Next-Generation Imaging

The facility will increase the production capacity of 177Lu-PSMA-617 to 250,000 doses in 2024 and beyond.

Data from the phase 2 TheraP trial showed that 177Lu-PSMA-617 induced comparable overall survival outcomes as cabazitaxel in patients with metastatic castration-resistant prostate cancer who progressed after receiving docetaxel.

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

Findings from the research showed that 68Ga-RM2 PET/MRI had an 85.2% sensitivity rate for diagnosing biochemical recurrence of prostate cancer.

Overall, 177Lu-PNT2002 demonstrated a median radiographic progression-free survival of 9.5 months, compared with 6.0 months among patients who were treated with an ARPI.

The BLA submission is supported by findings from the phase 3 ZIRCON study, which demonstrated high specificity and sensitivity of the agent for PET/CT imaging of ccRCC.

225Ac-PSMA-J591 showed promising efficacy in mCRPC metastatic sites that are commonly resistant to 177Lu-PSMA-617.

Utilizing a deep learning-based AI algorithm to differentiate between diagnostic and non-diagnostic quality of prostate MRI facilitated a 10% higher specificity rate for diagnosing extraprostatic extension on multiparametric MRI, according to research presented at the 2023 RSNA Annual Meeting.

The patents apply exclusively to the Ga-68 HBED-PSMA-11 production kit (Locametz), developed by Advance Accelerator Applications.

According to Clarity Pharmaceuticals, the final results are intended to support an application to the FDA for approval of 64Cu-SAR-bisPSMA for imaging in patients with prostate cancer.

No dose-limiting toxicities were observed among the initial 3 patients in cohort 3, and no patients experienced adverse events related to 64Cu-SAR-bisPSMA.

The investigators observed no dose limiting toxicities or serious adverse events among all patients who received an ARX517 dose of 3.4 mg/kg, the highest dose tested in the trial.

“[18F]DCFPyL was assessed to be a suitable alternative to [68Ga]Ga-PSMA-11 in PCa diagnosis and staging due to its similar lesion uptake rate with no increase in benign uptakes," the authors wrote.

"Rather than receiving definitive radiation treatment for localized disease, these patients may have received treatment aimed at preventing the further spread of what was incorrectly identified as metastatic disease," says Thomas Hope, MD.

In a study published in The Lancet Oncology, UC San Francisco researchers conducted a phase 1 clinical trial assessing the combination of 177Lu-PSMA-617 and pembrolizumab in patients with metastatic castration-resistant prostate cancer.

The ProstACT GLOBAL study is investigating second-line TLX591 in combination with the current standard of care (SOC) vs SOC alone in patients with mCRPC who have progressed on a novel androgen axis drug.

The CPT code will be effective beginning July 1, 2024.

Researchers utilized the PI-QUAL scoring system to assess 355 mpMRI exams performed at 41 facilities in 18 countries.

At the time of the data cutoff, a maximum tolerated dose of 225Ac-J591 had not yet been reached.

“Preclinical and clinical findings thus far indicate that SAR-Bombesin holds significant potential for improving the diagnosis and treatment of prostate cancer,” said lead principal investigator Andrei Iagaru, MD.

Novartis is now equipped to provide 177Lu-PSMA-617 to patients within 2 weeks of diagnosis with advanced disease.

The primary end point of the phase 3 CLARIFY trial is the diagnostic capability of 64Cu-SAR-bisPSMA PET to identify regional node metastases.

Treatment with TLX591 resulted in a PSA reduction in nearly two-thirds of evaluable patients with PSMA-expressing metastatic castration-resistant prostate cancer.

US and Chinese companies are partnering to bring the PSMA-PET imaging agent flotufolastat F 18 to the armamentarium for patients with prostate cancer in China.

Overall, 43.3% of patients who had received a diagnosis of NMIBC had 1 or more additional lesions detected with APL-1706 plus BLC compared with WLC alone.

A recently published study compared bone scan with PSMA-PET for initial staging of prostate cancer.

"This is a whole other approach to treating patients with this cancer. If you think about that from the perspective of prostate cancer as a whole, this is a big deal," says Thomas A. Hope, MD.

"We had very high specificities. The specificities amongst the 3 readers ranged from 92% to 96%," says Phillip H. Kuo, MD, PhD, FACR.

"Overall, we found that there was a high detection rate in patients with PSA less than 1 ng/mL," says Ashesh B. Jani, MD, MSEE, FASTRO.

"Results showed that more than two-thirds of these men were found to have positive Posluma scans, with a quarter of them having extrapelvic lesions," says Ashesh B. Jani, MD, MSEE, FASTRO.