Prostate Cancer Outcomes Registry-Victoria Research Articles

Bayesian Spatio-Temporal Multilevel Modelling of Patient-Reported Quality of Life following Prostate Cancer Surgery.

Globally, prostate cancer is the second leading cause of cancer deaths among males. It is the most commonly diagnosed cancer in Australia. The quality of life of prostate cancer patients is poorer when compared to the general population due to the disease itself and its related complications. However, there is limited research on the geographic pattern of quality of life and its risk factors in Victoria. Therefore, an examination of the spatio-temporal pattern and risk factors of poor quality of life, along with the impact of spatial weight matrices on estimates and model performance, was conducted. A retrospective study was undertaken based on the Prostate Cancer Outcome Registry-Victoria data. Patient data (n = 5238) were extracted from the Prostate Cancer Outcome Registry, a population-based clinical quality outcome assessment from 2015 to 2021. A Bayesian spatio-temporal multilevel model was fitted to identify risk factors for poor quality of life. This study also evaluated the impact of distance- and adjacency-based spatial weight matrices. Model convergence was assessed using Gelman-Rubin statistical plots, and model comparison was based on the Watanabe-Akaike Information Criterion. A total of 1906 (36.38%) prostate cancer patients who had undergone surgery experienced poor quality of life in our study. Belonging to the age group between 76 and 85 years (adjusted odds ratio (AOR) = 2.90, 95% credible interval (CrI): 1.39, 2.08), having a prostate-specific antigen level between 10.1 and 20.0 (AOR = 1.33, 95% CrI: 1.12, 1.58), and being treated in a public hospital (AOR = 1.35, 95% CrI: 1.17, 1.53) were significantly associated with higher odds of poor quality of life. Conversely, residing in highly accessible areas (AOR = 0.60, 95% CrI: 0.38, 0.94) was significantly associated with lower odds of poor prostate-specific antigen levels. Variations in estimates and model performance were observed depending on the choice of spatial weight matrices. Belonging to an older age group, having a high prostate-specific antigen level, receiving treatment in public hospitals, and remoteness were statistically significant factors linked to poor quality of life. Substantial spatio-temporal variations in poor quality of life were observed in Victoria across local government areas. The distance-based weight matrix performed better than the adjacency-based matrix. This research finding highlights the need to reduce geographical disparities in quality of life. The statistical methods developed in this study may also be useful to apply to other population-based clinical registry settings.

Population-based patient-reported quality of life outcomes following low-dose-rate versus high-dose-rate brachytherapy monotherapy for low-intermediate risk prostate cancer.

To evaluate patient reported quality of life outcomes (QoL) following low-dose-rate brachytherapy (LDR-BT) and high-dose-rate brachytherapy (HDR-BT) monotherapy for prostate cancer at a population-based setting. The study comprised men with low-intermediate risk prostate cancer in the Prostate Cancer Outcomes Registry Victoria (PCOR-Vic), who were treated with LDR-BT or HDR-BT monotherapy between 2015 and 2020 and completed the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire 12-month post-treatment. Men who had ADT were excluded (n = 12). Differences in substantial symptoms (i.e. 'moderate' or 'big' problem on a 5-point Likert scale) between LDR-BT and HDR-BT arms were evaluated using Pearson's chi-squared test. Multivariable linear regressions were used to estimate differences in EPIC-26 urinary, bowel and sexual functional domain scores between LDR-BT and HDR-BT arms. Overall, 198 men were included in this study, of which 167 (84%) had LDR-BT and 31 (16%) had HDR-BT. 9 (4.6%), 10 (5.1%) and 56 (28%) reported substantial symptoms for overall urinary, bowel and sexual function at 12-month post-treatment, with no significant difference between LDR-BT and HDR-BT arms. The adjusted mean differences in urinary incontinence, urinary obstructive, bowel and sexual function domain scores between LDR-BT and HDT-BT were: -3.53 (-8.21 to 1.14), -1.27 (-6.88 to 4.35), -0.01 (-5.63 to 5.63) and -8.68 (-21.44 to 4.07) respectively - these were not statistically significant and did not meet the minimal clinically important difference. This is the first Australian population-based study comparing QoL in men who had LDR-BT and HDR-BT, with no statistically or clinically significant differences in QoL observed at 12-month post-treatment.

Predictors of real-world utilisation of docetaxel combined with androgen deprivation therapy in metastatic hormone-sensitive prostate cancer.

Docetaxel has emerged as a standard-of-care for metastatic hormone-sensitive prostate cancer (mHSPC). Uptake of docetaxel for mHSPC in Australia has not previously been reported. To investigate the real-world uptake of docetaxel in mHSPC and to identify predictors of utilisation of docetaxel in mHSPC. Men diagnosed from June 2014 to December 2018 and enrolled in the Prostate Cancer Outcomes Registry-Victoria (PCOR-Vic) were included. Data collected include demographics, diagnosis method and institution, staging investigations and treatments within 12 months of diagnosis. Wilcoxon rank-sum, Chi-squared and trend tests were used to identify predictors of docetaxel utilisation. All predictors were entered as covariates simultaneously into a multivariable logistic regression model. Statistical significance was set at 0.05 (two sided). In all, 1014 men with mHSPC were analysed, 25% of whom received docetaxel with androgen deprivation therapy. Uptake of docetaxel increased from 20% in 2014 to 33% in 2018. Predictors of higher usage of docetaxel were younger age and treatment in a private hospital, with both remaining significant on multivariable analysis. Notably, the proportion of men aged <70 years receiving docetaxel increased from 54% in 2014-2015 to 64% in 2016-2018, while in men aged ≥70 years the comparative figures were 15% and 22% respectively. Although docetaxel was not used in the majority of cases, there was a clear increase in docetaxel uptake, especially in younger men following publication of the CHAARTED and STAMPEDE trials. Identifying barriers to real-world implementation of pivotal clinical trial data is critical to improving outcomes in mHSPC.

Comparison of urinary and sexual patient-reported outcomes between open radical prostatectomy and robot-assisted radical prostatectomy: a propensity score matched, population-based study in Victoria

BackgroundRobot-assisted radical prostatectomy (RARP) rates have been increasing worldwide despite a lack of evidence of superior patient-reported outcomes (PROs) compared to open radical prostatectomy (ORP).MethodsThis retrospective study included men who contributed data to the Prostate Cancer Outcomes Registry-Victoria (PCOR-Vic), underwent ORP or RARP between January 2014 and May 2018, and completed the EPIC-26 questionnaire 12 months post-surgery. Urinary and sexual bother items, the urinary incontinence domain score, the urinary irritative/obstructive domain score, the sexual domain score and the pad usage item from the EPIC-26 questionnaire were compared between the two cohorts. Unmatched and propensity score matched cohorts were used to determine if there were differences in urinary and sexual PROs between ORP and RARP after accounting for the patient case-mix and surgeon characteristics.ResultsOf 3826 patients undergoing radical prostatectomy (RP), 1047 received ORP and 2779 received RARP. Propensity score matching reduced the magnitude of the observed differences in four out of six outcomes (urinary bother, urinary incontinence domain, pad usage and sexual domain). Using a propensity score matched cohort, there were no statistically significant differences for RARP patients, compared to ORP patients, in terms of urinary bother (Rd = 0.47%, P = 0.707), urinary incontinence domain scores (Coeff = − 0.84, P = 0.506), urinary irritative/obstructive domain scores (Coeff = 1.03, P = 0.105), pad usage (Rd = − 0.75%, P = 0.771) and sexual bother (Rd = − 0.89%, P = 0.731). RARP patients had slightly higher sexual domain scores (Coeff = 3.65, P = 0.005).ConclusionThere were no differences in urinary PROs between ORP and RARP when assessed 12 months post-surgery. The sexual domain slightly favoured RARP, however this was not deemed clinically significant.

Impact of delay from transperineal biopsy to radical prostatectomy upon objective measures of cancer control

ObjectiveTreatment delays in prostate cancer have been characterised, although not explicitly in men undergoing transperineal prostate biopsies. We aimed to determine if delays to radical prostatectomy correlate with adverse outcomes using a contemporary population-based cohort of men diagnosed by transperineal biopsies. MethodsThis study analysed men with prostate cancer of the International Society for Urological Pathology grade group ≥2, diagnosed by transperineal prostate biopsies who underwent prostatectomy, using the prospectively data from 1 January 2014 to 30 June 2018 Prostate Cancer Outcomes Registry-Victoria. Data were analysed according to stratified demographic and disease characteristics. Time intervals from biopsy (28, 60, 90, 120, and 270 days) were compared using odds ratios and regression analyses for proportion of upgrading, early biochemical recurrence, pT3 disease at prostatectomy, and positive surgical margins. ResultsIn total, 2008 men were analysed. There were 306 (16.7%) men with upgrading, 151 (8.4%) with biochemical recurrence, 1068 (54.1%) with pT3 disease, and 464 (23.1%) with positive surgical margins (percentages excluded patients with missing data). All adverse outcomes studied were significantly associated with higher prostate-specific antigen and grade at diagnosis. Delays of 120–270 days did not adversely alter the incidence of Gleason upgrading, pT3, or recurrence. Delays (most frequent 60–89 days, 28%) were associated with positive surgical margins but not monotonically. Regression modelling demonstrated no increased likelihood of most adverse outcomes for up to 270 days. ConclusionMen with prostate cancer of grade group ≥2 diagnosed through transperineal biopsy may wait up to 270 days for a prostatectomy without a greater likelihood of upgrading, pT3 disease, positive surgical margins, or biochemical recurrence.

Mapping geographical disparities in population-level patient-reported quality of life following prostate cancer management.

e18531 Background: Prostate cancer patients generally have good survival outcomes, but some survivors have poor functional outcomes with persisting symptoms and poor quality of life (QoL). Socio-economic status (SES), access to specialist care and place of residence (including rural, remote areas) are associated with poor survival. These variables may also impact survivorship outcomes, including QoL. This study aimed to identify and visualise geographical disparities in QoL outcomes for prostate cancer survivors. Methods: We extracted complete data for 7690 patients, including patient-reported EPIC-26 QoL questionnaire results (12 months post-treatment), from the Prostate Cancer Outcomes Registry–Victoria (PCOR-VIC), a population-based clinical quality outcomes registry. Patient-matched geographic coordinates were obtained through the Victorian Cancer Registry. Scores from each of the 5 EPIC-26 functional domains were visualised using geospatial maps and correlated to the Index of Relative Socio-economic Advantage and Disadvantage (IRSAD) and geographical remoteness. A composite score condensing all 5 domains into a single number (range 5 – 20) was created for succinct visualisation of functional outcomes. We analysed hotspots using the Getis-Ord Gi* statistic. Results: Scores in all 5 functional domains were positively correlated to IRSAD, which remained an independent predictor of low functional score when controlling for age, disease stage, treatment modality and geographical remoteness (p &lt; 0.001 for all). Geographical remoteness predicted low functional score in all domains (p &lt; 0.05) except Urinary Irritative but was not statistically significant when adjusted for IRSAD. The constructed composite score was significantly correlated to IRSAD and remoteness in a univariate model (p &lt; 0.001). In a multivariate model, remoteness was not an independent predictor of outcome, but the composite score rose by 0.13 for each IRSAD decile (p &lt; 0.001), with patients in the bottom decile of IRSAD more likely to have composite scores below median ( &lt; 14) than those in the top decile (OR 1.8 CI 1.4-2.2 p &lt; 0.001). The composite score allowed visualisation of functional outcomes in a single figure and identification of geographic hotspots with poor outcome. Conclusions: Systematic collection of long-term patient-reported outcomes is feasible. Geographical disparities in QoL outcome following prostate cancer treatment correlated with SES and remoteness, and we note the relative importance of SES over remoteness. A single composite score for EPIC-26 showed face-validity. Our results will allow targeted efforts to further understand the drivers of these findings and improve equity in survivorship outcomes for prostate cancer survivors. The methods developed in this study can be extended and re-deployed to evaluate outcomes in other jurisdictions and cancer types.

Patterns of primary staging for newly diagnosed prostate cancer in the era of prostate specific membrane antigen positron emission tomography: A population-based analysis.

There has been a growing body of evidence highlighting the improved sensitivity and specificity for prostate specific membrane antigen (PSMA) positron emission tomography (PET) in advanced prostate cancer imaging. We aimed to assess prostate cancer staging practice patterns in Australia using population-based data. We extracted data on men diagnosed with prostate cancer between October 2016 and December 2018 from the Prostate Cancer Outcomes Registry-Victoria (PCOR-Vic). We evaluated trends and comparisons between patients receiving PET/CT (with or without conventional imaging (CImg)), and CImg alone, and analysed imaging modality as predictor of clinical regional node positive disease (cN1 vs cN0/X), metastatic disease (cM1 vs cM0/X), and treatment received. In total, 6139 patients in the registry had either a staging PET scan (n=889, 14%), CImg without PET scan (n=2464, 40%), or no recorded PET or CImg (n=2786, 45%). The proportion of allimaged patients who received staging PET increased from 19% to 36% from the first to last three-month period, and in the high-risk category the increase was 23-43%. After adjustment for grade group, PET vs CImg-only patients were observed to have a higher proportion of cN1 disease (OR=2.46, 95% CI: 1.90-3.20) but not cM1 disease (OR=1.10, 95% CI: 0.84-1.44). Our registry data highlights the rapid uptake of PET imaging, particularly in high-risk disease. Based on this data, we highlight the increased diagnosis of nodal disease, thus potentially optimizing patient selection prior to definitive treatment for prostate cancer.

(Dis)concordance of comorbidity data and cancer status across administrative datasets, medical charts, and self-reports

BackgroundBenchmarking outcomes across settings commonly requires risk-adjustment for co-morbidities that must be derived from extant sources that were designed for other purposes. A question arises as to the extent to which differing available sources for health data will be concordant when inferring the type and severity of co-morbidities, how close are these to the “truth”. We studied the level of concordance for same-patient comorbidity data extracted from administrative data (coded from International Classification of Diseases, Australian modification,10th edition [ICD-10 AM]), from the medical chart audit, and data self-reported by men with prostate cancer who had undergone a radical prostatectomy.MethodsWe included six hospitals (5 public and 1 private) contributing to the Prostate Cancer Outcomes Registry-Victoria (PCOR-Vic) in the study. Eligible patients from the PCOR-Vic underwent a radical prostatectomy between January 2017 and April 2018.Health Information Manager’s in each hospital, provided each patient’s associated administrative ICD-10 AM comorbidity codes. Medical charts were reviewed to extract comorbidity data. The self-reported comorbidity questionnaire (SCQ) was distributed through PCOR-Vic to eligible men.ResultsThe percentage agreement between the administrative data, medical charts and self-reports ranged from 92 to 99% in the 122 patients from the 217 eligible participants who responded to the questionnaire. The presence of comorbidities showed a poor level of agreement between data sources.ConclusionRelying on a single data source to generate comorbidity indices for risk-modelling purposes may fail to capture the reality of a patient’s disease profile. There does not appear to be a ‘gold-standard’ data source for the collection of data on comorbidities.

Trends in Conservative Management for Low-risk Prostate Cancer in a Population-based Cohort of Australian Men Diagnosed Between 2009 and 2016

Conservative management, specifically with active surveillance (AS), has emerged as the preferred approach for low-risk prostate cancer (LRPC). We evaluated the trend for conservative management (ie, no active treatment within 12mo of diagnosis) for LRPC in an Australian population-based cohort of men captured in the Prostate Cancer Outcomes Registry Victoria (PCOR-Vic). Of the 3201 men diagnosed with LRPC between January 2009 and December 2016, 60% (1928/3201) had conservative management, and 52% (1664/3201) were documented to be on AS. There was an increase in conservative management from 52% in 2009 to 73% in 2016 (p<0.001), largely attributable to an increase in AS from 33% in 2009 to 67% in 2016 (p<0.001). When stratified by age group, the increase in conservative management was more pronounced among younger patients: from 37% to 66% for men aged <60yr versus from 72% to 86% for men aged ≥70yr. In multivariable analyses, increasing age, lower prostate-specific antigen and clinical category, lower socioeconomic status, and being diagnosed in public metropolitan institutions were all independently associated with a greater likelihood of conservative management. Identification of sociodemographic and institutional variations in practice allows for targeted strategies to improve management for men with LRPC. Patient summaryWe looked at the uptake of conservative management (no active treatment within 12 mo of diagnosis) over time in an Australian population-based cohort of men with low-risk prostate cancer. The proportion of men with low-risk prostate cancer managed conservatively increased from 52% in 2009 to 73% in 2016. The increase in the uptake of conservative management for low-risk prostate cancer in Australia is concordant with international guidelines and other international population-based studies.

Management of low-risk prostate cancer in a population-based cohort of Australian men between 2008 and 2016.

13 Background: The aim of this study is to evaluate the practice pattern of management of NCCN low-risk prostate cancer (LRPC) in a population-based cohort of Australian men. Methods: This is prospective cohort of men captured in Prostate Cancer Outcomes Registry Victoria (PCOR-Vic), who were diagnosed with LRPC between Aug 2008 and Dec 2016. Conservative management was defined as no active treatment (surgery, radiotherapy, or other local therapy) within 12-month of LRPC diagnosis. Chi-squared test for trend was used to evaluate change in practice over time. Multivariate logistics regressions were used to patient-, tumour- and institutional factors influencing the likelihood of conservative management for LRPC. Results: A total of 3238 men with LRPC were identified in the PCOR-Vic database. The median age was 62.6 (range:37-94). The median PSA level was 5.1ng/mL (range: 0.01-9.96). Overall, 1934 (60%) had conservative management, of which 1668 (86%) were documented as being on active surveillance. Of the 1304 (40%) men who active treatment within 12-month of diagnosis, 977 (30%) had surgeries, 289 (9%) had radiotherapy, and 38 (1%) had other local treatment. Overall, there is increasing trend in conservative management for LRPC from 52% in 2009 to 73% in 2016 (P&lt;0.001). In multivariate analyses, age, PSA, clinical stage, institutions and year of diagnosis were all independently associated with conservative management. Men diagnosed in private and regional centres were 26% (95%CI=0.63-0.88, P=0.001) and 40% (95% CI=0.51-0.72, P&lt;0.001) less likely to have conservative management for LRPC. Conclusions: This is the largest Australian series on management of LRPC to date. We observe increasing use of conservative management for LRPC over time, however, there is large institutional variations in care with men diagnosed in private and regional centres more likely to have active local management for LRPC.

Androgen deprivation therapy use with post-prostatectomy radiotherapy in the Prostate Cancer Outcomes Registry Victoria.

The aim of this study is to evaluate the use of androgen deprivation therapy (ADT) with post-prostatectomy radiotherapy (PPRT) in a population-based cohort of Australian men. This is a prospective cohort of men with localised prostate cancer captured in the Prostate Cancer Outcomes Registry Victoria (PCOR-Vic), who received PPRT between January 2010 and December 2015. The primary outcome was ADT use with PPRT. Multivariate logistic regressions were used to identify patient, tumour and institutional factors influencing ADT use. 485 men were included in this study - 115 (24%) had pT2 disease, 231 (48%) pT3a, 134 (28%) pT3b and 5 (1%) pT4. Eighteen (4%) men had ISUP grade 1 disease, 139 (29%) ISUP grade 2, 170 (35%) ISUP grade 3 and 158 (33%) ISUP grade 4/5, while 267 (64%) men had positive surgical margins. Median time from prostatectomy to PPRT was 8.1months (IQR=5.3-13.9). Sixty-six (14%) patients had ADT with PPRT. In multivariate analyses, men who had increased age (OR=1.06; 95% CI=1.01-1.11), seminal vesicle involvement (OR=3.81; 95% CI=1.63-8.91) and underwent treatment in regional centres (OR=2.17; 95% CI=1.08-4.33) were more likely to have ADT with PPRT. We reported that 14% of men treated with PPRT received ADT in a population-based cohort of Australian men, which was less than half of the proportion of ADT use with PPRT in the US. It will be of interest to evaluate the uptake of ADT with PPRT in the coming years following recent publications of level 1 evidence confirming overall survival benefits of ADT with PPRT.

Active surveillance of men with low risk prostate cancer: evidence from the Prostate Cancer Outcomes Registry-Victoria.

To characterise the practice of active surveillance (AS) for men with low risk prostate cancer by examining the characteristics of those who commence AS, the rate of adherence to accepted AS follow-up protocols over 2 years, and factors associated with good adherence. Design, setting: Retrospective cohort study; analysis of data collected from 38 sites participating in the Prostate Cancer Outcomes Registry-Victoria. Men diagnosed with prostate cancer between August 2008 and December 2014 aged 75 years or less at diagnosis, managed by AS for at least 2 years, and with an ISUP grade group of 3 or less (Gleason score no worse than 4 + 3 = 7). Adherence to an AS schedule consisting of at least three PSA measurements and at least one biopsy in the 2 years following diagnosis. Of 1635 men eligible for inclusion in the analysis, 433 (26.5%) adhered to the AS protocol. The significant predictor of adherence in the multivariate model was being diagnosed in a private hospital (v public hospital: adjusted odds ratio [aOR], 1.83; 95% CI, 1.42-2.37; P < 0.001). Significant predictors of non-adherence included being diagnosed by transurethral resection of the prostate (v transrectal ultrasound biopsy [TRUS]: OR, 0.54; 95% CI, 0.39-0.77; P < 0.001) or transperineal biopsy (v TRUS: OR, 0.32; 95% CI, 0.19-0.52; P < 0.001), and being 66 years of age or more at diagnosis (v < 55 years: OR, 0.65; 95% CI, 0.45-0.92; P = 0.015). Almost three-quarters of men who had prostate cancer with low risk of disease progression did not have follow-up investigations consistent with standard AS protocols. The clinical consequences of this shortcoming are unknown.

Interpolation to define clinical tumor stage in prostate cancer using clinical description of digital rectal examination.

This study aims to assess characteristics of patients with prostate cancer for whom clinical T stage category (cT) was not documented in the medical record and assess whether specialists had concordant conclusions regarding cT based on digital rectal examination (DRE) notes. Data from the Prostate Cancer Outcome Registry - Victoria (PCOR-Vic) were interrogated. Four specialists independently assigned cT to DRE notes. Words, or part thereof, associated with agreement between clinicians were identified. Of the 10587 men, cT was documented in 8758 (82.7%) cases. Multivariate analysis indicated that poor cT documentation was associated with older patient age (odds ratio [OR] 0.80, 95% confidence interval [CI] 0.66-0.99 if 75.1-85 years; OR 0.50, 95%CI 0.36-0.72 if>85 years); diagnosis via transperineal compared to transrectal ultrasound-guided biopsy (TRUS) (OR 0.68, 95%CI 0.51-0.91); diagnosed in a private hospital (OR 0.85, 95%CI 0.75-0.96); and a diagnostic Gleason score of>8 compared to ≤6 (OR 0.59, 95%CI=0.48-0.73). cT was more likely documented in men diagnosed via transurethral resection of prostate (OR 2.06, 95%CI 1.64-2.58) compared to TRUS and/or if receiving treatment in a radiotherapy center (OR 3.44, 95%CI 2.80-4.23 for external beam radiotherapy; OR 3.57 95%CI 2.44-5.23 for brachytherapy and OR 1.34, 95%CI 1.06-1.69 for combination surgery and radiotherapy) compared to those undergoing radical prostatectomy. Agreement in cT assignment ranged from kappa of 0.158 to 0.582. Stem word components in DRE notes associated with poorest level of agreement were "abnorm," "hard," "nodul" and those with highest level of agreement were terms "benign" and "smooth." Mode of diagnosis/subsequent treatment, and cancer characteristics were associated with cT documentation. Third party interpretation of clinical notes is problematic.

Men\u2019s perceptions of prostate cancer diagnosis and care: insights from qualitative interviews in Victoria, Australia

BackgroundThe Victorian Prostate Cancer Registry (Australia) revealed poorer rates of survival for men diagnosed with prostate cancer in one Victorian regional area than for men in metropolitan Melbourne. We sought to explore the perceptions and experiences of prostate cancer diagnosis, treatment, and care of men diagnosed with prostate cancer who lived in regional or metropolitan areas and of men who had not been so diagnosed. Our goal was to contribute to the evidence from which can be built continuing improvements in prostate health care.MethodsUsing the qualitative method of in-depth interviews to gain access to explanation and meaning, we interviewed 21 men: 10 recruited through the Prostate Cancer Outcome Registry-Victoria and 11 from the community. Transcripts were analysed thematically.ResultsWe identified four main themes within which men discussed prostate cancer: Case-finding, Diagnosis, Treatment and Care, and Spreading the Word. Contrasts revealed between regional and metropolitan areas related mostly to the more limited supportive care in regional areas.ConclusionsIt is evident from the perspectives of these men that every aspect of prostate cancer care would benefit from attention: publicising the need to check prostate health, treatment, and supporting men in the years after treatment. Continuing to work on systemic improvements is an important goal for all those committed to men’s health.

Population-based study of grade progression in patients who harboured Gleason 3+3.

This study aimed to evaluate (1) the time interval between a decision to commence on active surveillance (AS) and grade progression in community practice; (2) factors predicting grade progression in localised prostate cancer (CaP) patients apparently undergoing AS. Data from the Prostate Cancer Outcomes Registry-Victoria were used to analyze men with Gleason 3+3 CaP or less who had at least one repeat biopsy. Unadjusted and adjusted 5-year Kaplan-Meier survival curves were used to assess the time to grade progression. Both univariate and multivariate analyses for grade progression were performed using Cox proportional hazards. The cohort included 951 men. Overall, 39% of men had Gleason grade reclassified to a higher risk disease state with median of 2.2years [IQR 1.2-3.7years]. Men who harboured cT2 disease were 30% more likely to have upgrading compared to men with cT1 disease (adjusted HR: 1.3, 95% CI 1.0-1.6, p=0.048). Half of the men with cT2 in our cohort had their Gleason grade reclassified within 1.6years from diagnosis as compared with 2.7years for the cT1 group. The presence of percentage of core involvement >25.0% and a PSA velocity of >1.01ng/mL/year remained significant for a higher progression rate. The adjusted HR: 1.6; 95% CI [1.2-2.3], p=0.004; adjusted HR: 1.6, 95% CI [1.2-2.4], p=0.021, for percent of core involvement of 25.1-37.5%, and ≥37.6%, respectively. The adjusted HRs and p value associated with PSA velocity were 1.5; 95% CI [1.1-2.1], p=0.016 and 1.6; 95% CI [1.2-2.3], p=0.003 for PSA velocity values of 1.01-2ng/mL per year and >2ng/mL per year, respectively. Men who were diagnosed in regional hospital and subsequently had biopsy in metropolitan hospital were twice at risk of having Gleason upgrade compared to those whom both diagnostic and surveillance biopsies were carried out in metropolitan hospitals (adjusted HR: 1.9; 95% CI 1.1-3.3, p=0.029). When placing men on AS and considering time to histologic progression, clinicians should pay particular attention to the likely accuracy of the diagnostic specimen, their tumour stage, volume of tumour (percent of core involvement), and rising PSA. Those diagnosed with T2 disease and had >25.0% of core involvement, and a PSA velocity greater than 1ng/mL per year is at particular risk for more rapid disease progression and, for this reason, should be counselled on the importance of following the recommended surveillance regimen. For half of these men, their disease will have 'progressed' according to biopsy results in 2 years.

Study protocol of an equivalence randomized controlled trial to evaluate the effectiveness of three different approaches to collecting Patient Reported Outcome Measures (PROMs) data using the Prostate Cancer Outcomes Registry-Victoria (PCOR-VIC)

BackgroundPatient-reported outcome measures (PROMs) are used by clinical quality registries to assess patients’ perspectives of care outcomes and quality of life. PROMs can be assessed through a self-administered survey or by a third party. Use of mixed mode approaches where PROMs are completed using a single or combination of administration method is emerging. The aim of this study is to identify the most cost-effective efficient approach to collecting PROMs among three modes (telephone, postal service/mail and email) in a population-based clinical quality registry monitoring survivorship after a diagnosis of prostate cancer. This is important to assist the registry in achieving representative PROMs capture using the most cost-effective technique and in developing cost projections for national scale-up.Methods/designThis study will adopt an equivalence randomised controlled design. Participants are men diagnosed with and/or treated for prostate cancer (PCa) participating in PCOR-VIC and meet the criteria for 12-month follow-up. Participants will be individually randomized to three independent groups: telephone, mail/postal, or email to complete the 26-item Expanded Prostate Cancer Index Composite (EPIC-26) survey. It is estimated each group will have 229 respondents. We will compare the proportion of completed surveys across the three groups.The economic evaluation will be undertaken from the perspective of the data collection centre and consider all operating costs (personnel, supplies, training, operation and maintenance). Cost data will be captured using an Activity Based Costs method. To estimate the most cost-effective approach, we will calculate incremental cost-effectiveness ratios. A cost projection model will be developed based on most cost-effective approach for nationwide scale-up of the PROMs tool for follow-up of PCa patients in Australia.DiscussionThis study will identify the most cost-effective approach for collecting PROMs from men with PCa, and enable estimation of costs for national implementation of the PCa PROMs survey. The findings will be of interest to other registries embarking on PROMs data collection.Trial registrationACTRN12615001369516 (Registered on December 16, 2015)

Quality of care achievements of the Prostate Cancer Outcomes Registry-Victoria.

To analyse the performance of the quality of prostate cancer (CaP) care over a 5-year period with reference to three quality indicators (QIs) reported by the Prostate Cancer Outcomes Registry-Victoria (PCOR-Vic):QI-1: Alignment with the modified Prostate Cancer Research International Active Surveillance (PRIAS) protocol guideline;QI-2: Timeliness of CaP care for men with high risk and locally advanced disease;QI-3: Positive surgical margins (PSMs) for organ-confined pathological T2 disease. Between 1 January 2009 and 31 December 2013, 4708 men diagnosed with CaP who met the QI-1, QI-2 or QI-3 inclusion criteria were recruited from Victorian hospitals.Outcome measures and statistical analysis: Trend analysis was conducted to monitor performance according to QI-1, QI-2 and QI-3. We used the autoregressive integrated moving average (ARIMA) model to account for any inherent autocorrelation in the data when analysing the monthly incidence of each indicator. Differences in the annual figures for the indicators across years were also analysed by aggregating data by year and applying the ARIMA model. There was a downward trend over the 5 years in the percentage of men with low risk disease who underwent active treatment (45% to 34%; P = 0.024), an upward trend in the percentage of those with high risk and locally advanced disease who received active treatment within 12 months of diagnosis (88% to 93%; P = 0.181), and a decline in PSM rate in men with pathological T2 disease after radical prostatectomy (21% to 12%; P = 0.036). Limitations of the study include the fact that the improvement in the QIs was detected using PCOR-Vic as a single population, but there may be institutional variations in quality improvement. Over 2009-2013, the performance of the Victorian health system improved according to the three processes of care indicators reported by the PCOR-Vic.