Assessments
tumor
ADVERSE EVENTS, DISEASE, SECONDARY, TUMOR
The primary endpoints were composite response rate (CRR; evaluated in the intent-to-treat [ITT] efficacy population) and frequency and severity of adverse events (AEs; evaluated in the safety population). CRR is defined as the proportion of patients with ≥1 of the following: objective radiographic response in subjects with measurable disease, overall circulating tumor cell (CTC) response, or prostate-specific antigen decline ≥50% (PSA50). Overall CTC response is defined as a patient with CTC0 response at 8 weeks (baseline CTC per 7.5 mL of blood >0 and 8 weeks post-baseline CTC = 0) or CTC conversion (baseline CTC per 7.5 mL of blood ≥5 and post-baseline CTC <5 with a confirmation CTC <5 taken ≥4 weeks later). Key secondary endpoints were overall CTC response rate, objective response rate (ORR) (per RECIST 1.1), and radiographic progression-free survival (rPFS).