A Randomized Feasibility Trial Comparing Surveillance Regimens for Patients with Low and Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer.

BACKGROUND: Surveillance regimens for non-muscle invasive bladder cancer (NMIBC) are disparate and controlled trials could inform guidelines. The feasibility of randomizing patients to variable frequency surveillance is unknown. OBJECTIVES: To determine patient willingness to randomization to high frequency (HF) versus low frequency (LF) surveillance regimen for NMIBC and compare patient comfort and healthcare costs across regimens. METHODS: A non-blinded, two-arm, randomized-controlled study of patients with low or low-intermediate risk NMIBC was conducted at two institutions where patients were offered randomization to HF vs. LF surveillance following initial tumor resection. The HF group underwent cystoscopy every three months for 2 years, then every 6 months for 2 years, then annually. The LF group underwent cystoscopy at 9 months following the 3-month cystoscopy, then annually. Assuming 75% of patients approached would agree to enrollment, a sample size of n = 35 patients per arm provided a one-sided 95% exact Clopper-Pearson confidence lower-limit of 60%. RESULTS: Of 70 patients approached, 45 (64.3%) agreed to participate and 25 (35.7%) declined enrollment due to preference for HF. Twelve biopsies were performed, including 4 (19%) of 21 patients in the HF group and 8 (33.3%) of 24 patients in the LF group. Disease recurrence (low grade Ta) was observed in 3 (14.3%) and 5 (20.8%) patients in the HF and LF groups, respectively. No patients experienced high grade recurrence or progression. Both groups had similar patient-reported procedure-related discomfort and quality of life measures over time. Patient out-of-pocket cost and healthcare systems costs were $383.80 more per patient annually in the HF group. CONCLUSIONS: Randomization to variable frequency surveillance is challenging as over a third of patients declined participation. However, these data provide important preliminary insights into the potential effects of surveillance frequency on oncologic and economic outcomes in patients with low and low-intermediate risk bladder cancer.

Prospective Implementation of a Point-of-Care PCR-Based Detection Method to Guide Antibiotic Use Prior to Prostate Biopsy Compared to Targeted Prophylaxis and Physician Choice.

OBJECTIVE: To perform pilot testing regarding implementation of a point-of-care qPCR-based test (EST200) targeting bacterial clonal groups representing the majority of sepsis-causing Escherichia coli before prostate biopsy to determine antibiotic selection. MATERIALS AND METHODS: After IRB approval, we obtained rectal swabs to compare real-time qPCR analysis on a Rotor-Gene Q instrument (Qiagen, Hilden, Germany) to standard culture on ciprofloxacin infused (10mg/L) MacConkey agar and susceptibility testing. Techniques are compared by an area under the receiver operative curve (AUC). RESULTS: A total of 140 men participated in the study, 102 prebiopsy cultures were utilized to guide prophylaxis. We did not meet our accrual for the randomized portion of the clinical study, yet we did randomized 38 men without prebiopsy cultures to physician choice of antibiotic versus PCR-based approach. Regarding predicting Fluoroquinolone Resistant (FQR) at biopsy, prebiopsy cultures had an AUC of 0.91 (95%CI 0.84-1.00, P > .001) and polymerase chain reaction (PCR) had an AUC of 0.71 (95%CI 0.58-0.84, P = .005) (AUC comparison; Z = 2.31, P = .02). PCR correctly identified 4 of 5 FQR specimens. The PCR test attained an AUC of 0.79 (95%CI 0.56-1.00, P = .044) for detection of total FQR on the day of the biopsy. Risk-based techniques may overcompensate with additional antibiotics (21% versus 0%, P = .10). CONCLUSION: EST200 is a rapid PCR-based microbial detection system that has moderate ability to detect total FQR at the time of biopsy. Our study is underpowered, yet provide opportunities to improve the point of care PCR method, such as table tope testing in less than 20 minutes and include additional antibacterial resistant genes.

Prediagnostic prostate-specific antigen kinetics and the risk of biopsy progression in active surveillance patients.

OBJECTIVE: To analyze the association between prediagnostic prostate-specific antigen kinetics and the risk of biopsy progression in prostate cancer patients on active surveillance, and to study the effect of prediagnostic prostate-specific antigen values on the predictive performance of prostate-specific antigen velocity and prostate-specific antigen doubling time. METHODS: The study included 137 active surveillance patients with two or more prediagnostic prostate-specific antigen levels measured over a period of at least 3 months. Two sets of analyses were carried out. First, the association between prostate-specific antigen kinetics calculated using only the prediagnostic prostate-specific antigen values and the risk of biopsy progression was studied. Second, using the same cohort of patients, the predictive value of prostate-specific antigen kinetics calculated using only post-diagnostic prostate-specific antigens and compared with that of prostate-specific antigen kinetics based on both pre- and post-diagnostic prostate-specific antigen levels was analyzed. RESULTS: Of 137 patients included in the analysis, 37 (27%) had biopsy progression over a median follow-up period of 3.2 years. Prediagnostic prostate-specific antigen velocity of more than 2 ng/mL/year and 3 ng/mL/year was statistically significantly associated with the risk of future biopsy progression. However, after adjustment for baseline prostate-specific antigen density, these associations were no longer significant. None of the tested prostate-specific antigen kinetics based on combined pre- and post-diagnostic prostate-specific antigen values were statistically significantly associated with the risk of biopsy progression. CONCLUSIONS: Historical prediagnostic prostate-specific antigens seems to be not clinically useful in patients diagnosed with low-risk prostate cancer on active surveillance.