Next-Generation Imaging

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.

The detection rate for [99mTc]Tc-HYNIC-iPSMA SPECT imaging was 77.5%.

The BLA for TLX250-CDx was initially submitted to the FDA in June 2024.

The investigators found a positive correlation between PSA levels and SUVmax.

As the year comes to a close, we revisit some of this year’s top content on next-generation imaging agents in urology.

The trial is evaluating the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in men with suspected biochemical recurrence of prostate cancer following treatment with curative intent.

The primary objective is to compare the detection rate of sites of prostate cancer recurrence between the 2 agents.

The phase 1/2a SECuRE trial is evaluating the safety and efficacy of 67Cu-SAR-bisPSMA in the treatment of patients with mCRPC.

The sensitivity of 99mTc-sestaMIBI SPECT/CT was 97%, and the specificity was 53.8%.

“For us, being able to know where the cancer is allows us to target it, and I think that lets us be much more effective with our treatment,” says Bridget F. Koontz, MD, FASTRO.

The revised policy will take effect on January 1, 2025.

Dhingra discusses the utility of PSMA-PET imaging when treating patients with prostate cancer.

“The majority (76%) of patients not yet meeting the Phoenix criteria did have PSMA-avid lesions on PSMA-PET, suggesting [prostate cancer] recurrence," says Evelien J E van Altena.

The trial is comparing the diagnostic performance of 61Cu-NODAGA-PSMA I&T with that of 18F-piflufolastat.

Data from the EMPIRE-2 trial also showed that 18F-fluciclovine resulted in significantly more boosts to the prostate bed.

"This is a very exciting time for nuclear medicine and molecular medicine," says Jitesh Dhingra, MD, FRCEM.

Overall, 15/16 patients had a true positive scan based on confirmatory imaging and/or biopsy, equating to a PPV of 93.75%.