The Duke Cancer Center is among the first in the nation to offer a targeted radiopharmaceutical therapy for men with advanced metastatic prostate cancer that progressed on other treatments.
 
PLUVICTO™ (Novartis, Basel, Switzerland) is a radiopharmaceutical that targets the prostate-specific membrane antigen (PSMA). The PSMA protein is highly expressed on the surface of most prostate cancer cells. Investigators in the Duke Genitourinary Oncology group participated in the international clinical trial that led to Food and Drug Administration approval of this radiopharmaceutical in March 2022.
 
“The results of this clinical trial are striking,” says Terence Wong, MD, PhD, chief of the Duke Division of Nuclear Medicine and Radiotheranostics. “These patients had failed every other treatment, so the fact that this treatment can slow progression and improve survival so late in the disease is really exciting.” This early experience enabled Duke to begin treating clinical patients in June 2022. Since that time, the group has provided over 200 treatments.
 
To be considered for this treatment patients must first undergo a diagnostic PSMA-PET/CT scan to determine if their prostate cancer is PSMA-positive. “If enough of the tumor has the receptor, then we can go ahead and treat using a similar molecular probe attached to a therapeutic radionuclide—like PLUVICTOTM—that will deliver a high radiation dose to the tumor targets,” Wong says.

PLUVICTO™ (177Lu vipivotide tetraxetan) consists of lutetium-177 attached to a small molecule that binds to PSMA. The lutetium delivers a high dose of beta radiation to PSMA-expressing cells, including the primary tumor and metastases. Because beta radiation consists of electrons that do not travel far, the treatment can selectively destroy the tumor cells with little effect on surrounding tissues. In addition, the treatment is mostly target-specific that side effects are typically mild. The therapy is administered intravenously every six weeks for up to six cycles as an outpatient.
 
Currently, PLUVICTOTM is FDA-approved only for patients with advanced castrate-resistant prostate cancer that has progressed on conventional treatments. “We would expect a targeted agent like this to be at a big disadvantage this late in the disease because the tumor has had so much opportunity to become resistant to treatment,” Wong says. That makes its effectiveness particularly impressive, Wong says, adding that he looks forward to the results of further trials that are already underway to test the treatment’s efficacy earlier in the disease process.
 
Duke is a national leader in radiotheranostics (using radiolabeled molecular probes for both imaging and therapy) with years of experience applying this approach to treat relatively uncommon cancers such as pheochromocytoma and neuroendocrine tumors. But this is the first application of the technology to a condition as common as prostate cancer.
 
“This application will really put radiotheranostics on the map,” Wong says. Duke is the only facility in the region that is designated as a Comprehensive Radiopharmaceutical Therapy Center of Excellence.