One-Year, Open-Label Extension Study on the Safety and Efficacy of Abiraterone Acetate Fine Particle Formulation in Patients With Metastatic Castration-Resistant Prostate Cancer

Purpose: Abiraterone acetate is an androgen synthesis inhibitor used to treat metastatic castration-resistant prostate cancer. The therapeutic equivalence, pharmacokinetics, and safety of abiraterone acetate fine particle (AAFP) versus originator abiraterone acetate (OAA) were examined in a Phase-2 study; sufficient similarity was observed between the 2 treatments. This 1-year, open-label, extension study evaluated the long-term safety and efficacy of AAFP. Patients and methods: This was an open-label, single-arm extension study. Patients who completed the 84-day, Phase-2, run-in study could enroll to receive 500 mg AAFP once daily and 4 mg methylprednisolone twice daily for up to 1 year. Safety was the primary endpoint, as assessed by adverse event monitoring throughout the study. Secondary efficacy endpoints included change from run-in study baseline levels of serum testosterone and prostate-specific antigen measured at baseline, 6 months, and 1 year. Results: Twenty patients enrolled, of whom 9 and 11 received prior AAFP and OAA in the run-in study, respectively. Both prior treatment groups maintained a significant decrease in serum testosterone from run-in baseline at all timepoints; mean change from run-in baseline ± standard deviation at 1 year of −6.24 ± 2.02 ( P = .0023) and −5.87 ± 3.64 ( P = .0026) ng/dL for the prior AAFP and OAA group, respectively. Change from run-in baseline in serum prostate-specific antigen was not significant. Most (84.0%) adverse events were Grade 1 or 2. Conclusion: No new safety signals were identified, and patients were able to successfully switch from OAA to AAFP with no impact.

Clinical Outcomes of Retrograde Intrarenal Surgery as a Primary Treatment for Staghorn Calculi: A Single-Center Experience

Objective: We investigated the efficacy and safety of retrograde intrarenal surgery (RIRS) as a primary treatment for staghorn calculi. Methods: From 2012 to 2016, we identified 39 patients with staghorn calculi who received RIRS as a primary treatment. During the study period, no staghorn calculi were treated primarily with percutaneous nephrolithotomy or any other modality. A stone-free status after RIRS was defined as no detectable stone fragments on X-rays or computed tomography scans. Results: Of 39 patients who received 134 procedures (median 3 procedures per patient; range: 1-11; mean stone length: 60.5 ± 23.0 mm), 18 (46%) and 21 (54%) had staghorn calculi <60 and >60 mm in maximum length, respectively. The stone-free rates after the first and final procedures were 21% (8 of 39) and 62% (24 of 39), respectively; overall, 39% (7 of 18) and 78% (14 of 18), respectively, for the 18 patients with <60 mm staghorn calculi; and 5% (1 of 21) and 48% (10 of 21), respectively, for the 21 patients with >60 mm calculi. Multivariate analysis revealed a maximum stone length >60 mm to be the only independent predictor of a stone-free status after the first and final procedures. During the treatment series, perioperative complications occurred in 16 (41%) patients. Only one patient presented with a Clavien-Dindo grade III complication (malposition of a ureteral stent). Conclusions: RIRS is a safe and effective treatment option for staghorn calculi.

The Prevalence and Forecast Prevalence of Overactive Bladder in the Medicare Population

Objectives: To determine current and future prevalence of overactive bladder (OAB) among Medicare fee-for-service beneficiaries in the United States. Methods: Prevalence of OAB in US adults ⩾ 65 years was determined using the 2013 Medicare Beneficiary Part B Carrier Claims File, Part D Drug Event File, and Medicare Beneficiary Annual Summary File. Prevalence for 2027 was forecasted with US Census population projections. Regional projections were based on applying national OAB rates by age, sex, and race/ethnicity to zip code tabulation area beneficiary populations. Results: In the 2013 dataset, the prevalence of OAB was 7.2% (male: 7.7%; female: 6.7%). Across demographic categories, prevalence was the highest among those aged more than 74 years (9.3%), identifying as White (7.4%), and residing in urban areas (7.5%). By 2027, OAB is projected to increase by 48.1%. Discussion: OAB affects a substantial proportion of the US fee-for-service beneficiary population, with the prevalent population projected to rise substantially by 2027.

Role of Serum and Urinary Biomarkers in Evaluation and Management of Patients With Overactive Bladder

Background: This study compared urinary and serum nerve growth factor levels and serum C-reactive protein levels in patients with overactive bladder, before and after treatment with antimuscarinic agents, to evaluate their diagnostic and therapeutic importance. Methods: This was a prospective case-control study conducted between February 2014 and December 2014 which included patients with a confirmed diagnosis of overactive bladder (overactive bladder group) and healthy controls (control group). All patients visiting urology out-patient department with urgency, frequency, and urge incontinence were assessed for overactive bladder and, if eligible, were enrolled in the study. Biomarkers were evaluated before in both groups and after antimuscarinic treatment in the overactive bladder group. Results: Overall, 80 participates were enrolled (overactive bladder, n = 40; control, n = 40). The mean age was not different between the two groups (overactive bladder, 48.6 years; control, 46.9 years [ P = 1.01]) and females were more in both the groups (60% and 55%, respectively). The majority (70%) of patients presented with frequency and urgency. After 3 months of treatment with antimuscarinics, the mean overactive bladder symptom score decreased significantly from 8.4 to 4.85 ( P < .001). The mean urinary and serum nerve growth factor levels and serum C-reactive protein levels also decreased significantly from baseline after 3 months of treatment with antimuscarinics (24.78 pg/mL, 22.46 pg/mL, 0.89 mg/L, respectively; P < .0001). Conclusions: Measurement of urinary and serum nerve growth factor levels has diagnostic and therapeutic potential in patients with overactive bladder.

Urinary pH as a Target in the Management of Lithiasic Patients in Real-World Practice: Monitoring and Nutraceutical Intervention for a Nonlithogenic pH Range

Introduction: We assessed the effectiveness of the joint use of a pH meter in combination with dietary supplements in restoring the urinary pH balance of patients with medical history of uric acid or calcium phosphate/calcium oxalate stones in real-world practice. Methods: An interventional, prospective, and open-label study was performed. At baseline visit, patients were assigned to a group according to the type of previous calculus and urinary pH: the alkalinizer group (uric acid stones and/or pH < 5.5) and acidifier group (calcium oxalate stones and/or pH > 6.2) received dietary supplement to increase or decrease, respectively, urinary pH. Patients were examined at baseline and after treatment for 30, 60, and 90 days. Urinary pH, type of therapy, compliance, and self-reported renal colic events were recorded at each visit. Results: The study included 143 patients, 45.5% in the alkalinizer group and 54.5% in the acidifier group, and the mean age was 53.60 years. Both nutraceuticals were significantly effective in normalizing urinary pH ( P < 0.00001) at all follow-up visits compared with baseline, with a maximum percentage of patients who achieved nonlithogenic pH (54.9%) at day 60 ( P < 0.00001). Analysis of the effect of treatment compliance at 60 days indicated that 71.8% of compliant and 45.9% of noncompliant patients achieved nonlithogenic pH (odds ratio [OR]: 3.03, 95% confidence interval [CI]: 1.29-6.66). A Cox-regression model indicated that nonlithogenic pH at 90 days (hazard ratio [HR]: 0.428, 95% CI: 0.193-0.947) and compliance at 60 days (HR: 0.428, 95% CI: 0.189-0.972) were independently associated with colic complaints-free survival. Conclusions: In patients with medical history of renal lithiasis, monitoring of pH in combination with dietary supplements may be useful in maintaining nonlithogenic pH values, yielding very high ratios of success, especially in compliant patients. Besides this main outcome, a reduction in self-reported colic complaints associated with pH balance was also observed.

Treatment of Metastatic Renal Cell Carcinoma: Latest Evidence and Ongoing Challenges

Recently, the development of antiangiogenic drugs has changed the therapy for metastatic renal cell carcinoma (RCC). As a result, the survival of individuals with advanced RCC has more than doubled. The median overall survival improved from 12 months during the cytokines era to near 30 months with antiangiogenic drugs. In this decade, the advent of immune checkpoint inhibitors showed enthusiastic results and is the new standard of care for patients with metastatic RCC previously treated with antiangiogenic drugs. The combination of immune checkpoint inhibitors plus antiangiogenic drugs may have a synergistic activity. As a result, current studies investigate the combination for treatment-naïve patients. This may potentially change clinical practice. In this article, we will highlight new therapeutic options available and agents or combinations that are being investigated for metastatic RCC.