Urologic oncology
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Non-muscle-invasive bladder cancer (NMIBC) comprises a wide spectrum of tumors with different behaviors and prognoses. It follows that the surveillance for these tumors should be adapted according to the risks of recurrence and progression and should be dynamic in design. ⋯ Surveillance of NMIBC should follow a risk-adapted approach, with a combination of cystoscopy, cytology, and upper tract imaging. The aim of this approach is to minimize the therapeutic burden of a disease with high recurrence rates without missing progressing tumors. When designing a diagnostic pathway, first-line diagnostic imaging tests should have high sensitivity to ensure disease positives are included in the test population for further investigation. Second-line investigations should be highly specific, to ensure false-positives are minimized.
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Despite recent advances in the treatment of advanced prostate cancer (PCa), metastatic castrate-resistant PCa remains incurable at this time. The androgen receptor (AR) plays a key role in the development and progression of PCa, continuing to be active in most patients even after the development of castration resistance. ⋯ We also review therapies targeting each of these mechanisms. We also discuss the potential role of AR-CAG repeats and AR splice variants as potential biomarkers of response to hormonal manipulation therapies.
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Intravesical Bacillus Calmette-Guérin (BCG) remains the standard of care in the treatment of bladder carcinoma in situ and as adjuvant therapy after thorough transurethral resection of high-grade non-muscle-invasive bladder cancer. Despite BCG therapy, in up to 40% of patients it would recur and 60% to 70% of those would fail repeat BCG induction be deemed BCG unresponsive. For such patients, cystectomy remains the preferred treatment option per the American Urological Association and European Association of Urology, though some patients would be medically unfit or refuse radical surgery. ⋯ There are numerous non-BCG intravesical salvage options available, including immunotherapy, single-agent chemotherapy, combination chemotherapy, and device-assisted chemotherapy. In addition, investigation of radiation-based treatment and other novel therapies including checkpoint inhibitors (programmed death-1/programmed death ligand-1), are currently underway. In this review, we examine the current status of alternatives to BCG in salvage therapy for bladder preservation.
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Medical devices are regulated by the US Food and Drug Administration (FDA) within the Center for Devices and Radiological Health. Center for Devices and Radiological Health is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices, ensuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products we oversee, throughout the total product life cycle. The FDA was granted the authority to regulate the manufacturing and marketing of medical devices in 1976. ⋯ Premarket approval applications must contain data demonstrating reasonable assurance of safety and efficacy, and this information typically includes clinical data. For novel devices that are not high risk, the de novo process allows FDA to simultaneously review and classify new devices. Devices that are not legally marketed are permitted to be used for clinical investigation purposes in the United States under the Investigational Device Exemptions regulation.