RESUMEN
BACKGROUND: Between 1999 and 2009 in the United Kingdom, 82,429 men between 50 and 69 years of age received a prostate-specific antigen (PSA) test. Localized prostate cancer was diagnosed in 2664 men. Of these men, 1643 were enrolled in a trial to evaluate the effectiveness of treatments, with 545 randomly assigned to receive active monitoring, 553 to undergo prostatectomy, and 545 to undergo radiotherapy. METHODS: At a median follow-up of 15 years (range, 11 to 21), we compared the results in this population with respect to death from prostate cancer (the primary outcome) and death from any cause, metastases, disease progression, and initiation of long-term androgen-deprivation therapy (secondary outcomes). RESULTS: Follow-up was complete for 1610 patients (98%). A risk-stratification analysis showed that more than one third of the men had intermediate or high-risk disease at diagnosis. Death from prostate cancer occurred in 45 men (2.7%): 17 (3.1%) in the active-monitoring group, 12 (2.2%) in the prostatectomy group, and 16 (2.9%) in the radiotherapy group (P = 0.53 for the overall comparison). Death from any cause occurred in 356 men (21.7%), with similar numbers in all three groups. Metastases developed in 51 men (9.4%) in the active-monitoring group, in 26 (4.7%) in the prostatectomy group, and in 27 (5.0%) in the radiotherapy group. Long-term androgen-deprivation therapy was initiated in 69 men (12.7%), 40 (7.2%), and 42 (7.7%), respectively; clinical progression occurred in 141 men (25.9%), 58 (10.5%), and 60 (11.0%), respectively. In the active-monitoring group, 133 men (24.4%) were alive without any prostate cancer treatment at the end of follow-up. No differential effects on cancer-specific mortality were noted in relation to the baseline PSA level, tumor stage or grade, or risk-stratification score. No treatment complications were reported after the 10-year analysis. CONCLUSIONS: After 15 years of follow-up, prostate cancer-specific mortality was low regardless of the treatment assigned. Thus, the choice of therapy involves weighing trade-offs between benefits and harms associated with treatments for localized prostate cancer. (Funded by the National Institute for Health and Care Research; ProtecT Current Controlled Trials number, ISRCTN20141297; ClinicalTrials.gov number, NCT02044172.).
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Antígeno Prostático Específico , Neoplasias de la Próstata , Humanos , Masculino , Antagonistas de Andrógenos/uso terapéutico , Andrógenos , Estudios de Seguimiento , Antígeno Prostático Específico/sangre , Prostatectomía , Neoplasias de la Próstata/sangre , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/mortalidad , Neoplasias de la Próstata/terapia , Espera Vigilante , Persona de Mediana Edad , Anciano , Radioterapia , Medición de RiesgoRESUMEN
Hormonal treatments (HT) for prostate cancer (e.g., androgen deprivation therapy) yield clinical and survival benefits, yet adverse cognitive changes may be a side effect. Since psychosocial factors are largely modifiable, interventions targeting these factors may help mitigate these adverse cognitive effects. This systematic review aimed to identify a range of psychosocial factors associated with cognitive function in individuals with prostate cancer undergoing HT and to determine whether these factors mitigate or exacerbate this effect. Applying PRISMA guidelines, a comprehensive search of relevant databases conducted in September 2023 using terms related to prostate cancer, hormone therapy, and cognitive outcomes was undertaken. The search yielded 694 unique abstracts, with 11 studies included for analysis examining the relationship between cognitive function and the following psychosocial factors: psychological distress, fatigue, insomnia, and coping processes. Findings were mixed with only two studies reporting significant associations between cognitive performance with fatigue and depression. Three studies that included measures of perceived cognitive function identified associations with depression, anxiety, fatigue, insomnia, illness threat appraisals, and coping styles. However, no studies found evidence for an association between self-reported and objective measures of cognitive functioning. Evidence regarding the association of interpersonal factors is lacking. Moreover, whether these factors mitigate or exacerbate the effect of HT on cognitive function still needs to be determined. Overall, the research exploring the association between psychosocial factors and cognitive function in prostate cancer survivors undergoing HT is still in its infancy. Further research is required to optimize the implementation of neuropsychological interventions for prostate cancer survivors.
RESUMEN
OBJECTIVE: Prostate cancer hormonal treatments (e.g. androgen deprivation therapy) yield clinical benefits. However, there is increasing evidence these treatments may adversely impact cognitive functioning. This study aimed to qualitatively characterise the nature and impact of cognitive difficulties following these treatments. METHODS: Prostate cancer survivors (PCS) self-reporting cognitive difficulties following hormonal treatments (via an online survey) and their partners were invited to participate in semi-structured interviews. Telephone or videoconferencing interviews were conducted, then transcribed, double-coded and analysed using the Framework Method, following the principles of Interpretative Phenomenological Analysis. RESULTS: Eleven participants (six PCS and five partners) were interviewed. PCS reported a range of cognitive difficulties, verified by their partners, including forgetfulness, "fogginess", fatigue and slowed processing speed. For some PCS, word-finding difficulties, tangential speech and memory problems were apparent during interviews. The aetiology of the reported cognitive difficulties was unclear as it was attributed to a possible combination of cancer treatments, compounding side-effects (e.g. fatigue, sleep problems, hot flashes), exacerbation of pre-existing conditions and/or age-related changes. Cognitive difficulties were reported to have led to shifts in self-perception, interpersonal dynamics and increased emotionality. Engagement in cognitively-stimulating activities and reliance on compensatory strategies were reported to be helpful in managing some cognitive difficulties. All participants endorsed the potential benefits of neuropsychological intervention. CONCLUSIONS: There are a diverse range of cognitive difficulties following hormonal treatments for prostate cancer experienced by PCS and their partners. Understanding the impact of these difficulties is important for the development of targeted neuropsychological interventions.
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Antagonistas de Andrógenos , Supervivientes de Cáncer , Neoplasias de la Próstata , Humanos , Masculino , Neoplasias de la Próstata/tratamiento farmacológico , Neoplasias de la Próstata/psicología , Anciano , Persona de Mediana Edad , Antagonistas de Andrógenos/efectos adversos , Supervivientes de Cáncer/psicología , Antineoplásicos Hormonales/efectos adversos , Disfunción Cognitiva/etiología , Disfunción Cognitiva/inducido químicamente , Investigación Cualitativa , Entrevistas como Asunto , Femenino , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To investigate the functional and quality of life (QoL) outcomes of treatments for localised prostate cancer and inform treatment decision-making. PATIENTS AND METHODS: Men aged 50-69 years diagnosed with localised prostate cancer by prostate-specific antigen testing and biopsies at nine UK centres in the Prostate Testing for Cancer and Treatment (ProtecT) trial were randomised to, or chose one of, three treatments. Of 2565 participants, 1135 men received active monitoring (AM), 750 a radical prostatectomy (RP), 603 external-beam radiotherapy (EBRT) with concurrent androgen-deprivation therapy (ADT) and 77 low-dose-rate brachytherapy (BT, not a randomised treatment). Patient-reported outcome measures (PROMs) completed annually for 6 years were analysed by initial treatment and censored for subsequent treatments. Mixed effects models were adjusted for baseline characteristics using propensity scores. RESULTS: Treatment-received analyses revealed different impacts of treatments over 6 years. Men remaining on AM experienced gradual declines in sexual and urinary function with age (e.g., increases in erectile dysfunction from 35% of men at baseline to 53% at 6 years and nocturia similarly from 20% to 38%). Radical treatment impacts were immediate and continued over 6 years. After RP, 95% of men reported erectile dysfunction persisting for 85% at 6 years, and after EBRT this was reported by 69% and 74%, respectively (P < 0.001 compared with AM). After RP, 36% of men reported urinary leakage requiring at least 1 pad/day, persisting for 20% at 6 years, compared with no change in men receiving EBRT or AM (P < 0.001). Worse bowel function and bother (e.g., bloody stools 6% at 6 years and faecal incontinence 10%) was experienced by men after EBRT than after RP or AM (P < 0.001) with lesser effects after BT. No treatment affected mental or physical QoL. CONCLUSION: Treatment decision-making for localised prostate cancer can be informed by these 6-year functional and QoL outcomes.
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Braquiterapia , Disfunción Eréctil , Neoplasias de la Próstata , Anciano , Antagonistas de Andrógenos , Humanos , Masculino , Persona de Mediana Edad , Próstata/patología , Prostatectomía , Neoplasias de la Próstata/patología , Calidad de Vida , Resultado del TratamientoRESUMEN
PURPOSE: Improved medical care throughout childhood and adolescence has enabled patients with complex urological abnormalities to live longer into adulthood. These patients are now at risk of developing common, age-related, urological conditions. This review aims to review existing data and make recommendations in areas where expert opinion is currently lacking METHODS: This review represents the joint SIU-ICUD (Société Internationale d'Urologie-International Consultation on Urological Disease) consultation on congenital lifelong urology. The results of this analysis were first presented at a joint consultation of the ICUD and SIU at the 2018 SIU annual conference in Seoul, South Korea. RESULTS: BPH may present differently in patients with neurogenic bladder. Thorough assessment of neurological status, bladder and sphincter function is required before offering any bladder outlet surgery. Prostate specific antigen screening should be offered to men aged 50-69 with neurogenic bladders if they have good life expectancy. Multi-parametric MRI and transperineal biopsy would be the investigations of choice if feasible. Surgery for localized disease should only be done by surgeons with the relevant expertise. Bladder cancer in this patient group is more likely to present at a later stage and have a worse prognosis. Parenthood is achievable for most, but often requires assistance with conception. Pregnant women who have had previous urogenital reconstructive surgery should be managed in appropriate obstetric units with the involvement of a reconstructive urologist. CONCLUSIONS: Most evidence regarding complex urogenital abnormalities comes from the pediatric population. Evidence regarding common, age-related urological issues is generally from the 'normal' adult population. As patients with complex congenital urological conditions live longer, more data will become available to assess the long-term benefits of intervention.
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Enfermedades Urológicas/complicaciones , Adulto , Factores de Edad , Niño , Humanos , Enfermedades Urológicas/epidemiología , Enfermedades Urológicas/etiologíaRESUMEN
OBJECTIVES: To investigate whether anti-glypican-1 antibody Miltuximab conjugated with near-infrared dye IRDye800CW can be used for in vivo fluorescence imaging of urothelial carcinoma. METHODS: The conjugate, Miltuximab-IRDye800CW, was produced and characterized by size exclusion chromatography and flow cytometry with glypican-1-expressing cells. Balb/c nude mice bearing subcutaneous urothelial carcinoma xenografts were intravenously injected with Miltuximab-IRDye800CW or control IgG-IRDye800CW and imaged daily by fluorescence imaging. After 10 days, tumors and major organs were collected for ex vivo study of the conjugate biodistribution, including its accumulation in the tumor. RESULTS: The intravenous injection of Miltuximab-IRDye800CW to tumor-bearing mice showed its specific accumulation in the tumors with the tumor-to-background ratio of 12.7 ± 2.4, which was significantly higher than that in the control group (4.6 ± 0.9, P < 0.005). The ex vivo imaging was consistent with the in vivo findings, with tumors from the mice injected with Miltuximab-IRDye800CW being significantly brighter than the organs or the control tumors. CONCLUSIONS: The highly specific accumulation and retention of Miltuximab-IRDye800CW in glypican-1-expressing tumors in vivo shows its high potential for fluorescence imaging of urothelial carcinoma and warrants its further investigation toward clinical translation.
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Carcinoma de Células Transicionales , Neoplasias de la Vejiga Urinaria , Animales , Línea Celular Tumoral , Glipicanos , Ratones , Ratones Desnudos , Imagen Molecular , Imagen Óptica , Distribución Tisular , Neoplasias de la Vejiga Urinaria/diagnóstico por imagenRESUMEN
BACKGROUND: The comparative effectiveness of treatments for prostate cancer that is detected by prostate-specific antigen (PSA) testing remains uncertain. METHODS: We compared active monitoring, radical prostatectomy, and external-beam radiotherapy for the treatment of clinically localized prostate cancer. Between 1999 and 2009, a total of 82,429 men 50 to 69 years of age received a PSA test; 2664 received a diagnosis of localized prostate cancer, and 1643 agreed to undergo randomization to active monitoring (545 men), surgery (553), or radiotherapy (545). The primary outcome was prostate-cancer mortality at a median of 10 years of follow-up. Secondary outcomes included the rates of disease progression, metastases, and all-cause deaths. RESULTS: There were 17 prostate-cancer-specific deaths overall: 8 in the active-monitoring group (1.5 deaths per 1000 person-years; 95% confidence interval [CI], 0.7 to 3.0), 5 in the surgery group (0.9 per 1000 person-years; 95% CI, 0.4 to 2.2), and 4 in the radiotherapy group (0.7 per 1000 person-years; 95% CI, 0.3 to 2.0); the difference among the groups was not significant (P=0.48 for the overall comparison). In addition, no significant difference was seen among the groups in the number of deaths from any cause (169 deaths overall; P=0.87 for the comparison among the three groups). Metastases developed in more men in the active-monitoring group (33 men; 6.3 events per 1000 person-years; 95% CI, 4.5 to 8.8) than in the surgery group (13 men; 2.4 per 1000 person-years; 95% CI, 1.4 to 4.2) or the radiotherapy group (16 men; 3.0 per 1000 person-years; 95% CI, 1.9 to 4.9) (P=0.004 for the overall comparison). Higher rates of disease progression were seen in the active-monitoring group (112 men; 22.9 events per 1000 person-years; 95% CI, 19.0 to 27.5) than in the surgery group (46 men; 8.9 events per 1000 person-years; 95% CI, 6.7 to 11.9) or the radiotherapy group (46 men; 9.0 events per 1000 person-years; 95% CI, 6.7 to 12.0) (P<0.001 for the overall comparison). CONCLUSIONS: At a median of 10 years, prostate-cancer-specific mortality was low irrespective of the treatment assigned, with no significant difference among treatments. Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring. (Funded by the National Institute for Health Research; ProtecT Current Controlled Trials number, ISRCTN20141297 ; ClinicalTrials.gov number, NCT02044172 .).
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Prostatectomía , Neoplasias de la Próstata/terapia , Espera Vigilante , Factores de Edad , Anciano , Investigación sobre la Eficacia Comparativa , Progresión de la Enfermedad , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia , Evaluación de Resultado en la Atención de Salud , Antígeno Prostático Específico/sangre , Neoplasias de la Próstata/mortalidad , Neoplasias de la Próstata/radioterapia , Neoplasias de la Próstata/cirugíaRESUMEN
PURPOSE: Inguinal hernia is a known sequel of radical prostatectomy which contributes to patient morbidity and health care expenditure. In this systematic review we evaluated the incidence of inguinal hernia associated with minimally invasive radical prostatectomy, in addition to predictive factors and preventive measures. MATERIALS AND METHODS: We searched PubMed® and Embase® between 2000 and February 2018 using the search terms inguinal hernia and radical prostatectomy. RESULTS: In concordance with search terms and selection criteria we identified a total of 155 reports with 27 studies eligible for inclusion. Collated results demonstrated a variable prevalence of inguinal hernia after laparoscopic radical prostatectomy and robotic assisted radical prostatectomy ranging from 4.3% to 8.3% and from 3% to 19.4 %, respectively. There was a higher mean prevalence of inguinal hernia after robotic assisted prostatectomy. Factors predicting inguinal hernia following minimally invasive radical prostatectomy included low body mass index, poor stream and straining prior to prostatectomy detected on symptom score instruments, a patent processus vaginalis or an intraoperative incidental inguinal hernia. Herniotomy or herniorrhaphy with onlay mesh repair was the most commonly reported intraoperative repair technique at the time of minimally invasive radical prostatectomy. Recurrence of repaired incidental hernia is rare. CONCLUSIONS: Inguinal hernia is common after minimally invasive radical prostatectomy. There is a lack of high level evidence to clarify risk factors and preventive strategies for inguinal hernia after minimally invasive radical prostatectomy. There is a justification for randomized controlled trials to further evaluate this under recognized clinical problem.
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Hernia Inguinal/epidemiología , Laparoscopía/efectos adversos , Complicaciones Posoperatorias/epidemiología , Prostatectomía/efectos adversos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Hernia Inguinal/etiología , Hernia Inguinal/prevención & control , Herniorrafia , Humanos , Incidencia , Laparoscopía/métodos , Masculino , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Prostatectomía/métodos , Neoplasias de la Próstata/cirugía , Factores de Riesgo , Procedimientos Quirúrgicos Robotizados/métodosRESUMEN
PURPOSE: Salvage radical prostatectomy has historically yielded a poor functional outcome and a high complication rate. However, recent reports of robotic salvage radical prostatectomy have demonstrated improved results. In this study we assessed salvage radical prostatectomy functional outcomes and complications when comparing robotic and open approaches. MATERIALS AND METHODS: We retrospectively collected data on salvage radical prostatectomy for recurrent prostate cancer after local nonsurgical treatment at 18 tertiary referral centers from 2000 to 2016. The Clavien-Dindo classification was applied to classify complications. Complications and functional outcomes were evaluated by univariable and multivariable analysis. RESULTS: We included 395 salvage radical prostatectomies, of which 186 were open and 209 were robotic. Robotic salvage radical prostatectomy yielded lower blood loss and a shorter hospital stay (each p <0.0001). No significant difference emerged in the incidence of major and overall complications (10.1%, p=0.16, and 34.9%, p=0.67), including an overall low risk of rectal injury and fistula (1.58% and 2.02%, respectively). However, anastomotic stricture was more frequent for open salvage radical prostatectomy (16.57% vs 7.66%, p <0.01). Overall 24.6% of patients had had severe incontinence, defined as 3 or more pads per day, for 12 or 6 months. On multivariable analysis robotic salvage radical prostatectomy was an independent predictor of continence preservation (OR 0.411, 95% CI 0.232-0.727, p=0.022). Limitations include the retrospective nature of the study and the absence of a standardized surgical technique. CONCLUSIONS: In this contemporary series to our knowledge salvage radical prostatectomy showed a low risk of major complications and better functional outcomes than previously reported. Robotic salvage radical prostatectomy may reduce anastomotic stricture, blood loss and hospital stay, and improve continence outcomes.
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Recurrencia Local de Neoplasia/cirugía , Prostatectomía/efectos adversos , Neoplasias de la Próstata/cirugía , Procedimientos Quirúrgicos Robotizados/efectos adversos , Terapia Recuperativa/efectos adversos , Anciano , Pérdida de Sangre Quirúrgica/estadística & datos numéricos , Constricción Patológica/epidemiología , Constricción Patológica/etiología , Estudios de Seguimiento , Humanos , Incidencia , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/sangre , Recurrencia Local de Neoplasia/patología , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Próstata/patología , Próstata/cirugía , Antígeno Prostático Específico/sangre , Prostatectomía/métodos , Neoplasias de la Próstata/sangre , Neoplasias de la Próstata/patología , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/métodos , Terapia Recuperativa/métodos , Resultado del Tratamiento , Incontinencia Urinaria/epidemiología , Incontinencia Urinaria/etiologíaRESUMEN
OBJECTIVES: Men diagnosed with low-risk prostate cancer are typically eligible for active surveillance of their cancer, involving monitoring for cancer progression and making judgements about the risks of prostate cancer against those of active intervention. Our study examined how risk for prostate cancer is perceived and experienced by patients undergoing active surveillance with their clinicians, how risk is communicated in clinical consultations, and the implications for treatment and care. METHOD: Participants were nine patients and three clinicians from a university hospital urology clinic. A staged, qualitative, multi-method data collection approach was undertaken, comprising: observations of consultations; patient and clinician interviews; and patient surveys. The three data sets were analysed separately using thematic analysis and then integrated to give a comprehensive view of patient and clinician views. RESULTS: Thirty data points (eight patient surveys; 10 observations of consultations between patients and clinicians; 10 patient interviews; and two clinician interviews) combined to create a detailed picture of how patients perceived and appraised risk, in three themes of "Making sense of risk", "Talking about risk" and "Responding to risk". CONCLUSION: Effective risk communication needs to be finely tuned and timed to individual patient's priorities and information requirements. A structured information exchange process that identifies patients' priorities, and details key moments in risk assessment, so that complexities of risk are discussed in ways that are meaningful to patients, may benefit patient care. These findings could inform the development of patient-centric risk assessment procedures and service delivery models in prostate cancer care more broadly.
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Neoplasias de la Próstata/diagnóstico , Medición de Riesgo , Espera Vigilante , Anciano , Humanos , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Neoplasias de la Próstata/psicología , Investigación Cualitativa , Medición de Riesgo/métodos , Encuestas y Cuestionarios , Espera Vigilante/métodosRESUMEN
OBJECTIVE: To determine the contemporary survival outcomes from a whole population and identify significant predictors of survival, as contemporary population-based survival outcomes after radical cystectomy (RC) for the treatment of bladder cancer (BC) are sparse. Reports suggest a large disparity between population outcomes and those of centres of excellence. PATIENTS AND METHODS: All invasive BC cases diagnosed between 2001 and 2007 in New South Wales, Australia, were identified from the Central Cancer Registry. Records of treatment and death were electronically linked. All patients who underwent RC between 2001 and 2009 were selected for this study (804 patients). Follow-up was to the end of 2009. Outcomes assessed were disease-specific survival (DSS) and overall survival (OS). Multivariable Cox regression and log-rank analysis were used to model and compare survival within groups. RESULTS: Of 804 patients diagnosed during the study period 420 (52.2%) died during follow-up. The 5-year DSS and OS for all patients was 59.6% and 53.2%, respectively. The 5-year DSS for patients with localised, regional and distant disease, undergoing RC was 72%, 51% and 10%, respectively. Age (P < 0.001) and stage (P < 0.001) were associated with 5-year DSS and OS after adjusting for all other variables. High-volume centres had significantly better 5-year DSS compared with low-volume centres (P < 0.05). The 30-day mortality for high- vs low-volume centres was 1.8% and 3.6%, respectively. Perioperative mortality improved over time for high- and moderate-volume centres but not for low-volume centres. CONCLUSION: Contemporary survival outcomes after RC are much improved compared with older studies and appear close to results from academic centres of excellence. High-volume centres report better 5-year DSS outcomes than lower volume centres.
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Cistectomía/métodos , Neoplasias de la Vejiga Urinaria/patología , Neoplasias de la Vejiga Urinaria/cirugía , Vejiga Urinaria/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Australia , Cistectomía/mortalidad , Supervivencia sin Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Invasividad Neoplásica , Nueva Gales del Sur , Pronóstico , Análisis de Supervivencia , Resultado del Tratamiento , Vejiga Urinaria/patología , Neoplasias de la Vejiga Urinaria/mortalidadRESUMEN
OBJECTIVES: To assess the impact of the introduction of robot-assisted radical cystectomy (RARC) on an established enhanced recovery programme (ERP) and to examine the effect on mortality and morbidity rates, transfusion rates, and length of stay (LOS). PATIENTS AND METHODS: Data on 102 consecutive patients undergoing RARC with full intracorporeal reconstruction were obtained from our prospectively updated institutional database. These data were compared to previously published retrospective results from three separate groups of patients undergoing open radical cystectomy (ORC) at our centre. Our primary focus was perioperative outcomes including transfusion rate, complication rates, 30- and 90-day mortality rates, and LOS. RESULTS: The demographics of the comparative groups showed no significant difference in age, gender distribution, and American Society of Anesthesiologists grade. A significant reduction in transfusion rate was seen in RARC vs ORC (P < 0.001). The median LOS for the RARC group was 8 vs 13 days for the ORC group (P < 0.001). There was trend to a lower total complication rate (48% vs 31%). The 30- and 90-day mortality rates were equivalent between the groups (2%). CONCLUSIONS: Introduction of RARC and intracorporeal reconstruction represents the single biggest impact on our ERP, with significant reduction in transfusion rates and LOS, and a trend towards a lower complication rate.
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Cistectomía , Procedimientos Quirúrgicos Robotizados , Neoplasias de la Vejiga Urinaria/cirugía , Derivación Urinaria , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Cistectomía/efectos adversos , Cistectomía/métodos , Cistectomía/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/métodos , Procedimientos Quirúrgicos Robotizados/estadística & datos numéricos , Vejiga Urinaria/cirugía , Neoplasias de la Vejiga Urinaria/epidemiología , Derivación Urinaria/efectos adversos , Derivación Urinaria/métodos , Derivación Urinaria/estadística & datos numéricos , Adulto JovenRESUMEN
OBJECTIVE: To investigate whether poor preoperative cardiopulmonary reserve and comorbid state dictate high-risk status and can predict complications in patients undergoing radical cystectomy (RC). PATIENTS AND METHODS: In all, 105 consecutive patients with transitional cell carcinoma (TCC; stage T1-T3) undergoing robot-assisted (38 patients) or open (67) RC in a single UK centre underwent preoperative cardiopulmonary exercise testing (CPET). Prospective primary outcome variables were all-cause complications and postoperative length of stay (LOS). Binary logistic regression analysis identified potential predictive factor(s) and the predictive accuracy of CPET for all-cause complications was examined using receiver operator characteristic (ROC) curve analysis. Correlations analysis employed Spearman's rank correlation and group comparison, the Mann-Whitney U-test and Fisher's exact test. Any relationships were confirmed using the Mantel-Haenszel common odds ratio estimate, Kaplan-Meier analysis and the chi-squared test. RESULTS: The anaerobic threshold (AT) was negatively (r = -206, P = 0.035), and the ventilatory equivalent for carbon dioxide (VE/VCO2) positively (r = 0.324, P = 0.001) correlated with complications and LOS. Logistic regression analysis identified low AT (<11 mL/kg/min), high VE/VC02 (≥33) and hypertension as significant factors, such that, in their presence patients were 5.55-times more likely to have complications at 90 days postoperatively [P = 0.001, 95% confidence interval (CI) 2.2-13.9]. ROC analysis showed a high significance (area under the curve 0.78, 95% CI 0.69-0.87; P < 0.001). In addition, based on CPET criteria >50% of patients presenting for RC had significant heart failure, whereas preoperatively only very few (2%) had this diagnosis. Analysis using the Mann-Whitney test showed that a VE/VCO2 ≥33 was the most significant determinant of LOS (P = 0.004). Kaplan-Meier analysis showed that patients in this group had an additional median LOS of 4 days (P = 0.008). Finally, patients with an American Society of Anesthesiologists grade of 3 (ASA 3) and those on long-term ß-blocker therapy were found to be at particular risk of myocardial infarction (MI) and death after RC with odds ratios of 4.0 (95% CI 1.05-15.2; P = 0.042) and 6.3 (95% CI 1.60-24.8; P = 0.008). CONCLUSION: Patients with poor cardiopulmonary reserve and hypertension are at higher risk of postoperative complications and have increased LOS after RC. Heart failure is known to be a significant determinant of perioperative death and is significantly under diagnosed in this patient group.
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Umbral Anaerobio/fisiología , Cistectomía/métodos , Prueba de Esfuerzo , Neoplasias de la Vejiga Urinaria/fisiopatología , Neoplasias de la Vejiga Urinaria/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Cistectomía/efectos adversos , Cistectomía/mortalidad , Femenino , Humanos , Estimación de Kaplan-Meier , Tiempo de Internación , Modelos Logísticos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/etiología , Valor Predictivo de las Pruebas , Cuidados Preoperatorios , Estudios Prospectivos , Curva ROCRESUMEN
Various conflicting guidelines and recommendations about prostate cancer screening and early detection have left both clinicians and their patients quite confused. At the Prostate Cancer World Congress held in Melbourne in August 2013, a multidisciplinary group of the world's leading experts in this area gathered together and generated this set of consensus statements to bring some clarity to this confusion. The five consensus statements provide clear guidance for clinicians counselling their patients about the early detection of prostate cancer.
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Biomarcadores de Tumor/sangre , Tacto Rectal/estadística & datos numéricos , Detección Precoz del Cáncer/estadística & datos numéricos , Tamizaje Masivo/organización & administración , Antígeno Prostático Específico/sangre , Neoplasias de la Próstata/diagnóstico , Anciano , Australia/epidemiología , Consenso , Toma de Decisiones , Humanos , Masculino , Persona de Mediana Edad , Guías de Práctica Clínica como Asunto , Neoplasias de la Próstata/sangre , Neoplasias de la Próstata/mortalidad , Neoplasias de la Próstata/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de RiesgoRESUMEN
OBJECTIVES: This study aimed to describe the adaptation of a group cognitive rehabilitation program for prostate cancer survivors (PCS) via telehealth delivery using a codesign approach with PCS experiencing cancer-related cognitive impairment. The Theoretical Domains Framework (TDF) also informed the intervention development. METHODS: Intervention development consisted of three steps: 1) Adapting an existing cancer-related cognitive rehabilitation program for PCS; 2) Conducting a codesign focus group workshop to gather feedback that was analyzed using a template approach; and 3) Incorporation of consumer feedback to refine the program for future piloting in PCS. Components of the finalized intervention were mapped onto the TDF domains. RESULTS: Six PCS were involved in the codesign focus group workshop, providing feedback on program structure, the topics and its order, and rehabilitation activities. A manualized four-week online group cognitive rehabilitation program titled "Promoting Cognitive Wellbeing in Prostate Cancer Survivors (ProCog)" was developed. Four sessions of 2-hours' duration were designed exploring: cognitive/brain functions; the impact of cancer treatments and ageing; the relationship between thoughts, feelings and behaviors; values-based goal-setting; and skills/strategies to manage fatigue and improve attention, memory, aspects of executive functioning, and emotional functioning. CONCLUSIONS: Consumer input and guidance from the TDF ensures a robust development process for the online ProCog intervention, designed for and with PCS experiencing cognitive difficulties. As an important initial step before piloting, this adaptation and development process ensures that ProCog addresses consumer needs and preferences and targets factors increasing behavior change. IMPLICATIONS FOR NURSING PRACTICE: This research raises awareness of possible cancer-related cognitive impairments in prostate cancer survivors and strategies for rehabilitation. ProCog is an accessible online intervention that nurses can use to refer patients needing cognitive rehabilitation.
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BACKGROUND: A diagnosis of prostate cancer leads to emotional distress and anxiety, prompting calls for rapid diagnostic pathways. Nevertheless, it remains unclear what impact time between diagnosis and surgery has upon prostate cancer survival. METHODS: Using national databases for England (cancer registries, Hospital Episode Statistics and Office of National Statistics), we identified 17,043 men with prostate cancer, aged 15 years and older, diagnosed in 1996-2009, and who had surgical resection with curative intent within 6 months of diagnosis. We used relative survival to investigate associations between waiting times and five- and ten-year survival. RESULTS: Five- and ten-year relative survival estimates for the total study sample were 1.04 (95% CI: 1.04 to 1.05) and 1.08 (95% CI: 1.06-1.09), respectively. There were no notable differences in survival between patients who had surgery at 0-3 and 4-6 months after diagnosis. Relative survival was higher among the elderly (>65) and those with well and moderately differentiated tumours. CONCLUSION: The high relative survival in our cohort probably reflects adherence to selection criteria for surgery among men with localised prostate cancer. Among men treated with surgery within 6 months of diagnosis, we found little evidence of an association between time from diagnosis to surgery and survival.
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Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/mortalidad , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Inglaterra , Humanos , Masculino , Persona de Mediana Edad , Clasificación del Tumor , Neoplasias de la Próstata/cirugía , Sistema de Registros , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Adulto JovenRESUMEN
Background: At present, the only definitive treatment for adult phimosis is circumcision, which is a surgical removal of the prepuce. Novoglan is a novel device that could offer patients with phimosis an alternative to surgery. It is based on application of custom-moulded balloons for gradual skin remodelling and prepuce dilatation. This open-label clinical trial aimed to investigate the safety, efficacy and tolerability of the Novoglan treatment. Methods: A prospective trial was conducted on 20 patients with adult phimosis recruited at Macquarie University Hospital and Princess Alexandra Hospital. After eligibility screening and enrolment, patients were provided with the Novoglan product and training. The treatment involved twice daily 10-minute applications for a duration of 4-8 weeks with patient's degree of phimosis assessed before and at 6-8 weeks after the initiation of the treatment. Participants were also asked to complete questionnaires aimed to assess the safety and tolerability of the Novoglan treatment. Results: The treatment was successful with improved foreskin retraction in 90% of patients and all patients achieving full foreskin retraction after the treatment. Ninety-five percent of patients reported reduced level of anxiety, and over 60% of patients reported reduced pain/discomfort during sexual activity or in general. Similarly, 95% of patients were moderately-to-very satisfied with the treatment and would recommend Novoglan to others. No adverse events were observed and only 15% of participants reported minor side effects. Conclusions: The Novoglan-01 trial demonstrated high safety, efficacy and tolerability of the Novoglan treatment for adult phimosis and its high potential as a conservative alternative to circumcision or steroid cream treatment. Trial Registration: The Novoglan-01 study has been registered with the Australia and New Zealand Clinical Trial Registry under the reference ACTRN 1262 10009 24853, dated 15 July 2021.
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INTRODUCTION: Addressing clinical variation in elective surgery is challenging. A key issue is how to gain consensus between largely autonomous clinicians. Understanding how the consensus process works to develop and implement perioperative pathways and the impact of these pathways on reducing clinical variation can provide important insights into the effectiveness of the consensus process. The primary objective of this study is to understand the implementation of an organisationally supported, consensus approach to implement perioperative care pathways in a private healthcare facility and to determine its impact. METHODS: A mixed-methods Effectiveness-Implementation Hybrid (type III) pre-post study will be conducted in one Australian private hospital. Five new consensus-based perioperative care pathways will be developed and implemented for specific patient cohorts: spinal surgery, radical prostatectomy, cardiac surgery, bariatric surgery and total hip and knee replacement. The individual components of these pathways will be confirmed as part of a consensus-building approach and will follow a four-stage implementation process using the Exploration, Preparation, Implementation and Sustainment framework. The process of implementation, as well as barriers and facilitators, will be evaluated through semistructured interviews and focus groups with key clinical and non-clinical staff, and participant observation. We anticipate completing 30 interviews and 15-20 meeting observations. Administrative and clinical end-points for at least 152 participants will be analysed to assess the effectiveness of the pathways. ETHICS AND DISSEMINATION: This study received ethical approval from Macquarie University Human Research Ethics Medical Sciences Committee (Reference No: 520221219542374). The findings of this study will be disseminated through peer-reviewed publications, conference presentations and reports for key stakeholders.
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Atención a la Salud , Procedimientos Quirúrgicos Electivos , Masculino , Humanos , Consenso , Australia , Atención PerioperativaRESUMEN
BACKGROUND: There is a clinical need to identify patients with an elevated PSA who would benefit from prostate biopsy due to the presence of clinically significant prostate cancer (CSCaP). We have previously reported the development of the MiCheck® Test for clinically significant prostate cancer. Here, we report MiCheck's further development and incorporation of the Roche Cobas standard clinical chemistry analyzer. OBJECTIVES: To further develop and adapt the MiCheck® Prostate test so it can be performed using a standard clinical chemistry analyzer and characterize its performance using the MiCheck-01 clinical trial sample set. DESIGN, SETTINGS, AND PARTICIPANTS: About 358 patient samples from the MiCheck-01 US clinical trial were used for the development of the MiCheck® Prostate test. These consisted of 46 controls, 137 non-CaP, 62 non-CSCaP, and 113 CSCaP. METHODS: Serum analyte concentrations for cellular growth factors were determined using custom-made Luminex-based R&D Systems multi-analyte kits. Analytes that can also be measured using standard chemistry analyzers were examined for their ability to contribute to an algorithm with high sensitivity for the detection of clinically significant prostate cancer. Samples were then re-measured using a Roche Cobas analyzer for development of the final algorithm. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Logistic regression modeling with Monte Carlo cross-validation was used to identify Human Epidydimal Protein 4 (HE4) as an analyte able to significantly improve the algorithm specificity at 95% sensitivity. A final model was developed using analyte measurements from the Cobas analzyer. RESULTS: The MiCheck® logistic regression model was developed and consisted of PSA, %free PSA, DRE, and HE4. The model differentiated clinically significant cancer from no cancer or not-clinically significant cancer with AUC of 0.85, sensitivity of 95%, and specificity of 50%. Applying the MiCheck® test to all evaluable 358 patients from the MiCheck-01 study demonstrated that up to 50% of unnecessary biopsies could be avoided while delaying diagnosis of only 5.3% of Gleason Score (GS) ≥3+4 cancers, 1.8% of GS≥4+3 cancers and no cancers of GS 8 to 10. CONCLUSIONS: The MiCheck® Prostate test identifies clinically significant prostate cancer with high sensitivity and negative predictive value (NPV). It can be performed in a clinical laboratory using a Roche Cobas clinical chemistry analyzer. The MiCheck® Prostate test could assist in reducing unnecessary prostate biopsies with a marginal number of patients experiencing a delayed diagnosis.
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Próstata , Neoplasias de la Próstata , Masculino , Humanos , Próstata/patología , Antígeno Prostático Específico , Neoplasias de la Próstata/patología , Biopsia , Valor Predictivo de las PruebasRESUMEN
BACKGROUND: Long-term patient-reported outcomes are needed to inform treatment decisions for localized prostate cancer. METHODS: Patient-reported outcomes of 1643 randomly assigned participants in the ProtecT (Prostate Testing for Cancer and Treatment) trial were evaluated to assess the functional and quality-of-life impacts of prostatectomy, radiotherapy with neoadjuvant androgen deprivation, and active monitoring. This article focuses on the outcomes of the randomly assigned participants from 7 to 12 years using mixed effects linear and logistic models. RESULTS: Response rates exceeded 80% for most measures. Among the randomized groups over 7 to 12 years, generic quality-of-life scores were similar. Among those in the prostatectomy group, urinary leakage requiring pads occurred in 18 to 24% of patients over 7 to 12 years, compared with 9 to 11% in the active monitoring group and 3 to 8% in the radiotherapy group. In the prostatectomy group, 18% reported erections sufficient for intercourse at 7 years, compared with 30% in the active monitoring and 27% in the radiotherapy groups; all converged to low levels of potency by year 12. Nocturia (voiding at least twice per night) occurred in 34% in the prostatectomy group compared with 48% in the radiotherapy group and 47% in the active monitoring group at 12 years. Fecal leakage affected 12% in the radiotherapy group compared with 6% in the other groups by year 12. The active monitoring group experienced gradual age-related declines in sexual and urinary function, avoiding radical treatment effects unless they changed management. CONCLUSIONS: ProtecT provides robust evidence about continued impacts of treatments in the long term. These data allow patients newly diagnosed with localized prostate cancer and their clinicians to assess the trade-offs between treatment harms and benefits and enable better informed and prudent treatment decisions. (Funded by the UK National Institute for Health and Care Research Health Technology Assessment Programme projects 96/20/06 and 96/20/99; ISRCTN number, ISRCTN20141297; ClinicalTrials.gov number, NCT02044172.)