Next-Generation Imaging

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.

"I think a take-home message there is that in the prostate/prostate bed, you have to take extra time and caution in reading that region," says Phillip H. Kuo, MD, PhD.

The use of pre-diagnostic MRI was 3.8% in 2012, which increased to 32.6% in 2019.

Gozellix – after radiolabeling with 68Ga – is indicated for PET imaging of PSMA positive lesions in men with prostate cancer who have suspected metastases and are candidates for initial definitive therapy and those who have suspected recurrence based on an elevated serum prostate-specific antigen level.

The detection rate ranged from 44% to 58% on day 0 and 58% to 80% on day 1.

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

The PDUFA date is August 27, 2025.

Total detection rate was 36% (13/36) in the ultralow PSA group and 51% (47/93) in the low-PSA group.

The results encompassed the first 100 patients enrolled in the registry.

The designation is supported by preliminary data from the ongoing phase 1/2a SECuRE trial.

PSMA staging did not appear to have a significant impact on radiation therapy utilization.

Illuccix has been previously approved in the US, Australia, Canada, and Europe.

Check out the key regulatory decisions set to happen early this year.

64Cu-SAR-bisPSMA was previously granted a fast track designation in August 2024 for PET imaging of PSMA-positive prostate cancer lesions in patients with suspected metastasis who are candidates for initial definitive therapy.

The median time to correct treatment was 98 days with initial TURBT compared with 53 days with initial mpMRI.

The European approval of Illuccix adds on to prior approvals in the US, Australia, and Canada.

In total, 40.3% of patients experienced a change in staging between initial assessment on conventional imaging and PSMA PET.

“However, it was informative to uncover such a high number of metastatic findings in a well-defined cohort of patients resembling the EMBARK trial population that was supposed to only include those without metastases," says Adrien Holzgreve, MD, MHA.