GU Cancers 2023 | Next steps following the FORMULA-509 trial: PROSTATE-IQ

Paul L. Nguyen, MD, Dana-Farber Cancer Institute, Boston, MA, talks on the next steps of the Phase II randomized FORMULA-509 (NCT03141671) trial assessing post-operative salvage radiotherapy and 6 months of GnRH agonist with or without abiraterone acetate/prednisone and apalutamide post-radical prostatectomy in patients with a rising PSA after radical prostatectomy. Although this primary analysis did not meet the pre-specified threshold for statistical significance, it strongly suggests that the addition of abiraterone acetate/prednisone and apalutamide to salvage radiation +6 months of ADT may improve PFS and MFS, particularly in the subgroup of patients with a PSA level more than 0.5. Next, the results of the FORMAULA-509 regimen with the Phase III RADICALS-HD (NCT00541047) regimen of regular ADT. The comparison will be assessed in the PROSTATE-IQ trial. Patients will be stratified by the Artera classifier, evaluating which patients may benefit more from hormone therapy. Patients in the PSMA-negative group will be randomized to receive either 6 months of apalutamide versus 6 months of standard ADT with salvage radiation. Patients in the PSMA-Positive group will be randomized to receive either 2 years of ADT versus 6 months of ADT with 6 months of apalutamide.

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