Longitudinal follow-up and performance validation of an mRNA-based urine test (Xpert® Bladder Cancer Monitor ) for surveillance in patients with non-muscle-invasive bladder cancer.

OBJECTIVE: To evaluate the performance of the Xpert Bladder Cancer Monitor (Xpert; Cepheid, Sunnyvale, CA, USA) test as a predictor of tumour recurrence in patients with non-muscle-invasive bladder cancer (NMIBC). PATIENTS AND METHODS: Patients (n = 429) undergoing surveillance for NMIBC underwent Xpert, cytology, and UroVysion testing. Patients with a positive Xpert and a negative cystoscopy result (positive-negative [PN] group, n = 66) and a control group of double negative patients (negative Xpert and cystoscopy results [NN] group) were followed for 12 months (±90 days). RESULTS: Histology-confirmed recurrences were detected in 58 patients (13.5%). Xpert had an overall sensitivity of 60.3% and a specificity of 76.5%. The sensitivity for high-grade (HG) cancer was 87% with a negative predictive value (NPV) of 99%. Urine cytology showed an overall sensitivity of 23.2% (47.6% sensitivity for HG tumours) and a specificity of 88.3%. In the PN group, 32% (n = 21) developed a recurrence within 12 months, 11 of which were HG tumours. In the NN control group, 14% (n = 9) developed a recurrence and only two were HG tumours. The hazard ratio for developing recurrence in the PN group was 2.68 for all tumours and 6.84 for HG cancer. CONCLUSIONS: The Xpert test has a high sensitivity for detecting the recurrence of cancer and a high NPV for excluding HG cancer. In addition, the data suggest that patients with a positive Xpert assay in the setting of negative cystoscopy are at high risk for recurrence and need close surveillance.

Transperineal Prostate Biopsies Using Local Anesthesia: Experience with 1,287 Patients. Prostate Cancer Detection Rate, Complications and Patient Tolerability.

PURPOSE: We report our experience with transperineal prostate biopsy as well as the cancer diagnosis rate, complications and patient tolerability in 1,287 consecutive patients at risk for prostate cancer. MATERIALS AND METHODS: Beginning in October 2016 transperineal prostate biopsy was performed using local anesthesia in all patients undergoing prostate biopsy. Data on prebiopsy characteristics and results, including the cancer detection rate, complications and patient tolerability scores, were collected retrospectively from patient records. RESULTS: The cancer detection rate of transperineal prostate biopsy was 49.8% (641 of 1,287 patients). Clinically significant prostate cancer was detected in 385 patients and 62 (9.7%) had exclusively anterior zone pathology findings. Urinary retention developed in 20 patients (1.6%) following transperineal prostate biopsy, requiring temporary catheterization. In 4 patients (0.3%) lower urinary tract symptoms were suggestive of infection but only 1 had a positive urine culture. The only hospital admission was for a patient with persistent hypotension after biopsy. Patients tolerated transperineal prostate biopsy reasonably well and generally reported only mild levels of discomfort on a pain visual analogue scale. Infiltration of the anesthesia was rated more painful than the biopsy. CONCLUSIONS: Transperineal prostate biopsy with the patient under local anesthesia is a feasible alternative to transrectal biopsy in the detection of prostate cancer. Transperineal prostate biopsy has an acceptable cancer detection rate with additional detection of anterior zone cancers. It is a safer alternative in patients due to the low risk of complications, in particular urosepsis, and it is well tolerated. Transperineal prostate biopsy using local anesthesia could be considered a standard modality for the initial diagnosis of prostate cancer.

Improving prostate cancer care collaboratively - a multidisciplinary, formal, consensus-based approach.

INTRODUCTION: There are numerous standard treatment options for men diagnosed with localized prostate cancer. Multidisciplinary consultation before decision-making is a consensus- and quality-based objective in Ontario. With the goals of working together more collaboratively and to provide higher quality information for patients at the time of decision-making, a prostate cancer community partnership consensus (PCPC) panel was formed among six partnering centers in the Greater Toronto Area. MATERIALS AND METHODS: Five iterative meetings were held among 40 prostate cancer specialists (32 urologists and 8 radiation oncologists) who participate in multidisciplinary clinics. The meetings defined the goals of the partnership as well as the topics and questions the group would address together. Answers to these questions were developed by formal consensus: >= 75% of participants had to agree with wording based on secret ballots to achieve consensus. RESULTS: All six groups wanted to participate to improve patient care/decision-making. Forty-one questions addressing 30 issues were derived from the literature and the group's collective experience. These issues were cross-tabbed against five management options: active surveillance, radical prostatectomy, low dose rate brachytherapy, high dose rate brachytherapy boost and external beam radiation. Answers common to all modalities were coalesced. Eighty-six issues were subjected to formal consensus. After three rounds of secret ballots, consensus was achieved for the answers to all issues. CONCLUSIONS: A formal consensus-based partnership between urology and radiation oncology to support newly diagnosed prostate cancer patients was feasible and resulted in a patient information guide which may improve decision-making.

Metastatic progression following multimodal therapy for unfavorable-risk prostate cancer.

INTRODUCTION: Identifying the optimal management of unfavorable-risk (Prostate Cancer Risk Stratification [ProCaRS] high intermediate-, high-, and very high-risk categories) non-metastatic prostate cancer is an important public health concern given the large burden of this disease. We compared the rate of metastatic progression-free survival among men diagnosed with unfavorable-risk non-metastatic prostate cancer who were initially treated with radiation therapy or radical prostatectomy. METHODS: Information was obtained from medical records at two academic centers in Canada from 333 men diagnosed with unfavorable-risk non-metastatic prostate cancer between 2007 and 2012. Median followup was 90.4 months. Men were eligible for the study if they received either primary radiation therapy (n=164) or radical prostatectomy (n=169), in addition to various adjuvant and salvage therapies when deemed clinically appropriate. Patients were matched on prognostic covariates using two matching techniques. Multivariable Cox proportional hazards models were used to estimate the hazard ratios (HR) and confidence intervals (CI) for metastatic progression-free survival between groups. RESULTS: After matching, treatment groups were balanced on prognostic variables except for percent core positivity. Hazard ratios from all Cox proportional hazards models (i.e., before and after matching, and with and without multivariable adjustment) showed no difference in the rate of metastatic progression-free survival between groups (adjusted unmatched HR 1.16, 95% CI 0.63, 2.13, p=0.64). CONCLUSIONS: Metastatic progression-free survival did not differ between men diagnosed with unfavorable risk non-metastatic prostate cancer who were treated with either radiation therapy or radical prostatectomy.

Diagnosis, referral, and primary treatment decisions in newly diagnosed prostate cancer patients in a multidisciplinary diagnostic assessment program.

INTRODUCTION: We aimed to report on data from the multidisciplinary diagnostic assessment program (DAP) at the Gale and Graham Wright Prostate Centre (GGWPC) at North York General Hospital (NYGH). We assessed referral, diagnosis, and treatment decisions for newly diagnosed prostate cancer (PCa) patients as seen over time, risk stratification, and clinic type to establish a deeper understanding of current decision-making trends. METHODS: From June 2007 to April 2012, 1277 patients who were diagnosed with PCa at the GGWPC were included in this study. Data was collected and reviewed retrospectively using electronic patient records. RESULTS: 1031 of 1260 patients (81.8%) were seen in a multidisciplinary clinic (MDC). Over time, a decrease in low-risk (LR) diagnoses and an increase intermediate-risk (IR) diagnoses was observed (p<0.0001). With respect to overall treatment decisions 474 (37.1%) of patients received primary radiotherapy, 340 (26.6%) received surgical therapy, and 426 (33.4%) had conservative management; 57% of patients who were candidates for active surveillance were managed this way. No significant treatment trends were observed over time (p=0.8440). Significantly, different management decisions were made in those who attended the MDC compared to those who only saw a urologist (p<0.0001). CONCLUSIONS: In our DAP, the vast majority of patients presented with screen-detected disease, but there was a gradual shift from low- to intermediate-risk disease over time. Timely multidisciplinary consultation was achievable in over 80% of patients and was associated with different management decisions. We recommend that all patients at risk for prostate cancer be worked up in a multi-disciplinary DAP.

Gasless laparoscopy for the urologist.

PURPOSE: To explore the use of gasless laparoscopy in urology. MATERIALS AND METHODS: Over 120 patients underwent various urological procedures with this technique from September 1994. For extraperitoneal procedures, balloon dissection was used to develop the extraperitoneal space. A mechanical retraction system was used with conventional laparotomy instruments to perform laparoscopic Burch bladder neck suspensions, staging pelvic lymphadenectomies, two-team abdominovaginal slings, nephrectomies, and ureterectomy. RESULTS: Early results indicate that this gasless technique may result in much quicker operative times with similar success rates to the conventional carbon dioxide laparoscopy with respect to bladder neck suspensions. Conversion to an open procedure was also lower with this technique. CONCLUSIONS: Gasless laparoscopic techniques may facilitate urological procedures, and may be easier and quicker to learn. Previous multiple surgeries and excess weight are not contraindications to performing this laparoscopic technique.

Improved wait time intervals for prostate cancer patients in a multidisciplinary rapid diagnostic unit compared to a community-based referral pattern.

BACKGROUND: Wait times in cancer diagnosis and treatment may significantly affect a patient's treatment outcome, prognosis and quality of life. The purpose of this study was to capture wait time intervals for patients with prostate cancer treated with radiotherapy (RT) at the Odette Cancer Centre, Toronto, Ontario, Canada and to compare patients diagnosed in a rapid diagnostic unit (RDU) versus the usual community referral process. METHODS: Patients agreed to participate in the study during their RT planning sessions. A semi-structured interview and chart abstraction was conducted to record key wait time milestones. RESULTS: A total of 87 patients participated in the study: 44 RDU patients and 43 community patients. The median overall wait time intervals from suspicion of prostate cancer to RT was 138 and 183 days, respectively (p = 0.046). There were statistically significant differences observed for other key wait time intervals favouring the RDU cohort: suspicion to decision-to-treat (DTT; p = 0.012), urologist visit to diagnosis (p = 0.0094), diagnosis to DTT (p = 0.018), and diagnosis to treatment (p = 0.016). Risk category and Gleason sum was independently predictive of longer intervals from diagnosis to DTT. INTERPRETATION: Wait time intervals from suspicion to treatment are significantly shorter for prostate cancer patients in 2011 to 2012 than in 2003 when patients were diagnosed and referred in the community setting. A prostate-specific RDU further reduced a number of key wait time intervals supporting more multidisciplinary RDUs for common diseases. Further work needs to be done to identify why delays are occurring and to develop new processes to minimize delays.

Levofloxacin for chronic prostatitis/chronic pelvic pain syndrome in men: a randomized placebo-controlled multicenter trial.

OBJECTIVES: To perform a Canadian multicenter randomized placebo-controlled trial to evaluate the safety and efficacy of 6 weeks of levofloxacin therapy compared with placebo in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Uncontrolled studies have supported the use of antibiotics in CP/CPPS. METHODS: Men with a National Institutes of Health (NIH) diagnosis of CP/CPPS (specifically, no infection localized to the prostate) were randomized to levofloxacin (500 mg/day) or placebo for 6 weeks in 11 Canadian centers. Patients were assessed at baseline and at 3, 6, and 12 weeks with the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) and global patient assessments (subjective global assessment and patient assessment questionnaire). RESULTS: Eighty men (average age 56.0 years, range 36 to 78; duration of symptoms 6.5 years, range 0.6 to 32) were randomized to receive levofloxacin (n = 45) or placebo (n = 35). All were evaluated in an intent-to-treat analysis. Both groups experienced progressive improvement in symptoms as measured by the NIH-CPSI. However, the difference in response was not statistically or clinically significant at end of treatment (6 weeks) or at the end of the follow-up visits (12 weeks). No patients withdrew because of adverse events. One patient withdrew before the 6-week assessment. Adverse events (all mild) were reported in 20% of the levofloxacin group and 17% of the placebo group. CONCLUSIONS: This pilot placebo-controlled study showed that 6 weeks of levofloxacin therapy in men diagnosed with CP/CPPS resulted in symptom improvement that was not significantly different from that with placebo at end of treatment or follow-up. The clinical ramifications of these findings need to be addressed.