PURPOSE:For men with localized prostate cancer, NRG Oncology/Radiation Therapy Oncology Group (RTOG) 9408 demonstrated that adding short-term androgen deprivation therapy (ADT) to radiation therapy (RT) improved the primary endpoint of overall survival (OS) and improved disease-specific mortality (DSM), biochemical failure (BF), local progression, and freedom from distant metastases (DM). This study was performed to determine whether the short-term ADT continued to improve OS, DSM, BF, and freedom from DM with longer follow-up.METHODS AND MATERIALS:From 1994 to 2001, NRG/RTOG 9408 randomized 2028 men from 212 North American institutions with T1b-T2b, N0 prostate adenocarcinoma and prostate-specific antigen (PSA) ≤20ng/mL to RT alone or RT plus short-term ADT. Patients were stratified by PSA, tumor grade, and surgical versus clinical nodal staging. ADT was flutamide with either goserelin or leuprolide for 4 months. Prostate RT (66.6 Gy) was started after 2 months. OS was calculated at the date of death from any cause or at last follow-up. Secondary endpoints were DSM, BF, local progression, and DM. Acute and late toxic effects were assessed using RTOG toxicity scales.RESULTS:Median follow-up in surviving patients was 14.8 years (range, 0.16-21.98). The 10-year and 18-year OS was 56% and 23%, respectively, with RT alone versus 63% and 23% with combined therapy (HR 0.94; 95% confidence interval [CI], 0.85-1.05; P = .94). The hazards were not proportional (P = .003). Estimated restricted mean survival time at 18 years was 11.8 years (95% CI, 11.4-12.1) with combined therapy versus 11.3 years with RT alone (95% CI, 10.9-11.6; P = .05). The 10-year and 18-year DSM was 7% and 14%, respectively, with RT alone versus 3% and 8% with combined therapy (HR 0.56; 95% CI, 0.41-0.75; P < .01). DM and BF favored combined therapy at 18 years. Rates of late grade ≥3 hepatic, gastrointestinal, and genitourinary toxicity were ≤1%, 3%, and 8%, respectively, with combined therapy versus ≤1%, 2%, and 5% with RT alone.CONCLUSIONS:Further follow-up demonstrates that OS converges at approximately 15 years, by which point the administration of 4 months of ADT had conferred an estimated additional 6 months of life.

36 Background: Multidisciplinary management improves complex treatment decision making in cancer care but its impact for metastatic castration resistant prostate cancer (M1 CRPC) has not been documented. The Edmonton Prostate Interdisciplinary Cancer Clinic (EPICC) is a multidisciplinary specialized clinic focused on the delivery of novel therapeutics (Androgen Receptor Axis Therapy; ARAT) to men with chemotherapy-naïve M1 CRPC. The objective of the current study was to assess the efficacy of ARAT in the EPICC. Methods: The study was a retrospective quality assurance analysis. Eligible patients had a new diagnosis of chemotherapy-naïve M1 CRPC with minimal symptoms. EPICC patients were assessed and treated by a multidisciplinary cancer control team that included nursing oncology, pharmacy oncology and physician oncology (urologic, medical and radiation). Patients were treated in first line with an ARAT (abiraterone (AA) or enzalutamide (EZ)) from October 2017 to March 2018. The main efficacy outcome was overall survival (OS). The Kaplan-Meier method and Cox regression model were used to analyze survival data. Statistical tests were two-sided (p≤0.05). Results: From October 2017 to March 2018, 160 chemotherapy-naïve M1 CRPC patients were assessed in the EPICC. Median age at EPICC admission was 77 years (range, 54-92 years). Median PSA level at EPICC admission was 26.6 ng/mL (range, 0.1-5000 ng/mL). 84 out of 160 (53%) patients had received prior radical local therapy (RLT) with curative intent. 83 (57%) patients were treated with EZ and 64 (43%) patients were treated AA. Median OS for the entire cohort was 23 months. In multivariable analysis, absence of prior RLT (HR 3.6, 95% CI 1.9 to 6.6, p < 0.001), PSA > 20 ng/mL (HR 3.2, 95% CI 1.4 to 7.2, p = 0.004), and higher ECOG performance status (1 vs 0: HR 2.4, 95% CI 1.3 to 4.4, p = 0.005; 2 versus 0: HR 3.5, 95% CI 1.5 to 8.0, p = 0.003; and 3 versus 0: HR 12.7, 95% CI 2.5 to 63.8, p = 0.002) were independently associated with poorer OS. Conclusions: Multidisciplinary management of chemotherapy-naïve M1 CRPC with ARAT is feasible. Real world efficacy of ARAT in EPICC are similar to data reported in phase 3 trials.

PURPOSE:The Alberta Prostate Cancer Research Initiative (APCaRI) Registry and Biorepository was established in 2014 by the APCaRI to facilitate the collection of clinical and patient-reported data, biospecimen, to measure prostate cancer outcomes and to support the development and clinical translation of innovative technologies to better diagnose and predict outcomes for patients with prostate cancer. PARTICIPANTS:Men suspected with prostate cancer and referred to Urology centres in Alberta were enrolled in the APCaRI 01 study, while men with a prior prostate cancer diagnosis participated in the APCaRI 03 study from 1 July 2014 to 30 June 2019. The APCaRI Registry and Biorepository links biospecimens and data from a wide representation of patients drawn from an Alberta population of more than 4 million. FINDINGS TO DATE:From 1 July 2014 to 30 June 2019, total APCaRI 01 and 03 study recruitment was 3754 men; 142 (4%) of these men withdrew in full, 65 men (2%) withdrew biospecimens and 123 men (3%) died of any cause. Over this same time, 8677 patient-reported outcome measure (PROM) surveys and 7368 biospecimens were collected and are available from the registry and biorepository, respectively. The data entry error rate was 0.8% and 0.95% for critical and non-critical values, respectively, and 1.8% for patient-reported surveys. FUTURE PLANS:The APCaRI Registry and Biorepository will collect longitudinal data and PROM surveys until 2024, patient outcomes up to 25 years after recruitment and biospecimen storage for up to 25 years. The APCaRI cohorts will continue to provide data and samples to researchers conducting retrospective studies. The richness of the data and biospecimens will complement many different research questions, ultimately to improve the quality of care for men with prostate cancer.

Introduction: Salvage cryotherapy is a guideline-recommended treatment of localized prostate cancer recurrence after radiation therapy. There is little published evidence analyzing the outcomes of salvage cryotherapy for recurrent prostate cancer following different primary therapy energy modalities. Methods: We performed a retrospective analysis of patients who received whole gland salvage cryotherapy from 2007–2017 at a large tertiary referral center after either primary radiation therapy (RT) or primary whole gland cryotherapy. Primary outcome was biochemical failure, defined as per the Phoenix criteria (prostate-specific antigen [PSA] nadir + 2.0 ng/ml). Secondary outcomes included time to biochemical failure and development of metastatic disease. Results: Fifty-eight out of 391 patients who received cryotherapy were identified as having received salvage cryotherapy (after RT, n=37; after primary cryotherapy, n=21). Biochemical recurrence occurred in 21 (57%) patients with previous RT and in 17 (81%) patients with previous cryotherapy (p=0.001). Median time to biochemical recurrence was 18 months for patients with previous RT and 13 months for patients with previous cryotherapy (p=0.002). The biochemical free survival rate for primary radiation therapy patients was 71% at two years compared to 23% at two years for patients who underwent primary cryotherapy (p<0.01). There was no difference in the development of metastatic disease between groups (19% vs. 18%, cryo vs. radiation, p=0.34). Conclusions: These results suggest that salvage cryotherapy may offer more durable oncological control to patients after radiation compared to primary cryotherapy with a lower rate and longer duration before biochemical recurrence.

INTRODUCTION Salvage cryotherapy is a guideline-recommended treatment of localized prostate cancer recurrence after radiation therapy. There is little published evidence analyzing the outcomes of salvage cryotherapy for recurrent prostate cancer following different primary therapy energy modalities. METHODS We performed a retrospective analysis of patients who received whole gland salvage cryotherapy from 2007-2017 at a large tertiary referral center after either primary radiation therapy (RT) or primary whole gland cryotherapy. Primary outcome was biochemical failure, defined as per the Phoenix criteria (prostate-specific antigen [PSA] nadir + 2.0 ng/ml). Secondary outcomes included time to biochemical failure and development of metastatic disease. RESULTS Fifty-eight out of 391 patients who received cryotherapy were identified as having received salvage cryotherapy (after RT, n=37; after primary cryotherapy, n=21). Biochemical recurrence occurred in 21 (57%) patients with previous RT and in 17 (81%) patients with previous cryotherapy (p=0.001). Median time to biochemical recurrence was 18 months for patients with previous RT and 13 months for patients with previous cryotherapy (p=0.002). The biochemical free survival rate for primary radiation therapy patients was 71% at two years compared to 23% at two years for patients who underwent primary cryotherapy (p\u003c0.01). There was no difference in the development of metastatic disease between groups (19% vs. 18%, cryo vs. radiation, p=0.34). CONCLUSIONS These results suggest that salvage cryotherapy may offer more durable oncological control to patients after radiation compared to primary cryotherapy with a lower rate and longer duration before biochemical recurrence.

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Quality Improvement & Patient Safety I (MP10)1 Apr 2019MP10-20 INPATIENT WORKLOAD HAS INCREASED BY UP TO 300% OVER THE LAST DECADE: ANALYSIS OF A UROLOGY RESIDENCY TRAINING PROGRAM FROM 2007-2017 Adam Kinnaird*, Logan Zemp, Andrew Rasmussen, Michael Chetner, Keith Rourke, and Trevor Schuler Adam Kinnaird*Adam Kinnaird* More articles by this author , Logan ZempLogan Zemp More articles by this author , Andrew RasmussenAndrew Rasmussen More articles by this author , Michael ChetnerMichael Chetner More articles by this author , Keith RourkeKeith Rourke More articles by this author , and Trevor SchulerTrevor Schuler More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555164.06369.85AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Resident education in Canada is currently undergoing major changes in the way it is administered. As the Canadian population grows, the strain on our health care resources, including workloads of surgeons and surgical residents, increases within our resource-limited, universal healthcare system. Within the last year, multiple high-impact publications suggest that surgical residents express high levels of burnout, depression and suicidal ideation. Therefore, our objective is to assess how resident workload has changed over the last decade to gain insight into potential contributing factors to resident well-being. METHODS: We retrospectively analyzed prospectively collected institutional datasets, managed by expert database managers, to obtain information within the following domains (specific dataset): Urology ward admissions (Tandem), Urology ORs (ORM), Emergency Department consults (EDIS) and Urology service pagers (Citipage). Data was collected for 2007 to 2017, inclusive, and stratified by hospital (University of Alberta Hospital, Royal Alexandra Hospital, Misericordia Hospital and Stollery Children′s Hospital when available). Spearman′s rank correlation coefficient was calculated and p<0.05 considered significant. RESULTS: Data was available for 2007 to 2017 in all domains except for Urology service pagers due to this data being deleted every 6 months as per confidentiality policy. The number of Urology ward admissions (during a one-year interval) increased by 1192 during the study period with an average percent increase of 46% across sites (p<0.01 all sites). Similarly, the number of Urology ORs increased by 134 procedures per month during the study period with an average increase of 46% across sites (p<0.001 all sites except Misericordia, p=0.11). The Urology service received 999 more Emergency Department consults in 2017 compared to 2007 with an average increase of 300% across sites (p<0.001 all sites except Stollery, p=0.06). The Urology day pagers (which operate from 07:00-17:00 at our tertiary and quaternary care centers) were paged an average of 37 times per day per site. CONCLUSIONS: The Urology service workload has increased across all domains captured in this study. This increased clinical volume may benefit the educational experience of residents while paradoxically also potentially contributing to work-related stress for residents and staff Urologists. These data may be interpreted as an impetus to explore further assistance from allied health professionals such as Physician Assistants and Nurse Practitioners to assist with increased inpatient workload. Source of Funding: None Edmonton, Canada© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e126-e126 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Adam Kinnaird* More articles by this author Logan Zemp More articles by this author Andrew Rasmussen More articles by this author Michael Chetner More articles by this author Keith Rourke More articles by this author Trevor Schuler More articles by this author Expand All Advertisement PDF downloadLoading ...

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy VI1 Apr 2016PD43-05 PROSPECTIVE COMPARISON OF OPEN VERSUS ROBOT-ASSISTED RADICAL PROSTATECTOMY FOR CLINICALLY LOCALIZED PROSTATE CANCER: ANALYSIS OF 1806 CONSECUTIVE MEN TREATED IN A UNIVERSAL HEALTHCARE SYSTEM Adrian Fairey, Sunita Ghosh, Niels Jacobsen, Lucas Dean, Derek Bochinski, Michael Chetner, Howard Evans, Michael Hobart, David Mador, Blair St. Martin, Keith Rourke, and Eric Estey Adrian FaireyAdrian Fairey More articles by this author , Sunita GhoshSunita Ghosh More articles by this author , Niels JacobsenNiels Jacobsen More articles by this author , Lucas DeanLucas Dean More articles by this author , Derek BochinskiDerek Bochinski More articles by this author , Michael ChetnerMichael Chetner More articles by this author , Howard EvansHoward Evans More articles by this author , Michael HobartMichael Hobart More articles by this author , David MadorDavid Mador More articles by this author , Blair St. MartinBlair St. Martin More articles by this author , Keith RourkeKeith Rourke More articles by this author , and Eric EsteyEric Estey More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1783AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES There are limited prospective data comparing outcomes of Open Radical Prostatectomy (ORP) and Robot-Assisted Radical Prostatectomy (RARP) for clinically localized prostate cancer (CLPC). Our primary objective was to compare ORP and RARP with respect to cancer control outcomes in men treated within a universal healthcare system. METHODS A prospective analysis of data from the University of Alberta Radical Prostatectomy Database was performed. Between September 2007 and January 2013, 1,806 consecutive men underwent radical prostatectomy for CLPC. The surgeon selected the surgical approach. The primary end point was biochemical recurrence (BCR). BCR was defined as a PSA≥0.2 µg/L followed by a subsequent confirmatory value or initiation of salvage therapy. Secondary endpoints included positive surgical margin (R1) rate, 1-year urinary and erectile function preservation rate, 90-day complication rate, and 90-day return to emergency room or readmission to hospital rate. The Kaplan-Meier method and multivariable Cox regression analyses were used to analyze BCR. Statistical tests were two-sided (p<0.05). RESULTS Complete data were evaluable for 1,769 out of 1,806 patients. 333 patients underwent ORP and 1,436 patients underwent RARP. The median follow-up duration was 48 months. Baseline age (62 years vs. 61 years, p=0.07), BMI (29 kg/m2 vs. 29 kg/m2, p=0.29), and D'Amico risk stratification score (low risk: 50% vs. 45%; intermediate risk: 42% vs. 46%; high risk: 8% vs. 9%, p=0.15) were similar between the ORP and RARP groups. The 5-year freedom from BCR rate differed between the ORP and RARP groups (79% vs. 86%, log rank p=0.006). In multivariable Cox regression analysis that adjusted for surgical margin status, pathologic Gleason score, pathologic T stage, and preoperative PSA, ORP was independently associated with an increased risk of BCR (HR 1.62, 95% CI 1.21 to 2.18, p=0.001). The 1-year urinary function preservation rate (60% vs. 72%, p=0.004), 1-year erectile function preservation rate (10% vs. 17%, p=0.007), and blood transfusion rate (4% vs. 1%, p<0.001) differed between the ORP and RARP groups. There were no significant differences between groups for R1 rate (24% vs. 26%, p=0.57) 90-day complication rate (27% vs. 27%, p=0.27), return to emergency room rate (21% vs. 20%, p=0.54), or readmission to hospital rate (3% vs. 4%, p=0.15). CONCLUSIONS In men treated at a Canadian academic center within a universal healthcare system, RARP provided superior cancer control, functional preservation, and blood product transfusions rates compared to ORP. Further analyses designed to examine mechanisms of differences in cancer control and functional preservation is needed. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e994 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Adrian Fairey More articles by this author Sunita Ghosh More articles by this author Niels Jacobsen More articles by this author Lucas Dean More articles by this author Derek Bochinski More articles by this author Michael Chetner More articles by this author Howard Evans More articles by this author Michael Hobart More articles by this author David Mador More articles by this author Blair St. Martin More articles by this author Keith Rourke More articles by this author Eric Estey More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

A systematic literature search was conducted in the following electronic bibliographic databases: MEDLINE, including PreMedline (2004 to November 2010), EMBASE (2004 to Week 44, 2010) and the Cochrane Central Register of Controlled Trials (2010, 4th Quarter). This search was restricted to studies published in English. The search queries were based on a combination of exploded and non-exploded subject headings and free-text keywords. These terms included prostate cancer, prostatic neoplasms, prostate tumour, prostate-specific antigen (PSA), digital rectal examination (DRE), DRE, mass screening, screening test, early detection of cancer, cancer screening, screening, PSA, transrectal ultrasound (TRUS), TRUS, randomized, false-negative and false-positive; we used alternative word spellings and endings. The search strategy was modified for each database using database-specific thesaurus terms, syntax and search fields. We excluded case reports, editorials, news and letters. To identify additional relevant studies, we also examined bibliographies of the relevant articles and selected reviews. We compiled 1938 unique citations and, after removing the duplicates, 1036 citations were assessed for relevance. The screening process yielded 49 articles for a full-text review.

Screening for prostate cancer remains a contentious issue. As withother cancer screening programs, a key feature of the debate isverification of cancer-specific mortality reductions. Unfortunatelythe present evidence, two systematic reviews and six randomizedcontrolled trials, have reported conflicting results. Furthermore, halfof the studies are poor quality and the evidence is clouded by keyweaknesses, including poor adherence to screening in the interventionarm or high rates of screening in the control arm. In highquality studies of prostate cancer screening (particularly prostatespecificantigen), in which actual compliance was anticipated inthe study design, there is good evidence that prostate cancer mortalityis reduced. The numbers needed to screen are at least as goodas those of mammography for breast cancer and fecal occult bloodtesting for colo-rectal cancer. However, the risks associated withprostate cancer screening are considerable and must be weighedagainst the advantage of reduced cancer-specific mortality. Adverseevents include 70% rate of false positives, important risks associatedwith prostate biopsy, and the serious consequences of prostatecancer treatment. The best evidence demonstrates prostate cancerscreening will reduce prostate cancer mortality. It is time for thedebate to move beyond this issue, and begin a well-informed discussionon the remaining complex issues associated with prostatecancer screening and appropriate management.

OBJECTIVETo determine the prevalence, diagnostic patterns and management of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in Canadian urology outpatient practice.METHODSRepresentative urologists were randomly selected from lists provided by the Canadian and Quebec Urological Associations. Each patient identified with a BPH diagnosis during a typical 2-consecutive-week period during April, May or June 2007 was asked to complete a corresponding International Prostate Symptom Score (IPSS) questionnaire. Each day, the participant urologist completed an outpatient log and a detailed programmed chart review to transcribe demographics, investigations and treatments associated with each BPH patient.RESULTSEighty-six urologists were invited to participate. Thirty-eight (44.2%) agreed, and 27 of those (71.1%) submitted evaluable data for the audit. Of the 5616 patients seen in outpatient practice (average 208 per urologist), 4324 (77%) were male. A BPH diagnosis was identified in 19.6% of the men (n = 849; mean age 69.5, standard deviation [SD] 10, yr; age range 40-100 yr; mean duration of symptoms 4.8, SD 4.2, yr; mean IPSS score 12.3, SD 7.4; mean prostate specific antigen [PSA] 3.9, SD 3.9, ng/mL). Twenty-four percent of patients had prostates that were rated as large, 50% as medium and 26% as small. PSA level correlated positively with prostate volume. Twenty-two percent were initial consultations for LUTS and 78% were repeat visits. Diagnostic evaluation tended to follow those examinations and tests recommended by the Canadian BPH guidelines. Treatment choices tended to follow an evidence-based algorithm with respect to treatment choices for men in the various prostate-volume and PSA groups.CONCLUSIONThis prospective audit indicates that BPH remains a common condition managed by urologists in outpatient practice. Investigations and treatments confirm that Canadian urologists appear to be following Canadian BPH guidelines as well as the most recent evidence from the literature.

Renal cell carcinoma (RCC) comprises approximately 2% of all malignancies. It is the seventh most common cancer and tenth most common cause of cancer-related deaths among men.1 Risk factors for RCC include smoking, obesity, and hereditary conditions associated with a mutation in the von-Hippel-Lindau gene (level 2).2,3 Surgical resection (radical or partial nephrectomy) remains the only effective therapy for clinically localized RCC. Publications that address surveillance after surgical extirpation are based on retrospective analysis, including some larger multicentre studies and well-designed controlled studies.4 Randomized prospective studies are sparse, rendering it difficult to obtain qualified evidence-based data. Although there is no clear consensus on surveillance after surgical extirpation for patients with RCC, this document attempts to provide some clarity and guidance for the practising urologist based on the current literature. Where possible, levels of evidence and grades of recommendations are provided employing the modified Oxford Centre for Evidence-based Medicine scheme.

Le printemps est enfin arrive au Canada et la planification de notre congres annuel bat son plein. Bientot, nous convergerons tous vers Banff pour l’excellent congres scientifique organise par les Drs Trevor Schuler et Jay Lee. Pour bien alimenter nos hemispheres gauches, les Drs Howard Evans et Marty Duffy assureront que nous sommes bien divertis et bien nourris et que ne manquons pas de quoi boire. En tant qu’organisme, l’AUC trouve de plus en plus sa voie. L’association s’est transformee, partant d’un groupe autonome dirige a partir des sous-sols et repaires de la secretaire et du tresorier avec l’appui des dirigeants pour devenir une veritable entite par un bureau gere de facon professionnelle et dote d’une diversite nettement plus grande en matiere de responsabilite et de portee. Le Bureau central est regle comme une horloge suisse. Il repond a nos besoins en matiere de planification de congres annuel, d’appui logistique, de financement et d’exercice des activites quotidiennes de l’association. Le Bureau central assure la bonne succession des dirigeants et la reussite (scientifique et economique) des congres annee apres annee. Il nous a aides a diversifier nos sources de revenus, plutot que de continuer a dependre totalement des recettes excedentaires du congres annuel. Le Bureau de l’education est pleinement fonctionnel et travaille sur de multiples projets, et constitue une excellente source de revenus. Le JAUC a toujours brille en tant que publication scientifique, mais grâce a l’appui du Bureau central, il genere enfin des profits. Dans un autre ordre d’idees, les interactions avec d’autres associations d’urologues ont atteint de nouveaux sommets. La deuxieme annee de notre echange avec l’AEU se termine en juin. Lors du congres annuel de l’AEU en mars, de longs pourparlers ont eu lieu entre l’AUC et l’AEU concernant la facon pour chaque partie d’ameliorer les relations, d’echanger des idees et d’accroitre les interactions. De son cote, l’AUA a etabli des ponts avec l’AUC, reconnaissant ainsi la presence de plus en marquee de notre association, et explore de nouvelles interactions potentielles qui seront benefiques pour les deux organismes. Des membres de l’AUC seront desormais inclus de facon officielle dans les principaux comites de l’AUA, non seulement a titre de « membres canadiens » de l’AUA mais aussi a titre de representants de l’AUC sur des comites particuliers. Grâce au recent lien avec l’autre AUC, l’Association des urologues de Chine, le premier contingent officiel d’urologues chinois sera present a Banff pour le Congres annuel de cette annee. De grands efforts ont ete deployes et beaucoup d’energie a ete investie par nos membres pour favoriser ces relations, mais ces efforts et cette energie auraient ete en vain sans l’appui de notre Bureau central. Je suis tres heureux d’avoir servi cet organisme de differentes facons au cours des annees. Ce fut un veritable plaisir de cotoyer les urologues des quatre coins du Canada. Nous avons de nombreuses raisons d’etre fiers et de celebrer. Nous formons une vraie famille. Nous devons garder a l’esprit les humbles debuts de notre association nationale. En effet, ce sont ces debuts qui nous ancrent solidement et nous aident a garder le cap dans les temps turbulents. Je suis persuade que nous continuerons de croitre, de connaitre du succes et d’augmenter notre portee dans des voies que nous n’entrevoyons pas encore. J’ai bien hâte de celebrer nos accomplissements scientifiques et sociaux lors du Congres annuel de l’AUC a Banff.

In late 2010, the U.S. Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) recommended against prostate cancer chemoprevention labelling for the 5-alpha reductase inhibitors (5ARIs). The ODAC met on December 1, 2010 to hear presentations from GlaxoSmithKline (GSK) and Dr. Ian Thompson (Merck) regarding dutasteride and finasteride.1 GSK was seeking a prostate cancer risk reduction label. Merck was not seeking a risk-reduction label, but rather a change in their product monograph. The FDA presented new, unpublished analyses of the data from the Prostate Cancer Prevention Trial (PCPT) and the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial, as well as risk-benefit analyses unadjusted for detection-bias.2–4 The FDA asked the voting panel to consider whether the “real world” risk-benefit ratio was favourable for: Finasteride in men >55 years old with a normal digital rectal examination (DRE) and prostate-specific antigen (PSA) <3 ng/mL Dutasteride in men with an elevated PSA and a negative biopsy In discussing the real world risks and benefits of these drugs, panel members expressed concern that some men would take the drug without adequate follow-up. ODAC voted against recommending dutasteride for the prostate cancer risk reduction indication because, in the view of the ODAC members, the risk for an increase in high-grade tumours outweighed the benefits of prostate cancer risk reduction, given the potential for widespread use of this agent in the United States. The ODAC recommended against prostate cancer chemoprevention labelling for 5ARIs (Table 1). Table 1. Results of the ODAC vote chemoprevention On June 9, 2011, the FDA notified health care professionals that the Warnings and Precautions section of the labels for 5ARIs was revised to include new safety information about the increased risk of high-grade prostate cancer. This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5ARIs in the approved indication for benign prostatic hyperplasia (BPH). To review the FDA’s decision from a Canadian perspective, the Canadian Urological Association (CUA), with direction from Dr. Laurence Klotz, assembled a team of experts and a meeting was convened on November 20, 2011 in Toronto, Ontario. The objectives of the meeting were as follows: To review the FDA’s decision regarding the use of 5ARIs in prostate cancer prevention, specifically with respect to the increase in high-grade cancer. To develop a Canadian consensus statement based on expert opinion and review of the evidence, on the use of 5ARIs in prostate cancer prevention and BPH.3–9 The deliverables proposed by the consensus panel chair and the CUA Office of Education are as follows: (a) To prepare a Canadian statement on the use of 5ARIs in prostate cancer prevention, which reflects a broad consensus of academic and community practitioners, and primary care physicians with an interest in prostate cancer; (b) To publish this statement as a peer-reviewed article in CUAJ; and (c) To produce a patient brochure, which reflects this Canadian consensus. Meeting participants were provided with all pertinent data, a description outlining the meeting objectives, expected outcomes and presentations and three position statements for voting (Appendices 1–4). After an introduction and review of the positions by Dr. Laurence Klotz, participants were asked to vote on the three positions prior to the initiation of discussion. After the initial vote, 7 presentations were made to the group: A summary of the ODAC hearing and the FDA position: Laurence Klotz and David Penson Personal take on the ODAC hearing as a participant: Howard Parnes Pathology issues/Gleason scoring system: Linda Sugar The CCO position on risk reduction of prostate cancer: Neil Fleshner The modelling of cytoreduction and PSA effects: Eric Klein The link between the FDA decision and the United States Preventive Services Task Force (USPSTF) screening decision: Laurence Klotz Implications for use of 5ARIs in surveillance: Tony Finelli Key findings 1. Preliminary vote Attendees were given a ballot containing three positions (Appendix 1–4) and were asked to vote secretly. Position 1: The FDA Position (3 votes) Position 2: The “Pro” Position (3 votes) Position 3: The Middle Ground (6 votes) Expert Presentations a) David Penson: A summary of the ODAC hearing Dr. Penson reviewed the ODAC decision and the data that were presented. His recommended use of 5ARIs moving forward is: Continue to use 5ARIs for BPH with the following proviso: – Explain possible increased risk of high-grade prostate cancer to patients and DOCUMENT in chart – Closely monitor PSA kinetics after starting therapy – Unclear if you need to send a letter to your patients currently on 5ARIs Only consider 5ARI use for chemoprevention for men at increased risk of prostate cancer who are motivated to pursue chemoprevention – Explain to patient that it is off-label use and highlight the possible risks of treatment and DOCUMENT in chart – Closely monitor PSA after starting therapy and contact patient if he misses follow-up PSA mean scores or appointments to reschedule b) Howard Parnes: A personal take on the ODAC hearing as a participant Dr. Parnes also provided a summary of the decision-making process by the ODAC panel. Of note: - ODAC met on 12/1/2010 to hear presentations by GSK and Merck regarding dutasteride and finasteride, respectively. GSK was seeking a risk-reduction label Merck was not seeking a risk-reduction label - Merck stated that the post-hoc analyses addressing the observed increase in high-grade prostate cancer “did not rise to the level of a label.” - ODAC took the position that mortality reduction is the goal of chemoprevention - Burden of prostate cancer was not considered by ODAC - No weight was given to the possible role of detection-bias - The addition of the “real world” setting did not leave much choice for the panel to vote in favour of dutas-teride as widespread use has significant public health implications. The crux of the controversy is whether the observed increase in high-grade cancer in the two trials was an artifact caused by several unavoidable biases associated with the use of 5ARIs, or represents a true increased risk. If the latter, it is unclear what the mechanism for the increase in high grade cancer is.

Spring is finally upon us across Canada and our planning for the Annual Meeting has reached a fervent pitch. Soon, we will all convene in Banff for the outstanding academic meeting planned by Dr. Trevor Schuler and Dr. Jay Lee. To support our left brains, Dr. Howard Evans and Dr. Marty Duffy will entertain us and ensure we are well fed and have lots to quench our thirsts. As an organization, the CUA is coming into its own. It has transformed itself from a self-driven association run from basements and dens of the secretary and treasurer with the support of the executive, to a true corporate entity run from an office professionally managed and with much more diversity in responsibility and reach. The Corporate Office is running like a perfectly tuned Swiss watch. It is fulfilling our needs from the perspective of planning the Annual Meeting, supporting logistics, fundraising and the day-to-day operations of the organization. The Corporate Office ensures proper succession and successful meetings (both academic and financial) year-to-year. It has helped us diversify our funding sources from relying totally on excess revenues at the Annual Meeting. The Office of Education is fully developed and working on multiple projects and providing an excellent revenue stream. CUAJ has always been successful as an academic publication, but with help from the Corporate Office, CUAJ is finally operating in the black. Also, interaction with other urologic associations has reached a new high. The second year of our exchange with the EUA will be completed this June. At the EAU Annual Meeting in March, there were extended conversations between the CUA and the EAU about how each organization can improve relations, exchange ideas and increase interaction. The AUA has approached the CUA, recognizing the growing presence of the CUA, and is exploring new potential interactions that will benefit both organizations. It will formally include CUA members on key AUA committees not just as “Canadian” members of the AUA but as CUA representatives on specific AUA committees. New interaction with the other “CUA,” the Chinese Urological Association, will bring the first official contingent from China to Banff for this year’s Annual Meeting. Huge effort and much work have been done by our members to facilitate these relationships, but none would succeed with out the support of our Corporate Office. I am thrilled to have served this organization in multiple facets over the years. It has been my true pleasure to associate with the urologists across Canada; we have much to be proud of and much to celebrate. It is a true family. We must always remember the humble beginnings of our national organization. These roots will ground us and keep our ship pointed into the wind. I am confident as we move forward that the CUA will continue to grow, thrive and expand in ways we have not yet conceived. I look forward to celebrating the academic and social accomplishments of the CUA at our Annual Meeting in Banff.