Dr. Lee on Inclusion Criteria of the ARAMIS, SPARTAN, and PROSPER Trials in M0CRPC

Richard (Rick) JaeBong Lee, MD, PhD, medical oncologist at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, discusses inclusion criteria of the phase III ARAMIS, SPARTAN, and PROSPER trials in nonmetastatic castration-resistant prostate cancer (M0CRPC).

In this space, there are 3 trials that have defined the way clinicians think about treatments, says Lee. Each trial that has come out, the ARAMIS trial for darolutamide, the SPARTAN trial for apalutamide (Erleada), and the PROSPER trial for enzalutamide (Xtandi), incorporated patients with M0CRPC. These are patients who have a prostate-specific antigen (PSA) doubling time that is less than 10 months. The 2 studies with apalutamide and darolutamide included patients who might have had nodal disease in the pelvis. Each trial randomized patients 2:1 and looked at metastasis-free survival, as assessed by PSA, as well as a bone scan and CT scan of the chest abdomen and pelvis every 16 weeks.

Additional inclusion criteria included negative scans with conventional imaging studies. One of the studies included at CT scan of the brain, but none of these included the more novel PET tracers that have become more widespread in practice due to their increased sensitivity, concludes Lee.