Next-Generation Imaging

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.

“It encompasses and contains the miTNM, PROMISE, PRIMARY, RECIP, PSMA-RADS, and E-PSMA concept and criteria all together,” says Jeremie Calais, MD, PhD.

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%.

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

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