No abstract

Background A barrier to the uptake of robotic-assisted surgery (RAS) continues to be the perceived high costs. A lack of detailed costing information has made it difficult for public hospitals in particular to determine whether use of the technology is justified. This study aims to provide a detailed description of the patient episode costs and the contribution of RAS specific costs for multiple specialties in the public sector. Methods A retrospective descriptive costing review of all RAS cases undertaken at a large public tertiary referral hospital in Sydney, Australia from August 2016 to December 2018 was completed. This included RAS cases within benign gynaecology, cardiothoracic, colorectal and urology, with the total costs described utilizing various inpatient costing data, and RAS specific implementation, maintenance and consumable costs. Results Of 211 RAS patients, substantial variation was found between specialties with the overall median cost per patient being $19,269 (Interquartile range (IQR): $15,445 to $32,199). The RAS specific costs were $8828 (46%) made up of fixed costs including $4691 (24%) implementation and $2290 (12%) maintenance, both of which are volume dependent; and $1848 (10%) RAS consumable costs. This was in the context of 37% robotic theatre utilisation. Conclusions There is considerable variation across surgical specialties for the cost of RAS. It is important to highlight the different cost components and drivers associated with a RAS program including its dependence on volume and how it fits within funding systems in the public sector.

Study Type – Prognosis (case series)
Level of Evidence 4 OBJECTIVE To investigate the effect of prostate‐specific antigen (PSA) testing on stage migration in an Australian population, and its consequences on the prognostic accuracy of the post‐radical prostatectomy (RP) Kattan nomogram, as in North America widespread PSA testing has resulted in prostate cancer stage migration, questioning the utility of prognostic nomograms in this setting. PATIENTS AND METHODS The study comprised 1008 men who had consecutive RP for localized prostate cancer between 1991 and 2001 at one institution. Two groups were assessed, i.e. those treated in 1991–96 (group 1, the early PSA era), and 1997–2001 (group 2, the contemporary PSA era). Differences in clinicopathological features between the groups were analysed by chi‐squared testing and survival modelling. Individual patient data were entered into the post‐RP Kattan nomogram and the efficacy assessed by receiver‐ operating characteristic curve analysis. RESULTS Patients in group 2 had lower pathological stage disease (P = 0.01) and fewer cancers with Gleason score ≥8 (P < 0.001) than group 1. Multivariate analysis identified preoperative serum PSA level (P < 0.01) and Gleason score (P < 0.01) as strong predictors of biochemical relapse in both groups. In group 2 pathological stage was not significant, but margin involvement became highly significant (P = 0.004). There was no difference in the predictive accuracy of the Kattan nomogram between the groups (P = 0.253). CONCLUSIONS These findings show a downward stage migration towards organ‐confined disease after the introduction of widespread PSA testing in an Australian cohort. Despite this, the Kattan nomogram remains a robust prognostic tool in clinical practice.

No abstract

No abstract

IntroductionDespite the development of new therapies for advanced prostate cancer, it remains the most common cause of cancer and the second leading cause of cancer death in men. It is critical to develop novel agents for the treatment of prostate cancer, particularly those that target aspects of androgen receptor (AR) signalling or prostate biology other than inhibition of androgen synthesis or AR binding. Neoadjuvant pharmacodynamic studies allow for a rational approach to the decisions regarding which targeted therapies should progress to phase II/III trials. CDK4/6 inhibitors have evidence of efficacy in breast cancer, and have been shown to have activity in preclinical models of hormone sensitive and castrate resistant prostate cancer. The LEEP trial aims to assess the pharmacodynamic effects of LEE011 (ribociclib), an orally bioavailable and highly selective CDK4/6 inhibitor, in men undergoing radical prostatectomy for high-risk, localised prostate cancer.Methods and analysisThe multicentre randomised, controlled 4:1 two-arm, phase II, open label pharmacodynamic study will recruit 47 men with high risk, localised prostate cancer who are planned to undergo radical prostatectomy. Participants who are randomised to receive the study treatment will be treated with LEE011 400 mg daily for 21 days for one cycle. The primary endpoint is the frequency of a 50% reduction in Ki-67 proliferation index from the pretreatment prostate biopsy compared to that present in prostate cancer tissue from radical prostatectomy. Secondary and tertiary endpoints include pharmacodynamic assessment of CDK4/6 cell cycle progression via E2F levels, apoptotic cell death by cleaved caspase-3, changes in serum and tumour levels of Prostate Specific Antigen (PSA), pathological regression, safety via incidence of adverse events and exploratory biomarker analysis.Ethics and disseminationThe protocol was approved by a central ethics review committee (St Vincent’s Hospital HREC) for all participating sites (HREC/17/SVH/294). Results will be disseminated in peer-reviewed journals and at scientific conferences.Drug supplyNovartis.Protocol version2.0, 30 May 2019Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618000354280).

To assess baseline clinical and urodynamic profiles of a contemporary cohort of men undergoing radical prostatectomy as part of the ROSE study. Methods: Men with localised prostate cancer undergoing radical prostatectomy were prospectively recruited to undergo clinical assessment and urodynamic testing prior to surgery as part of a clinical trial. Results: 85 men with median age 64.5 years and median PSA 6.3 ng/ml were prospectively recruited. Of patients with complete baseline data, 36(50.7%), 28(39.4%) and 7(9.9%) had mild (IPSS <8), moderate (IPSS 8-19) and severe (IPSS>20) LUTS. Obstruction was identified in 18 (29.5%) men and 9 (14.8%) showed detrusor underactivity. Of 15 patients with detrusor overactivity, 12(80%) reported OAB. Of men with urodynamic obstruction, 5 (31.3%), 10(62.5%) and 1(6.3%) reported mild, moderate and severe LUTS. Of men without OAB, 4 (11.8%, p=0.002) showed filling phase abnormalities, 13 (46.4%, p=0.611) had flow rates < 15ml/s and 7 (30.4%, p=0.767) were obstructed. Of men with mild or absent LUTS, 5 (20%, p=0.072) were obstructed and 4 (16%, p=0.524) showed poor contractility. Conclusion: LUTS and OAB are common in men with localised prostate cancer undergoing radical prostatectomy. Detrusor overactivity and urodynamic filling phase abnormalities are strongly correlated with OAB. IPSS did not correlate well with bladder outflow obstruction or detrusor underactivity. Urodynamic filling abnormalities were found in 11.8% of men without OAB. Symptomatic and functional assessment may therefore have a role in the preoperative counselling of patients and possibly guide post-operative management of LUTS especially if OAB is present.

Objective• To evaluate the impact of laparoscopic sacrocolpopexy on symptoms, health-related quality of life (HRQL) and sexuality among women with symptomatic urogenital prolapse (UGP). Patients and Methods• A prospective analysis was carried out including 148 women with symptomatic UGP.• Baseline characteristics, medical and obstetric history were recorded.• The Pelvic Organ Prolapse Quantification (POP-Q) classification was used to stage the UGP. Validated tools were used to evaluate symptoms (Pelvic Floor Distress Inventory, PFDI-20) and HRQL (Pelvic Floor Impact Questionnaire, PFIQ-7). Sexual function was evaluated using the Pelvic organ prolapse urinary Incontinence Sexual Questionnaire (PISQ-12).• Measurements were recorded at the preoperative examination, then at 3 and 12 months after surgery. We compared the follow-up results with preoperative data. Results• The anatomical results at 3 months showed a significant correction (P < 0.05) relative to the preoperative values, on the three pelvic floor parameters measured, with a clinical relapse rate of 6.3%. This improvement remained significant after 12 months (P < 0.05). There was no difference between the results obtained at 3 months and those at 12 months.• At 3 months compared with the preoperative data, there was a significant improvement in PFDI-20 total mean score (32.24 vs 94.31, P < 0.05). At 12 months, the improvement remained significant (38.06 vs 94.31, P < 0.05) for all scores compared with the preoperative scores. Again, there was no difference between results at 3 months, and those at 12 months.• The results showed a significant improvement in the PFIQ-7 score at 3 (16.61 vs 64.04, P < 0.05) and 12 months (18.21 vs 64.04, P < 0.05). There was no significant difference between the scores at 3 months and those at 12months.• The total PISQ-12 score was linked significantly to urinary symptoms (P < 0.05), pelvic symptoms (P < 0.05) but not with ano-rectal ones.• At 3 months, the total mean PISQ-12 score had improved significantly compared with the preoperative score (35.42 vs 32.07, P < 0.05). At this time, only two items of the PISQ-12 questionnaire were significantly increased: 'existence of negative emotions during sexual activity' (P < 0.05) and 'the avoidance of sexual activity because of prolapse' (P < 0.05). The total mean score remained significantly improved at 12 months (36.56 vs 32.07, P < 0.05) and there was no statistical difference compared with the results at 3 months. Conclusions• Laparoscopic sacrocolpopexy resulted in the early improvement (primarily during the first 3 months) of all symptoms, HRQL and sexual function. This improvement was persistent in the medium term.• Symptoms linked with UGP had different effects on sexuality fields. • Anatomical improvement was not related to an improvement in all sexual fields.