Timing of radiotherapy (RT) after radical prostatectomy (RP): long-term outcomes in the RADICALS-RT trial (NCT00541047).

BACKGROUND: The optimal timing of radiotherapy (RT) after radical prostatectomy for prostate cancer has been uncertain. RADICALS-RT compared efficacy and safety of adjuvant RT versus an observation policy with salvage RT for prostate-specific antigen (PSA) failure. PATIENTS AND METHODS: RADICALS-RT was a randomised controlled trial enrolling patients with ≥1 risk factor (pT3/4, Gleason 7-10, positive margins, preoperative PSA≥10 ng/ml) for recurrence after radical prostatectomy. Patients were randomised 1:1 to adjuvant RT ('Adjuvant-RT') or an observation policy with salvage RT for PSA failure ('Salvage-RT') defined as PSA≥0.1 ng/ml or three consecutive rises. Stratification factors were Gleason score, margin status, planned RT schedule (52.5 Gy/20 fractions or 66 Gy/33 fractions) and treatment centre. The primary outcome measure was freedom-from-distant-metastasis (FFDM), designed with 80% power to detect an improvement from 90% with Salvage-RT (control) to 95% at 10 years with Adjuvant-RT. Secondary outcome measures were biochemical progression-free survival, freedom from non-protocol hormone therapy, safety and patient-reported outcomes. Standard survival analysis methods were used; hazard ratio (HR)<1 favours Adjuvant-RT. RESULTS: Between October 2007 and December 2016, 1396 participants from UK, Denmark, Canada and Ireland were randomised: 699 Salvage-RT, 697 Adjuvant-RT. Allocated groups were balanced with a median age of 65 years. Ninety-three percent (649/697) Adjuvant-RT reported RT within 6 months after randomisation; 39% (270/699) Salvage-RT reported RT during follow-up. Median follow-up was 7.8 years. With 80 distant metastasis events, 10-year FFDM was 93% for Adjuvant-RT and 90% for Salvage-RT: HR=0.68 [95% confidence interval (CI) 0.43-1.07, P=0.095]. Of 109 deaths, 17 were due to prostate cancer. Overall survival was not improved (HR=0.980, 95% CI 0.667-1.440, P=0.917). Adjuvant-RT reported worse urinary and faecal incontinence 1 year after randomisation (P=0.001); faecal incontinence remained significant after 10 years (P=0.017). CONCLUSION: Long-term results from RADICALS-RT confirm adjuvant RT after radical prostatectomy increases the risk of urinary and bowel morbidity, but does not meaningfully improve disease control. An observation policy with salvage RT for PSA failure should be the current standard after radical prostatectomy. TRIAL IDENTIFICATION: RADICALS, RADICALS-RT, ISRCTN40814031, NCT00541047.

Initial [18F]DCFPyL PET/CT in treatment-naïve prostate cancer: correlation with post-ADT PSA outcomes and recurrence.

PURPOSE: Positron emission tomography (PET) with prostate-specific membrane antigen (PSMA) targeting tracers has emerged as a valuable diagnostic tool for prostate cancer (PCa), androgen deprivation therapy (ADT) stands as the cornerstone treatment for advanced PCa, yet forecasting the response to hormonal therapy poses a significant clinical hurdle. METHODS: In a prospective cohort of 86 PCa patients undergoing short-term ADT, this study evaluated the prognostic potential of [18F]DCFPyL PET/CT scans. Comprehensive data encompassing clinical profiles, baseline prostate-specific antigen (PSA) levels, and imaging metrics were assessed. We developed predictive models for assessing decreases in PSA levels (PSA50 and PSA70) based on a combination of PET-related parameters and clinical factors. Kaplan-Meier survival analysis was utilized to ascertain the prognostic value of PET-based metrics. RESULTS: In this study, elevated [18F]DCFPyL uptake within the primary tumor, as indicated by a SUV ≥ 6.78 (p = 0.0024), and a reduction in the tumor volume (TV) of primary PSMA-avid tumor with PSMA-TV < 41.96 cm3 (p = 0.038), as well as an increased burden of metastatic PSMA-avid tumor, with PSMA-TV (PSMA-TV ≥ 71.39 cm3) (p = 0.012) were identified in association with diminished progression-free survival (PFS). PET and clinical parameters demonstrated constrained predictive capacity for PSA50 response as indicated by an area under the curve (AUC) of 0.442. CONCLUSION: Our study revealed that pretreatment [18F]DCFPyL uptake in primary or metastatic tumor sites is prognostically relevant in high-risk PCa patients undergoing ADT. Further research is needed to develop robust predictive models in this multifaceted landscape of PCa management.

American Indian/Alaska Native men are less likely to receive prostate-specific antigen testing and digital rectal exams from primary care providers than White men: a secondary analysis of the National Ambulatory Medical Care Survey from 2012-2018.

PURPOSE: (1) Identify the proportion of primary care visits in which American Indian/Alaska Native (AI/AN) men receive a prostate-specific antigen test (PSAT)and/or a digital rectal exam (DRE), (2) describe characteristics of primary care visits in which AI/AN receive PSA and/or DRE, and (3) identify whether AI/AN receive PSA and/or DRE less often than non-Hispanic White (nHW) men. METHODS: This was a secondary analysis of the National Ambulatory Medical Care Survey (NAMCS) during 2013-2016 and 2018 and the NAMCS Community Health Center (CHC) datasets from 2012-2015. Weighted bivariate and multivariable tests analyzed the data to account for the complex survey design. RESULTS: For AI/AN men, 1.67 per 100 visits (95% CI = 0-4.24) included a PSATs (or PSAT) and 0 visits included a DRE between 2013-2016 and 2018. The rate of PSA for non-AI/AN men was 9.35 per 100 visits (95% CI = 7.78-10.91) and 2.52 per 100 visits (95% CI = 1.61-3.42) for DRE. AI/AN men were significantly less likely to receive a PSA than nHW men (aOR = 0.09, 95% CI = 0.01-0.83). In CHCs, AI/AN men experienced 4.26 PSAT per 100 visits (95% CI = 0.96-7.57) compared to 5.00 PSAT per 100 visits (95% CI = 4.40-5.68) for non-AI/AN men. DRE rates for AI/AN men was 0.63 per 100 visits (95% CI = 0-1.61) compared to 1.05 per 100 (95% CI = 0.74-1.37) for non-AI/AN men. There was not a statistically significant disparity in the CHC data regarding PSA (OR = 0.91, 95% CI = 0.42-1.98) or DRE (OR = 0.75, 95% CI = 0.15-3.74), compared to nHW men. CONCLUSION: Efforts are needed to better understand why providers may not use PSA and DRE with AI/AN men compared to nHW men.

Single-port versus multiport robotic-assisted radical prostatectomy: A systematic review and meta-analysis on the da Vinci SP platform.

CONTEXT: Prostate cancer is the most common cancer in men; robotic prostatectomy has cemented itself as part of the standard of care. Since its approval by the Food and Drug Administration in 2018, the SP console's application has been increasingly studied and compared with the multiport (MP) robotic approach. METHODS: Following PRISMA guidelines and PROSPERO registration CRD42021228744, a systematic review was performed in April 2021 on single-port robotic-assisted radical prostatectomies (SP-RARPs) compared to MP. Outcomes of interest were operative time, bleeding, complications, analgesic use, and postoperative continence, and erectile function. Data were analyzed with Review Manager 5.3. RESULTS: Seven studies were included, of which six studies met the inclusion criteria for quantitative synthesis, totalling 1068 patients, out of which 324 underwent SP-RARP and 744 underwent MP-RARP. No differences were found in baseline characteristics such as age, body mass index, prostatic-specific antigen, or stage. No differences in blood loss-15.77 mL [-42.44, 10.89], p = 0.25, operative time 3.93 min [-4.12, 11.98], p = 0.34, or positive surgical margins, with an odds ratio (OR) of 0.78 [0.55, 1.10], p = 0.15-were found. Length of stay was significantly shorter in SP -0.94 days [-1.56, -0.33], p = 0.003, with no differences in complication rates, with an OR of 1.29 [0.78, 2.14], p = 0.32, continence rates, with an OR of 1.29 [0.90, 1.83], p = 0.16, erectile function, with an OR of 0.86 [0.52, 1.40], p = 0.54, or biochemical recurrence. Qualitative evidence suggests decreased opioid consumption. CONCLUSION: SP-RARPs are feasible alternatives to the traditional MP with possible benefits in pain management and length of stay. Future high-quality studies are needed to confirm these findings.

A Randomized Trial of the Effects of Exercise on Anxiety, Fear of Cancer Progression and Quality of Life in Prostate Cancer Patients on Active Surveillance.

PURPOSE: We examined the effects of exercise on prostate cancer-specific anxiety, fear of cancer progression, quality of life and psychosocial outcomes in patients with prostate cancer on active surveillance. MATERIALS AND METHODS: The ERASE (Exercise during Active Surveillance for Prostate Cancer) Trial randomized 52 patients with prostate cancer undergoing active surveillance to high-intensity interval training (HIIT, 26 patients) or usual care (UC, 26 patients). The HIIT group performed a 12-week, thrice weekly, supervised, aerobic HIIT program. The UC group did not exercise. Patient-reported outcomes were assessed at baseline and after intervention, including prostate cancer-specific anxiety (Memorial Anxiety Scale for Prostate Cancer), fear of cancer progression (Fear of Cancer Recurrence Inventory), prostate cancer symptoms (Expanded Prostate Cancer Index Composite), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core) and psychological health outcomes (eg fatigue, stress and self-esteem). Analysis of covariance was used to compare between-group differences. RESULTS: Fifty of 52 participants (96%) completed patient-reported outcome assessments at 12 weeks. Adherence to HIIT was 96%. Compared to UC, HIIT significantly improved total prostate cancer-specific anxiety (adjusted between-group mean difference -2.7, 95% confidence interval, range -5.0 to -0.4, p=0.024), as well as the fear of progression subscale (p=0.013), hormonal symptoms (p=0.005), perceived stress (p=0.037), fatigue (p=0.029) and self-esteem (p=0.007). CONCLUSIONS: A 12-week supervised HIIT program may improve prostate cancer-specific anxiety, fear of cancer progression, hormone symptoms, stress, fatigue and self-esteem in men with prostate cancer on active surveillance. Larger trials are needed to confirm the effects of HIIT on patient-reported outcomes in the active surveillance setting.

Is there still a role for digital rectal examination in the prostate cancer diagnostic pathway in the COVID-19 and post COVID-19 era?

Digital rectal examination (DRE) is routinely performed as part of a urology clinical assessment in patients with a clinical suspicion of prostate cancer. An abnormal DRE or a raised prostate specific antigen (PSA) level are part of the criteria for primary care referral to secondary care due to a suspicion of prostate cancer. The current Coronavirus-19 (COVID-19) pandemic has resulted in the rapid adoption of virtual consultations in the form of telephone or video consultations making clinical examination difficult. In the case of prostate cancer diagnostic pathways, often clinicians now rely on PSA measurements and MRI, where radiological services are available, without the requirement for a DRE. We discuss the limited role DRE has in the modern prostate cancer diagnostic pathway due to the widespread adoption of MRI particularly in the COVID-19 era.

A population K-PD model analysis of long-term testosterone inhibition in prostate cancer patients undergoing intermittent androgen deprivation therapy.

Intermittent androgen deprivation therapy with gonadotropin-releasing-hormone (GnRH) agonists can prevent or delay disease progression and development of castration resistant prostate cancer for subpopulations of prostate cancer patients. It may also reduce risk and severity of side effects associated with chemical castration in prostate cancer (PCa) patients. One of the earliest comprehensively documented clinical trials on this was reported in a Canadian patient population treated with leuprorelin preceded by a lead-in with cyproterone acetate. A systems-based mixed effect analysis of testosterone response in active and recovery phases allows inference of new information from this patient population. Efficacy of androgen deprivation therapy is presumed to depend on a treshold value for testosterone at the nadir, below which no additional beneficial effects on PSA reponse can be expected, and occurance of testosterone breakthroughs during active therapy. The present analysis results in a mixed effect model, incorporating GnRH receptor activation, testosterone turnover and feedback mechanisms, describing and predicting testosterone inhibition under intermittent androgen deprivation therapy on the individual and population level, during multiple years of therapy. Testosterone levels in these patients decline over time with an estimated first order rate constant of 0.083 year-1(T1/2 = 8.4 y), with a substantial distribution among this patient population, compared to the general population. PCa patients leaving the trial due to unmanageble PSA relapse appear to have slightly higher testosterone levels at the nadir than sustained responders. These findings are expected to contribute to an increased understanding of the role of testosterone in long term disease progression of prostate cancer.

A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients.

OBJECTIVES: To determine the safety, efficacy and pharmacokinetic (PK) profile of a pre-mixed depot formulation of leuprolide mesylate subcutaneous injectable suspension (LMIS) 50 mg for up to 1 year of treatment for subjects with advanced prostate cancer. PATIENTS AND METHODS: In this open-label, multicenter study, prostate cancer patients with indication for androgen ablation therapy received two subcutaneous injection of LMIS 50 mg 6 months apart and were followed for an additional 6 months. Two efficacy primary end points were the percentage of subjects with a serum testosterone level ≤ 50 ng/dL by Day 28 as well as the percentage of subjects with similar testosterone suppression from Day 28 to Day 336. RESULTS: Of the 137 enrolled subjects, 15 (10.9%) subjects did not complete the study, including 5 subjects who terminated early due to an adverse event. By Day 28, 98.5% (95% confidence interval 94.8-99.8) of the subjects achieved a castrate testosterone level. At the end of the study, 97% and 95.9% of the subjects had serum testosterone level ≤ 50 ng/dL and ≤ 20 ng/dL, respectively. LMIS 50 mg significantly reduced serum prostate-specific antigen levels after its first injection and this PSA declination effect remained until the end of the study. No statistically significant change was observed in worsening bone pain or urinary symptom assessments during the study. Hot flush (48.9%) and hypertension (14.6%) were the two most common adverse events reported. CONCLUSIONS: LMIS 50 mg, administered at 6-month intervals, effectively suppressed serum testosterone level, and demonstrated a consistent safety profile.

Phase II open-label study investigating apalutamide in patients with biochemical progression after radical prostatectomy.

Apalutamide, a competent inhibitor of the androgen receptor, has shown promising clinical efficacy results for patients with advanced prostate cancer. Here, we describe the rationale and design for the SAVE trial, a multi-center, Phase II study, wherein 202 men with biochemical progression after radical prostatectomy are randomly assigned 1:1 to apalutamide plus salvage radiotherapy (SRT) or androgen-deprivation therapy with an luteinizing hormone-releasing hormone agonist or antagonist plus SRT. The primary objective is to compare sexual function between the two treatment arms based on the expanded prostate cancer index-26 sexual domain score at nine months after start of hormonal treatment. The key secondary objectives are to assess quality of life, to evaluate the safety profile and the short-term efficacy of apalutamide in combination with SRT. ClinicalTrials.gov identifier: NCT03899077.

Androgen deprivation therapy improves the in vitro capacity of high-density lipoprotein (HDL) to receive cholesterol and other lipids in patients with prostate carcinoma.

BACKGROUND: Androgen deprivation therapy (ADT) is widely used in the treatment of testosterone-dependent prostate carcinomas. ADT often increases plasma LDL and HDL cholesterol and triglycerides. The aim was to test whether ADT changes the transfer of lipids to HDL, an important aspect of this metabolism and HDL protective functions, and related parameters. METHODS: Sixteen volunteers with advanced prostate carcinoma submitted to pharmacological ADT or orchiectomy had plasma collected shortly before and after 6 months of ADT. In vitro transfer of lipids to HDL was performed by incubating plasma with donor emulsion containing radioactive lipids by 1 h at 37 °C. After chemical precipitation of apolipoprotein B-containing lipoprotein, the radioactivity of HDL fraction was counted. RESULTS: ADT reduced testosterone to nearly undetectable levels and markedly diminished PSA. ADT increased the body weight but glycemia, triglycerides, LDL and HDL cholesterol, HDL lipid composition and CETP concentration were unchanged. However, ADT increased the plasma unesterified cholesterol concentration (48 ± 12 vs 56 ± 12 mg/dL, p = 0.019) and LCAT concentration (7.15 ± 1.81 vs 8.01 ± 1.55µg/mL, p = 0.020). Transfer of unesterified (7.32 ± 1.09 vs 8.18 ± 1.52%, p < 0.05) and esterified cholesterol (6.15 ± 0.69 vs 6.94 ± 1.29%, p < 0.01) and of triglycerides (6.37 ± 0.43 vs 7.18 ± 0.91%, p < 0.001) to HDL were increased after ADT. Phospholipid transfer was unchanged. CONCLUSION: Increase in transfer of unesterified and esterified cholesterol protects against cardiovascular disease, as shown previously, and increased LCAT favors cholesterol esterification and facilitates the reverse cholesterol transport. Thus, our results suggest that ADT may offer anti-atherosclerosis protection by improving HDL functional properties. This could counteract, at least partially, the eventual worse effects on plasma lipids.

Diagnosis of prostate cancer: the implications and proper utilization of PSA and its variants; indications and use of MRI and biomarkers.

Prostate cancer screening remains highly controversial in medicine. The College of Family Physicians of Canada currently endorses positions that recommend against prostate-specific antigen (PSA) screening in men of all ages, while the Canadian Urological Association recommends shared and informed decision making for PSA screening in men 50-70 years old. Unfortunately, these opposing stances have left Family Physicians responsible for interpreting the appropriate course of action for their patients. Recent studies demonstrating an increase in incidence of metastatic prostate cancer have led to our support of the Canadian Urological Association recommendations. In an attempt to facilitate initial patient investigation, this article aims to outline current prostate cancer screening recommendations, as well as the various screening modalities available. The utility of PSA-based tests, serum and non-serum biomarkers, and multiparametric magnetic resonance imaging is discussed and evaluated.

Prostate Cancer Characteristics in the US Preventive Services Task Force Grade D Era: A Single-Center Study and Meta-Analysis.

BACKGROUND: In May 2012, the US Preventive Services Task Force assigned prostate-specific antigen-based screening a grade D recommendation, advising against screening at any age. Our objective was to compare prostate cancer characteristics pre- and post-recommendation with an adjusted analysis of our data and a pooled analysis including other primary data sources. METHODS: We identified all incident prostate cancer diagnoses at our institution from 2007 to 2016. Multivariable log binomial regression was used to determine the relative risk (RR) of metastasis at diagnosis, ≥Gleason Group 4, and high D'Amico risk disease pre- versus post-recommendation. The meta-analysis included primary data studies evaluating these outcomes. RESULTS: At our institution, 287 (44.6%) and 224 (48.8%) patients were diagnosed in the pre- and post-cohorts. The RR of metastatic disease at diagnosis did not differ between groups (p = 0.224), nor did the risk of high D'Amico category disease (p = 0.089). The risk of ≥Gleason Group 4 was 1.58 times higher post-recommendation (p = 0.007). The pooled risk of ≥Gleason Group 4 disease was 1.5 (p < 0.001) post-recommendation and was 1.29 (p = 0.006) for high D'Amico risk disease. CONCLUSIONS: While the number of metastatic cases did not differ after the recommendation, the risk of high-grade cancers increased at both a local and aggregated level.

Prostate-Specimen Antigen (PSA) Screening and Shared Decision Making Among Deaf and Hearing Male Patients.

Some deaf men who use American Sign Language (ASL) experience barriers in patient-physician communication which may leave them at disparity for shared decision making compared to hearing men. Transparent communication accessibility is needed between deaf male ASL users and their physicians to maximize the benefit to risk ratio of using the prostate-specific antigen (PSA) as a screening tool for early detection. The objective is to compare shared decision-making outcomes between deaf and hearing males who are (1) age-eligible for PSA screening and (2) younger than 45 years old with a family history of cancer. An accessible health survey including questions about PSA test, PCC, modes of communication, and cancer history was administered in ASL to a nationwide sample of deaf adults from February 2017 to April 2018. Two subsamples were created: (1) 45- to 69-year-old men who were age-eligible for PSA testing and (2) 18- to 44-year-old men with a family history of cancer. Age-eligible and younger deaf men with a family history of cancer are at disparity for shared decision making compared to their hearing peers. Regardless of age and PSA testing status, deaf men felt significantly less engaged in shared decision making with their health care providers compared to hearing men. Participation in shared decision making requires not only accessible communication but also cultural competency in working with deaf patients. This is critical in the shared decision-making era in maximizing the benefit of prostate cancer screening in deaf male patient population.

Minimally Invasive Radical Prostatectomy after Previous Bladder Outlet Surgery: A Systematic Review and Pooled Analysis of Comparative Studies.

PURPOSE: Prostate cancer surgery after previous bladder outlet surgery of benign prostatic hyperplasia is an uncommon yet challenging scenario. We performed a systematic review and pooled analysis of comparative studies on laparoscopic and robotic minimally invasive radical prostatectomy after bladder outlet surgery. MATERIALS AND METHODS: We searched the literature on PubMed®, Embase® and Web of Science™ up to February 2019 according to the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analyses) statement to identify eligible studies. Surgical, oncologic and functional outcomes in patients who underwent minimally invasive radical prostatectomy after bladder outlet surgery were compared to those without a history of bladder outlet surgery. Sensitivity analysis was done according to surgical technique (laparoscopic or robotic). RevMan 5.3 was used for statistical analysis. RESULTS: A total of 12 comparative studies were included in analysis. Patients who underwent minimally invasive radical prostatectomy after bladder outlet surgery were older (p ≤0.00001) and had a smaller prostate (p = 0.04) and lower prostate specific antigen (p = 0.003). The previous bladder outlet surgery group had lower odds of nerve sparing procedures, longer operative time, a higher rate of bladder neck reconstruction (each p <0.0001) and longer catheter time (p = 0.03). They were at higher risk for intraoperative (p = 0.001), overall (p <0.00001) and major complications (p = 0.0008), a higher positive surgical margin rate (p = 0.0005) and biochemical recurrence (p = 0.05). Moreover, potency (p = 0.03) and continence recovery (p = 0.007) at 12 months were lower in men with previous bladder outlet surgery. Robotic surgery seemed to offer better outcomes than laparoscopy. CONCLUSIONS: Minimally invasive radical prostatectomy after previous bladder outlet surgery represents a challenging surgical task with a higher risk of complications, and higher odds of worse functional and oncologic outcomes. Patients should be aware of these drawbacks and these factors should be considered during patient counseling. When surgery is pursued, robot-assisted radical prostatectomy should be preferred over laparoscopic radical prostatectomy since it can offer superior outcomes. The overall literature on this topic is of low quality and further efforts should be made to obtain higher levels of evidence.

PSA Testing Use and Prostate Cancer Diagnostic Stage After the 2012 U.S. Preventive Services Task Force Guideline Changes.

BACKGROUND: Most patients with prostate cancer are diagnosed with low-grade, localized disease and may not require definitive treatment. In 2012, the U.S. Preventive Services Task Force (USPSTF) recommended against prostate cancer screening to address overdetection and overtreatment. This study sought to determine the effect of guideline changes on prostate-specific antigen (PSA) screening and initial diagnostic stage for prostate cancer. PATIENTS AND METHODS: A difference-in-differences analysis was conducted to compare changes in PSA screening (exposure) relative to cholesterol testing (control) after the 2012 USPSTF guideline changes, and chi-square test was used to determine whether there was a subsequent decrease in early-stage, low-risk prostate cancer diagnoses. Data were derived from a tertiary academic medical center's electronic health records, a national commercial insurance database (OptumLabs), and the SEER database for men aged ≥35 years before (2008-2011) and after (2013-2016) the guideline changes. RESULTS: In both the academic center and insurance databases, PSA testing significantly decreased for all men compared with the control. The greatest decrease was among men aged 55 to 74 years at the academic center and among those aged ≥75 years in the commercial database. The proportion of early-stage prostate cancer diagnoses (

Prostate cancer screening in low- and middle-income countries: the Mexican case.

Prostate-specific antigen (PSA)-based early detection for prostate cancer is the subject of intense debate. Implementation of organized prostate cancer screening has been challenging, in part because the PSA test is so amenable to opportunistic screening. To the extent that access to cancer screening tests increases in low- and middle-income countries (LMICs), there is an urgent need to thoughtfully evaluate existing and future cancer screening strategies to ensure benefit and control costs. We used Mexico's prostate cancer screening efforts to illustrate the challenges LMICs face. We provide five considerations for policymakers for a smarter approach and implementation of PSA-based screening.

El uso del Antígeno Prostático Específico (APE) para tamizaje para cáncer de próstata sigue siendo tema de amplio debate. La implementación de estrategias de tamiz organizado de cáncer de próstata ha sido un reto en parte porque la prueba de APE se presta para detección oportunista. A medida que aumenta el acceso a las pruebas de detección de cáncer en los países de ingresos bajos y medianos (PIBM), existe la necesidad urgente de evaluar cuidadosamente las estrategias actuales y futuras de detección oportuna de cáncer para garantizar su beneficio y controlar sus costos. Utilizamos los esfuerzos de tamizaje de cáncer de próstata de México para ilustrar los retos para PIBM. Ofrecemos cinco consideraciones dirigidas a tomadores de decisión que permitan contar con estrategias racionales de implementación de tamizaje para cáncer de próstata basado en el uso de APE.

[Chemotherapy combined with androgen-deprivation therapy in high-volume metastatic hormone sensitive prostate cancer: a short-term efficacy and safety analysis].

Objective: To investigate the short-term efficacy and adverse events of chemotherapy combined with androgen-deprivation therapy in high-volume metastatic hormone sensitive prostate cancer. Methods: From March 2015 to August 2017, 55 patients with high-volume metastatic hormone sensitive prostate cancer were enrolled at Department of Urology, Fudan University Shanghai Cancer Center receiving chemotherapy combined with androgen-deprivation therapy. The age was 65(8) years (M(Q(R))) (range: 46 to 79 years). Patients were enrolled in the study for continuous androgen-deprivation therapy (medical or surgical castration), combined with docetaxel 75 mg/m(2) intravenous injection on the first day, repeated every 21 days (6 cycles). Endpoints included overall survival, progression-free survival of prostate cancer, prostate specific antigen (PSA) response rate, and adverse events. Results: The follow-up time was 21.2(11.7) months. The PSA value before chemotherapy was 144.9(415.3) µg/L. The days in patients undergoing androgen deprivation therapy before chemotherapy was 14(23) days. Four patients (7.3%) presented 0 in Eastern Cooperative Oncology Group scoring system and 51 patients(92.7%) presented 1. Thirty-nine patients (70.9%) completed more than 6 cycles of combined chemotherapy, 17 patients (30.9%) showed PSA<0.2 µg/L at 6 months after treatment, and 14 patients (25.5%) showed PSA<0.2 µg/L at 12 months after treatment. Twenty-eight patients (50.9%) had grade 3 to 4 neutropenia and 1 patient (1.8%) developed infectious neutropenia and died. Nausea and vomit occurred in 16 patients (29.1%). Twelve patients (21.8%) underwent dose adjustment due to adverse events in blood system. Conclusions: The short-term effect was confirmed in high-volume metastatic hormone sensitive prostate cancer using chemotherapy combined androgen-deprivation therapy, and the long-term effect remains to be seen. Myelosuppression during chemotherapy requires close attention, and taking timely examination is recommended.

Efficacy and safety of 3-month dosing regimen of degarelix in Japanese subjects with prostate cancer: A phase III study.

Non-inferiority in the cumulative castration rate of the 3-month formulation of degarelix compared with the 3-month formulation of goserelin was evaluated in subjects with prostate cancer. A phase III, open-label, parallel-arm study was carried out. An initial dose of 240 mg degarelix or 3.6 mg goserelin was given s.c.; after day 28, a maintenance dose of 480 mg degarelix or 10.8 mg goserelin was given once every 84 days. Non-inferiority in castration rate and safety of degarelix to goserelin were evaluated. The primary end-point was the cumulative castration rate from day 28 to day 364 and the non-inferiority margin was set to be 10%. A total of 234 subjects with prostate cancer were randomized to the degarelix group (n = 117) and the goserelin group (n = 117). The cumulative castration rate was 95.1% in the degarelix group and 100.0% in the goserelin group. As there were no events in the goserelin group, an additional analysis was carried out using 95% confidence intervals of the difference in the proportion of subjects with castration. Analyses indicated the non-inferiority of the 3-month formulation of degarelix to goserelin. Degarelix showed more rapid decreases in testosterone, luteinizing hormone, follicle stimulating hormone, and prostate-specific antigen levels compared with goserelin. The most common adverse events in the degarelix group were injection site reactions. Non-inferiority of the 3-month formulation of degarelix to goserelin was shown for testosterone suppression. The 3-month formulation of degarelix was also found to be tolerated as an androgen deprivation therapy for patients with prostate cancer. This trial was registered with ClinicalTrials.gov (identifier NCT01964170).

Association Between Online Information-Seeking and Adherence to Guidelines for Breast and Prostate Cancer Screening.

INTRODUCTION: From 2012 through 2014, the US Preventive Services Task Force (USPSTF) recommended biennial mammography for women aged 50 to 75 and recommended against the prostate specific antigen (PSA) test for men of any age, emphasizing informed decision making for patients. Because of time constraints and other patient health priorities, health care providers often do not discuss benefits and risks associated with cancer screening. We analyzed the association between seeking information online about breast and prostate cancer and undergoing mammography and PSA screening. METHODS: We assessed guideline concordance in mammogram and PSA screening, according to USPSTF guidelines for those at average risk for disease. We used data on 4,537 survey respondents from the National Cancer Institute's Health Information National Trends Survey (HINTS) for 2012 through 2014 to assess online information-seeking, defined as whether people searched for cancer-related information online in the past 12 months. We used HINTS data to construct multivariable logistic regression models to isolate the effect of exposure to online information on the incidence of cancer screening. RESULTS: After controlling for available covariates, we found no significant association between online information-seeking and guideline-concordant screening for breast or prostate cancer. Significant covariate values suggest that factors related to access to care were significantly associated with conformance to mammography guidelines for women recommended for screening and that physician discussion was significantly associated with nonconformance to guidelines for prostate-specific antigen screening (ie, having a PSA test in spite of the recommendation not to have it). Decomposition of differences between those who sought online information and those who did not indicated that uncontrolled confounders probably had little effect on findings. CONCLUSION: We found little evidence that online information-seeking significantly affected screening for breast or prostate cancer in accordance with USPSTF guidelines among people at average risk.

Bilateral subcapsular orchiectomy versus bilateral total orchiectomy: Comparison of the quality of life post-orchiectomy.

OBJECTIVE: Bilateral subcapsular orchiectomy (BSO) is said to be more aesthetic and psychologically satisfying when compared to bilateral total orchiectomy (BTO). This study compared the quality of life (QoL) of men with advanced prostate cancer who had BTO to those who had BSO, with an emphasis on their perception of self or identity as a man. SUBJECTS AND METHODS: Sixty-one patients with advanced prostate cancer opting for bilateral orchiectomy were recruited. Pre-orchiectomy and at 1 month and 3 months post-orchiectomy, the Functional Assessment of Cancer Therapy for Prostate cancer (FACT-P) questionnaires were administered and scored. RESULTS: Thirty (49.18%) patients had BTO (BTO group), while 31 (50.82%) patients had BSO (BSO group) for advanced prostate cancer. On comparison of the two groups, there were no statistically significant differences in FACT-P scores at 1 month and 3 months. The subscale scores also showed no significant statistical difference except for the physical well-being score at 3 months post-orchiectomy, which was lower in the BSO group (P = 0.041). The average scores of Item P5 (I am able to feel like a man) which were used to assess the sex-role identity declined on an average over 3 months with no statistically significant difference on comparison of the two groups. CONCLUSION: The QoL scores (FACT-P and FACT-G) assessed over 3 months post-orchiectomy did not differ on comparison of the BTO group and the BSO group. Performing a BSO in our region did not result in any psychological benefit when compared to performing a BTO.