Stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a non-randomised phase 2 trial.

BACKGROUND: Stereotactic ablative body radiotherapy (SABR) is a novel non-invasive alternative for patients with primary renal cell cancer who do not undergo surgical resection. The FASTRACK II clinical trial investigated the efficacy of SABR for primary renal cell cancer in a phase 2 trial. METHODS: This international, non-randomised, phase 2 study was conducted in seven centres in Australia and one centre in the Netherlands. Eligible patients aged 18 years or older had biopsy-confirmed diagnosis of primary renal cell cancer, with only a single lesion; were medically inoperable, were at high risk of complications from surgery, or declined surgery; and had an Eastern Cooperative Oncology Group performance status of 0-2. A multidisciplinary decision that active treatment was warranted was required. Key exclusion criteria were a pre-treatment estimated glomerular filtration rate of less than 30 mL/min per 1·73 m2, previous systemic therapies for renal cell cancer, previous high-dose radiotherapy to an overlapping region, tumours larger than 10 cm, and direct contact of the renal cell cancer with the bowel. Patients received either a single fraction SABR of 26 Gy for tumours 4 cm or less in maximum diameter, or 42 Gy in three fractions for tumours more than 4 cm to 10 cm in maximum diameter. The primary endpoint was local control, defined as no progression of the primary renal cell cancer, as evaluated by the investigator per Response Evaluation Criteria in Solid Tumours (version 1.1). Assuming a 1-year local control of 90%, the null hypothesis of 80% or less was considered not to be worthy of proceeding to a future randomised controlled trial. All patients who commenced trial treatment were included in the primary outcome analysis. This trial is registered with ClinicalTrials.gov, NCT02613819, and has completed accrual. FINDINGS: Between July 28, 2016, and Feb 27, 2020, 70 patients were enrolled and initiated treatment. Median age was 77 years (IQR 70-82). Before enrolment, 49 (70%) of 70 patients had documented serial growth on initial surveillance imaging. 49 (70%) of 70 patients were male and 21 (30%) were female. Median tumour size was 4·6 cm (IQR 3·7-5·5). All patients enrolled had T1-T2a and N0-N1 disease. 23 patients received single-fraction SABR of 26 Gy and 47 received 42 Gy in three fractions. Median follow-up was 43 months (IQR 38-60). Local control at 12 months from treatment commencement was 100% (p<0·0001). Seven (10%) patients had grade 3 treatment-related adverse events, with no grade 4 adverse events observed. Grade 3 treatment-related adverse events were nausea and vomiting (three [4%] patients), abdominal, flank, or tumour pain (four [6%]), colonic obstruction (two [3%]), and diarrhoea (one [1%]). No treatment-related or cancer-related deaths occurred. INTERPRETATION: To our knowledge, this is the first multicentre prospective clinical trial of non-surgical definitive therapy in patients with primary renal cell cancer. In a cohort with predominantly T1b or larger disease, SABR was an effective treatment strategy with no observed local failures or cancer-related deaths. We observed an acceptable side-effect profile and renal function after SABR. These outcomes support the design of a future randomised trial of SABR versus surgery for primary renal cell cancer. FUNDING: Cancer Australia Priority-driven Collaborative Cancer Research Scheme.

Encouraging Patients to Ask Questions: Development and Pilot Testing of a Question Prompt List for Patients Undergoing a Biopsy for Suspected Prostate Cancer.

This study assessed the acceptability and feasibility of a question prompt list (QPL) to facilitate informed treatment decision-making in men with suspected localised prostate cancer, which involves values-based choices between options with similar efficacy but different side effects. The QPL was developed through iterative consultation with consumers, clinicians and researchers. Acceptability was assessed using study-specific questions regarding QPL satisfaction and usefulness and qualitative interviews. Feasibility was determined via the proportion of men given the QPL according to medical records and the completion of standardised measures of decisional outcomes. Quantitative data were analysed using descriptive and univariate statistics. Qualitative data were thematically analysed. Fifty-two men consented; 34 provided data for analysis. The QPL recipients reported moderate-high content satisfaction (70.6%) and perceived usefulness in guiding appointments when receiving biopsy results (64.7%). Two main qualitative themes also indicated the QPL acceptability: (1) the freedom to ask-acceptable timing, flexible usage and usefulness of the QPL, and (2) satisfaction with the QPL content. However, only 18.4% of eligible men received the QPL, indicating limited feasibility. The QPL is safe and acceptable, but further research is needed regarding how to facilitate the uptake of the question prompt list in clinical practice.

Low conflict and high satisfaction: Decisional outcomes after attending a combined clinic to choose between robotic prostatectomy and radiotherapy for prostate cancer.

BACKGROUND: Decisional conflict and post-treatment decisional regret have been documented in men with localised prostate cancer (LPC). However, there is limited evidence regarding decisional outcomes associated with the choice between robotic-assisted radical prostatectomy (RARP) and radiotherapy, when both treatment options are available in the public health system. There is increasing support for multidisciplinary approaches to guide men with LPC in their decision-making process. This study assessed decisional outcomes in men deciding between RARP or radiotherapy treatment before and after attending a LPC combined clinic (CC). METHODS: Quantitative longitudinal data were collected from 52 men who attended a LPC CC, where they saw both a urologist and radiation oncologist. Patients completed questionnaires assessing involvement in decision-making, decisional conflict, satisfaction and regret before and after the CC, three months, six months and 12 months post-treatment. Urologists and radiation oncologists also reported their perceptions regarding patients' suitability for, openness to, perceived preferences and appropriateness for each treatment. Data was analysed using paired/independent samples t-tests and McNemar's tests. RESULTS: Most participants (n = 37, 71%) opted for RARP over radiotherapy (n = 14, 27%); one participant deferred treatment (2%). Urologists and radiation oncologists reported low agreement (κ = 0.26) regarding the most appropriate treatment for each patient. Participants reported a desire for high levels of control over their decision-making process (77.5% patient-led, 22.5% shared) and high levels of decisional satisfaction (M = 4.4, SD = 0.47) after the CC. Decisional conflict levels were significantly reduced (baseline: M = 29.3, SD = 16.9, post-CC: M = 16.3, SD = 11.5; t = 5.37, P < 0.001) after the CC. Mean decisional regret scores were 'mild' at three-months (M = 16.0, SD = 17.5), six-months (M = 18.8, SD = 18.7) and 12-months (M = 18.2, SD = 15.1) post-treatment completion. CONCLUSION: This is the first Australian study to assess decisional outcomes when patients are offered the choice between RARP and radiotherapy in the public health system. A CC seems to support decision-making in men with LPC and positively impact some decisional outcomes. However, larger-scale controlled studies are needed to confirm these findings.

COVID-19 had no impact on emergency urological admissions at an Australian tertiary hospital.

BACKGROUNDS: The COVID-19 pandemic is an unprecedented threat to health and healthcare systems. There is no published data on the impact on urological presentations in Australia. METHODS: A retrospective analysis of all admissions under the urology service at Liverpool Hospital, Australia from February 1st to April 30th for 2020 and the previous 5 years. RESULTS: There was a total of 397 admissions in 2020 and 438 in 2019. The mean age, proportion of male, and mean length of stay were similar. In 2020, there were 229 emergency admissions. Over the same period during the previous 5 years, there were between 195 and 218 emergency admissions. In 2019, there were 220 planned admissions and 168 in 2020. Between 2019 and 2020, there was no significant difference in the proportion of patients with admission longer than 10 days (P = 0.602), requiring intensive care unit admission (P = 0.708) or inpatient operative management (P = 0.171). Among the emergency admissions, the mean Charlson Comorbidity Index was significantly lower in 2020 compared to 2019 (P = 0.009). CONCLUSIONS: Despite the pervasive fear of the COVID-19 pandemic and multiple, substantial alterations to hospital systems, structures and elective operating restrictions, no significant difference in numbers or acuity of emergency admissions were observed. Due to limitations in elective operating, there was an expected reduction in planned admissions. Our findings are in contrast to multiple recent studies and may be the result of our patient demographic where health-seeking behaviours appear to have not been significantly influenced by the pandemic.

Music during flexible cystoscopy for pain and anxiety - a patient-blinded randomised control trial.

OBJECTIVES: To assess the role of music in reducing the pain and anxiety associated with flexible cystoscopy using a blinded trial design. PATIENTS AND METHODS: A patient-blinded randomised control trial of music during flexible cystoscopy was performed comparing the pain, measured by visual analogue scale (VAS), anxiety, measured by the State-Trait Anxiety Inventory (STAI), and vital signs of 109 patients across two public hospitals in New South Wales, Australia. The purpose and hypothesis of the study was concealed from patients until after results had been collected. RESULTS: There were no statistically significant differences detected between the No Music and Music groups in VAS pain score (mean [SD] 2.04 [1.94] vs 2.10 [1.90], P = 0.86), change in STAI anxiety score (mean [SD] 4.87 [9.87] vs 6.8 [11.07], P = 0.33) or post-procedural vital signs (mean [SD] heart rate 74 [14] vs 72 [13] beats/min, P = 0.66; systolic blood pressure 144 [20] vs 141 [19] mmHg, P = 0.47) between the two groups. CONCLUSION: Music does not appear to decrease perceived pain or anxiety when used during flexible cystoscopy. These findings may differ from the literature due to several factors, most significantly blinding of participants, but also potentially due to the ethnic composition of the study population or lack of choice of music.

High negative predictive value of 68Ga PSMA PET-CT for local lymph node metastases in high risk primary prostate cancer with histopathological correlation.

BACKGROUND: Current guidelines highlight the importance of accurate staging in the management and prognostication of high risk primary prostate cancer. Conventional radiologic imaging techniques are insufficient to reliably detect lymph node metastases in prostate cancer. Despite promising results, there is limited published data on the diagnostic accuracy of PSMA PET-CT to assess local nodal metastases prior to radical prostatectomy. This study aims to assess the diagnostic efficacy of 68Ga PSMA PET-CT in local lymph node staging of high risk primary prostate cancer when compared to histopathological findings following radical prostatectomy with pelvic lymph node dissection. METHODS: We retrospectively analysed consecutive patients with high risk primary prostate cancer referred by urologists for primary staging PSMA PET-CT using a 68Ga-labeled PSMA ligand, Glu-NH-CO-NHLys-(Ahx)-[HBEDD-CC], from October 2015 to October 2017. The scans of patients who underwent radical prostatectomy with pelvic lymph node dissection were interpreted by the consensus reading of two experienced nuclear medicine physicians blinded to clinical and histopathological data. The contemporaneous records of the referring urologists were retrospectively reviewed for noteworthy unexpected PET findings that altered their personal preference for surgical management. RESULTS: Seventy-one patients were recruited and analysed. PSMA PET-CT showed findings compatible with local disease in 47 patients (66.2%), lymph node metastases in 10 patients (14.1%) and distant metastases in 14 patients (19.7%). Twenty-eight patients (twenty-seven of whom had local disease only) underwent surgery yielding 214 lymph nodes, all of which were negative on histopathological analysis. On a node-based analysis, 213 of 214 lymph nodes were accurately identified as negative for disease with a negative predictive value of 100%. 11 patients had unexpected PET findings contemporaneously documented by urologists to alter their preference for surgical management. CONCLUSIONS: PSMA PET-CT appears to have a high negative predictive value for local lymph node metastases in high risk primary prostate cancer when compared to histopathological findings following radical prostatectomy with pelvic lymph node dissection.

Robot or radiation? A qualitative study of the decision support needs of men with localised prostate cancer choosing between robotic prostatectomy and radiotherapy treatment.

OBJECTIVE: To understand how best to support men diagnosed with localised prostate cancer to decide which treatment option best suits their needs, when robotic prostatectomy and radiotherapy are equally appropriate to offer them. METHODS: Twenty-five men recently diagnosed with localised prostate cancer completed semi-structured interviews asking about information/decision-making needs before and/or after attending a combined clinic in which they consulted a urologist and a radiation oncologist regarding treatment options. Data was transcribed verbatim and thematically analysed. RESULTS: Most men preferred robotic prostatectomy pre-combined clinic and chose it afterwards. The thematic analysis revealed four themes: 1) trust in clinicians and the information they provide is critical for treatment choice, 2) perceived fit between treatment characteristics and personal circumstances, 3) additional considerations: specific side effects, socio-emotional and financial factors, and 4) need for tailored information delivery. Robotic prostatectomy was mistakenly believed to provide a more definitive cure than radiotherapy, which was seen as having a lesser lifestyle impact. CONCLUSIONS: Treatment choice is largely dependent on clinicians' (mainly urologists') recommendations. PRACTICE IMPLICATIONS: Patients need more balanced information about alternatives to robotic prostatectomy earlier in the treatment decision-making process. Referral to a radiation oncologist or combined clinic shortly after diagnosis is recommended.

A standardized analysis of the current surgical and non-surgical treatment selection process for men with localized prostate cancer.

Robot-assisted radical prostatectomy to treat localized prostate cancer has increased in popularity, although other options exist, including radiotherapy and active surveillance. The decision about choosing the right treatment has become pertinent for many patients. This literature review aimed to assess the current state-of-the-art regarding decisional aids and the associated decisional outcomes for the purpose of designing a method for both patients and doctors to use to make the best treatment decision for the patient. A literature search was conducted via MEDLINE, Embase, and Web of Science databases using the keywords "prostate" and "cancer" and "impact" and "decisio*" and "treatment." Articles were included that focused on treatment outcomes, decision-making processes, and the use of decisional aids for localized prostate cancer. Articles that investigated prostate cancer in general or prostate cancer screening were excluded, as were articles that were not written in English. Altogether, 13 articles were finally critically reviewed for this study. Results were conflicting regarding the relations between patient factors, use of decisional aids, and decisional outcomes. There was a large gap in the literature regarding the optimal decision-making process for men with localized prostate cancer. The role of currently available decisional aids is limited to helping patients make the right decisions. There is a need to develop a novel decisional aid in which patient-physician discussion-involving evaluation of a spectrum of patient-, doctor-, and treatment-related factors-is included.

Systematic Review of Decision Aids for the Management of Men With Localized Prostate Cancer.

A broader range of decisional tools should be investigated. This paper will update the decisional outcome data and assess the features of decisional tool. Literature search strictly followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Articles that cited Lin et al and Violette et al were searched. Features of decisional tools were analyzed using the International Patient Decision Aid Standards Instrument criteria. The scores of the 31 decisional tools ranged from 6 to 15, which did not correlate proportionally with the positive decisional outcomes. Personal importance appeared to be a significant component. Multidisciplinary clinics are superior in improving decisional outcomes as they promote more at shared decision making.

Prostatectomy versus radiotherapy for early-stage prostate cancer (PREPaRE) study: protocol for a mixed-methods study of treatment decision-making in men with localised prostate cancer.

BACKGROUND: Men diagnosed with localised prostate cancer (LPC) wanting curative treatment face a highly preference-sensitive choice between prostatectomy and radiotherapy, which offer similar cure rates but different side effects. This study aims to determine the information, decision-making needs and preferences of men with LPC choosing between robotic prostatectomy and standard external beam or stereotactic radiotherapy. METHODS AND ANALYSIS: This study will be conducted at a large public teaching hospital in Australia offering the choice between robotic prostatectomy and radiotherapy from early 2017. Men (20-30) diagnosed with LPC who want curative treatment and meet criteria for either treatment will be invited to participate. In this mixed-methods study, patients will complete semistructured interviews before and after attending a combined clinic in which they consult a urologist and a radiation oncologist regarding treatment and four questionnaires (one before treatment decision-making and three after) assessing demographic and clinical characteristics, involvement in decision-making, decisional conflict, satisfaction and regret. Combined clinic consultations will also be audio-recorded and clinicians will report their perceptions regarding patients' suitability for, openness to and preferences for each treatment. Qualitative data will be transcribed verbatim and thematically analysed and descriptive statistical analyses will explore quantitative decision-making outcomes, with comparison according to treatment choice. DISCUSSION: Results from this study will inform how to best support men diagnosed with LPC deciding which curative treatment option best suits their needs and may identify the need for and content required in a decision aid to support these men. ETHICS AND DISSEMINATION: All participants will provide written informed consent. Data will be rigorously managed in accordance with national legislation. Results will be disseminated via presentations to both scientific and layperson audiences and publications in peer-reviewed scientific journals.

A Case Report of Priapism With Unusual Presentation and Clinical Course.

This is a case report on a patient with an unusual presentation and clinical course of priapism. It further discusses treatment options with reflection on current literatures and guidelines. 48 year old patient presented with a history of more than 50 episodes of priapism, each lasting for five minutes. Patient had history of brain tumor that was resected and had since been in remission. On examination and further biochemistry assessment revealed conflicting clinical findings, making it difficult to ascertain the type of priapism in this case. The patient, however, recovered from the acute attacks of priapism after 24 hours of conservative management and no obvious cause had been identified on post-discharge follow-up. Priapism, despite being rare, is a medical emergency. This case report reflected upon the limitations of treatment guidelines and the lack of level one evidence to support treatment decisions.

Utilization and Surgical Skill Transferability of the Simulator Robot to the Clinical Robot for Urology Surgery.

INTRODUCTION: Virtual reality is an increasingly popular surgical training tool in Australia, following the introduction of Australia's first virtual reality simulation machine at Liverpool Hospital, Sydney. This literature review aims at identifying gaps in previous studies, and in providing a comprehensive review of future studies to be further developed in Australia. METHOD: A multi-field research was performed combining the key terms 'uro*' and 'virtua*' and 'simula*' and 'robo*'. Academic search engines used in this literature review included 'Medline', 'Scopus', and 'Sciencedirect'. Studies with laparoscopic skills as a focused investigation but not robotic skills were excluded. Critical appraisal of each of the article was conducted with a discussion of key topic involving urologists with expert skills on robotic surgery. RESULT: A thorough literature review discovered 3 main types of studies in this area. These are: (1) validity studies; (2) studies specific for urology procedures; (3) studies on skill transfer, in general. Cohort study and randomized control trial are the 2 dominant forms of research designs. CONCLUSION: Future studies need to focus more around the investigation of operation-specific training, in conjunction with skills-based teaching. Also, it is important that these studies incorporate teamwork, decision-making, and communication skills.

Prostate-specific antigen velocity (PSAV): a practical role for PSA?

BACKGROUND: Prostate cancer is a leading cause of morbidity and mortality in Australian men. Early detection and treatment are critical to patient outcome, but detection is often difficult because of the limited accuracy of available tests. This paper assesses whether the use of prostate specific antigen kinetics has a practical use in the contemporary urological setting. METHODS: A Medline literature review was performed examining related articles on the commonly available tests for prostate cancer, what they mean, their limited accuracy in cancer detection, and how this accuracy can be improved. DISCUSSION: Detection of significant organ-confined prostate cancer should be the goal of general practitioners and urologists alike. Prostate-specific antigen and digital rectal examination are commonly used but lack specificity and sensitivity, especially for small organ-confined cancers. The additional use of prostate-specific antigen velocity may enhance the specificity and sensitivity of detection.

Nerve grafting at the time of radical prostatectomy: should we be doing it?

BACKGROUND: With increasing numbers of younger men being diagnosed with prostate cancer and subsequently undergoing radical prostatectomy, there is an increasing focus on quality of life postoperatively, especially potency. In patients with locally advanced disease, it has been suggested that use of nerve grafts at the time of radical prostatectomy may improve potency. The technique was first described in 1999 and several papers have been published about its utility. However, there is still controversy over its use because of the lack of any large, blinded trials, the anatomy of the cavernous nerves and the necessity of excising the neurovascular bundles (especially bilaterally). In addition, the results achieved with nerve grafting, a procedure not without significant morbidity and mortality, do not exceed those produced by surgeons carrying out nerve-sparing procedures. RESULTS: In the published work reviewed, erections sufficient to produce vaginal penetration following unilateral nerve grafting (with contralateral nerve sparing) were evident in 41.7-63.6% of patients. This is similar to the rates of 23-64% with unilateral nerve sparing alone. The rates of erectile function sufficient to produce vaginal penetration following bilateral nerve grafting were 34-72%, whereas it is widely accepted that very few men without nerve grafting would have any degree of potency. CONCLUSIONS: Currently, there does not appear to be a widespread role for nerve grafting at the time of radical prostatectomy.

Androgen deprivation therapy--managing side effects.

BACKGROUND: Prostate cancer is the most common nondermatologic cancer in Australian men. Androgen deprivation therapy (ADT) as a modality of treatment is being increasingly used much earlier and for a longer period of time. Its various regimens all have side effects which influence the patient's health and quality of life. OBJECTIVE: This article discusses practical evidence based management options for treating the short and long term side effects of ADT. DISCUSSION: The side effects of ADT can be categorised as sexual, physical, metabolic, emotional and systemic. A combination of prediction and early recognition is useful in diagnosing side effects. Tailored strategies are available to combat the problems.

Prostate cancer detection in men with an initial diagnosis of atypical small acinar proliferation.

OBJECTIVE: To determine the subsequent prostatic adenocarcinoma detection rate amongst men with an initial diagnosis of atypical small acinar proliferation (ASAP). PATIENTS AND METHODS: We reviewed the Illawarra Prostate Pathology Database over a 10-year period (January 1994 to January 2004) for specimens diagnosed as ASAP. These specimens were re-reviewed and clinical data obtained. RESULTS: Of 61 cases of ASAP, there were complete follow-up data for 31. In this group nine patients had no further biopsies at our institution; the other 22 had at least one repeat biopsy. The incidence of prostatic adenocarcinoma in this group was 17/31 (55%). This included 13 diagnoses on second biopsy, three on third biopsy and one diagnosed at another institution. CONCLUSION: This study showed a detection rate for prostatic adenocarcinoma of 55% after an initial diagnosis of ASAP, which indicates that an initial diagnosis of ASAP mandates re-biopsy.