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 4

Summary of serum testosterone recovery (T > 150 ng/dL) at 24 months with or without PSA progression.

	Apalutamide + ADT (n = 29)	Apalutamide (n = 27)	ADT (n = 26)
Patients who achieved testosterone >150 ng/dL	17 (58.6%)	24 (88.9%)	14 (53.8%)
Median time to serum testosterone recovery, months	24.0	12.1	23.3
(Range)	(10.9–32.8)	(11.4–24.0)	(6.4–25.2)
Serum testosterone >150 ng/dL with PSA progression	6 (20.7%)	14 (51.9%)	9 (34.6%)
Serum testosterone >150 ng/dL without PSA progression^†	11 (37.9%)	10 (37.0%)	5 (19.2%)

Includes a serum testosterone value > 150 ng/dl from start of treatment up to and including 24 months. ^†Proportion of patients in each treatment group without PSA or radiographic progression.