UF PSMA Study Examines Highly Personalized Approach for Managing Advanced Prostate Cancer

PSMA trial to begin enrollment at UFIn collaboration with Novartis, the UF Health Radiation Oncology and Genitourinary Oncology teams will begin screening eligible patients for the PSMAfore trial, which examines a new highly targeted, systemic radiopharmaceutical therapy for men with castrate-resistant prostate cancer.

Men with metastatic prostate cancer have an approximately 30% chance of surviving 5 years.[1] Initial results of PSMA-based therapy, published in the New England Journal of Medicine in September 2021, demonstrated that 177Lu-PSMA-617 therapy significantly prolonged survival when added to standard care in patients with advanced prostate cancer.[2]

Approximately 450 participants will be randomized for the trial (225 per treatment group), titled “PSMAfore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naïve Men with Progressive Metastatic Castrate Resistant Prostate Cancer.” Patients will be selected for trial treatment with immediate Lu-PSMA-617 or continued alternative systemic therapy, with the provision for crossover to receive Lu-PSMA as indicated.   The radiopharmaceutical therapy will be delivered as an outpatient intravenous infusion every 6 weeks for a maximum of 6 cycles in combination with continuation of all best standards of care.

“PSMA represents a new future in radiotherapy in the treatment of metastatic cancer,” said Robert Zlotecki, MD, PhD, UF Radiation Oncology Professor, Vice Chair of Clinical Affairs, and Medical Director. “This new modality of therapy is very similar in principle and practice to the use of Lutathera systemic radio-ligand therapy, which has been successfully employed at UF for nearly two years for the treatment of metastatic neuroendocrine cancers of the gastrointestinal tract.”

Ashton Monismith, RN, BSN, CCRP will be the study’s UF Clinical Research Coordinator.

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[1] SEER. Cancer stat facts: prostate cancer April 2021.

[2] Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer.  N Engl J Med 2021; 385:1091-1103. DOI: 10.1056/NEJMoa2107322

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