The SUB-urothelial DUrvalumab InjEction-1 (SUBDUE-1) trial: first-in-human trial in patients with bladder cancer.

OBJECTIVES: To assess the safety of sub-urothelial injection of durvalumab and examine the impact on tissue and circulating immune cell populations. PATIENTS AND METHODS: The patients were chemotherapy and immunotherapy naïve (bacille Calmette-Guérin allowed) with non-metastatic muscle-invasive bladder cancer or non-muscle-invasive bladder cancer planned for radical cystectomy (RC). The study was a Phase Ib 3 + 3 dose-escalation design with sub-urothelial injection of durvalumab at three pre-determined doses (25, 75, 150 mg) diluted in 25 mL normal saline, injected at 25 locations (25 × 1 mL injections), at least 2 weeks before RC. RESULTS: A total of 11 patients were recruited (10 male, one female). No significant changes were reported on American Urological Association Symptom Score or O'Leary Interstitial Cystitis Scale. In all, 14 adverse events (AEs) were reported (10 Grade 1, three Grade 2, one Grade 3), none considered immune-related. No Grade 4 or 5 AEs were recorded. All the patients underwent RC. Tissue immune populations changed following durvalumab injection (P = 0.012), with a statistically significant increase in M2-macrophage (CD163) when comparing the 25-150 mg dose (P = 0.021). Basal/mixed cancers showed a larger CD163 increase than luminal cancers (P = 0.033). CONCLUSION: Sub-urothelial injection of durvalumab is feasible and safe without immune-related AEs and shows local immunological effects.

Technetium-99 m-sestamibi single-photon emission computerised tomography (CT)/CT in the prediction of malignant versus benign small renal masses.

OBJECTIVES: To determine the effectiveness of technetium-99m (99m Tc)-sestamibi single-photon emission computerised tomography/computerised tomography (SPECT/CT) in distinguishing between malignant and benign renal lesions. PATIENTS AND METHODS: Between June 2018 and October 2020 all patients with new indeterminate small renal masses (SRMs) underwent 99m Tc-sestamibi renal SPECT/CT before biopsy or surgery. The accuracy of 99m Tc-sestamibi imaging diagnoses was assessed against histopathology. Receiver operating characteristic (ROC) analysis was used to determine the optimum cut-off for the tumour:normal uptake ratio. Logistic regression was used to determine if quantitative analysis significantly added to visual interpretation alone. RESULTS: A total of 74 patients with SRMs were investigated with 99m Tc-sestamibi SPECT/CT. The SPECT/CT correctly identified 49 malignant tumours and 11 benign tumours, resulting in a sensitivity of 0.89 (95% confidence interval [CI] 0.77-0.95) and a specificity of 0.73 (95% CI 0.45-0.91). The ROC analysis of uptake ratios demonstrated that a tumour:normal uptake ratio of 0.41 provided optimal diagnostic accuracy (sensitivity 0.81, specificity 0.88, area under the curve 0.883 [95% CI 0.794-0.971]). The uptake ratio was also highly significant in excluding malignancy on univariate logistic regression analysis whereby the higher the uptake ratio, the lower the chances were for malignancy (odds ratio 0.009, 95% CI 0.001-0.118, P < 0.001). However, this did not improve diagnostic accuracy when compared to visual interpretation alone. CONCLUSION: 99m Tc-sestamibi SPECT/CT is a non-invasive technique with good accuracy in determining if a SRM is benign or malignant.

'Pain-free TRUS B': a phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasonography-guided prostate biopsy (ANZUP 1501).

OBJECTIVE: To determine whether the addition of inhaled methoxyflurane to periprostatic infiltration of local anaesthetic (PILA) during transrectal ultrasonography-guided prostate biopsies (TRUSBs) improved pain and other aspects of the experience. PATIENTS AND METHODS: We conducted a multicentre, placebo-controlled, double-blind, randomized phase 3 trial, involving 420 men undergoing their first TRUSB. The intervention was PILA plus a patient-controlled device containing either 3 mL methoxyflurane, or 3 mL 0.9% saline plus one drop of methoxyflurane to preserve blinding. The primary outcome was the pain score (0-10) reported by the participant after 15 min. Secondary outcomes included ratings of other aspects of the biopsy experience, willingness to undergo future biopsies, urologists' ratings, biopsy completion, and adverse events. RESULTS: The mean (SE) pain scores 15 min after TRUSB were 2.51 (0.22) in those assigned methoxyflurane vs 2.82 (0.22) for placebo (difference 0.31, 95% confidence interval [CI] -0.75 to 0.14; P = 0.18). Methoxyflurane was associated with better scores for discomfort (difference -0.48, 95% CI -0.92 to -0.03; P = 0.035, adjusted [adj.] P = 0.076), whole experience (difference -0.50, 95% CI -0.92 to -0.08; P = 0.021, adj. P = 0.053), and willingness to undergo repeat biopsies (odds ratio 1.67, 95% CI 1.12-2.49; P = 0.01) than placebo. Methoxyflurane resulted in higher scores for drowsiness (difference +1.64, 95% CI 1.21-2.07; P < 0.001, adj. P < 0.001) and dizziness (difference +1.78, 95% CI 1.31-2.24; P < 0.001, adj. P < 0.001) than placebo. There was no significant difference in the number of ≥ grade 3 adverse events. CONCLUSIONS: We found no evidence that methoxyflurane improved pain scores at 15 min, however, improvements were seen in patient-reported discomfort, overall experience, and willingness to undergo repeat biopsies.

Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study.

BACKGROUND: Conventional imaging using CT and bone scan has insufficient sensitivity when staging men with high-risk localised prostate cancer. We aimed to investigate whether novel imaging using prostate-specific membrane antigen (PSMA) PET-CT might improve accuracy and affect management. METHODS: In this multicentre, two-arm, randomised study, we recruited men with biopsy-proven prostate cancer and high-risk features at ten hospitals in Australia. Patients were randomly assigned to conventional imaging with CT and bone scanning or gallium-68 PSMA-11 PET-CT. First-line imaging was done within 21 days following randomisation. Patients crossed over unless three or more distant metastases were identified. The primary outcome was accuracy of first-line imaging for identifying either pelvic nodal or distant-metastatic disease defined by the receiver-operating curve using a predefined reference-standard including histopathology, imaging, and biochemistry at 6-month follow-up. This trial is registered with the Australian New Zealand Clinical Trials Registry, ANZCTR12617000005358. FINDINGS: From March 22, 2017 to Nov 02, 2018, 339 men were assessed for eligibility and 302 men were randomly assigned. 152 (50%) men were randomly assigned to conventional imaging and 150 (50%) to PSMA PET-CT. Of 295 (98%) men with follow-up, 87 (30%) had pelvic nodal or distant metastatic disease. PSMA PET-CT had a 27% (95% CI 23-31) greater accuracy than that of conventional imaging (92% [88-95] vs 65% [60-69]; p<0·0001). We found a lower sensitivity (38% [24-52] vs 85% [74-96]) and specificity (91% [85-97] vs 98% [95-100]) for conventional imaging compared with PSMA PET-CT. Subgroup analyses also showed the superiority of PSMA PET-CT (area under the curve of the receiver operating characteristic curve 91% vs 59% [32% absolute difference; 28-35] for patients with pelvic nodal metastases, and 95% vs 74% [22% absolute difference; 18-26] for patients with distant metastases). First-line conventional imaging conferred management change less frequently (23 [15%] men [10-22] vs 41 [28%] men [21-36]; p=0·008) and had more equivocal findings (23% [17-31] vs 7% [4-13]) than PSMA PET-CT did. Radiation exposure was 10·9 mSv (95% CI 9·8-12·0) higher for conventional imaging than for PSMA PET-CT (19·2 mSv vs 8·4 mSv; p<0·001). We found high reporter agreement for PSMA PET-CT (κ=0·87 for nodal and κ=0·88 for distant metastases). In patients who underwent second-line image, management change occurred in seven (5%) of 136 patients following conventional imaging, and in 39 (27%) of 146 following PSMA PET-CT. INTERPRETATION: PSMA PET-CT is a suitable replacement for conventional imaging, providing superior accuracy, to the combined findings of CT and bone scanning. FUNDING: Movember and Prostate Cancer Foundation of Australia. VIDEO ABSTRACT.

A phase I open label dose-escalation study to evaluate the tolerability, safety and immunological efficacy of sub-urothelial durvalumab injection in adults with muscle-invasive or high-risk non-muscle-invasive bladder cancer (SUBDUE-1, SUB-urothelial DUrvalumab injection-1 study): clinical trial protocol.

OBJECTIVES: This article presents the clinical trial protocol for a phase I open label dose-escalation study to evaluate the tolerability, safety and immunological efficacy of sub-urothelial durvalumab injection in adults with muscle-invasive or high-risk non-muscle-invasive bladder cancer (NMIBC), the SUB-urothelial DUrvalumab injection-1 study (SUBDUE-1). The primary objectives of this study are to assess the safety of sub-urothelial injection of durvalumab using patient reported outcome measures and observed local or systemic adverse events. The secondary objectives are to examine the local immunological efficacy of sub-urothelial administration of durvalumab. PATIENTS AND METHODS: The SUBDUE-1 trial will include adult patients with either high-risk NMIBC or MIBC, who are scheduled for radical cystectomy or who have refused or are unsuitable for systemic neoadjuvant chemotherapy. Three fixed total dose levels of durvalumab (25, 75, 150 mg) will be studied to identify a dose suitable to be taken forward into phase II trials. The primary endpoint is to evaluate the safety and tolerability of the trial intervention in terms of the incidence and severity of adverse events and the potential establishment of dose-limiting toxicities. The secondary efficacy endpoints include rates of pT0 status at resection, lymph node status, as well as the change in distribution of tumour-infiltrating lymphocytes and tumour-activated macrophages between pre- and post-injection bladder biopsies. Translational studies will focus on bladder tumour molecular sub-typing, immune infiltrate characterisation, and immune checkpoint protein expression relative to efficacy end-points. OUTCOME AND SIGNIFICANCE: If proven safe and effective, this novel strategy comprising sub-urothelial durvalumab injections aimed at promoting an anti-tumour immune reaction, will provide additional treatment options for reducing tumour recurrence and progression in treatment-naïve patients with high-risk NMIBC or in patients with bacille Calmette-Guérin-refractory NMIBC. Local administration of durvalumab may be associated with a reduced rate of immunological side-effects and lower costs when compared to systemic delivery.

Nurse-led telephone notification of a prostate cancer diagnosis: Prospective analysis of men's preferences for and experiences of a same-day assessment and diagnostic clinic.

OBJECTIVE: The 'One Stop Prostate Clinic' (OSPC) was a same-day prostate cancer assessment and/or diagnostic clinic. Preferences and experiences of men who received initial telephone notification of their prostate biopsy results (cancer or benign) by the OSPC Clinical Nurse (CN) are reported. METHODS: Prospective mixed methods study using survey instrument and thematic analysis of OSPC preferences and experiences. RESULTS: One thousand men attended the OSPC between August 2011 and November 2017, 876 underwent prostate biopsies; 790/876 (90%) men consented to telephone notification of biopsy results, 5/876 (1%) declined and 79/876 (9%) were ineligible/not contacted. 220/403 men (55%) returned the OSPC questionnaire; 135/220 (61%) men received a cancer diagnosis, 119/132 (90%) would choose this method again and 7/132 (5.5%) would not and 6/132 (4.5%) were unsure; 94/135 (70%) reported no disadvantages with this notification method. Overall satisfaction rate with the OSPC was 96% (209/218) men. CONCLUSION: Initial telephone notification of prostate biopsy results by the OSPC CN was preferred by the vast majority of eligible men. Many men with a cancer diagnosis did not experience any disadvantages. This method of results delivery can be incorporated by other tumour groups.

Immediate versus delayed exercise in men initiating androgen deprivation: effects on bone density and soft tissue composition.

OBJECTIVES: To examine whether it is more efficacious to commence exercise medicine in men with prostate cancer at the onset of androgen-deprivation therapy (ADT) rather than later on during treatment to preserve bone and soft-tissue composition, as ADT results in adverse effects including: reduced bone mineral density (BMD), loss of muscle mass, and increased fat mass (FM). PATIENTS AND METHODS: In all, 104 patients with prostate cancer, aged 48-84 years initiating ADT, were randomised to immediate exercise (IMEX, n = 54) or delayed exercise (DEL, n = 50) conditions. The former consisted of 6 months of supervised resistance/aerobic/impact exercise and the latter comprised 6 months of usual care followed by 6 months of the identical exercise programme. Regional and whole body BMD, lean mass (LM), whole body FM and trunk FM, and appendicular skeletal muscle (ASM) were assessed by dual X-ray absorptiometry, and muscle density by peripheral quantitative computed tomography at baseline, and at 6 and 12 months. RESULTS: There was a significant time effect (P < 0.001) for whole body, spine and hip BMD with a progressive loss in the IMEX and DEL groups, although lumbar spine BMD was largely preserved in the IMEX group at 6 months compared with the DEL group (-0.4% vs -1.6%). LM, ASM, and muscle density were preserved in the IMEX group at 6 months, declined in the DEL group at 6 months (-1.4% to -2.5%) and then recovered at 12 months after training. FM and trunk FM increased (P < 0.001) over the 12-month period in the IMEX (7.8% and 4.5%, respectively) and DEL groups (6.5% and 4.3%, respectively). CONCLUSIONS: Commencing exercise at the onset of ADT preserves lumbar spine BMD, muscle mass, and muscle density. To avoid treatment-related adverse musculoskeletal effects, exercise medicine should be prescribed and commenced at the onset of ADT.

Delays in the diagnosis and initial treatment of bladder cancer in Western Australia.

OBJECTIVES: To quantify and examine the causes of delays in the diagnosis and initial treatment of patients with bladder cancer in Western Australia. SUBJECTS AND METHODS: All attendances at a one-stop haematuria clinic at a public tertiary-level hospital in Western Australia between May 2008 and April 2014 were reviewed retrospectively. All patients diagnosed with a bladder tumour over this period were identified. These patients and their general practitioners were contacted retrospectively and invited to participate in telephone interviews, with additional data collected from clinical records as required. Waiting times to presentation, referral, assessment, and initial treatment were established for patients who presented with visible haematuria. RESULTS: Of 1 365 attendances, 151 patients were diagnosed with a bladder tumour and 100 of these were both suitable and agreed to participate in the study. For patients with visible haematuria the median (range) waiting time from initial bleeding to surgery was 69.5 (9-1 165) days. This was comprised of a median (range) pre-referral waiting time of 12 (0-1 137) days, assessment waiting time of 23.5 (0-207) days, and treatment waiting time of 20 (1-69) days. Reasons for prolonged waiting times included poor public awareness, patient fear and anxiety, delayed and non-referral from primary care, administrative delays, and resource limitations. CONCLUSION: Many patients experience significant delays in the diagnosis and treatment of their bladder cancer in Western Australia, and this probably reflects national trends. These concerning data warrant consideration of how delays can be reduced to improve outcomes for these patients.

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer.

OBJECTIVES: To test the feasibility and efficacy of a multifaceted model of shared care for men after completion of treatment for prostate cancer. PATIENTS AND METHODS: Men who had completed treatment for low- to moderate-risk prostate cancer within the previous 8 weeks were eligible. Participants were randomized to usual care or shared care. Shared care entailed substituting two hospital visits with three visits in primary care, a survivorship care plan, recall and reminders, and screening for distress and unmet needs. Outcome measures included psychological distress, prostate cancer-specific quality of life, satisfaction and preferences for care and healthcare resource use. RESULTS: A total of 88 men were randomized (shared care n = 45; usual care n = 43). There were no clinically important or statistically significant differences between groups with regard to distress, prostate cancer-specific quality of life or satisfaction with care. At the end of the trial, men in the intervention group were significantly more likely to prefer a shared care model to hospital follow-up than those in the control group (intervention 63% vs control 24%; P<0.001). There was high compliance with prostate-specific antigen monitoring in both groups. The shared care model was cheaper than usual care (shared care AUS$1411; usual care AUS$1728; difference AUS$323 [plausible range AUS$91-554]). CONCLUSION: Well-structured shared care for men with low- to moderate-risk prostate cancer is feasible and appears to produce clinically similar outcomes to those of standard care, at a lower cost.

BCG+MMC trial: adding mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer: a randomised phase III trial (ANZUP 1301).

BACKGROUND: Despite adequate trans-urethral resection of the bladder tumour (TURBT), non-muscle-invasive bladder cancer (NMIBC) is associated with high rates of recurrence and progression. Instillation of Bacillus Calmette-Guérin (BCG) into the urinary bladder after TURBT (adjuvant intravesical administration) reduces the risk of both recurrence and progression, and this is therefore the standard of care for high-risk tumours. However, over 30 % of people still recur or progress despite optimal delivery of BCG. Our meta-analysis suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both mitomycin and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase III trial using standard techniques for intravesical administration. METHODS AND DESIGN: The BCG + MMC trial (ANZUP 1301) is an open-label, randomised, stratified, two-arm multi-centre phase III trial comparing the efficacy and safety of standard intravesical therapy (BCG alone) against experimental intravesical therapy (BCG and mitomycin) in the treatment of adults with resected, high-risk NMIBC. Participants in the control group receive standard treatment with induction (weekly BCG for six weeks) followed by maintenance (four-weekly BCG for ten months). Participants in the experimental group receive induction (BCG weeks 1, 2, 4, 5, 7, and 8; mitomycin weeks 3, 6, and 9) followed by four-weekly maintenance (mitomycin weeks 13, 17, 25, 29, 37, and 41; BCG weeks 21, 33, and 45). The trial aims to include 500 participants who will be centrally randomised to one of the two treatment groups in a 1:1 ratio stratified by T-stage, presence of CIS, and study site. The primary endpoint is disease-free survival; secondary endpoints are disease activity, time to recurrence, time to progression, safety, health-related quality of life, overall survival, feasibility, and resource use. TRIAL REGISTRATION: This trial is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12613000513718 ).

A 'One Stop' Prostate Clinic for rural and remote men: a report on the first 200 patients.

OBJECTIVE: To report on the structure and outcomes of a new 'One Stop' Prostate Clinic (OSPC) designed specifically for rural and remote men. PATIENTS AND METHODS: Prospective cohort study of the first 200 rural or remote men to access a new OSPC at a public tertiary-level hospital in Western Australia between August 2011 and August 2014. Men attended for urological assessment, and proceeded to same-day transrectal ultrasonography-guided prostate biopsies, if appropriate. Referral criteria were either two abnormal age-related prostate-specific antigen (PSA) levels in the absence of urinary tract infection (UTI), or an abnormal digital rectal examination (DRE) regardless of PSA level. RESULTS: The median (range) distance travelled was 1545 (56-3229) km and median (range) time from referral to assessment was 33 (2-165) days. The median (range) age was 62 (38-85) years, PSA level was 6.7 (0.5-360) ng/mL and 39% (78/200) had a suspicious DRE. In all, 92% (184/200) of men proceeded to prostate biopsies, and 60% (111/184) of these men were diagnosed with prostate cancer. Our complication rate was 3.5% (6/172). Radical prostatectomy (46/111), active surveillance (28/111) and external beam radiation therapy (26/111) were the commonest subsequent treatment methods. A $1045 (Australian dollars) cost-saving per person was estimated based on the reduced need for travel with the OSPC model. CONCLUSION: The OSPC is an effective and efficient model for assessing men suspected of having prostate cancer living in rural and remote areas of Western Australia, and this model may be applicable to other areas.

Retrograde ureteric stent insertion in the management of infected obstructed kidneys.

OBJECTIVES: To quantify the outcomes of retrograde ureteric stenting in the setting of infected hydronephrosis secondary to ureteric calculi. PATIENTS AND METHODS: Prospective analysis of all patients over a 15-month period admitted with infected obstructed kidneys secondary to ureteric calculi. Inclusion criteria were based on clinical evidence of systemic inflammatory response syndrome (SIRS) and radiological evidence of obstructing ureteric calculi. Outcome measures included success of procedure, admission to intensive care unit (ICU), length of hospital stay, morbidity, and all-cause mortality during hospital admission. RESULTS: In all, 52 patients were included. Success of retrograde ureteric stenting was 98%. In all, 17% of patients required an ICU admission, with a post ureteric instrumentation ICU admissions rate of 6%. The mean white cell count and serum creatinine improved significantly after the procedure. Major complication rate included septic shock 6%, but there were no episodes of major haemorrhage and no deaths. CONCLUSION: Retrograde ureteric stenting is safe and effective in infected obstructed kidneys with results comparable to percutaneous nephrostomy tube insertion. Post instrumentation ICU admissions occur in 6% of retrograde stentings.

The case of the shrinking testis.

We report the case of a man with idiopathic lymphocytic orchitis (LO) manifested by undifferentiated testicular pain and atrophy. Conventional investigation results were unremarkable. Oral ciprofloxacin only improved the pain temporarily. Scrotal exploration surgery was performed to exclude acute testicular torsion and a biopsy was taken during surgery for histological examination. Histology revealed severe LO with reduced spermatogenesis. A trial of oral steroids was initially effective but the effect was temporary. Due to chronic pain, he eventually underwent unilateral orchidectomy. Histology confirmed the initial diagnosis of LO. He was pain-free postoperatively. Idiopathic LO is a rarely reported cause of testicular atrophy.

A randomised controlled trial comparing use of lignocaine periprostatic nerve block alone and combined with diclofenac suppository for patients undergoing transrectal ultrasound (TRUS)-guided prostate biopsy.

OBJECTIVE: To examine whether or not the combination of diclofenac suppository with peri-prostatic nerve block (PPNB) was effective in reducing the degree of pain experienced during transrectal ultrasound (TRUS)-guided prostate biopsy in a randomised single-blind placebo-controlled trial. PATIENTS AND METHODS: In all, 96 patients having a planned TRUS-guided prostate biopsy were randomised into one of the following arms on a 1:1 basis: 10 mL 1% lignocaine PPNB and placebo suppository (control) or 10 mL 1% lignocaine PPNB and 100 mg diclofenac suppository (treatment). Pain scores were recorded using the Numerical Rating Scale for pain (0-10) at the following time-points: (i) introduction of probe, (ii) during biopsy, (iii) 1 h after biopsy, (iv) later that evening (≈6 h after biopsy) and (v) 1 day after biopsy. Patients were asked about their preferred method for pain control if a repeat TRUS-guided prostate biopsy was required: local anaesthetic (LA) again or intravenous sedation. RESULTS: There were no significant differences in age (P = 0.653) or PSA level (P = 0.584) between either study arm. The differences in pain scores between the control and treatment groups were not significant at Time 1 (probe insertion; P = 0.299), Time 2 (biopsy; P = 0.983), Time 4 (evening after; P = 0.231) and Time 5 (1 day after biopsy; P = 0.384). At Time 3 (1 h after biopsy), the control pain scale scores were statistically significantly higher than the treatment pain scale scores (P = 0.044). There was no difference between treatment (87%) and control (80%) groups as to whether they would prefer to repeat the biopsy under LA (P = 0.373). CONCLUSION: The use of a diclofenac suppository with PPNB did not show any clinically meaningful effect in decreasing pain or improving tolerability of TRUS-guided prostate biopsy and is not recommended. PPNB TRUS-guided biopsy is extremely well tolerated, with >80% of patients electing for subsequent LA biopsy if required.

The conservative management of renal trauma: a literature review and practical clinical guideline from Australia and New Zealand.

OBJECTIVE: To review the literature and make practical recommendations regarding the conservative management of renal trauma. PATIENTS AND METHODS: Relevant articles and guidelines published between 1980 and 2014 were reviewed. Graded recommendations were constructed by a multi-disciplinary panel consisting of urologists, radiologists, and infectious disease physicians. These recommendations underwent formal review and debate at the Western Australian USANZ 2013 state conference, and were presented at the USANZ 2014 annual scientific meeting. RESULTS: The literature on the conservative management of renal trauma is reviewed within the framework of the American Association for the Surgery of Trauma (AAST) kidney injury severity scale. Graded recommendations are made regarding several key topics including: imaging, inpatient management, antibiotics, return to activity, and follow-up. Grade IV injuries and intraoperative consults are examined separately in view of the difficulties these groups cause in making appropriate treatment decisions. CONCLUSION: A practical clinical guideline is provided regarding the conservative management of renal trauma.

Comparing fluorodeoxyglucose positron emission tomography with computed tomography in staging for nodal and distant metastasis in urothelial/bladder cancer.

Objectives: We aim to assess the clinical value of 18F-fluorodeoxyglucose positron (18F-FDG-PET) scan in detecting nodal and distant metastasis compared with computed tomography (CT) scan in patients with urothelial carcinoma or bladder cancer, aiming to improve staging accuracy and thereby better prognosticate and determine therapy. Methods: A retrospective review of 75 patients with invasive bladder cancer (≥T1) who were staged with both CT and 18F-FDG-PET within an 8-week interval was performed for the period between 2015 and 2020. Seventy-two per cent (54/75) had formal pelvic lymph node (LN) dissection or biopsy of lesions suspicious for metastases. FDG-PET definitions for positive sites were assessed depending on SUV Max (nodes with SUVmax >4 at any size, SUV > 2 for lymph nodes >8 mm, or any SUV if the lymph node was >10 mm on axial images). For CT scanning, enlarged LN by RECIST 1.1 criteria (>10 mm) as well as qualitative findings suggesting metastasis were considered positive. The analysis was based on the comparison of CT and 18F-FDG-PET findings to histopathology results from LN dissection or biopsies. Results: Sensitivity, specificity, positive predictive values (PPV) and negative predictive value (NPV) of CT versus FDG-PET for detecting metastasis, in patients who underwent pelvic LN dissection or biopsy of lesions suspicious of metastases, were 46.6% (95% CI: 21%-70%) versus 60% (95% CI: 32%-84%), 100% (95% CI: 91%-100%) versus 83.78% (95% CI: 69%-94%), 100% (95% CI: 63%-100%) versus 60% (95% CI: 32%-84%), and 82.2% (95% CI: 68%-92%) versus 83.78% (95% CI: 69%-94%), respectively. 7/75 (9.3%) patients avoided cystectomy due to 18F-FDG-PET features of metastases that were not detected by CT. Conclusion: FDG-PET may be more sensitive than CT for metastases in the staging of bladder cancer, which resulted in significant avoidance of aggressive local management in cases with occult metastasis.

Intravesical chemotherapy plus bacille Calmette-Guérin in non-muscle invasive bladder cancer: a systematic review with meta-analysis.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Non-muscle-invasive bladder cancer has a significant recurrence and progression rate despite transurethral resection. The current standard of care to lower the risk of recurrence and progression is adjuvant BCG followed by maintenance BCG. Despite this, a significant number of patients experience recurrence and progress to invasive cancer. Several randomized trials have studied combination therapy (BCG with chemotherapy) to try to reduce the recurrence and progression rate. We performed a systematic review with meta-analysis and found that adjuvant BCG followed by maintenance therapy is the appropriate standard of care when compared with combination therapy. We conclude that further trials are warranted to test the effects of adding chemotherapy to BCG in patients with Ta or T1 disease, but not in those with Tis alone. OBJECTIVE: To determine if the combination of intravesical chemotherapy and maintenance bacille Calmette-Guérin (BCG), used in sequence, is superior to maintenance BCG alone in the treatment of non-muscle-invasive bladder cancer (NMIBC). METHODS: We searched biomedical literature databases for randomized controlled trials that compared sequential, intravesical chemotherapy added to maintenance BCG with maintenance BCG alone. Studies that did not use maintenance BCG were excluded. The meta-analysis was performed using the fixed effects model. RESULTS: Four trials were identified, including 801 patients. Adding chemotherapy to maintenance BCG did not result in a significant reduction in recurrence (relative risk [RR] 0.92; 95% confidence interval [CI] 0.79-1.09; P = 0.32) or progression (RR 0.88; 95% CI 0.61-1.27; P = 0.5). The risk of recurrence (RR 0.75; 95% CI 0.61-0.92; P = 0.006) and progression (RR 0.45; 95% CI 0.25-0.81; P = 0.007) were reduced when the single trial that included isolated Tis was excluded. Toxicity was similar for both groups. CONCLUSIONS: Adjuvant therapy with induction BCG followed by maintenance BCG is the appropriate standard of care for patients with resected NMIBC at high risk of recurrence. Further trials are warranted to test the effects of adding chemotherapy to BCG in patients with Ta or T1 disease, but not in those with Tis alone.

Solitary fibrous tumour of the urinary bladder - A rare and potentially malignant neoplasm.

Solitary fibrous tumours (SFTs) of the urinary bladder are a rare mesenchymal neoplasm that occasionally has malignant potential. The tumour is characterised by haphazardly arranged spindle-shaped to ovoid cells, with a prominent, branching, thin-walled, dilated vasculature and NAB2-STAT6 gene rearrangement. While most SFTs are indolent in nature, difficulty arises predicting which SFTs are potentially malignant. There are now validated risk stratification tools to help identify which SFTs are likely to metastasize and help clinicians determine management. The mainstay of treatment for SFTs remains surgery, with emerging evidence in the combined use of surgery and radiotherapy.

Current trends in penile cancer survivorship amongst remote patients and Aboriginal people in Western Australia.

BACKGROUND: Penile cancer is a rare urological malignancy, accounting for less than 1% of all cancers in males. Given its rarity, few studies exist reporting survival outcomes. The primary objective of this project was to review the mortality of patients diagnosed with penile cancer in Western Australia between 1992 and 2017 and to determine if Aboriginal and Torres Strait Islander people and patients in rural and remote regions experience discrepancies in survival outcomes. METHODS: All cases of penile cancer recorded within the Western Australia Cancer Registry between 1992 and 2017 were reviewed. Analysis was performed using chi-squared test of association, binomial logistic regression and survival analysis was conducted using Kaplan Meier and Cox Regression analysis. RESULTS: One hundred eighty-six cases of penile cancer were identified; 62 patients (33%) were from regional or remote locations and nine patients (4.8%) were Aboriginal. 13 of the regional or remote patients and 5 of the Aboriginal patients died from penile cancer. Patients who were Aboriginal (HR 6.512, CI 2.123-19.968; P = 0.001) or from regional or remote Western Australia (HR 2.382, CI 1.050-5.401; P = 0.038) were at an increased risk of penile cancer-specific mortality. CONCLUSIONS: Aboriginal people with penile cancer and men from regional and remote Western Australia experience worse penile cancer-specific survival outcomes.