We are SPARTAN!
The Study: Obviously they will need something, the question is what and when. NCCN recommendations hinge on prostate specific antigen doubling-time (PSADT). If PSADT is >10 months you can observe. If PSADT is <10 months you can add some form of secondary androgen blockade (e.g., bicalutamide, ketoconazole, abiraterone). The SPARTAN trial reported last week in NEJM should help clear things up. It included men on androgen deprivation therapy (ADT) with a PSADT <10 months. Men with nodal positivity were included (16% in each arm), but those with distant mets were not. They were then randomized to continued ADT +/- apalutamide. Time to PSA progression went from 3.7 months to >2 years. More importantly, the addition of apalutamide improved median metastasis-free survival by TWO YEARS (16 vs 40 months). While all subgroups clearly benefited, younger men and those with nodal disease appeared to benefit the most.
Bottom Line: The addition of apalutamide to ADT for men with nonmetastatic CRPC and PSADT <10 months significantly improves times to PSA progression and metastatic disease.