Jack R. Andrews, MD, discusses BED-PSMA-411 findings comparing PSMA-PET detection rates and urinary excretion in prostate cancer biochemical recurrence.
News|Articles|March 3, 2025
FDA updates in urology: February 2025
Author(s)Hannah Clarke
A recap of the FDA submissions and regulatory decisions in urology from February 2025.
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Welcome to Urology Times’® monthly FDA update! This month, key developments include advances in prostate and kidney cancer detection, as well as an emerging treatment option in primary hyperoxaluria 1 (PH1).
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The phase 3 BiPASS trial is evaluating the use of 68Ga-PSMA-PET in combination with MRI for pre-biopsy prostate cancer detection.
Moderators and participants reviewed ARANOTE, ARACOG, and ARASEC data and how they inform individualized treatment for mCSPC.
VIR-5500 is a PSMA-targeted PRO-XTEN dual-masked T-cell engager entering phase 3 development for prostate cancer.
Sri Sivalingam, MD, discusses how suction-based technologies are improving stone clearance and raising expectations for ureteroscopic stone treatment.
Abraham Morgentaler, MD, reviews evidence showing no association between testosterone therapy and prostate cancer risk and explains the saturation model of androgen action.
Based on these results, the trial protocol has been amended to move enrollment earlier in the course of disease progression.
An analysis of NRG/RTOG 0815 found Decipher predicted distant metastasis risk and identified patients with greater benefit from short-term ADT.
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