Next-Generation Imaging

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.

“I think having the ability to monitor patients with imaging and using things like PSMA-PET is good, but yet we're we sometimes have pitfalls with PSMA-PET too,” says Michael Cookson, MD.

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.

“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.

“Nowadays with PET, it's not perfect, but even with a PSA less than 1 ng/mL, we can detect the site of recurrence about 2/3 of the time,” says Bridget Koontz, MD.

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%.

Patient recruitment for the phase 3 AMPLIFY trial is set to begin early next year.

Both 177Lu-PSMA-I&T and 64Cu-PSMA-I&T are currently in phase 3 development for use in prostate cancer diagnostics and treatment.

"We found that as soon as we got to the range of biochemical recurrence-defined PSA—0.2 ng/mL and up—the detection rate was very high," says Bridget Koontz, MD, FASTRO.

Illuccix is now indicated for use in the selection of patients with mCRPC for PSMA-targeted radionuclide therapy.