Next-Generation Imaging

The target enrollment goal has been reached in the phase 3 BiPASS study, evaluating PSMA-PET plus MRI for prostate cancer detection.

These results provided the basis for the ongoing randomized phase 3 ProstACT Global trial evaluating 177Lu-rosopatamab tetraxetan in mCRPC.

The approval adds another commercially available source of the PSMA-targeted radiotracer.

The OPTIMUM randomized trial demonstrated that microultrasonography-guided biopsy is noninferior to MRI fusion-guided biopsy for detecting clinically significant prostate cancer, with a streamlined in-office workflow, a manageable learning curve, and substantially lower cost that may help address diagnostic access gaps worldwide.

64Cu-SAR-bisPSMA demonstrated higher lesion detection rates, improved diagnostic accuracy, and a substantial impact on clinical management.

Data showed that the addition of PSMA-PET/CT reduced the need for prostate biopsy by nearly half without compromising the detection of clinically significant prostate cancer.

According to Lantheus, Pylarify TruVu is formulated to improve product stability at higher radioactive concentrations, facilitating more efficient manufacturing and distribution.

64Cu-SAR-bisPSMA PET/CT identified a statistically significant greater number of prostate cancer lesions per patient compared with 68Ga-PSMA-11 PET/CT.

The findings offer insights into how treatment may be optimized using PSMA-PET/CT results.

The phase 3 BiPASS trial is assessing earlier use of 68Ga-PSMA-PET imaging in the pre-biopsy setting.

The Safety Review Committee has recommended that the trial proceed with the cohort expansion phase with no modifications to the protocol.

Image-guided radiotherapy with reduced target margins may improve some dosimetric parameters and patient-reported urinary symptoms.

The phase 2 Co-PSMA trial has met its primary end point.

The registrational trial is aiming to expand the indications for Illuccix and Gozellix to include use in prostate cancer diagnosis.

A recap of the FDA submissions and regulatory decisions in urology from August 2025.

The FDA has declined to approve 89Zr-DFO-girentuximab for PET imaging of ccRCC.

The target action date for the application is March 6, 2026.

The phase 2 Co-PSMA trial enrolled 50 patients with biochemical recurrence of prostate cancer.

The level II code A9616 will be effective starting on October 1, 2025.

Arm D of the trial is assessing the performance of [68Ga]Ga-DPI-4452 in detecting ccRCC in patients with an indeterminate renal mass.

The label expansion follows the FDA approval of an expanded label for 177Lu-PSMA-617 for use in patients with mCRPC after ARPI therapy and before chemotherapy.

The results from the SABRE trial are intended to support the design of a registrational trial of 64Cu-SAR-Bombesin.

Gozellix was approved by the FDA in March 2025.

"For every 1 unit increase in whole body tumor SUVmean, there was a 12% decrease in the risk of an rPFS event and a 10% decrease in the risk of death," says Phillip H. Kuo, MD, PhD, FACR.

A recap of the FDA submissions and regulatory decisions in urology from March 2025.