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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 -
European Urology Open Science Oct 2023The Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) score has been developed to standardise prostate magnetic resonance imaging...
Clinical Application of the Prostate Cancer Radiological Estimation of Change in Sequential Evaluation Score for Reporting Magnetic Resonance Imaging in Men on Active Surveillance for Prostate Cancer.
BACKGROUND
The Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) score has been developed to standardise prostate magnetic resonance imaging (MRI) reporting in men on active surveillance (AS) for prostate cancer (PCa).
OBJECTIVE
To evaluate the feasibility of PRECISE scoring and assess its diagnostic accuracy.
DESIGN SETTING AND PARTICIPANTS
All PCa patients on AS with a baseline MRI and at least one follow-up MRI scan between January 2008 and September 2022 at a single tertiary referral centre were included in a database. The follow-up protocol of the Prostate Cancer International Active Surveillance (PRIAS) study was used. All scans were retrospectively re-reported by a dedicated uroradiologist and appointed a Prostate Imaging Reporting and Data System (version 2.1) and PRECISE score.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Clinically significant progression was defined by histopathological upgrading (on biopsy or radical prostatectomy) to grade group ≥3 and/or evolution to T3 stage. A survival analysis was performed to assess differential progression-free survival (PFS) according to the PRECISE score.
RESULTS AND LIMITATIONS
A total of 188 patients were included for an analysis with a total of 358 repeat MRI scans and 144 repeat biopsies. The median follow-up was 46 mo (interquartile range 21-74). Radiological progression (PRECISE 4-5) had sensitivity, specificity, negative predictive value, and positive predictive value of, respectively, 78%, 70%, 90%, and 49% for clinically significant progression. Four-year PFS was 91% for PRECISE 1-3 versus 66% for PRECISE 4-5 ( < 0.001). In total, 137 patients underwent a confirmation MRI scan within 18 mo after diagnosis. Four-year PFS in this group was 81% for PRECISE 1-3 versus 43% for PRECISE 4-5 ( < 0.001). Limitations include retrospective design and no strict adherence to AS protocol.
CONCLUSIONS
Implementation of PRECISE scoring for PCa patients on AS is feasible and offers a prognostic value. Patients with PRECISE score 4-5 on confirmation MRI within 18 mo after diagnosis have a three-fold higher risk of clinically significant progression after 4 yr.
PATIENT SUMMARY
Patients with low-risk prostate cancer can be followed up carefully. In this study, we evaluate the standardised reporting of repeat magnetic resonance imaging scans (using the Prostate Cancer Radiological Estimation of Change in Sequential Evaluation [PRECISE] recommendations). PRECISE scoring is feasible and helps identify patients in need of further treatment.
PubMed: 37822515
DOI: 10.1016/j.euros.2023.08.006 -
BMJ Open Oct 2023Patients undergoing prostate radiotherapy with an enlarged prostate can have short-term and long-term urinary complications. Currently, transurethral resection of the...
mparing Urolift and tandard ransurethral resection of prostate head of adiotherapy in men with urinary symptoms secondary to prostate enlargement in Southwest London and North Cumbria (CO-STAR): a study protocol for a randomised feasibility study.
INTRODUCTION
Patients undergoing prostate radiotherapy with an enlarged prostate can have short-term and long-term urinary complications. Currently, transurethral resection of the prostate (TURP) is the mainstay surgical intervention for men with urinary symptoms due to an enlarged prostate prior to radiotherapy. UroLift (NeoTract, Pleasanton, CA, USA) is a recent minimally invasive alternative, widely used in benign disease but is untested in men with prostate cancer.
METHODS AND ANALYSIS
A multicentre, two-arm study designed in collaboration with a Patient Reference Group to assess the feasibility of randomising men with prostate cancer and coexisting urinary symptoms due to prostate enlargement to TURP or UroLift ahead of radiotherapy. 45 patients will be enrolled and randomised (1:1) using a computer-generated programme to TURP or UroLift. Recruitment and retention will be assessed over a 12 month period. Information on clinical outcomes, adverse events and costs will be collected. Clinical outcomes and patient reported outcome measures will be measured at baseline, 6 weeks postintervention and 3 months following radiotherapy. A further 12 in-depth interviews will be conducted with a subset of patients to assess acceptability using the Theoretical Framework of Acceptability. Descriptive analysis on all outcomes will be performed using Stata (StataCorp V.2021).
ETHICS AND DISSEMINATION
The trial has been approved by the Research Ethics Committee (REC) NHS Health Research Authority (HRA) and Health and Care Research Wales (HCRW). The results will be published in peer-reviewed journals, presented at national meetings and disseminated to patients via social media, charity and hospital websites.
TRIAL REGISTRATION NUMBER
NCT05840549.
Topics: Humans; Male; Feasibility Studies; London; Prostate; Prostatic Hyperplasia; Prostatic Neoplasms; Transurethral Resection of Prostate; Randomized Controlled Trials as Topic
PubMed: 37802612
DOI: 10.1136/bmjopen-2023-076621 -
Journal of Medical Economics 2023Minimally invasive surgical therapies, such as water vapor thermal therapy (WVTT) and prostatic urethral lift (PUL), are typically second-line options for patients in...
BACKGROUND
Minimally invasive surgical therapies, such as water vapor thermal therapy (WVTT) and prostatic urethral lift (PUL), are typically second-line options for patients in whom medical management (MM) failed but who are unwilling or unsuitable to undergo invasive transurethral resection of the prostate (TURP). However, the incremental cost-effectiveness of WVTT or PUL as first- or second-line therapy is unknown. We evaluated the incremental cost-effectiveness of alternative first- and second-line treatments for patients with moderate-to-severe benign prostatic hyperplasia (BPH) in Singapore to help policymakers make subsidy decisions based on value for money.
METHODS
We considered six stepped-up treatment strategies, beginning with MM, WVTT, PUL or TURP. In each strategy, patients requiring retreatment advance to a more invasive treatment until TURP, which may be undergone twice. A Markov cohort model was used to simulate transitions between BPH severity states and retreatment, accruing costs and quality-adjusted life-years (QALYs) over a lifetime horizon.
RESULTS
In moderate patients, strategies beginning with MM had similar cost and effectiveness, and first-line WVTT was incrementally cost-effective to first-line MM (33,307 SGD/QALY). First-line TURP was not incrementally cost-effective to first-line WVTT (159,361 SGD/QALY). For severe patients, WVTT was incrementally cost-effective to MM as a first-line treatment (30,133 SGD/QALY) and to TURP as a second-line treatment following MM (6877 SGD/QALY). TURP was incrementally cost-effective to WVTT as a first-line treatment (48,209 SGD/QALY) in severe patients only. All pathways involving PUL were dominated (higher costs and lower QALYs).
CONCLUSION
Based on the common willingness-to-pay threshold of SGD 50,000/QALY, this study demonstrates the cost-effectiveness of WVTT over MM as first-line treatment for patients with moderate or severe BPH, suggesting it represents good value for money and should be considered for subsidy. PUL is not cost-effective as a first- nor second-line treatment. For patients with severe BPH, TURP as first-line is also cost-effective.
Topics: Male; Humans; Prostatic Hyperplasia; Cost-Benefit Analysis; Transurethral Resection of Prostate; Singapore; Minimally Invasive Surgical Procedures; Treatment Outcome
PubMed: 37800562
DOI: 10.1080/13696998.2023.2266958 -
International Neurourology Journal Sep 2023We aimed to identify the risk factors for salvage procedure (SP) required for refractory adenomatous tissue resistant to morcellation during holmium laser enucleation of...
PURPOSE
We aimed to identify the risk factors for salvage procedure (SP) required for refractory adenomatous tissue resistant to morcellation during holmium laser enucleation of the prostate (HoLEP).
METHODS
Patients who underwent HoLEP between January 2010 and April 2020 at Seoul National University Hospital were analyzed. SPs were defined as cases of conversion to resection of the prostatic tissue using an electrosurgical loop after morcellation or secondary morcellation a few days after surgery or conversion to open cystotomy.
RESULTS
Among a total of 2,427 patients, 260 were identified as having SP (SP group) (transurethral resection-nodule [n = 250, 96.1%], secondary morcellation a few days after surgery [n = 9, 3.5%], and conversion to open cystotomy [n = 1, 0.4%]). Patients in the SP group were older and had higher 5-α reductase inhibitors use, higher prostate-specific antigen, larger total prostate volume, and larger transition zone volume (TZV) than those in the non-SP group. In the multivariable logistic regression analysis, only age and TZV were associated with SP. Compared to 40s and 50s, the odds ratios (ORs) were 3.84 in 60s (95% confidence interval [CI] 1.37-10.78, P = 0.011), 4.53 in 70s (95% CI, 1.62-12.62, P = 0.004), and 6.59 in 80s or older (95% CI, 2.23-19.46, P = 0.001). The ORs of the SP were analyzed per TZV quartile. Compared to TZV ≤ 20.3 mL, the OR was 3.75 in 32.0 mL < TZV ≤ 50.4 mL (95% CI, 2.00-7.04, P < 0.001) and 8.25 in 50.4 mL < TZV (95% CI, 4.06-16.77, P < 0.001).
CONCLUSION
The risk of refractory morcellation increased in patients aged > 60 years or those with TZV > 32 mL. In order to more efficiently remove these resistant adenomas, it is necessary to develop more efficient morcellators in the future.
PubMed: 37798887
DOI: 10.5213/inj.2346076.038 -
Nigerian Journal of Clinical Practice Sep 2023Open prostatectomy (OP) is still a valid treatment option for benign prostatic hyperplasia (BPH), but it needs to be constantly reevaluated in the context of minimally...
BACKGROUND
Open prostatectomy (OP) is still a valid treatment option for benign prostatic hyperplasia (BPH), but it needs to be constantly reevaluated in the context of minimally invasive treatments (MITs).
AIM
Our purpose is to present contemporary data on patient presentation and surgical outcomes of OP with which other OP series and MITs can be compared.
METHODS
A retrospective study of all OP was carried out in our institution from January 2011 to December 2020. All patients had a thorough preoperative workup and optimization of comorbidities before surgery. Data were collected in a predesigned pro forma and analyzed.
RESULTS
The mean age of the 148 patients studied was 66.2 (±7.9) yrs. The mean duration of symptoms before surgery was 32.2 (±33.7) mos. The mean preoperative prostate volume was 118.0 (±67.1) cm. There was a 54.4% comorbidity rate with diabetes mellitus (DM) topping the list (16.0%). An incidental prostate cancer rate of 6.1% was found. The overall complication rate was 45.3%. Perioperative hemorrhage requiring blood transfusion (BT) was the most common complication (26.1%). There was no significant difference in age, duration of surgery, and prostrate volume between subjects with and without BT (P > 0.05). Wound infection was significantly associated with diabetes (P = 0.043, OR = 3.507, 95% CI = 1.042-11.805). The reoperation rate was 1.4%, and mortality rate was 0.7%. The International Prostate Symptom Score (IPSS), quality-of-life (QOL) score, and post-void residual urine (PVR) volume were significantly improved (P < 0.001).
CONCLUSION
OP was found to be a safe and effective procedure for the relief of bladder outlet obstruction (BOO) secondary to BPH. However, it was associated with high morbidity and low reoperation rate.
Topics: Male; Humans; Middle Aged; Aged; Prostatic Hyperplasia; Retrospective Studies; Quality of Life; Prostatectomy; Treatment Outcome
PubMed: 37794546
DOI: 10.4103/njcp.njcp_55_23 -
Journal of Cancer 2023Intravesical prostatic protrusion (IPP) is common in prostate-related diseases, whose clinical significance in radical prostatectomy was unknown. 791 patients...
Intravesical prostatic protrusion (IPP) is common in prostate-related diseases, whose clinical significance in radical prostatectomy was unknown. 791 patients underwent robot-assisted or open radical prostatectomy at our institution were enrolled. The transabdominal ultrasound examination of prostate and IPP was carried out preoperatively, by which IPP was classified as no (0-0.5cm, grade 0), slight (0.6-1.0cm, grade 1) and noticeable (>1.0cm, grade 2). 185 (23.4%), 170 (21.5%) and 436 (55.1%) patients had no, slight and noticeable IPP, respectively. Generally, prostate specific antigen (PSA), Gleason score and pT stage increased with IPP grade. In particular, cases with grade 0 IPP had a decreased proportion of seminal vesicles' involvement than those with grade 1 and grade 2 IPP (p=0.035). Reconstruction of the bladder neck (in robot-assisted group), increased surgical bleeding (>200ml), and prolonged postoperative hospital stays (>14 days) happened more in patients with grade 2 IPP. Blood transfusion only happened in patients with noticeable IPP. PSM of bladder neck was only associated with higher IPP grade in open surgery group (p=0.032), not in robot-assisted surgery group. IPP is associated with cancer aggressiveness, surgery difficulty and PSM of bladder neck in prostate cancer. Assessment of it provides more information for operations.
PubMed: 37781077
DOI: 10.7150/jca.86582 -
International Wound Journal Jan 2024In this article, we analysed the therapeutic efficacy of open radical prostatectomy (ORP) and minimally invasive surgery (MIS) after operation for the treatment of... (Meta-Analysis)
Meta-Analysis
In this article, we analysed the therapeutic efficacy of open radical prostatectomy (ORP) and minimally invasive surgery (MIS) after operation for the treatment of post-operation complications. In summary, because of the broad methodology of the available trials and the low number of trials, the data were limited. The investigators combined the results of six of the 211 original studies. We looked up 4 databases: PubMed, EMBASE, Web of Science and the Cochrane Library. A total of six publications were selected. The main result was the rate of post-operation wound complications. Secondary results were the time of operation and the duration of hospitalization. Our findings indicate that the minimal invasive operation can decrease the incidence of wound infections (OR, 0.61; 95% CI: 0.42,0.90, p = 0.01), bleeding (MD, -293.09; 95% CI: -431.48, -154.71, p < 0.0001), and length of stay in the hospital compared with open surgery (MD, -1.85; 95% CI: -3.52, -0.17, p = 0.03), but minimally invasive surgery increased patient operative time (MD, 51.45; 95% CI: 40.99, 61.92, p < 0.0001). Compared with the open operation, the microinvasive operation has the superiority in the treatment of the wound complications following the operation of radical prostatic carcinoma. But the operation time of the microinvasive operation is much longer. Furthermore, there is a certain amount of bias among the various studies, so it is important to be cautious in interpretation of the findings.
Topics: Humans; Male; Minimally Invasive Surgical Procedures; Postoperative Complications; Prostate; Prostatectomy; Treatment Outcome
PubMed: 37706271
DOI: 10.1111/iwj.14367