Top Line: Do patients with nonmetastatic, castration resistant prostate cancer and a longer PSA doubling time benefit from the addition of an androgen receptor antagonist?
The Study: With widespread PET imaging for recurrent prostate cancer, nmCRPC will hopefully be a dwindling population. Nevertheless, the ARAMIS trial has previously shown that the addition of darolutamide, an androgen receptor antagonist, to ADT improves overall survival in men with nonmetastatic, castration resistant prostate cancer (nmCRPC). In the pre-PET era and absent radiographic disease, PSA doubling time (PSADT) is an important factor to risk stratify patients. In fact, patients enrolled on ARAMIS had to have a PSADT ≤10 months. The question is whether treatment intensification is beneficial for those with a slower (higher) PSADT. This planned subgroup analysis of ARAMIS evaluated outcomes based on PSADT. Out of 1509 patients enrolled on the trial, 69% had a PSADT ≤6 months and 31% had a PSADT >6 months. In both subgroups, the addition of darolutamide to ADT significantly improved both metastasis-free survival and OS. In fact, those with PSADT >6 months saw a greater reduction in the risk of death with darolutamide (45%) than those with PSADT ≤6 months (26%). Similar subgroup analyses for enzalutamide and apalutamide did not show improved OS in the PSADT >6 months subgroup.
TBL: The addition of darolutamide to ADT significantly improves survival in men with nmCRPC and a PSADT ≤10 months, regardless of whether the PSADT is slower or faster than 6 months. | Bogemann, Eur Urol 2022