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 1
Inclusion and exclusion criteria in the ARN-509-002 study.
Inclusion criteria
1
Patients aged ≥18 years with BCR PC and PSADT ≤12 months after radical prostatectomy and/or radiation therapy undertaken with curative intent
2
No evidence of metastatic disease on conventional imaging consisting of computed tomography or magnetic resonance imaging of the abdomen/pelvis and whole-body nuclear bone scan
3
Prior primary or salvage radiation or not a candidate for localized salvage radiation based on patient preference or physician discretion
4
Minimum PSA of 1.0 ng/mL in patients who received prior radical prostatectomy with or without adjuvant or salvage radiation or PSA nadir plus 2.0 ng/mL in patients who had definitive radiation therapy without prior radical prostatectomy
5
Serum testosterone level ≥150 ng/dL
6
Eastern cooperative oncology group performance status of 0 or 1
Exclusion criteria
1
Treatment with an oral antiandrogen within 6 weeks prior to randomization
2
Prior treatment with ADT for BCR PC. ADT with or without prior local definitive and/or salvage therapy was allowed provided the last dose of ADT was >6 months before study entry and the screening serum testosterone was ≥150 ng/dL
3
Treatment with 5-alpha reductase antagonist within 6 weeks prior to randomization
