Urology Times staff

Podcasts

In this episode, Angela B. Smith, MD, MS, of UNC Lineberger Comprehensive Cancer Center, discusses the recent FDA approval of Jelmyto, which is the first therapy for the treatment of low-grade upper tract urothelial cancer.

Speaking of Urology podcast: Dr. Angela Smith discusses Jelmyto for low-grade UTUC

	Noninvasive prostate MRI system improves lesion conspicuity

	Siemens Healthcare received FDA clearance for its noninvasive SEEit prostate magnetic resonance imaging (MRI) solution. SEEit uses high-channel surface coils, providing a noninvasive image technique that improves lesion conspicuity in diffusion-weighted imaging with Siemens’ RESOLVE technology, the company says. It offers improved patient set-up and accelerated scans to help optimize process efficiency. Powered by syngo MR E11 software architecture, SEEit gives users high-performance MAGNETOM Aera 1.5 Tesla and MAGNETOM Skyra 3T MRI systems that can perform a routine prostate exam in just 10 minutes without using an endorectal coil. Use of Direct RF and high-density coil technology Tim 4G and RESOLVE technology delivers the essential signal-to-noise ratio and resolution that enable users to perform prostate MRI using only the company’s new Body 30/60 surface coil, according to Siemens.

	For more information, visit 

	Targeted prostate biopsy device receives FDA clearance

	Focal Healthcare Inc. received 510(k) FDA clearance for its targeted prostate biopsy device, Fusion Bx. It is designed to take targeted biopsies directly from suspicious cancer regions within the prostate using MRI-ultrasound fusion technology. According to the company, fusion biopsy has been shown to detect high-grade cancer in 30% more men compared to traditional systematic biopsy. By accurately determining the location and extent of the cancer, this procedure also allows clinicians to confidently monitor cancer progression over time and prescribe the appropriate course of treatment to patients with varying grades of cancer. The 510(k) clearance includes the use of Fusion Bx for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2-D and 3-D image visualization, including review, manipulation, and analysis tools.

	For more information, visit 

	FDA approves label update for LHRH treatment for prostate Ca

	TOLMAR Pharmaceuticals has announced that it received FDA approval for a label update for leuprolide acetate for injectable suspension (Eligard), a luteinizing hormone-releasing hormone (LHRH) agonist. Prior to mixing, the drug may be stored for up 8 weeks at room temperature (59–86° F) following removal from refrigeration, according to the FDA. Eligard, indicated for the palliative treatment of advanced prostate cancer, uses a controlled-release delivery system known as ATRIGEL. It is available in 1-, 3-, 4-, and 6-months doses.

	For more information, visit 

	FDA approves mobile-connected ultrasound device for urology

	Signostics has received FDA 510(k) clearance for Uscan, a smart mobile-connected ultrasound visualization device designed for urologic care. Uscan uses computer vision algorithms to actively recognize the 3-D contours of the bladder. It is able to capture up to 256 3-D bladder slices and can provide real-time ultrasound imaging of the kidneys, pelvic floor, prostate, gallbladder, bladder stones, and catheter emplacement. Uscan also offers integrated middleware and has capabilities beyond urology. It is compatible with Android operating systems and has built-in Wi-Fi and Bluetooth connectivity for interoperability with electronic medical record systems.

	For more information, visit 

	Test helps identify candidates for new bladder cancer agent

	Laboratory Corp. of America Holding (LabCorp) has made available VENTANA PD-L1 (SP142) Assay as a complementary diagnostic test in the treatment of urothelial cancer. Designed to be used in conjunction with atezolizumab (TECENTRIQ), which was recently FDA approved for the treatment of certain individuals with locally advanced or metastatic urothelial carcinoma, VENTANA PD-L1 Assay will help identify patients who may benefit from atezolizumab treatment. The test was developed by Roche Diagnostics. It can identify the PD-L1 protein on tumor infiltrating immune cells and will also provide physicians with an immune cell scoring algorithm. VENTANA PD-L1 Assay was approved by the FDA in May 2016.

	For more information, visit 

	FDA grants approval to treatment for advanced RCC

	Exelixis has announced that the FDA approved cabozantinib (Cabometyx), which targets multiple tyrosine kinases, for the treatment of patients with advanced renal cell carcinoma who have received prior angiogenic therapy. In a phase III trial of patients with advanced RCC, the therapy demonstrated clinically meaningful improvements in all three key efficacy parameters-overall survival, progression-free survival, and objective response rate. In comparison with treatments using everolimus, cabozantinib demonstrated a 42% reduction in the rate of disease progression or death. Median progression-free survival for cabozantinib was 7.4 months compared to 3.8 months for everolimus, and median overall survival was 21.4 months for cabozantinib-treated patients versus 16.5 months for those treated with everolimus. The most common side effects associated with cabozantinib include diarrhea, fatigue, nausea, decreased appetite, hand-foot syndrome, high blood pressure, vomiting, weight loss, and constipation.

	For more information, visit 

	FDA approves combination regimen to treat advanced RCC

	Eisai Inc. has announced that it has received FDA approval for lenvatinib (Lenvima), a multiple receptor tyrosine kinase inhibitor, in combination with everolimus (Afinitor) for the treatment of individuals with advanced renal cell carcinoma who were previously treated with an anti-angiogenic therapy. During the registration study, the once-daily combination of lenvatinib, 18 mg, and everolimus, 5 mg, demonstrated an improvement in progression-free survival, objective response rate, and overall survival when compared with treatments using only everolimus. Patients using the combination therapy experienced a 63% reduction in the risk of disease progression or death compared with everolimus alone. The combination regimen also saw patients experience a 10.1-month increase in average overall survival versus everolimus monotherapy. The most common adverse reactions in study patients were hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, proteinuria, diarrhea, renal failure and impairment, gastrointestinal perforation and fistula formation, and QT interval prolongation.

	For more information, visit 

	FDA approves RCC treatment that targets immune system

	Bristol-Myers Squibb received FDA approval for nivolumab (Opdivo) injection, for intravenous use, for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that works by targeting the immune system through the PD-1 immune checkpoint pathway. It is the first PD-1 inhibitor to deliver significant overall survival in patients with advanced RCC who have received prior anti-angiogenic therapy, according to Bristol-Myers Squibb. The approval was based on data from a study of patients with advanced RCC who were randomized to receive either nivolumab or everolimus (Afinitor). Those treated with nivolumab lived an average of 25 months after treatment initiation versus 19.6 months in those treated with everolimus. The most common side effects associated with the use of nivolumab include weakness and lack of energy, cough, nausea, rash, dyspnea, and arthralgia.

	For more information, visit 

	Laser fiber safety device helps prevent intraoperative fires and injuries

	Patient Pocket, LLC has launched the LaserDock, a single-use, disposable surgical laser fiber safety holder designed to house and protect laser fibers during laser surgery. “Regarding laser stone surgery, there are cases in which laser fiber safety is not addressed,” according to Steven Nakada, MD, of the Laser Safety Advisory Panel and the University of Wisconsin, Madison. The LaserDock has been cleared for marketing by the FDA under the 510(k) regulatory process. Used properly, it helps to prevent intraoperative fires and injuries due to accidental laser energy discharge, aiding surgeons and operating room personnel to better conform to FDA and Joint Commission standards. LaserDock can be used with holmium, GreenLight, and CO2 laser fibers.

	For more information, visit 

	FDA approves sNDA to update labeling of CRPC drug

	The FDA has approved a supplemental New Drug Application (sNDA) for enzalutamide (XTANDI) that will update the U.S. product labeling to include new clinical data about how the drug performed against bicalutamide, according to Astellas Pharma Inc. and Pfizer Inc. Based on the phase II TERRAIN Trial, data showed a nearly 40% improvement rate in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (CRPC) who were treated with enzalutamide versus those treated with bicalutamide. The enzalutamide group data showed a median rPFS of 19.5 compared with 13.4 months in the bicalutamide group. The trial enrolled 375 chemotherapy-naïve patients with metastatic CRPC and was designed to evaluate patients on a randomized 1:1 basis. The study found the safety profile of enzalutamide to be consistent with previous trials.

	For more information, visit 

	Brightwater Medical, Inc. has received FDA clearance for its ConvertX Nephroureteral Stent System to treat ureteral obstructions. Unlike traditional stent procedures, the ConvertX System does not require interventional radiologists to perform a second invasive procedure to exchange a nephrostomy catheter for an internal ureteral stent to circumvent the blockage. The system is converted from a catheter to a stent in a brief office procedure without the need for sedation or radiation and remains implanted in the patient like a standard internal ureteral stent. In addition to the FDA clearance, Brightwater also received a medical device manufacturing license from the California Department of Public Health for the ConvertX System.

	For more information, visit 

	What anti-PD-L1 immunotherapy approval means for urology

	FDA approval of a new form of immunotherapy as well as a companion diagnostic test will have a significant impact on patients with the most common type of bladder cancer in the U.S., a leading urologic cancer expert says. 

Articles

Urology-related FDA approvals from 2016 encompassed drugs and devices for prostate cancer, renal cell carcinoma, bladder cancer, stone disease, and more.

Urology FDA approvals of 2016

	University of Miami Miller School of Medicine, Miami

• BPH treatment with finasteride (Proscar)/tadalafil (Cialis) combination therapy led to a significant reduction in International Prostate Symptom Score. The treatment also provides early improvement in lower urinary tract symptoms in men with moderate-sized prostate volumes compared to finasteride alone; longer follow-up is needed to determine whether this attenuation of effects continues out further.

	• A randomized clinical trial of alfuzosin (Urotraxal)/propiverine combination therapy versus alfuzosin alone for patients with symptomatic bladder outlet obstruction and overactive bladder yielded a dose-dependent reduction in the OAB symptom score for the combination therapy group, as well as a drop in IPSS score. Storage and voiding symptoms also improved in the combination therapy group.

	• Imidafenacin and tamsulosin (Flomax) in patients with BPH/OAB refractory to alpha-blockers is a safe, effective, and durable combination therapy.

	• In two studies of acute urinary retention following antimuscarinic use in men with BPH, incidence of retention appeared to be higher than reported in most clinical trials. Retention occurs within the first 3 months 80% of the time. In addition, the incidence of acute urinary retention increases markedly in elderly patients.

	• In 40 BPH/OAB patients, treatment with mirabegron (Myrbetriq) led to a significant decrease in IPSS score, a slight improvement in Qmax, and a slight increase in post-void residual.

	• Long-term testosterone replacement therapy does not appear to affect LUTS in the majority of patients.

	• Men with BPH and a PSA >4.0 ng/mL who exercised vigorously for an hour raised their PSA level by an average of 25%. Over the next 2 days, they sustained the increase in PSA level, which subsequently declined. Men should abstain from physical exercise at least 24 hours before PSA screening.

	• Polymorphisms of cytochrome P450-17, glutathione S-transferase-M1, interleukin 4, steroid 5-alpha-reductase, and the vitamin D receptor appear to be associated with BPH/LUTS.

	• The antioxidants vitamin C, lutein/zeaxanthin, and β-cryptoxanthin may prevent LUTS in elderly men.

	• Two single-nucleotide polymorphisms were associated with exacerbation of LUTS in African-American men.

	• In the future, tyrosine kinase inhibitors or antiangiogenesis medications may be useful for patients with BPH.

	• Bipolar plasma vaporization of the prostate outperformed bipolar transurethral resection in saline and monopolar transurethral resection of the prostate in operative time, intraoperative bleeding, hospital stay, catheterization time, and transfusion requirements.

	• Photoselective vaporization of the prostate with the GreenLight XPS 180W laser (American Medical Systems) showed comparable efficacy to TURP with fewer serious side effects, decreased catheterization times, and shorter length of stay.

Bruce R. Kava, MD, presents the take home messages on BPH/LUTS from the AUA annual meeting in San Diego.

Best of AUA 2013: BPH/LUTS

	Columbia University Medical Center, New York

	• In 96 centers, successful stone-free percutaneous nephrolithotomy (PCNL) was predicted by many parameters, including stone volume. Researchers created a nephrolithometric nomogram with a predictive accuracy of 76%.

	• With strict computed tomography imaging criteria for assessment of residual stone status, the S.T.O.N.E. (Surgical Classification System for Renal Stones) nephrolithometry scoring system is reproducible and predictive of treatment success. The system also showed good interobserver reliability.

	• Nomograms can preoperatively predict which patients are likely to have residual fragments following PCNL. They can then be selected for earlier and stricter post-op imaging to identify residual fragments and undergo second-look procedures.

	• Greater dietary intake of vegetables, fruits, and total dietary fiber were each associated with a reduced risk of stone disease in postmenopausal women. Only dietary fiber was an independent predictor. Greater vegetable intake was associated with a 12%-24% decreased risk of kidney stones, and greater fruit intake was associated with a 6%-21% decreased risk of stone formation in adjusted analyses.

	• High caloric intake was indicative of future stone disease. But low calorie intake did not prevent kidney stone disease.

	• Caloric intake and food products predicted whether stone disease would increase. In particular, total calories, fat grams, protein ounces, and fruits and vegetables correlated positively with an annual increase in stone disease, specifically dark green vegetables, flour, cereal products, corn products, and especially high-fructose corn syrup and other sugars.

	• The incidence of nephrolithiasis is higher in geographic areas where the populations have low fruit and high sugar intake.

• The annual cost of urolithiasis related to obesity in the U.S. is expected to reach an additional $200 million per year by 2030 as obesity rates grow. Urologists may want to consider talking to patients in conjunction with nutritionists about heart-healthy diets.

	• Aminobisphosphonates improve bone mineral density and slow lithogenic activity. Their administration in association with thiazides produces the same clinical effects and also reduces calciuria and improves bone mineral density.

	• Stone analysis is recommended for each stone episode since composition may significantly change in subsequent stone analysis. Almost 30% of patients had a different stone composition on second analysis.

	• In patients who form calcium phosphate stones, brushite stones were associated with higher urinary calcium excretion and higher urinary mean super saturation calcium phosphate when compared to hydroxyapatite stones. Aggressive measures to reduce urinary calcium may be helpful to prevent brushite stone formation.

	• There is marked underutilization of 24-hour urine analysis in recurrent stone formers.

	• Compared to extracorporeal shock wave lithotripsy, focused ultrasonic propulsion produced no detectable tissue injury to the renal parenchyma when using clinical treatment parameters. Efforts are under way for FDA approval of human feasibility studies of the ultrasonic propulsion technique.

	• In ultrasound, a wide range of potentially therapeutic intensities have a low probability of causing injury.

	• Pre-PCNL nephrostomy drainage with renal pelvic urine culture and culture-specific antibiotic treatment decreases sepsis rates in high-risk patient populations.

	• Prophylactic antibiotics should be administered prior to ureteroscopic lithotripsy for stone disease, even with a negative urine culture.

	• Mortality following PCNL is rare and is associated with low surgeon volume and high preoperative mortality risk.

	• Routine post-op imaging is more expensive than selective imaging in patients with post-op pain, but prevention of renal loss and its attendant morbidity may justify the additional modest cost.

	• Based on a porcine study, the best method of delivery of adjuvant therapy to the upper urinary tract for urothelial carcinoma may be an open-ended catheter.

Mantu Gupta, MD, presents the take home messages on stone disease/endourology from the AUA annual meeting in San Diego.

Author | Urology Times staff

Articles

Speaking of Urology podcast: Dr. Angela Smith discusses Jelmyto for low-grade UTUC

Urology FDA approvals of 2016

Best of AUA 2013: BPH/LUTS

Best of AUA 2013: Stone Disease/Endourology