), 1 (0-2, P < .001), 2 (0-3, P < .001), respectively. Of 126 patients in the retention cohort, 119 (94%) were catheter-free at the 3-month follow-up. Ninety-patients (16% of reintervention eligible patients) required a second prostatic intervention up to 60 months after PAE. After PAE, 65.5% of patients were BPO medication-free at 1 year. Seven patients (0.65%) had severe AEs according to the SIR AE severity classification: (a) transient ischemic attacks, 3; (b) urosepsis, 2 (treated in the inpatient setting with intravenous antibiotics); and (c) prostate sloughing, 2 (needing transurethral resection of the prostate). All AEs resolved without permanent sequelae. Conclusions: In a large cohort with long-term longitudinal follow-up, PAE showed significant, sustained long-term relief of LUTS, improved QoL, low reintervention rate, and high BPO medication-free rates. Ninety-four percent of catheter- dependent patients at baseline were catheter-free at 3 months.
PURPOSE:We investigated whether expression signatures from Grade Group (GG) 1 biopsy cores can detect the presence of higher-grade cancer elsewhere in the prostate. MATERIALS AND METHODS:We enrolled 205 men with low to favorable intermediate-risk prostate cancer undergoing active surveillance on a prospective protocol. All participants underwent MRI and confirmatory biopsy at enrollment, followed by annual biopsies for 3 more years. Select cores were sent for Decipher Prostate Genomic Classifier (DGC) testing, and derived Oncotype DX Genomic Prostate Score (dGPS) and Prolaris Cell Cycle Progression (dCCP) signatures were obtained. We compared genomic scores from GG1 biopsy cores with vs without coexisting GG2 and GG3 or higher cancer (GG2+ and GG3+, respectively). We repeated this comparison using only the highest-volume GG1 core from each biopsy, which is the current standard of care. RESULTS:Genomic profiling was successful in 141 of 205 patients (324 GG1 cores). There were no significant differences in DGC, dCCP, or dGPS scores between GG1 cores with vs without coexisting GG2+ cancer elsewhere. This remained true when using the largest volume GG1 core from each biopsy. dGPS was higher among GG1 cores with coexisting GG3+ cancer compared with those without (0.24 vs 0.10, P = .012); however, there was no difference between the groups on DGC or dCCP scores. CONCLUSIONS:Genomic classifiers in GG1 cores did not predict coexisting GG2+ cancer, while dGPS signatures showed some promise in detecting GG3+ cancer elsewhere in the gland. None of the signatures showed a difference between groups when using the highest volume GG1 core, which is the standard practice for genomic classifiers.
In our study, there were no statistically significant associations between overweight or obesity with NonMuscle Invasive Bladder Cancer (NMIBC) recurrence, stage progression, and grade progression. Thus, in our cohort, body weight category may not be considered a critical risk factor in the oncological progression of NMIBC. Objective: To assess the association of being overweight or obese with Nonmuscle invasive bladder cancer (NMIBC) recurrence, stage progression, and grade progression. Methods: Patients with NMIBC were included and categorized into 3 groups based on their body mass index (BMI): normal weight, overweight, and obese. Recurrence was defined as any histologically proven bladder cancer on subsequent transurethral resection of bladder tumor (TURBT). Progression was defined as upgrading from low to high grade, upstaging to pT1 from pTa, or to muscle-invasion from pT1 disease. Results: A total of 457 patients were analyzed, 135 (29.5%) had normal weight, 192 (42.6%) were overweight, and 130 (28.4%) were obese, with a median BMI of 27.1 (24.4-30.7) Kg/m2. The study found no significant difference in the time to recurrence, stage progression, and grade progression within the BMI categories (P <.05). Additionally, no increased risk was observed in BMI categories (Obesity recurrence HR: 1.067, CI 95%: 0.783-1.453; Obesity stage progression HR: 1.315, 95% CI: 0.635-2.724; Obesity grade progression HR: 0.586, 95% CI: 0.195-1.760). Conclusions: In our cohort, body weight category showed no association with NMIBC recurrence, stage progression, or grade progression. These findings highlight the need to identify other potential risk factors that could improve NMIBC risk stratification. Further studies are warranted to validate our results and explore additional predictors of NMIBC outcomes. (c) 2024 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.
This narrative review aims to outline the current available evidence, challenges, and future perspectives of Artificial Intelligence (AI) in the diagnosis and management of priapism, a condition marked by prolonged and often painful erections that presents unique diagnostic and therapeutic challenges. Recent advancements in AI offer promising solutions to face the challenges in diagnosing and treating priapism. AI models have demonstrated the potential to predict the need for surgical intervention and improve diagnostic accuracy. The integration of AI models into medical decision-making for priapism can also predict long-term consequences. AI is currently being implemented in urology to enhance diagnostics and treatment work-up for various conditions, including priapism. Traditional diagnostic approaches rely heavily on assessments based on history, leading to potential delays in treatment with possible long-term sequelae. To date, the role of AI in the management of priapism is understudied, yet to achieve dependable and effective models that can reliably assist physicians in making decisions regarding both diagnostic and treatment strategies.
Abstract Introduction Collecting regional health data is imperative to guide the planning and implementation of programs and policies that will ultimately improve men’s health. Suicide is a leading cause of mortality among males of all age groups within the United States. Understanding the demographics of male suicide, as well as age, racial, and ethnic disparities is critical in developing targeted solutions to this devastating problem. Objective The objectives were to identify the magnitude of male suicide within the State of Florida in terms of overall incidence. Additionally, we sought to identify age, racial, and ethnic disparities within the state, as well as any potential trends in these variables. A description of the various disparities of the modality used to commit suicide was of interest, as well. Methods Data was obtained from the United States Census Bureau, the State Department of Health, and the Center for Disease Control and Prevention. Included within a number of reports prepared by these organizations were demographic data on population size, age, race, and ethnicity within our state. The Florida Department of Health provided health indicator data from several different sources, which included death certificates and results from the 2015 and 2019 Behavioral Risk Factor Surveillance Survey (BRFSS). The BRFSS is an annual random sample, state-based, telephone survey used to collect data from Florida residents regarding individual health practices and risk behaviors. Finally, we used the Centers for Disease Control and Preventions’ National Center for Health Statistics Mortality in the United States Report to obtain life expectancy at birth data in Florida and in the US by both race and sex. Causes of death for suicide were coded based on the International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). Comparative data was developed in the context of age, race/ethnicity, and mechanism of suicide. Results Suicide is the 4th leading cause of death in Floridian men ages 18-54, accounting for 1,700 deaths annually. Floridian males have more than three times the rate of suicide deaths compared to females. In 2021, non-Hispanic and White men had the highest suicide death rate per 100,000 individuals at 24.3 and 24 respectively compared to Black men at 10.3. (see Figure 1). In 2021, firearms were used in the majority of suicide deaths across the state and all age groups, accounting for 63%. Suffocation accounted for 21%, followed by poisoning at 8%. Conclusions This study corroborates national data suggesting that suicide is a major health problem that preferentially impacts males. Racial, ethnic, and geographic health disparities among Floridian males exist as demonstrated by accumulated data on suicide death rates. This data is extremely important for Men’s Health experts to recognize and understand. A continued focus on strengthening data and research on suicide is needed to provide prevention initiatives and strategies targeted towards these vulnerable populations. Disclosure No.
Abstract Introduction Collecting regional health data that identifies causes of morbidity and mortality is imperative in order to guide the planning and implementation of programs and policies that will ultimately improve men’s health. Unintentional impact accidents are a major source of morbidity and mortality for young males across the United States. Other potentially reversible behaviors that have adverse behaviors that n’s health include smoking, vaping, and failing to undergo recommended cancer screenings. Corroborating this data on a regional level within our state of Florida, as well as understanding the prevalence of activities and behaviors that may adversely impact men’s health is important to build a strategy that reverses these trends. Objective The overarching goal was to develop a Men’s Health Report Card for the State of Florida which elucidated important health data that could be used to drive an evidence-based men’s health initiative for our state. In this study, we sought to evaluate the impact of accidental injuries on mortality and define specifics associated with those accidental injuries that may be used to mitigate the incidence of accidental deaths, Methods Data was obtained from various sources to develop a Men's Health Report Card for the State of Florida. The sources include the United States Census Bureau (USCB), the State Department of Health, the Center for Disease Control and Prevention (CDC) and the Florida Department of Health (FDH). The demographic data obtained from the USCB includes information on the population size, age distribution, race, and ethnicity breakdown within Florida. FDH contributed health indicator data from multiple sources. This data includes information from death certificates, providing insight into the leading causes of death for men in Florida, including COVID-19 death reports specific to gender and age. USCB American Community Survey provides data on social determinants of health, such as high school graduation rates and income levels falling below the federal poverty guidelines. CDC National Center for Health Statistics Mortality in the United States Report provides data on life expectancy in Florida and the United States organized by race and sex. The data spanned from the years 2015 and 2018. Results Figure 1 highlights some of the important information that was gleaned with regard to the state of Men’s Health in Florida. On average, Floridian men had a 5- year shorter life expectancy at birth than their female counterparts. Leading causes of male deaths in our state include heart disease, cancer, unintentional injuries, chronic lung disease, and cerebrovascular disease. The relative incidence of these sources of mortality is age dependent. It is notable that among young males, ages 18-54 years old, unintentional injuries, homicide, and suicide accounted for approximately 75% of male deaths. With respect to health behaviors: smoking and vaping, a sedentary lifestyle, obesity, alcohol abuse, and not wearing a seat belt remain highly prevalent among Floridian males. Notable among the cancer screenings, 30% of Floridian men over 50 years have never had a colonoscopy and 40% of men 50 years and older have never had a serum PSA test. Finally, it is notable that 15% of Floridian males could not see a physician due to cost, and close to 20% had no healthcare insurance coverage. Conclusions The State of Florida Men’s Health Report card defines significant causes of morbidity and mortality for Floridian males. As can be seen in this report, many of the sources of morbidity and mortality arise from unhealthy lifestyle choices, which if addressed could potentially reverse some of these trends. Racial, ethnic, and geographic health disparities among Floridian males exist and will require further work in the future to remedy this situation. Disclosure No.