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BMJ Open Nov 2023Nowadays, invasive prostate biopsy is the standard diagnostic test for patients with suspected prostate cancer (PCa). However, it has some shortcomings such as... (Clinical Trial)
Clinical Trial
Protocol for SNOTOB study: radical prostatectomy without prostate biopsy following F-PSMA-1007 PET/CT based on a diagnostic model: a single-centre, single-arm, open-label study.
INTRODUCTION
Nowadays, invasive prostate biopsy is the standard diagnostic test for patients with suspected prostate cancer (PCa). However, it has some shortcomings such as perioperative complications, economic and psychological burden on patients, and some patients may undergo repeated prostate biopsy. In this study protocol, our aim is to provide a non-invasive diagnostic strategy we call the 'prostate-specific membrane antigen (PSMA) combined model' for the diagnosis of PCa. If patients are diagnosed with PCa using PSMA combined model, we want to prove these patients can receive radical prostatectomy directly without prior prostate biopsies.
METHODS
The SNOTOB trial adopts a prospective, single-centre, single-arm, open-label study design. The PSMA combined model consists of a diagnostic model based on what we previously reported and F-PSMA-1007 positron emission tomography/CT (F-PSMA-1007 PET/CT) examinations in series. First, patients use the diagnostic model (online address: https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/) to calculate the risk probability of clinically significant PCa (csPCa). When the risk probability of csPCa is equal or greater than 0.60, F-PSMA-1007 PET/CT will be applied for further diagnosis. If patients are still considered as csPCa after F-PSMA-1007 PET/CT examinations, we define this condition as positive results of PSMA combined model. Subsequently, we will recommend these patients to accept radical prostatectomy without prostate biopsy directly. Finally, the diagnostic performance of PSMA combined model will be verified with the pathological results. Totally, 57 patients need to be enrolled in this clinical trial.
ETHICS AND DISSEMINATION
This study was approved by the ethics committee of The First Affiliated Hospital of USTC (No. 2022KY-142). The results of this study will be published in peer-reviewed journals and reported at academic conferences.
TRIAL REGISTRATION NUMBER
NCT05587192.
Topics: Humans; Male; Biopsy; Gallium Radioisotopes; Positron Emission Tomography Computed Tomography; Prospective Studies; Prostate; Prostatectomy; Prostatic Neoplasms
PubMed: 37984956
DOI: 10.1136/bmjopen-2023-073983 -
BMC Urology Nov 2023Pelvic lymph node dissection (PLND) is recommended method for detecting prostate cancer (PCa) nodal metastases although associated with serious complications. In this...
BACKGROUND
Pelvic lymph node dissection (PLND) is recommended method for detecting prostate cancer (PCa) nodal metastases although associated with serious complications. In this study, we aimed to assess benefit/harm of routine PLND in intermediate risk PCa patients and to compare diagnostic yield of five different nomograms in predicting lymph node invasion (LNI).
METHODS
Retrospective analysis of consecutive PCa patients with intermediate risk of biochemical recurrence who underwent open radical prostatectomy (RP) with bilateral PLND between January 2017 and December 2019 at our institution. Partin, 2012-Briganti, 2018-Briganti, Cagiannos and Memorial Sloan Kettering Cancer Center (MSKCC) values were calculated. To compare accuracy, sensitivity, specificity, and area under receiver-operating curve (AUC) were calculated and then optimal cutoff values were estimated, analyses repeated and compared. To assess benefit and harm of PLND, relative risk (RR) and number need to treat (NNT) with LNI and complications set as outcome were calculated.
RESULTS
Total 309 subjects. Average age 62.2 years, average PSA 7.2 ng/mL; 18 (5.8%) had LNI; 88 (28.5%) suffered Clavien-Dindo grade 3-5 complication. AUC for predicting LNI: 0.729 for 2012-Briganti, 0.660 for MSKCC, 0.521 for 2018-Briganti, 0.486 for Cagiannos, and 0.424 for Partin. None of pairwise AUC comparisons based on default and newly established cutoff values were statistically significant. Lowest NNT was for Partin and Cagiannos with default cutoff (≥ 5%). Risks of serious complications between higher/lower than cutoff values were non-significant across nomograms.
CONCLUSIONS
2012-Briganti nomogram outperforms, although not significantly, MSKCC, 2018-Briganti, Cagiannos, and Partin nomograms in classifying LNI in intermediate risk PCa patients. Routine PLND in these patients should be avoided, due to high rate and severity of complications.
Topics: Male; Humans; Middle Aged; Nomograms; Retrospective Studies; Lymphatic Metastasis; Lymph Node Excision; Lymph Nodes; Prostatic Neoplasms; Prostatectomy
PubMed: 37980520
DOI: 10.1186/s12894-023-01362-y -
Research and Reports in Urology 2023Bladder neck contracture is a recognised complication associated with radical prostatectomy. The management can be challenging, especially when refractory to initial... (Review)
Review
Bladder neck contracture is a recognised complication associated with radical prostatectomy. The management can be challenging, especially when refractory to initial intervention strategies. For the patient, the burden of disease is high and continence status cannot be overlooked. This review serves to provide an overview of the management of this recognised clinical pathology. Consideration needs to be given to minimally invasive approaches such as endoscopic incision, injectables, implantable devices as well as major reconstructive surgery where the condition persists. For the latter, this can involve open and robotic surgery as well as use of grafts and artificial sphincter surgery. These elements underline the need for a tailored and a patient centred approach.
PubMed: 37954870
DOI: 10.2147/RRU.S350777 -
Urology Case Reports Nov 2023Bladder exstrophy (BE) is a rare congenital disorder causing bladder and urethral malformation due to an abdominal wall embryological defect. Traditionally, BE had a...
Bladder exstrophy (BE) is a rare congenital disorder causing bladder and urethral malformation due to an abdominal wall embryological defect. Traditionally, BE had a poor life expectancy, but advances now offer a normal lifespan. A 57-year-old male with BE history and ureterosigmoidostomy repair presented with intractable hematuria, urethral discharge, and recurrent prostatic infections. He underwent retropubic subtotal prostatectomy without major complications, resolving urinary symptoms. Advances in BE management extend patient lifespans. This case demonstrates successful surgical management of hematuria and urethral discharge through radical prostatectomy in an adult with a history of BE.
PubMed: 37928513
DOI: 10.1016/j.eucr.2023.102590 -
JAMA Network Open Nov 2023Patients with high-grade prostate cancer with low levels of prostate-specific antigen (PSA; <4 ng/mL) are at high risk of mortality, necessitating an improved treatment... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Patients with high-grade prostate cancer with low levels of prostate-specific antigen (PSA; <4 ng/mL) are at high risk of mortality, necessitating an improved treatment paradigm.
OBJECTIVE
To assess for these patients whether adding docetaxel to standard of care (SOC) treatment is associated with decreased prostate cancer-specific mortality (PCSM) and all-cause mortality (ACM).
DATA SOURCES
PubMed search from 2000 to 2022.
STUDY SELECTION
Five prospective randomized clinical trials (RCTs) performed in the US, France, and the United Kingdom evaluating SOC treatment with radiotherapy and androgen deprivation therapy (ADT) or with radical prostatectomy vs SOC plus docetaxel.
DATA EXTRACTION AND SYNTHESIS
Individual data were included from patients with nonmetastatic prostate cancer, a PSA level of less than 4 ng/mL, and a Gleason score of 8 to 10. Patients initiated treatment between February 21, 2006, and December 31, 2015 (median follow-up, 7.1 [IQR, 5.4-9.9] years). Data were analyzed on December 16, 2022.
MAIN OUTCOMES AND MEASURES
Hazard ratio (HR) of ACM and subdistribution HR (sHR) of PCSM adjusted for performance status (1 vs 0 or good health), Gleason score (9 or 10 vs 8), tumor category (T3-T4 vs T1-T2 or TX), and duration of ADT (2 years vs 4-6 months).
RESULTS
From a cohort of 2184 patients, 145 patients (6.6%) in 4 RCTs were eligible (median age, 63 [IQR, 46-67] years). Thirty-one patients died, and of these deaths, 22 were due to prostate cancer. Performance status was 0 for 139 patients (95.9%) and 1 for 6 patients (4.1%). A reduced but nonsignificant risk of ACM (HR, 0.51 [95% CI, 0.24-1.09]) and PCSM (sHR, 0.42 [95% CI, 0.17-1.02]) was associated with patients randomized to SOC plus docetaxel compared with SOC. The risk reduction in ACM (HR, 0.46 [95% CI, 0.21-1.02]) was more pronounced among patients with a performance status of 0 and was significant for PCSM (sHR, 0.30 [95% CI, 0.11-0.86]).
CONCLUSIONS AND RELEVANCE
Adding docetaxel to SOC treatment for patients who are in otherwise good health with a PSA level of less than 4 ng/mL and a Gleason score of 8 to 10 was associated with a significant reduction in PCSM and therefore has the potential to improve prognosis.
Topics: Male; Humans; Middle Aged; Docetaxel; Prostate-Specific Antigen; Prostatic Neoplasms; Prostate; Prostatectomy; Randomized Controlled Trials as Topic
PubMed: 37910103
DOI: 10.1001/jamanetworkopen.2023.40787 -
JAMA Network Open Oct 2023The Veterans Choice Program (VCP) was implemented in 2014 to help veterans gain broader access to specialized care outside of the Veterans Health Administration (VHA)...
IMPORTANCE
The Veterans Choice Program (VCP) was implemented in 2014 to help veterans gain broader access to specialized care outside of the Veterans Health Administration (VHA) facilities by providing them with purchased community care (CC).
OBJECTIVE
To describe the prevalence and patterns in VCP-funded purchased CC after the implementation of the VCP among veterans with prostate cancer.
DESIGN, SETTING, AND PARTICIPANTS
This cohort study used VHA administrative data on veterans with prostate cancer diagnosed between January 1, 2015, and December 31, 2018. These veterans were regular VHA primary care users. Analyses were performed from March to July 2023.
EXPOSURES
Driving distance (in miles) from residence to nearest VHA tertiary care facility. The location (VHA or purchased CC) in which treatment decisions were made was ascertained by considering 3 factors: (1) location of the diagnostic biopsy, (2) location of most of the postdiagnostic prostate-specific antigen laboratory testing, and (3) location of most of the postdiagnostic urological care encounters.
MAIN OUTCOMES AND MEASURES
The main outcome was receipt of definitive treatment and proportion of purchased CC by treatment type (radical prostatectomy [RP], radiotherapy [RT], or active surveillance) and by distance to nearest VHA tertiary care facility. Quality was evaluated based on receipt of definitive treatment for Gleason grade group 1 prostate cancer (low risk/limited treatment benefit by guidelines).
RESULTS
The cohort included 45 029 veterans (mean [SD] age, 67.1 [6.9] years) with newly diagnosed prostate cancer; of these patients, 28 866 (64.1%) underwent definitive treatment. Overall, 56.8% of patients received definitive treatment from the purchased CC setting, representing 37.5% of all RP care and 66.7% of all RT care received during the study period. Most patients who received active surveillance management (92.5%) remained within the VHA. Receipt of definitive treatment increased over the study period (from 5830 patients in 2015 to 9304 in 2018), with increased purchased CC for patients living farthest from VHA tertiary care facilities. The likelihood of receiving definitive treatment of Gleason grade group 1 prostate cancer was higher in the purchased CC setting (adjusted relative risk ratio, 1.79; 95% CI, 1.65-1.93).
CONCLUSIONS AND RELEVANCE
This cohort study found that the percentage of veterans receiving definitive treatment in VCP-funded purchased CC settings increased significantly over the study period. Increased access, however, may come at the cost of low care quality (overtreatment) for low-risk prostate cancer.
Topics: Male; United States; Humans; Aged; Veterans; United States Department of Veterans Affairs; Cohort Studies; Prostatic Neoplasms; Prostate
PubMed: 37856123
DOI: 10.1001/jamanetworkopen.2023.38326 -
JAMA Network Open Oct 2023Although active surveillance for patients with low-risk prostate cancer (LRPC) has been recommended for years, its adoption at the population level is often limited.
IMPORTANCE
Although active surveillance for patients with low-risk prostate cancer (LRPC) has been recommended for years, its adoption at the population level is often limited.
OBJECTIVE
To make active surveillance available for patients with LRPC using a research framework and to compare patient characteristics and clinical outcomes between those who receive active surveillance vs radical treatments at diagnosis.
DESIGN, SETTING, AND PARTICIPANTS
This population-based, prospective cohort study was designed by a large multidisciplinary group of specialists and patients' representatives. The study was conducted within all 18 urology centers and 7 radiation oncology centers in the Piemonte and Valle d'Aosta Regional Oncology Network in Northwest Italy (approximate population, 4.5 million). Participants included patients with a new diagnosis of LRPC from June 2015 to December 2021. Data were analyzed from January to May 2023.
EXPOSURE
At diagnosis, all patients were informed of the available treatment options by the urologist and received an information leaflet describing the benefits and risks of active surveillance compared with active treatments, either radical prostatectomy (RP) or radiation treatment (RT). Patients choosing active surveillance were actively monitored with regular prostate-specific antigen testing, clinical examinations, and a rebiopsy at 12 months.
MAIN OUTCOMES AND MEASURES
Outcomes of interest were proportion of patients choosing active surveillance or radical treatments, overall survival, and, for patients in active surveillance, treatment-free survival. Comparisons were analyzed with multivariable logistic or Cox models, considering centers as clusters.
RESULTS
A total of 852 male patients (median [IQR] age, 70 [64-74] years) were included, and 706 patients (82.9%) chose active surveillance, with an increasing trend over time; 109 patients (12.8%) chose RP, and 37 patients (4.3%) chose RT. Median (IQR) follow-up was 57 (41-76) months. Worse prostate cancer prognostic factors were negatively associated with choosing active surveillance (eg, stage T2a vs T1c: odds ratio [OR], 0.51; 95% CI, 0.28-0.93), while patients who were older (eg, age ≥75 vs <65 years: OR, 4.27; 95% CI, 1.98-9.22), had higher comorbidity (Charlson Comorbidity Index ≥2 vs 0: OR, 1.98; 95% CI, 1.02-3.85), underwent an independent revision of the first prostate biopsy (OR, 2.35; 95% CI, 1.26-4.38) or underwent a multidisciplinary assessment (OR, 2.65; 95% CI, 1.38-5.11) were more likely to choose active surveillance vs active treatment. After adjustment, center at which a patient was treated continued to be an important factor in the choice of treatment (intraclass correlation coefficient, 18.6%). No differences were detected in overall survival between active treatment and active surveillance. Treatment-free survival in the active surveillance cohort was 59.0% (95% CI, 54.8%-62.9%) at 24 months, 54.5% (95% CI, 50.2%-58.6%) at 36 months, and 47.0% (95% CI, 42.2%-51.7%) at 48 months.
CONCLUSIONS AND RELEVANCE
In this population-based cohort study of patients with LRPC, a research framework at system level as well as favorable prognostic factors, a multidisciplinary approach, and an independent review of the first prostate biopsy at patient-level were positively associated with high uptake of active surveillance, a practice largely underused before this study.
Topics: Humans; Male; Aged; Cohort Studies; Prospective Studies; Watchful Waiting; Prostatic Neoplasms; Prostate-Specific Antigen
PubMed: 37847502
DOI: 10.1001/jamanetworkopen.2023.38039 -
SAGE Open Medicine 2023Thirst is a real bother that most patients feel in the immediate postoperative period when they still need to fast. Many approaches regarding symptomatic relief...
Thirst is a real bother that most patients feel in the immediate postoperative period when they still need to fast. Many approaches regarding symptomatic relief strategies have been described in the literature, but strategies with cold water and/or menthol are effective in quenching thirst, as they act on pre-absorptive mechanisms. This study aims to evaluate the effectiveness of using menthol popsicles in relieving postoperative thirst in patients undergoing radical prostatectomy. This is a randomized controlled clinical trial with a quantitative approach. In all, 44 patients were evaluated in the immediate postoperative period of radical prostatectomy, with the intensity and discomfort of thirst being evaluated initially and subsequently. The study consisted of two groups: (1) the placebo group, popsicles without the addition of menthol substrates and (2) the experimental group, popsicles with the addition of 0.05% minty substrates. The results demonstrate that the sociodemographic and clinical characteristics were homogeneous at the α = 5% significance level, except the occupation variable. The test detected changes in the intensity and discomfort of thirst in relation to the pre- and post-intervention times for the primary outcome when the groups were analyzed separately and for the interaction of the group versus time, there was no statistical difference between the groups. It was possible to prove that both the menthol popsicle and the popsicle without the addition of menthol were effective in relieving postoperative thirst in patients undergoing radical prostatectomy, but there was no statistically significant difference when comparing the two groups. Trial registration: The Brazilian Registry of Clinical Trials (RBR-8c3chr7).
PubMed: 37846371
DOI: 10.1177/20503121231202231 -
Genome Medicine Oct 2023Prostate cancer (PrCa) genomic heterogeneity causes resistance to therapies such as androgen deprivation. Such heterogeneity can be deciphered in the context of...
BACKGROUND
Prostate cancer (PrCa) genomic heterogeneity causes resistance to therapies such as androgen deprivation. Such heterogeneity can be deciphered in the context of evolutionary principles, but current clinical trials do not include evolution as an essential feature. Whether or not analysis of genomic data in an evolutionary context in primary prostate cancer can provide unique added value in the research and clinical domains remains an open question.
METHODS
We used novel processing techniques to obtain whole genome data together with 3D anatomic and histomorphologic analysis in two men (GP5 and GP12) with high-risk PrCa undergoing radical prostatectomy. A total of 22 whole genome-sequenced sites (16 primary cancer foci and 6 lymph node metastatic) were analyzed using evolutionary reconstruction tools and spatio-evolutionary models. Probability models were used to trace spatial and chronological origins of the primary tumor and metastases, chart their genetic drivers, and distinguish metastatic and non-metastatic subclones.
RESULTS
In patient GP5, CDK12 inactivation was among the first mutations, leading to a PrCa tandem duplicator phenotype and initiating the cancer around age 50, followed by rapid cancer evolution after age 57, and metastasis around age 59, 5 years prior to prostatectomy. In patient GP12, accelerated cancer progression was detected after age 54, and metastasis occurred around age 56, 3 years prior to prostatectomy. Multiple metastasis-originating events were identified in each patient and tracked anatomically. Metastasis from prostate to lymph nodes occurred strictly ipsilaterally in all 12 detected events. In this pilot, metastatic subclone content analysis appears to substantially enhance the identification of key drivers. Evolutionary analysis' potential impact on therapy selection appears positive in these pilot cases.
CONCLUSIONS
PrCa evolutionary analysis allows tracking of anatomic site of origin, timing of cancer origin and spread, and distinction of metastatic-capable from non-metastatic subclones. This enables better identification of actionable targets for therapy. If extended to larger cohorts, it appears likely that similar analyses could add substantial biological insight and clinically relevant value.
Topics: Male; Humans; Middle Aged; Prostatic Neoplasms; Androgen Antagonists; Precision Medicine; Prostatectomy; Oncogenes
PubMed: 37828555
DOI: 10.1186/s13073-023-01242-y