A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
Status:
Not yet recruiting
Trial end date:
2027-05-31
Target enrollment:
Participant gender:
Summary
The purpose of the study is to determine if the intermittent use of androgen-deprivation
therapy (ADT) provides non-inferior radiographic progression-free survival (rPFS) measured by
18-month event-free survival rate and reduce the burden of hot flash measured as 18-month
percent change in severity adjusted hot flash score for participants with metastatic
castrate-sensitive prostate cancer (mCSPC) who reached prostate-specific antigen (PSA) level
at less than (<) 0.2 nanogram/millilitres (ng/mL) after 6 months of treatment with
apalutamide and ADT combination therapy