Educational content on VJOncology is intended for healthcare professionals only. By visiting this website and accessing this information you confirm that you are a healthcare professional.

Share this video  

GU Cancers 2023 | FORMULA-509: post-operative SRT + 6 months of GnRH agonist +/- AAP + apa post-radical prostatectomy

Paul L. Nguyen, MD, Dana-Farber Cancer Institute, Boston, MA, shares the results 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. The primary endpoint was PSA progression-free survival (PFS) and secondary endpoint was metastasis-free survival (MFS) determined by conventional imaging. 345 participants (332 evaluable) from 9 sites were randomized (172 bicalutamide, 173 abiraterone acetate/prednisone and apalutamide). Median follow-up was 34 (6-53) months; 29% were pN1 and 31% had PSA more than 0.5 ng/mL. The HR for PFS was 0.71 and the HR for MFS was 0.57. In a pre-planned analysis by stratification factors, acetate/prednisone and apalutamide was significantly superior for patients with a PSA level more than 0.5 and for MFS. No statistically significant benefit was detected in pre-planned analyses of stratification subgroups defined by PSA≤0.5, pN0, or pN1. Adverse events were consistent with the known safety profiles of the agents being studied. 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 plus 6 months of ADT may improve PFS and MFS, particularly in the subgroup of patients with a PSA level over 0.5. This interview took place at the ASCO GU Cancers Symposium 2023 in San Francisco, CA.

These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.