Next-Generation Imaging

“The main challenge at the moment is patients are being diagnosed with metastatic disease far earlier than they would have been otherwise, and therefore [are being] considered for combination systemic therapy potentially years earlier than they would have been if we just looked at conventional imaging," says Dr Louise Kostos.

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.

"For the MIRAGE trial specifically, we're going to continue following patients and we'll look at [data at] 5 years as well," says Amar U. Kishan, MD.

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

“I would say both there could be an increase in MRI-guided [SBRT] and there may be increase in investigation into shrinking margins with CT-guided SBRT as well,” says Amar U. Kishan, MD.

"Physician scored GU toxicity grade 2 or greater at 2 years was 51% with the CT-guided and 27% with the MRI-guided," says Amar U. Kishan, MD.

“The trial was specifically looking at whether that aggressive margin reduction from 4 mm to 2 mm would lead to a reduction in physician-reported urinary toxicity, specifically in the first 90 days after radiation,” says Amar U. Kishan, MD.

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.

“In some ways, it can be used to help if you want to get a biopsy to prove or confirm—it can be used to help detect in that range, too,” says Michael S. Cookson, MD, MMHC, FACS.

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.