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BACKGROUND: Benign prostatic hyperplasia (BPH) is the most common urologic disease among elderly men. The diagnosis of BPH is usually driven by lower urinary tract symptoms (LUTS) that can significantly affect patients' quality of life. This phase II prospective, randomized double-blinded, placebo-controlled study aimed to determine the efficacy and safety of a novel whole tomato-based food supplement on LUTS of patients diagnosed with BPH. METHODS: Forty consecutive patients with histologically proved BPH were randomized 1:1 to receive daily for 2 months a sachet (5 g) of a newly developed whole tomato food supplement (WTFS) (treatment = Group A) or placebo (Group B). Patients were asked to fill the International Prostatic Symptom Score (IPSS) questionnaire before and after treatment. RESULTS: All but 1 patient in Group B successfully completed the scheduled regimen. No side effects were recorded. Unlike placebo, treatment significantly reduced (P < 0.0002) LUTS since mean IPSS decreased from 9.05 ± 1.15 to 7.15 ± 1.04 (paired t-test, two-tailed P-value < 0.001), and improved life quality (P < 0.0001). A trend toward a reduction of total PSA levels was observed in WTFS treated patients (8.98 ng/mL ± 1.52 vs 6.95 ± 0.76, P = 0.065), with changes being statistically significant only in the subgroup of patients with baseline levels above 10 ng/mL (18.5 ng/mL ± 2.7 vs 10.3 ± 2.1, P = 0.009). CONCLUSIONS: The new WTFS may represent a valid option for the treatment of symptomatic BPH patients. Unlike pharmacological treatments, the supplement is side effects free and highly accepted among patients.
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Hiperplasia Prostática , Solanum lycopersicum , Sistema Urinario , Anciano , Suplementos Dietéticos , Humanos , Hiperplasia , Masculino , Estudios Prospectivos , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/tratamiento farmacológico , Calidad de Vida , Resultado del TratamientoRESUMEN
Purpose: Prostate cryoablation has been proposed as an alternative to radical prostatectomy for men with localized prostate cancer (PCa); however, it is limited by the lack of data regarding oncological outcomes and the impossibility of performing a lymph node dissection. The aim of this study was to assess if whole-gland cryoablation is oncologically safe, especially for patients in whom pelvic lymph node dissection would be necessary. Materials and Methods: After institutional review board approval, we identified 102 patients who underwent whole-gland prostate cryoablation between 2013 and April 2019. Lymph node invasion (LNI) probability was computed using Briganti nomogram, and a 5% cutoff probability was used to stratify the population in two groups. Biochemical recurrence after procedure was assessed using Phoenix criteria. Multiparametric magnetic resonance imaging, (CT), and bone scan or choline positron-emission tomography/CT were performed for the detection of distant metastases. Results: Seventeen (17%) patients were treated for a low-risk PCa, 48 (47%) patients were at intermediate-risk PCa, and 37 (36%) patients were at high-risk PCa. Patients with a probability of LNI >5% (n = 46) exhibited higher prostate-specific antigen (PSA), PSA density, ISUP Grade Group, CT stage, and european association of urology (EAU) risk. Recurrence-free survival rates at 3 years' follow-up were 93%, 82%, and 72%, respectively for low-, intermediate-, and high-risk patients. At a median follow-up of 37 months (17-62), additional treatment and metastasis-free survival were 84% and 97%, respectively. No differences in oncological outcomes were found in patients with a probability of LNI above and below 5%. Conclusions: Prostate whole-gland cryoablation can be considered a safe procedure with acceptable outcomes in low- and intermediate-risk patients. A high preoperative risk of nodal involvement could not be considered an exclusion criterion to perform cryoablation. Further studies are required.
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PURPOSE: To evaluate oncological outcomes of partial gland cryoablation (PGC) for localized prostate cancer (PCa) in a cohort of elderly patients who required an active treatment. METHODS: Data from 110 consecutive patients treated with PGC for localized PCa were collected. All patients underwent the same standardized follow-up with serum-PSA level and digital rectal examination. Prostate MRI and eventual re-biopsy were performed at twelve months after cryotherapy or in case of suspicion of recurrence. Biochemical recurrence was defined according to Phoenix criteria (PSA nadir + 2 ng/ml). Kaplan-Meier curves and Multivariable Cox Regression analyses were used to predict disease progression, biochemical recurrence- (BCS) and additional treatment-free survival (TFS). RESULTS: Median age was 75 years (IQR 70-79). PGC was performed in 54 (49.1%) patients with low-risk PCa, 42 (38.1%) with intermediate risk and 14 (12.8%) high risk. At a median follow-up of 36 months, we recorded a BCS and TFS of 75 and 81%, respectively. At 5 years, BCS was 68.5% and CRS 71.5%. High-risk prostate cancer was associated with lower TFS and BCS curves when compared with low-risk group (all p values < .03). A PSA reduction < 50% between preoperative level and nadir resulted as an independent failure predictor for all outcomes evaluated (all p values < .01). Age was not associated with worse outcomes. CONCLUSIONS: PGC could be a valid treatment for low- to intermediate PCa in elderly patients, when a curative approach is suitable in terms of life expectancy and quality of life.
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Criocirugía , Neoplasias de la Próstata , Masculino , Humanos , Anciano , Criocirugía/métodos , Antígeno Prostático Específico , Resultado del Tratamiento , Calidad de Vida , Neoplasias de la Próstata/patología , Recurrencia Local de Neoplasia/etiologíaRESUMEN
INTRODUCTION: The aim of this article was to determine the impact of bioptic prostatic inflammation (PI) on the false positive rate of multiparametric magnetic resonance imaging (mp-MRI) in detecting clinically significant prostate ancer (csPCa). MATERIAL AND METHODS: Our prostate biopsy database was queried to identify patients who underwent mp-MRI before PB at our institution. A dedicated uropathologist prospectively assessed bioptic PI using the Irani scores. We evaluated the association between mp-MRI findings, bioptic Gleason grade (GG) and aggressiveness of PI, and PCa detection. RESULTS: In total, 366 men were included. In patients with Prostate Imaging Reporting and Data System (PIRADS) 4-5 lesions, the csPCa (GG ≥2) rate was significantly higher in those with low-grade than in those with high-grade PI (36% vs 29.7%; p = 0.002), and in those with low-aggressive than in those with high-aggressive PI (37.7% vs 30.1%; p = 0.0003). The false positive rates of PIRADS 4-5 lesions for any PCa were 34.2% and 57.8% for low- and high-grade PI, respectively (p = 0.002); similarly, they were 29.5% and 59.4% for mildly and highly-aggressive PI (p = 0.0003). Potential study limitations include its retrospective analysis and single-center study and lack of assessment of the type of PI. CONCLUSIONS: Bioptic PI directly correlates with false positive rates of mp-MRI in detecting csPCa. Clinicians should be aware that PI remains the most common pitfall of mp-MRI.
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BACKGROUND: Today, the goal of surgery is to achieve oncological efficacy with the lowest complication rate. Computed Tomography (CT)-guided cryoablation is proposed as a safe and effective technique. We report, our series of small renal masses treated with cryoablation in elderly (> 70 years). METHODS: From May 2014 to April 2019, 32 patients with median (IQR) age of 75.5 years (range 71-80) with small renal masses (< T1a) diagnosis, clinical anesthesia contraindications to nephron-sparing surgery or patient's will previous informed consent have been selected at our Urology Department. All patients underwent CT-guided cryoablation, preceded by needle biopsy. The cryoablation consisted in a procedure with an argon/helium gas-based system under local anesthesia. The follow-up included CT abdomen at 3, 6 and 12 months. The definition of incomplete treatment was the persistence of the lesion contrast enhancement (CE) at the end of the scan; the definition of relapse was the appearance of the CE to the 6-month control CT. RESULTS: The median follow-up was 30 months (IQR 1-59). The median size of the tumor was 3.85 cm (IQR 1.6-4.5). All patients underwent lesion biopsy resulting in diagnosis of Renal Cell Carcinoma (RCC) in 29 patients (90.7%) and oncocytoma in 3 patients (9.3%). A median of 2 cryoprobes (IQR 1- 3) was used and 2/3 cycles of freeze-thaw of the duration of 10 minutes or 5 minutes were performed. Complications were: 3 asymptomatic transitional perirenal effusion, 2 lumbar pain well-controlled by analgesic drug. Hospital stay was 2 days (range 1-3). No case showed incomplete treatment and local relapse or metastates at the CT abdomen-pelvis with contrast medium at 12 months. CONCLUSIONS: This study shows the efficacy and safety of percutaneous cryoablation of small renal masses in elderly population. The procedure is easy to perform, with low complication rates and well tolerated by the elderly patients.
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Carcinoma de Células Renales/terapia , Criocirugía/métodos , Neoplasias Renales/terapia , Cirugía Asistida por Computador , Tomografía Computarizada por Rayos X , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Procedimientos Quirúrgicos Mínimamente Invasivos , Estudios RetrospectivosRESUMEN
BACKGROUND: European Association of Urology (EAU) guidelines recommend using risk-calculators (RCs), imaging or additional biomarkers in asymptomatic men at risk of prostate cancer (PCa). OBJECTIVES: To compare the performance of mpMRI, a RC we recently developed and two commonly used RC not including mpMRI in predicting the risk of PCa, as well as the added value of mpMRI to each RC. DESIGN SETTING AND PARTICIPANTS: Single-center retrospective study evaluating 221 biopsy-naïve patients who underwent prebiopsy mpMRI. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Patients' probabilities of any PCa and clinically significant PCa (csPC, defined as Gleason-Score ≥3 + 4) were computed according to mpMRI, European Randomized Study of Screening for Prostate Cancer RC (ERSPC-RC), the Prostate Biopsy Collaborative Group RC (PBCG-RC) and the Foggia Prostate Cancer RC (FPC-RC). Logistic regression, AUC, and Decision curve analysis (DCA) were used to assess the accuracy of tested models. RESULTS AND LIMITATION: The FPC-RC outperformed mpMRI in diagnosing both any PCa (AUC 0.76 vs 0.69) and csPCa (AUC 0.80 vs 0.75). Conversely mpMRI showed a higher accuracy in predicting any PCa compared to the PBCG-RC and the ERSPC-RC but similar performances in predicting csPCa. At multivariable analysis predicting csPCa and any PCa, the addition of mpMRI findings improved the accuracy of each calculator. DCA showed that the FPC-RC provided a greater net benefit than mpMRI and the other RCs. The addition of mpMRI findings improved the net benefit provided by each calculator. CONCLUSIONS: mpMRI was outperformed by the novel FPC-RC and showed similar performances compared to the PBCG and ERSPC RCs in predicting csPCa. The addition of mpMRI findings improved the diagnostic accuracy of each of these calculators.
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PURPOSE: To determine the potential role of bioptic inflammation (Irani score) in predicting adverse pathology (AP) at radical prostatectomy (RP) in patients with low-grade (ISUP Gleason Group [ISUP GG] 1 and 2) prostate cancer (CaP). METHODS: After institutional review board-approval, we identified patients who underwent prostate biopsy, had bioptic Irani score assessment, were diagnosed with low-grade CaP (ISUP GG 1-2, prostate-specific antigen [PSA] <20 ng/ml), and underwent RP. The impact of standard clinicopathological variables and bioptic Irani Score (Gâ¯=â¯grade and Aâ¯=â¯aggressiveness) on AP at RP, defined as stage ≥T3 and/or ISUP GG ≥3, was assessed by univariate and multivariate logistic regression analysis. RESULTS: A total of 282 patients were eligible for this study. AP at RP occurred in 37 of 214 (17.3%) patients with ISUP GG 1, and 26 of 68 (38.2%) with ISUP GG 2. At univariate analysis, serum PSA, PSA density, bioptic ISUP GG, number of positive cores, total percentage of core involvement and Irani G score emerged as significant risk factors of AP. At multivariate analysis, however, only PSA density, bioptic ISUP GG, total percentage of core, and Irani G score kept statistical significance. The area under the curve for the resulting model was 0.75. CONCLUSIONS: This is the first study demonstrating that low-grade inflammation is associated with a significantly increased risk of AP at RP. These findings would support the concept of prostatic inflammation being inversely correlated with presence and aggressiveness of CaP. Further studies are needed to externally validate the role of this readily available parameter in the decision-making process of patients with low-grade CaP.