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The efficacy and safety of cabazitaxel, as compared with an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who were previously treated with docetaxel and had progression within 12 months while receiving the alternative inhibitor (abiraterone or enzalutamide) are unclear. We randomly assigned, in a 1:1 ratio, patients who had previously […]

A Phase 1, Multiple-Dose, Dose-Escalation and Expansion Trial of PT2977, a HIF-2α Inhibitor, in Patients With Advanced Solid Tumors Condition: Advanced Solid Tumors, Solid Tumor, Solid Carcinoma, Solid Tumor, Adult, ccRCC, RCC, Clear Cell Adenocarcinoma, RCC, Kidney Cancer, Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma, Metastatic, Renal Cell Carcinoma Recurrent, Renal Cell Carcinoma, Clear […]

Neoadjuvant AXITINIB and AVELUMAB for Patients With Localized Clear-cell RCC and a Moderate to High Risk Condition: Renal Cell Carcinoma Intervention: Drug: Axitinib Drug: Avelumab Purpose: a monocenter, open label, single arm, phase II study of the combination of axitinib with avelumab as neoadjuvant therapy in patients with intermediate to high-risk non-metastatic RCC. Study Type: […]

Before the androgen target therapy era, flutamide was widely used for castration-resistant prostate cancer in Japan. Enzalutamide is currently the recommended treatment; however, the efficacy and safety of enzalutamide and flutamide after combined androgen blockade therapy with bicalutamide, has not been compared. Patients with castration-resistant prostate cancer who received combined androgen blockade therapy with bicalutamide […]

To determine the diagnostic capabilities of combined prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) and sentinel node (SN) biopsy in PSMA PET/CT negative patients for the primary lymph node (LN) staging in prostate cancer (PCa) patients. Methods Between January 2017 and March 2019, retrospectively, all consecutive patients with primary diagnosed intermediate- or high-risk […]

STAMPEDE has previously reported that the use of upfront docetaxel improved overall survival (OS) for metastatic hormone naïve prostate cancer patients starting long-term androgen deprivation therapy. We report on long-term outcomes stratified by metastatic burden for M1 patients. We randomly allocated patients in 2 : 1 ratio to standard-of-care (SOC; control group) or SOC + docetaxel. Metastatic disease burden […]

Background: MRI-guided transurethral ultrasound ablation (TULSA) has been evaluated for organ-confined prostate cancer (PCa). The purpose of this study was to assess the safety and toxicity, accuracy and short-term evolution of cell-death after lesion-targeted TULSA. Methods: This prospective, registered, Phase-I treat-and-3-week-resect-study enrolled six patients with MRI-visible-biopsy-concordant PCa. Lesions were targeted using TULSA with radical intent, […]

Standard adverse event (AE) reporting in oncology clinical trials has historically relied on clinician grading, which prior research has shown can lead to underestimation of rates of symptomatic AEs. Industry sponsors are beginning to implement in trials the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), which was […]

There is a lack of accepted consensus on what should constitute appropriate quality-of-care indicators for bladder cancer. To evaluate the optimal management of bladder cancer and propose quality indicators (QIs). A systematic review was performed to identify literature on current optimal management and potential quality indicators for both non-muscle-invasive (NMIBC) and muscle-invasive (MIBC) bladder cancer. […]

The objective of this study was to assess the value of fluorescence in situ hybridization (FISH) for predicting early recurrence in intermediate-, and high-risk NMIBC patients treated with BCG. A systematic review was conducted using MEDLINE, Embase and the Cochrane library. Individual patient data (IPD) from prospective observational studies evaluating FISH in patients treated with […]