In this paper, the use of north and south families of halo orbits, around the L
1 and L
2 collinear libration points of the Earth–Moon system, to realize a lunar global positioning system (LGPS) is ...proposed. The computation of the reference trajectories and the required station-keeping manoeuvres with the associated ΔV are described, as well as different configurations for the satellites’ constellation. The combination of the north and south families of halo orbits results in an X-shaped configuration allowing optimal performances. A visibility study, from different locations on the lunar surface, has been performed together with a performance analysis in terms of availability of the LGPS signal and quality of the position solution, resulting in a candidate architecture able to guarantee the availability of the LGPS service at the scientifically interesting lunar poles. In addition, the proposed constellations are also interesting from a connection point of view, assuring continuous communication capabilities between the Earth and every location on the surface of the Moon, as well as between any of the points on the ground.
Purpose
The conventional imaging flowchart for prostate cancer (PCa) staging may fail in correctly detecting lymph node metastases (LNM). Pelvic lymph node dissection (PLND) represents the only ...reliable method, although invasive. A new amino acid PET compound,
18
F-fluciclovine, was recently authorized in suspected PCa recurrence but not yet included in the standard staging work-up of primary PCa. A prospective monocentric study was designed to evaluate
18
F-fluciclovine PET/CT diagnostic performance for preoperative LN staging in primary high-risk PCa.
Methods
Consecutive patients (pts) with biopsy-proven PCa, standard staging (including
11
Ccholine PET/CT), eligible for PLND, were enrolled to undergo an investigational
18
F-fluciclovine PET/CT. Nodal uptake higher than surrounding background was reported by at least two readers (blinded to
11
Ccholine) using a visual 5-point scale (1–2 probably negative; 4–5 probably positive; 3 equivocal); SUVmax, target-to-background (aorta—A; bone marrow—BM) ratios (TBRs), were also calculated. PET results were validated with PLND.
18
F-fluciclovine PET/CT performance using visual score and semi-quantitative indexes was analyzed both per patient and per LN anatomical region, compared to conventional
11
Ccholine and clinical predictive factors (to note that diagnostic performance of
18
F-fluciclovine was explored for LNM but not examined for intrapelvic or extrapelvic M1 lesions).
Results
Overall, 94 pts underwent
18
F-fluciclovine PET/CT; 72/94 (77%) high-risk pts were included in the final analyses (22 pts excluded: 8 limited PLND; 3 intermediate-risk; 2 treated with radiotherapy; 4 found to be M1; 5 neoadjuvant hormonal therapy). Median LNM risk by Briganti nomogram was 19%. LNM confirmed on histology was 25% (18/72 pts). Overall, 1671 LN were retrieved; 45/1671 (3%) LNM detected. Per pt, median no. of removed LN was 22 (mean 23 ± 10; range 8–51), of LNM was 2 (mean 3 ± 2; range 1–10). Median LNM size was 5 mm (mean 5 ± 2.5; range 2–10). On patient-based analyses (n = 72), diagnostic performance for LNM resulted significant with
18
F-fluciclovine (AUC 0.66,
p
0.04; 50% sensitivity, 81% specificity, 47% PPV, 83% NPV, 74% accuracy), but not with
11
Ccholine (AUC 0.60,
p
0.2; 50%, 70%, 36%, 81%, and 65% respectively). Briganti nomogram (OR = 1.03,
p
= 0.04) and
18
F-fluciclovine visual score (≥ 4) (OR = 4.27,
p
= 0.02) resulted independent predictors of LNM at multivariable analyses. On region-based semi-quantitative analyses (n = 576), PET/CT performed better using TBR parameters (TBR-A similar to TBR-BM; TBR-A fluciclovine AUC 0.61,
p
0.35, vs choline AUC 0.57
p
0.54; TBR-BM fluciclovine AUC 0.61,
p
0.36, vs choline AUC 0.58,
p
0.52) rather than using absolute LN SUVmax (fluciclovine AUC 0.51,
p
0.91, vs choline AUC 0.51,
p
0.94). However, in all cases, diagnostic performance was not statistically significant for LNM detection, although slightly in favor of the experimental tracer
18
F-fluciclovine for each parameter. On the contrary, visual interpretation significantly outperformed PET semi-quantitative parameters (choline and fluciclovine: AUC 0.65 and 0.64 respectively;
p
0.03) and represents an independent predictive factor of LNM with both tracers, in particular
18
F-fluciclovine (OR = 8.70,
p
0.002, vs OR = 3.98,
p
= 0.03).
Conclusion
In high-risk primary PCa,
18
F-fluciclovine demonstrates some advantages compared with
11
Ccholine but sensitivity for metastatic LN detection is still inadequate compared to PLND. Visual (combined morphological and functional), compared to semi-quantitative assessment, is promising but relies mainly on readers’ experience rather than on unquestionable LN avidity.
Trial registration
EudraCT number: 2014–003,165-15
Purpose
Diagnosis of anterior prostate cancer (PCa) can be quite challenging, often leading to delay in treatment. mpMRI-guided biopsy (GB) has been introduced aiming to increase the number of ...diagnoses of clinically significant PCa with fewer cores. The aim of our study is to compare pathological findings of prostate biopsy, In-bore or Fusion technique, with histopathological evaluation of radical prostatectomy.
Methods
We prospectively collected data from 90 consecutive patients who underwent either In-bore or Fusion biopsy following the detection of an index suspicious lesion at mpMRI in the anterior part of the prostatic gland. Bioptical pathological findings were compared with pathological findings reported after robot-assisted radical prostatectomy.
Results
Patients who underwent In-bore GB had a higher rate of previous negative prostate biopsies (19% vs 44%,
p
= 0.02). Median number of bioptic cores taken (13 vs 2) and number of positive cores (3 vs 2) were significantly superior in the Fusion group compared to the In-bore group (
p
< 0.001 and
p
= 0.002, respectively), whilst clinical International Society of Urological Pathology (ISUP) grade was homogeneous within groups. The concordance between anterior lesions detected at biopsy and those reported in the histopathological finding of radical prostatectomy was very high, without statistically significant difference between groups.
Conclusion
Both Fusion and In-bore GB are accurate in detecting anterior PCa, with enhanced precision detecting clinically significant tumours, as evidenced by pathologic examinations which confirmed the presence of index anterior PCa in > 50% of patients overall. Additional sextant biopsy is still required, especially among biopsy-näive patients, to avoid missing clinically significant PCa.
Holmium laser has demonstrated high efficacy in urethral disobstruction. Venous air embolism (VAE) is a rare complication of prostate surgery. Only two cases of venous air embolism (VAE) in patients ...submitted to HoLEP, have been described. In this paper we show a third case of not fatal VAE after HoLEP.
A case of VAE occurred in holmium laser enucleation (HoLEP) due to obstructive lower urinary tract symptoms (LUTS) in a 70 years old patient. After the procedure, patient's end tidal carbon dioxide (ETCO2) levels dramatically decreased at 17 mmHg, with pressure airway (PAW)16 mmHg; oxygen saturation level was at 75%, without any loss in the ventilation circuit and with arterial blood pressure of 94/54 mmHg. Due to the negativity for other suspicions, the suspect of VAE was postulated.
The immediate switching from laryngeal mask to Oro Tracheal Intubation increased the oxygen level. A cardiac transthoracic ultrasound was negative for air bubbles inside cardiac cavities, without any alteration in the cardiac kinetics. Arterial blood sample turned negative for any alteration compatible with VAE and catheter continuous vesical irrigation was started to obtain clear washing fluid without blood cloths. The extubated patient showed no neurological defects.
An invasive monitoring system is the key to rapidly and correctly identify any embolic episode during this kind of surgery.
The Italian Radical Cystectomy Registry (RIC) is an observational prospective study aiming to understand clinical variables and patient characteristics associated with short- and long-term outcomes ...among bladder cancer (BC) patients undergoing radical cystectomy (RC). Moreover, it compares the effectiveness of three RC techniques - open, robotic, and laparoscopic.
From 2017 to 2020, 1400 patients were enrolled at one of the 28 centers across Italy. Patient characteristics, as well as preoperative, postoperative, and follow-up (3, 6, 12, and 24 months) clinical variables and outcomes were collected.
Preoperatively, it was found that patients undergoing robotic procedures were younger (p<.001) and more likely to have undergone preoperative neoadjuvant chemotherapy (p<.001) and BCG instillation (p<.001). Hypertension was the most common comorbidity among all patients (55%), and overall, patients undergoing open and laparoscopic RC had a higher Charlson Comorbidities Index (CCI) compared to robotic RC (p<.001). Finally, laparoscopic patients had a lower G-stage classification (p=.003) and open patients had a higher ASA score (p<.001).
The present study summarizes the characteristic of patients included in the RIC. Future results will provide invaluable information about outcomes among BC patients undergoing RC. This will inform physicians about the best techniques and course of care based on patient clinical factors and characteristics.
Combination therapy with 5 alpha-reductase inhibitor (5-ARI) and alpha-blocker can be considered as a gold standard intervention for medical management of lower urinary tract symptoms related to ...benign prostatic hyperplasia (LUTS/BPH). On the other hand, 5-ARI monotherapy and in particular Finasteride alone is currently getting focus of attention especially due to lack of systematic reviews investigating efficacy outcomes and/or adverse events associated.
Aim of the present critical review was to analyze current knowledge of clinical efficacy and incidence of adverse events associated with 5-ARI treatment for LUTS/BPH.
A systematic review of clinical trials of the literature of the past 20 years was performed using database from PubMed, Cochrane Collaboration and Embase. A total of 8821 patients were included in this study and inclusion criteria for studies selection were: data from randomized clinical trials (RCTs) focusing their attention on the clinical role of Finasteride monotherapy for symptomatic BPH. Parameters of research included prostate specific antigen (PSA), prostate volume (PV), International Prostate Symptom Score (IPPS), postvoid residual urine (PVR), voiding symptoms of IPSS (voiding IPSS), maximum urinary flow rate (Qmax), and adverse events (AEs).
Overall 12 original articles were included and critically evaluated. Sample sizes of patient actively treated with finasteride varied from 13 to 1524 cases analyzed in a single study. Follow-up after treatments ranged from 3 to 54 months. The effect of finasteride in reducing prostate volume (PV) was moderate (standardized mean difference (SMD) effect between 0.5 to 0.8 for all trials evaluable) while the effect on IPSS score and Qmax was considered significant (SMD in the 0.2 to 0.5 variation range). No severe AEs and/or psychiatric disorders were retrieved among the studies. Sexual health dysfunctions were significantly influenced by finasteride therapy when compared with placebo treated patients.
Although significant clinical benefits of finasteride monotherapy were demonstrated, the effective size of the available reports included in the analysis is limited. Additional head-to-head studies would be needed to re-evaluate clinical efficacy and safety of 5-ARI in combination or not with alpha blockers.
Purpose of our study was to investigate the role of a negative in-bore MRI-guided biopsy (MRI-GB) in comparison to a negative multiparametric prostate MRI (mpMRI) and a contextual negative ...transrectal ultrasound guided biopsy of the prostate with regard to incidental prostate cancer findings in the surgical specimen of men who underwent to Holmium Laser enucleation of prostate (HoLEP) with a preoperative suspicion of prostate cancer.
Data of 117 of symptomatic patients for bladder outflow obstruction who subsequently underwent to HoLEP was retrospectively analyzed form a multicentric database. All patients had a raised serum PSA and/or an abnormal digital rectal examination (DRE) with a pre-interventional mpMRI. Prostate cancer was excluded either with an en-bore MRI-GB (group "IN-BORE MRI-GB" n = 57) in case of a suspect area at the mpMRI or with a standard biopsy (group "mpMRI + TRUS-GB" n = 60) in case of a negative mpMRI. Preoperative characteristic surgical and histological outcomes were analyzed. Univariate and multivariate logistic regression model was performed to investigate independent predictors of incidental Prostate Cancer (iPCa).
Both groups presented moderate to severe lower tract urinary symptoms: median IPSS was 19 (IQR: 17.0-22.0) in the IN-BORE MRI-GB group and 20 (IQR: 17.5-22.0) in the mpMRI + TRUS-GB (p = 0.71). No statistically significant difference was found between the two groups besides total prostate volume with 68 cc (IQR: 58.0-97.0) in the IN-BORE MRI-GB group and 84 cc (IQR: 70.0-115.0) in the mpMRI + TRU-GB group (p = 0.01) No differences were registered in surgical time, removed tissue, catheterization time, hospital stay and complications rate. No different rates (p = 0.50) of iPCa were found in the IN-BORE MRI-GB group (14%) in comparison with mpMRI + TRUS-GB group (10 %); pT stage and ISUP Grade Group in iPCa stratification were comparable between the two groups. In multivariate analysis a statistically significant correlation with age as an independent predictive factor of iPCa was found (OR 1.14; 95% CI: 1.02-1.27; p = 0.02) while no correlations were revealed with PSA (OR 1.12; 95% CI: 0.99-1.28; p = 0.08) and a negative in-bore MRI-GB (OR 1.72; 95% CI: 0.51-5.77; p = 0.37).
Including a mpMRI and an eventual in-bore MRIGB represents a novel clinical approach before surgery in patients with symptomatic obstruction with a concomitant suspicion of PCa, leading to low rate of iPCa and avoiding unnecessary standard TRUS-GB biopsies.
Radical Cystectomy (RC) with ileal urinary diversion is one of the most complex urological surgical procedure, and many Fast Track (FT) protocols have been described to reduce hospitalization, ...without increasing postoperatory complications. We present the one-year results of a dedicated protocol developed at a high volume centre.
The FT protocol was designed after a review of the literature and a multidisciplinary collegiate discussion, and it was applied to patients scheduled to open RC with intestinal urinary diversion. To validate its feasibility, we compared its results with data collected from a 1:1 matched population of patients who had undergone the same surgical procedure, without the implementation of the FT protocol.
We enrolled in the FT group 11 (55%) patients scheduled to RC with ileal conduit diversion, and 9 patients (45%) scheduled to orthotopic neobladder (Studer) substitution, while a numerically equivalent population was enrolled in the control group, matched according to age at surgery, BMI, gender, ASA score, CCI, preoperative stage and type of urinary diversion. No statistically significant difference was found in terms of pre-operatory and intra-operatory domains. Median overall age was 71 years (Inter Quartile Range - IQR: 63-76) and mean operatory time was 276 ± 57 minutes. Hospitalization time was significantly reduced in the FT group, considering oralization and canalization items we found a significant advantage in the FT group. No statistically significant difference was found in the control of the post-operatory pain. We found no difference, in terms of both early and late complications ratio, among the two populations. Complications graded Clavien ≥ 3 were found in 4 patients of the control group (20%), while in only one patient (5%) in the Fast Track group, though this difference was not statistically significant.
The Fast Track protocol developed in this study has proven to be effective in significantly reducing hospitalization time in patients submitted to RC with intestinal urinary diversion, without increasing post-operatory complications ratio.
To evaluate the detection rate of prostate cancer (PCa) in patients who underwent to "in bore" Magnetic Resonance Imaging -guided prostate (MRI-GB) biopsy compared to the standard transrectal ...ultrasound guided prostate biopsy (TRUS-GB).
Between January 2017 and March 2015 a cohort of 39 consecutive patients was prospectively enrolled. All the patients underwent an "in-bore" guided MRI prostatic biopsy and subsequently ultrasound-guided standard prostate biopsy.
Median age of patients was 65.5 years (SD ± 6.6), median total PSA serum level was 6.6 ng/ml (SD ± 4.1), median prostate total volume was 51.1 cc (SD ± 26.7). Thirty of 39 (76.9%) were biopsy-naïve patients while 7/39 (17.9%) had at least one previous negative random TRUS-GB; 2/39 (5.1%) patients were already diagnosed as PCa and were on active surveillance. In 18/39 (53.8%) men Pca was diagnosed; as regards the MRI-GB results related to the PI-RADS score, biopsies of PIRADS 3 lesions were positive in 5/18 cases (27.8%), while the number of positive cases of PI-RADS 4 and 5 lesions was 7/11 (63.6%) and 6/10 (60%)respectively. At the histological examination, 4/39 (10.3%) had a PCa ISUP grade group 1, 11/39 (28.2%) had a ISUP 2, 6/39(15.4%) had a ISUP grade group 3 and 2/39 (5.1%) had a ISUP 4-5.
MRI-GB represents a promising technique that may offer some of advantages compared to standard systematic TRUSGB. Our preliminary experience in MRI-GB resulted safe and feasible and represents a viable procedure for the diagnosis and characterization of PCa.
To evaluate the detection rate of Magnetic Resonance Imaging/Transrectal Ultrasound (MRI/TRUS) Fusion Biopsy performed in a series of patients with suspicious prostate cancer in an ambulatory ...setting.
Between March 2018 and January 2019 a series of 155 patients undergoing MRI/TRUS fusionguided biopsy were prospectively enrolled. All patients presented a suspected diagnosis for prostate cancer because of raised Prostate Specific Antigen (PSA) serum level and/or abnormal physical examination (digital rectal examination), and showed at least one suspicious area at the multiparametric Magnetic Resonance Imaging (mpMRI).
Of 155 patients, 58 (37.4%) were biopsy-naïve, 97 (62.6%) had at least 1 previous negative TRUS-guided biopsy. The median age of the patient cohort was 66 years (IQR, 61- 69); the median prebiopsy PSA value was 7.1 ng/ml (IQR, 5- 8.9). Overall, the Fusion-TB findings were positive in 94 of 155 patients with a detection rate (DR) of 60%; a significantly high DR was obtained in terms of clinically significant prostate cancer (csPCa) by Fusion-TB (61 pts; 41.9%). The overall DR in the 121 biopsy-naive patients was 60.6%. In the subgroup of the 34 patients with at least 1 previous set of TRUS-GB, overall DR was 39.3% (35/50).
The targeted MRI/TRUS fusion-guided biopsy represents a safe and accurate approach for diagnosis of csPCa, especially in patient with previous TRUS guided biopsy negative and suspicious prostate cancer.