FORMULA-509: A Multicenter Randomized Trial of Postprostatectomy Salvage Radiotherapy and 6 months of a GNRH Agonist with Either Bicalutamide or Abiraterone Acetate plus Prednisone and Apalutamide
Puntos clave
The trial aims to evaluate the efficacy of various hormonal treatments combined with salvage radiotherapy after prostate surgery.
Conducted as a multicenter randomized trial
Participants received salvage radiotherapy and a GnRH agonist
Comparative analysis of bicalutamide versus abiraterone acetate plus prednisone and apalutamide
Subgroup analysis for patients with PSA levels greater than 0.5 ng/ml
No overall benefit was observed in the entire population
Addition of abiraterone acetate plus apalutamide significantly improved progression-free survival in the subgroup
Metastasis-free survival also improved in the subgroup with elevated PSA levels
Resumen
This study did not reveal a benefit for the overall population, but addition of AAP + apalutamide (vs bicalutamide) to sRT and ADT improved PFS and MFS in the prespecified subgroup with PSA >0.5 ng/ml.
FORMULA-509: A Multicenter Randomized Trial of Postprostatectomy Salvage Radiotherapy and 6 months of a GNRH Agonist with Either Bicalutamide or Abiraterone Acetate plus Prednisone and Apalutamide | Synapse