Jason M. Broderick

Treatment with the temporary implantable nitinol device led to a marked reduction in symptoms and improvement in quality of life and functional parameters.

Neoadjuvant axitinib facilitated partial nephrectomy in patients with an imperative indication for nephron-sparing surgery but no viable strategy to receive the procedure.

The guidelines now include the use of piflufolastat F 18, along with all approved PSMA-PET imaging agents, for the selection of prostate cancer patients to receive PSMA-targeted radioligand therapy.

The blood-based, non-invasive IsoPSA test is used prior to an initial biopsy to assess the likelihood that a patient has high-grade prostate cancer.

177Lu-PSMA-617 is FDA-approved for the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer.

The phase 2 STARLITE 2 trial is exploring the combination of the novel radiopharmaceutical TLX250 (177Lu-DOTA-girentuximab) and nivolumab in patients with advanced renal cell carcinoma.

Urologists made up only 25% of shock wave therapy providers and 13% of the providers were not physicians.

“In this subgroup analysis of data from the EMPOWUR trial, vibegron was associated with significant reductions in urgency episodes and micturitions compared with placebo in both the OAB dry and wet populations,” said lead author Jeffrey Frankel, MD.

The downgrade of PSA screening over the past 15 years has reduced the overdiagnosis and overtreatment of low-grade prostate cancer; however, there has been a simultaneous increase in the rate of metastatic cancer at diagnosis.

Combination therapy with the novel TKI sitravatinib and the anti–PD-1 immune checkpoint inhibitor nivolumab showed promising efficacy and safety in patients with clear cell renal cell carcinoma and progression after antiangiogenic therapy.

A computerized artificial intelligence (AI)-based decision support system (CDSS-T) enhanced the performance of clinicians when assessing patients’ response to chemotherapy prior to radical cystectomy.

The ongoing phase 1/2 COBRA trial is exploring the PSMA-PET imaging agent 64Cu SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy.

The FDA is evaluating a new drug application for oral tebipenem pivoxil hydrobromide for the treatment of patients with complicated urinary tract infection, including acute pyelonephritis.

The novel radionuclide combination was safe and effective in men with progressive mCRPC who had previously received chemotherapy and novel androgen signaling inhibitors.

"Tools such as Illuccix PSMA-PET are incredibly valuable as we look for better ways to manage prostate cancer in men," said Michael Koch, MD.

The approval was based on data from the phase 3 EV-301 trial, in which enfortumab vedotin reduced the risk of death by 30% versus chemotherapy in patients with heavily pretreated locally advanced or metastatic urothelial carcinoma.

The strategic partnership involves the PSMA-PET imaging agent piflufolastat F18 and the PSMA-targeted therapy lutetium Lu 177 vipivotide tetraxetan.

The approval was based on results from the randomized, double-blind phase 3 CheckMate-274 trial.

The phase 1/2 study is exploring the anti–CTLA-4 immunotherapy zalifrelimab (UGN-301) in patients with recurrent non–muscle-invasive bladder cancer.

The ready-to-inject formulation was approved by the FDA in May 2021.

Eligible patients for the multicenter, nonrandomized, single-arm trial (NCT05249127) will have suspected recurrence of prostate cancer as determined by a rising prostate-specific antigen following definitive therapy.

The pivotal trial supporting approval of the oral testosterone undecanoate was Study 16-002, which included 95 hypogonadal males.

Key outcome measures include disease status adjustment, disease staging adjustment, and change in clinical management plan.

In the phase 3 KEYLYNK-010 trial, pembrolizumab/olaparib did not improve overall survival versus either abiraterone or enzalutamide in heavily pretreated patients with metastatic castration-resistant prostate cancer.

Over 90% of patients had a ≥50% reduction in their PSA level when receiving the PSMA-targeted therapy 225Ac-PSMA-617.

The approval was based on results from a pivotal, open-label, single-arm trial that were published in the Journal of Urology.

The approval recommendation for the GnRH receptor antagonist is based on data from the phase 3 HERO study.

5-year results from the pivotal WATER trial showed IPSS improvement was greater with Aquablation compared with TURP.

The application for enfortumab vedotin is based on data from the phase 3 EV-301 trial.

The emergence of tumor-agnostic approvals, such as pembrolizumab for MSI-H solid tumors, has increased the significance of genomic profiling in urology, as patients with prostate, bladder, or kidney cancer may benefit from these therapies.