Improvements in bone-metastasis-related pain and QoL demonstrated in mCRPC with Lutetium-177 PSMA-617

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.

"We're excited that the FDA approval of this radiotracer gives us yet more tools at our disposal to diagnose prostate cancer in all its forms, from early to late in the disease process," says David M. Schuster, MD, FACR.

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.