Page 46 - Monitoring Prostate Cancer to Guide Treatment Decision-Making

SPARTAN Study Design

International, randomized, phase 3 trial

Eligibility Primary endpoint
 nmCRPC R  MFS
– Pelvic nodes < 2 cm A Apalutamide (APA) Secondary endpoints
below aortic bifurcation N 240 mg QD  Time to metastasis
D
(N1) allowed O + ADT  PFS
 PSADT ≤ 10 mo M (n = 806)  Time to symptomatic
I
On-Study Requirement Z progression
 Continuous ADT A  OS
T  Time to cytotoxic
I Placebo (PB)
Stratification factors O + ADT chemotherapy
 PSADT > 6 mo or ≤ 6 mo N (n = 401) Exploratory endpoints
 Bone-sparing agents  Time to PSA progression
(yes/no) 2:1
 N0 or N1  PSA response rate
 Patient-reported outcomes
 PFS2

ADT = androgen-deprivation therapy; MFS = metastasis-free survival; nmCRPC = non-metastatic castration-resistant prostate cancer; OS = overall survival;
PFS = progression-free survival; PFS2 = second progression-free survival; PSADT = prostate-specific antigen doubling time.
Smith MR, et al. N Engl J Med. 2018;378:1408-18.
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