![.7.3: Performance Scales -Karnofsky & ECOG Scores [614]](https://www.researchgate.net/profile/Thomas-Lam-3/publication/274064386/figure/tbl7/AS:613851284402219@1523364959749/Performance-Scales-Karnofsky-ECOG-Scores-614_Q320.jpg)
![.2.2: Intra-and peri-operative complications of retropubic RP and RALP (Adapted from [312])](https://www.researchgate.net/profile/Thomas-Lam-3/publication/274064386/figure/tbl2/AS:613851284385833@1523364959548/Intra-and-peri-operative-complications-of-retropubic-RP-and-RALP-Adapted-from-312_Q320.jpg)
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European Association of Urology Guidelines on Prostate Cancer 2015
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... Согласно действующим стандартам при уровне простатспецифического антигена (ПСА) более 4,0 нг/мл у мужчин в возрасте старше 55 лет или более 2,5 нг/мл в возрасте 45-55 лет рекомендуется выполнять систематическую биопсию предстательной железы под контролем трансректального ультразвукового исследования (ТрУЗИ) [8][9][10][11]. Однако гипоэхогенные опухоли предстательной железы, которые визуализируются в серошкальном режиме при ТрУЗИ, встречаются при РПЖ не более чем в 10,0-20,0% случаев, по этой причине результат диагностики в значительной степени зависит от стадии заболевания [12,13]. В клинической практике серошкальное ТрУЗИ в B-режиме по-прежнему служит инструментом навигации при биопсии, а не методом ранней диагностики РПЖ, несмотря на новые УЗ-режимы, которые становятся более распространенными и постепенно включаются в протоколы исследования [9,11,14]. ...
... Однако гипоэхогенные опухоли предстательной железы, которые визуализируются в серошкальном режиме при ТрУЗИ, встречаются при РПЖ не более чем в 10,0-20,0% случаев, по этой причине результат диагностики в значительной степени зависит от стадии заболевания [12,13]. В клинической практике серошкальное ТрУЗИ в B-режиме по-прежнему служит инструментом навигации при биопсии, а не методом ранней диагностики РПЖ, несмотря на новые УЗ-режимы, которые становятся более распространенными и постепенно включаются в протоколы исследования [9,11,14]. ...
... Одним из перспективных методов исследования, позволяющим приблизиться к улучшению ранней диагностики РПЖ, является ТрУЗИ с эластографией и использованием технологии сдвиговой волны (ЭСВ), которая способна усовершенствовать возможности количественной оценки жесткости ткани [12,[14][15][16][17][18] и определить локализацию дополнительного подозрительного к РПЖ очага. Однако данный режим еще находится на стадии исследований и не включен отдельным дополнением в ведущие рекомендации по диагностике и лечению РПЖ [9,11,[17][18][19]. ...
В статье представлен анализ диагностических признаков рака предстательной железы с разработкой новой модели прогнозирования с использованием мультипараметрической МРТ, трансректального УЗИ с эластографией сдвиговой волны и изоформ ПСА. С целью верификации диагноза проводилась систематическая биопсия, дополненная целевым этапом.
The article presents an analysis of the diagnostic features of prostate cancer with the development of a new prediction model using multiparametric MRI, transrectal ultrasound with shear wave elastography and PSA isoforms. To verify the diagnosis, a systematic biopsy was performed, supplemented by a target stage.
... The Pr ostate cancer (PCa) remains the most prevalent malignancy among men, with metastatic progression contributing significantly to patient mortality (1). Current therapeutic decision-making regarding primary-tumor treatment depends on parameters such as prostate-specific antigen (PSA) value, clinical tumor stage, and biopsy Gleason score (2). However, the existing imaging tools and nomograms fall short in accurately staging early pelvic lymph node, bone, and distant metastases. ...
... Nonetheless, standardization efforts are under way to enhance the reproducibility and applicability of PSMA PET across different centers. Despite PSMA PET's superior accuracy in detecting metastatic spread and high-risk PCa, its ability to improve clinically relevant outcomes in advanced PCa remains unproven, and it cannot yet replace extended pelvic lymph node dissection (2). Currently, only preliminary data are available, from Djaïleb et al. (9). ...
This study aimed to compare the efficacy of [18F]F-choline PET/CT with conventional imaging for staging and managing intermediate- to high-risk prostate cancer (PCa). The primary objective was to assess the ability of PET/CT with [18F]F-choline to identify lymph node and systemic involvement during initial staging. Secondary objectives included evaluating the impact of [18F]F-choline PET/CT on unnecessary local treatments and assessing the safety of [18F]F-choline agents. Additionally, the study aimed to analyze recurrence-free survival and overall survival 5 y after randomization. Methods: A prospective controlled, open, randomized multicenter phase III trial involving 7 Italian centers was conducted. Eligible patients with intermediate- to high-risk PCa were randomized in a 1:1 ratio. Two groups were formed: one undergoing conventional imaging (abdominopelvic contrast-enhanced CT and bone scanning) and the other receiving conventional imaging plus [18F]F-choline PET/CT. The study was terminated prematurely; however, all the endpoints were thoroughly analyzed and enriched. Results: Between February 2016 and December 2020, 256 patients were randomly assigned. In total, 236 patients (117 in the control arm and 119 in the experimental arm) were considered for the final assessment. In the experimental arm, the sensitivity for lymph node metastases, determined by final pathology and serial prostate-specific antigen evaluations, was higher than in the control arm (77.78% vs. 28.57% and 65.62% vs. 17.65%, respectively). The [18F]F-choline was tolerated well. The use of [18F]F-choline PET/CT resulted in an approximately 8% reduction in unnecessary extended lymphadenectomy compared with contrast-enhanced CT. Additionally, [18F]F-choline PET/CT had a marginal impact on 5-y overall survival, contributing to a 4% increase in survival rates. Conclusion: In the initial staging of PCa, [18F]F-choline PET/CT exhibited diagnostic performance superior to that of conventional imaging for detecting metastases. [18F]F-choline PET/CT reduced the rate of unnecessary extensive lymphadenectomy by up to 8%. These findings support the consideration of discontinuing conventional imaging for staging PCa.
... Inclusion criteria were (1) trials that enrolled patients with mHSPC (PCa confirmed by histological examination with radiologically proven metastases) with no age restriction, previously administered local treatment or diagnosed with de novo metastatic disease; (2) the interventions of interest included the combination of abiraterone, apalutamide, enzalutamide, docetaxel, darolutamide, and ADT; (3) trials that reported at least one of the clinical outcomes including OS, progression-free survival (PFS), radiographic PFS (rPFS), clinical PFS (cPFS), prostate-specific antigen (PSA) PFS, CRPC-free survival, time to symptomatic skeletal event (SSE), or toxicity; and (4) phase II or III RCTs. ...
This study compared different doublet and triplet therapies for efficacy and safety in metastatic hormone-sensitive prostate cancer (mHSPC). PubMed, EMBASE, and the Cochrane Library were comprehensively searched for eligible randomized controlled trials (RCTs) published from inception to October 2023. Interventions included abiraterone, apalutamide, enzalutamide, docetaxel, darolutamide, and androgen deprivation therapy (ADT), either as doublet or triplet therapies. The outcomes examined were overall survival (OS), progression-free survival (PFS), castration-resistant prostate cancer (CRPC)-free survival, time to symptomatic skeletal event (SSE), and toxicity. The surface under the cumulative ranking curve (SUCRA) was determined to identify the preferred treatments. Ten RCTs were included. The combination of darolutamide, docetaxel, and ADT had the highest SUCRA of 84.3 for OS, followed by combined abiraterone, docetaxel, and ADT (SUCRA = 71.6). The highest SUCRAs for PFS were observed for triplet therapies (abiraterone, docetaxel, and ADT [SUCRA = 74.9], followed by enzalutamide, docetaxel, and ADT [SUCRA = 74.3]) and other androgen receptor axis-targeted therapy-based doublet therapies (SUCRAs: 26.5–59.3). Darolutamide, docetaxel, and ADT had the highest SUCRAs, i.e., 80.8 and 84.0 regarding CRPC-free survival and time to SSE, respectively. Regarding Grade >3 adverse events (AEs), the SUCRAs of triplet therapies (SUCRAs: 14.8–31.5) were similar to that of docetaxel and ADT (SUCRA = 39.5). Three studies had a low risk of bias in all categories; the remaining studies had at least an unclear risk of bias in at least one category. Triplet therapy demonstrated potentially enhanced effectiveness than doublet therapy in mHSPC, with acceptable safety concerns. Darolutamide might be the optimal option for triplet therapy in combination with docetaxel and ADT.
... Multiparametric MRI (mpMRI) with functional MRI sequences has become the investigation of choice for staging of local disease in PCa, especially to demonstrate capsular invasion and seminal vesicle involvement. [8][9][10][11] However, interpretation of prostate tumors in transitional zone remains challenging because of intrinsic heterogeneity due to benign prostatic hyperplasia, and significant overlap in the appearance of tumor and benign disease. 12 The pooled sensitivity and specificity of mpMRI in PCa detection are 74 and 88%, respectively. ...
Background Multiparametric magnetic resonance imaging (mpMRI) is widely used for the evaluation of prostate cancer and is known to have better accuracy. Gallium-68 prostate-specific membrane antigen (Ga-68 PSMA) is a radiotracer that shows high localization in prostate cancer cells.
Purpose The purpose of this study was to assess the sensitivity and utility of Ga-68 PSMA positron emission tomography/computed tomography (PET/CT) in comparison with mpMRI as a noninvasive imaging technique for the initial diagnosis and locoregional staging of prostate cancer using transrectal ultrasound (TRUS)-guided biopsy as gold standard.
Materials and Methods This prospective observational study conducted from August 2017 to April 2020 evaluated 60 men (n = 60) with biopsy-proven prostate carcinoma. They underwent mpMRI and Ga-68 PSMA PET/CT scans within 14 days with TRUS biopsy being gold standard. T staging of disease, N staging of lymph nodes within the pelvis, and M staging of lesions in pelvic bones (within the imaging field of mpMRI) were compared using PSPP version 1.0.1 statistical software.
Results All 60 men with a mean age of 69.9 ± 9.35 years showed Ga-68 PSMA avid disease, whereas 55 were detected by mpMRI. The sensitivity in detection of prostate lesions (with 95% confidence interval) was 99.08% for Ga-68 PSMA PET/CT and 84.40% for mpMRI. Ga-68 PSMA PET/CT detected greater number of patients with regional lymph nodal involvement (19/60) as compared with mpMRI (12/60). Ga-68 PSMA PET/CT showed PSMA avid pelvic skeletal lesions in nine patients, whereas mpMRI detected pelvic lesions in six patients. In addition, four other patients showed extrapelvic skeletal lesions on Ga-68 PSMA PET/CT.
Conclusion Ga-68 PSMA PET/CT has superior sensitivity in detection of primary prostate tumor, as compared with mpMRI. Both modalities correlate well in detection of seminal vesicle involvement. Ga-68 PSMA PET/CT outperformed mpMRI in detection of lymph nodal and skeletal metastases. Hence, Ga-68 PSMA PET/CT should be considered as first-line diagnostic modality for carcinoma prostate.
Summary Statement: Ga-68 PSMA PET/CT shows superior diagnostic performance than mpMRI in the evaluation of prostate cancer.
... 8,9 Consequently, guidelines from the European Association of Urology and the National Swedish Guidelines now recommend doublet therapy for men with mCSPC. 12,13 As a result, use of doublet therapy has increased substantially in Sweden, and in 2021 approximately half of all individuals with de novo mCSPC received doublet therapy. At the same time, earlier detection of metastatic disease has led to lower tumor burden in patients with de novo mCSPC, as mirrored by lower prostatespecific antigen (PSA) levels at diagnosis. ...
Importance
Recently, life-prolonging treatments for patients with advanced prostate cancer have been introduced in clinical practice.
Objective
To investigate if the introduction of doublet therapy is associated with changes in survival on a population-basis.
Design, Setting, and Participants
This nationwide population-based cohort study used data from the Prostate Cancer data Base Sweden from 2008 to 2020. Men registered with de novo metastatic castration-sensitive prostate cancer (mCSPC) were included.
Exposure
The proportion of men with mCSPC who received doublet therapy, ie, androgen deprivation therapy plus androgen receptor pathway inhibitor drugs or chemotherapy was assessed.
Main Outcomes and Measures
Standardized overall survival, taking age, comorbidity, and cancer characteristics into consideration, was estimated by use of a parametric survival model.
Results
A total of 11 382 men were included in this study (median [IQR] age, 74.0 [68-81] years). There was a shift toward less advanced prostate cancer during the study period with a decrease in median (IQR) prostate-specific antigen at diagnosis in men with mCSPC from 145 (39-571) ng/mL to 107 (27-426) ng/mL. Upfront treatment with doublet therapy in these men simultaneously increased from 1% (7 of 991) in 2016 to 44% (402 of 922) in 2020. The adjusted 5-year overall survival increased from 26% (95% CI, 25%-28%) from 2008 to 2012 to 35% (95% CI, 31%-40%) from 2017 to 2020. During the first 5 years after diagnosis, there was an increase in mean survival of 6 months, from 2.7 (95% CI, 2.6-2.8) years from 2008 to 2012 to 3.2 (95% CI, 3.1-3.1) years from 2017 to 2020.
Conclusions and Relevance
In parallel with improvements in treatment of advanced prostate cancer, a clinically meaningful increase in mean survival was observed in men with de novo mCSPC in Sweden between 2008 and 2020 in this study.
... [1,2] Changes in PSA value and abnormal digital rectal examination (nodules and stiffness) are the findings that lead the patient to biopsy. [3] Transrectal finger-guided needle prostate biopsy has evolved into the present form with Takahashi et al. using ultrasound in the field of urology and 1989 by Hodge et al. reporting a TRUS-guided sextant biopsy. [4,5] At present, TRUS-guided 10-12 quadrant prostate biopsy is considered the gold standard. ...
Objectives
We aimed to evaluate the effectiveness of the additive transurethral anesthetic agent to transrectal anesthetic agent.
Methods
Transrectal ultrasound-guided 12 core prostate biopsy planned, 237 patients included in our study. The patients randomly divided into two groups. Group 1 (n=113): Only transrectal 2% lidocaine, Group 2 (n=124): Transrectal + Transurethral(Sandwiches) lidocaine gel given to the patients 10 min before the procedure as anesthesia. Immediately after the biopsy, the patient questioned about the level of pain he felt during the needle entry. The evaluation measured by the VAS score. Immediately after biopsy satisfaction rate with the procedure and if rebiopsy was required, acceptance was scored between 1 and 4. The two groups compared statistically.
Results
The mean VAS score of Group 1 and Group 2 was 4.88±1.89 and 3.77±1.83, respectively. The pain level of Group 2 was lower than Group 1’ pain level. The difference between the two groups was considered statistically significant (p<0.001). The patient satisfaction rates of Group 1 and Group 2 found to be 2.45±0.71 and 2.78±0.66, and the acceptance rate of rebiopsy was 2.81±0.69 and 3.02±0.51, respectively. The patient satisfaction rate and acceptance rate of the rebiopsy of Group 2 were higher than Group 1. Patient satisfaction level (p<0.001) and rebiopsy acceptance rate (p=0.014) between the two groups found to be statistically significant.
Conclusion
In the TRUS-guided prostate biopsies, sandwich anesthesia is a cheap, convenient, tolerable, and effective method.
Sommario
L’ecografia del tratto genitale maschile (TGM) rappresenta uno strumento diagnostico essenziale in andrologia. L’ecografia scrotale ha dimostrato un impatto rilevante sulla salute riproduttiva e generale maschile, valutando caratteristiche legate a infertilità, dolore, masse e traumi scrotali. L’ecografia transrettale ha assunto crescente rilevanza nella valutazione dell’infertilità e del dolore pelvico. Sono qui riportati gli standard dell’ecografia andrologica derivati da recenti linee guida e studi basati sull’evidenza e analizzate le anomalie ecografiche del TGM in relazione alla salute riproduttiva e generale maschile.
Over a decade ago, the United States Preventive Services Taskforce (USPSTF) recommended against prostate-specific antigen (PSA)-based screening for prostate cancer in all men, which considerably influenced prostate cancer screening policies worldwide after that. Consequently, the world has seen increasing numbers of advanced stages and prostate cancer deaths, which later led the USPSTF to withdraw its initial statement. Meanwhile, the European Union has elaborated a directive to address the problem of implementing prostate cancer screening in “Europe’s Beating Cancer Plan”. In Switzerland, concerned urologists formed an open Swiss Prostate Cancer Screening Group to improve the early detection of prostate cancer. On the 20th of September 2023, during the annual general assembly of the Swiss Society of Urology (SGU/SSU) in Lausanne, members positively voted for a stepwise approach to evaluate the feasibility of implementing organised prostate cancer screening programs in Switzerland. The following article will summarise the events and scientific advances in the last decade during which evidence and promising additional modalities to complement PSA-based prostate cancer screening have emerged. It also aims to provide an overview of contemporary strategies and their potential harms and benefits.
5058
Background: To develop a prognostic model and nomogram using baseline clinical variables to predict death among men with metastatic hormone-refractory prostate cancer (HRPC). Methods: TAX 327 was a clinical trial that randomized 1,006 men with metastatic HRPC to receive 3-weekly or weekly docetaxel or mitoxantrone, each with prednisone. Of these, 635 men had baseline data that included PSA kinetics, with 518 mortality events recorded as of November 2006. We developed a multivariate Cox model and nomogram to predict survival at two, three, and five years. Results: Ten independent prognostic factors were identified in multivariate analysis and include: 1) presence of liver metastases (HR 1.64, p=0.02), 2) number of metastatic sites (HR 1.58 if =2 sites, p=0.001), 3) clinically significant pain at baseline (HR 1.46, p<0.0001), 4) Karnofsky Performance Status (HR 1.42 if =70, p=0.01), 5) type of progression at baseline (HR 1.40 for measurable disease progression and 1.28 for bone scan progression, p=0.002 and 0.014 respectively), 6) pretreatment PSA doubling time (PSADT, HR 1.20 if <55 days, p=0.048), 7) baseline PSA (HR 1.17 per log rise, p<0.0001), 8) tumor grade (HR 1.18 for high grade, p=0.076), 9) alkaline phosphatase (HR 1.26 per log rise, p<0.0001), and 10) hemoglobin (HR 1.10 per unit decline, p=0.006). A PSADT <55 days (median value for this dataset) was associated with other adverse prognostic factors, but was independently associated with shortened overall survival. Men with a PSA less than the median of 114 ng/ml and longer PSADT (=55 days) had a median survival of 24.7 months, while those with higher PSA and shorter PSADT had a median survival of 13.8 months. A nomogram was developed based on this Cox multivariate model and validated internally using bootstrap methods, with a concordance index of 0.69. Conclusions: This multivariate model identified several prognostic factors in men with metastatic HRPC including PSADT, and led to the successful development of a clinically applicable nomogram. External prospective validation may support the wider use of this prognostic baseline model for men with HRPC treated with chemotherapy.
No significant financial relationships to disclose.
5074
Background: Concentrations of blood proteins such as PSA, hemoglobin (HGB), and LDH are associated with survival in men with AIPC. We sought to identify additional blood proteins associated with prognosis in chemotherapy-treated AIPC patients. Methods: Baseline plasma samples were stored (-80°C) from 160 patients enrolled in the ASCENT trial, a randomized placebo-controlled phase 2 trial comparing weekly docetaxel plus DN-101, an oral high-dose formulation of calcitriol, to weekly docetaxel. Multiplex immunoassays measured 16 cytokine/chemokine or cardiovascular/inflammation markers including IL-1a, IL-1β, IL-2, IL-6, IL-8, IL-10, TNFa, MCP-1, EGF, VEGF, PAI-1, MMP-9, sE-Selectin, sICAM-1, sVCAM-1 and C-reactive protein (CRP). Cox’s proportional hazard model was used to assess association between baseline biomarkers and survival or skeletal-related event (SRE)-free survival, and logistic regression for PSA Working Group Criteria response. Results: Baseline characteristics were similar to those of the 90 patients without samples, except for age (mean 68.0 vs. 70.6 yrs) and HGB (12.8 vs. 12.2 g/dL). CRP was the only biomarker that significantly predicted shorter overall survival (HR 1.41, 95% CI 1.20–1.65, p < 0.0001). When CRP (continuous) was entered into a multivariate model using 13 baseline variables (including PSA, LDH, alkaline phosphatase, HGB, ECOG Performance Status, age) only elevated CRP remained a significant predictor (p<0.0001) of shorter survival. When categorized as normal (= 8 mg/L) or abnormal (> 8 mg/L), elevated CRP was a significant predictor of shorter survival (HR 2.96 95% CI 1.52–5.77, p = 0.001) as was HGB (p=0.007). Elevated CRP was also associated with a lower probability of PSA response (OR 0.74, 95% CI 0.60–0.92, p = 0.007) and a shorter SRE-free survival (HR 1.30, 95% CI 1.15–1.48, p < 0.0001). Conclusions: Elevated levels of plasma CRP appear to be a strong predictor of poor survival and development of SREs in AIPC patients receiving docetaxel-based therapy. The use of CRP as a risk marker and its potential as a surrogate marker of treatment effect should be prospectively evaluated in future clinical trials in advanced prostate cancer.
[Table: see text]
Aims:
The CHHiP trial investigated the use of moderate hypofractionation for the treatment of localised prostate cancer using intensity-modulated radiotherapy (IMRT). A radiotherapy quality assurance programme was developed to assess compliance with treatment protocol and to audit treatment planning and dosimetry of IMRT. This paper considers the outcome and effectiveness of the programme.
Materials and methods:
Quality assurance exercises included a pre-trial process document and planning benchmark cases, prospective case reviews and a dosimetry site visit on-trial and a post-trial feedback questionnaire.
Results:
In total, 41 centres completed the quality assurance programme (37 UK, four international) between 2005 and 2010. Centres used either forward-planned (field-in-field single phase) or inverse-planned IMRT (25 versus 17). For pre-trial quality assurance exercises, 7/41 (17%) centres had minor deviations in their radiotherapy processes; 45/82 (55%) benchmark plans had minor variations and 17/82 (21%) had major variations. One hundred prospective case reviews were completed for 38 centres. Seventy-one per cent required changes to clinical outlining pre-treatment (primarily prostate apex and base, seminal vesicles and penile bulb). Errors in treatment planning were reduced relative to pre-trial quality assurance results (49% minor and 6% major variations). Dosimetry audits were conducted for 32 centres. Ion chamber dose point measurements were within ±2.5% in the planning target volume and ±8% in the rectum. 28/36 films for combined fields passed gamma criterion 3%/3 mm and 11/15 of IMRT fluence film sets passed gamma criterion 4%/4 mm using a 98% tolerance. Post-trial feedback showed that trial participation was beneficial in evolving clinical practice and that the quality assurance programme helped some centres to implement and audit prostate IMRT.
Conclusion:
Overall, quality assurance results were satisfactory and the CHHiP quality assurance programme contributed to the success of the trial by auditing radiotherapy treatment planning and protocol compliance. Quality assurance supported the introduction of IMRT in UK centres, giving additional confidence and external review of IMRT where it was a newly adopted technique.
When and to what extent lymphadenectomy should be performed in patients undergoing radical prostatectomy remains a matter of intense debate. Lymphadenectomy provides important information for prognosis (number of nodes involved, tumor volume, capsular perforation) that is not matched by any other procedures. Whether, in addition, a potential therapeutic effect of extended lymph node dissection with removal of all diseased nodes can be expected has still not been fully documented, due to the relatively benign course of this disease. In contrast, in other malignancies such as gastric, breast, colorectal, and cervical cancer, and in recent years also bladder cancer, it has become apparent that survival and accuracy of staging improve with the number of nodes removed and therefore the extent of lymph node dissection.1-6 Precise tumor staging is the basis for optimal therapeutic management. In prostate cancer the availability of biochemical markers and preoperative biopsies allows a differentiated staging. Based on these, nomograms have been developed to help decide which patients will benefit from pelvic lymphadenectomy and in which it can be avoided.7 To date all nomograms are based on standard lymph node dissection and with the increasing awareness of possible lymph node metastasis outside the region of standard dissection, these nomograms may prove increasingly inadequate.
