Randomized, Open-Label Phase 2 Study of Apalutamide plus Androgen Deprivation Therapy versus Apalutamide Monotherapy versus Androgen Deprivation Monotherapy in Patients with Biochemically Recurrent Prostate Cancer

Table 2

Prespecified endpoints in the ARN-509-002 study.

Primary endpoint
1	Mean change from baseline to 12 months in FACT-P total score
Secondary endpoints
1	Mean change from baseline in EORTC QLQ-C30/QLQ-PR25 over time
2	Mean change from baseline in SHIM over time
3	Time to PSA progression^†
Exploratory endpoints
1	Proportion of patients without evidence of PSA or radiographic progression in the setting of recovered serum testosterone (≥150 ng/dL) at 24 months
2	Proportion of patients with PSA <0.2 ng/mL after 7 months of therapy^‡
3	Time to testosterone recovery >150 ng/dL during the off-therapy observation period
4	Mean change from baseline in bone mineral density at 12 months^§

Treatment period of 12 months was selected based on previously published studies of intermittent ADT that used, in general, an induction period of 8 to 12 months [12,13]. ^†Time to PSA progression was defined as PSA rise to ≥50% of the baseline serum PSA or rise of ≥2 ng/mL above the nadir, whichever was higher, confirmed by repeat measurement at least 2 weeks later. ^‡Based on a prior clinical study of men with mCSPC that showed that after 7 months of ADT induction, men with a nadir PSA level of <0.2 ng/mL, versus 0.2–4.0 ng/mL, or versus >4.0 ng/mL had progressively shorter median overall survival [21]. ^§The endpoint of mean change from baseline in bone mineral density at 12 months was based on a clinical study that found a significant decrease in bone mineral density after 12 months of ADT [22].