Study Design

SPARTAN was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of patients with non-metastatic castration-resistant prostate cancer (CRPC)1-3

Patients in SPARTAN had a PSA doubling time ≤10 months and serum testosterone levels <50 ng/dL. All patients in the SPARTAN trial received a concomitant GnRH analog or had a bilateral orchiectomy. All patients enrolled were confirmed to be non-metastatic by blinded central imaging review. Patients with a history of seizure, predisposing factors for seizure, or receiving drugs known to decrease the seizure threshold or to induce seizure were excluded.1,2

Primary endpoint: metastasis-free survival (MFS)

Defined as the time from randomization to the time of first evidence of blinded independent central review-confirmed distant metastasis, defined as new bone or soft tissue lesions or enlarged lymph nodes above the iliac bifurcation, or death due to any cause, whichever occurred first1

Selected baseline patient characteristics1,2

Median age 74 years (range: 48 to 97 years)
Median time from initial diagnosis of prostate cancer to randomization 7.9 years (range: 0.3 to 30.4 years)
Prior surgery or radiation therapy for prostate cancer 77%
Prior treatment with a first-generation androgen receptor inhibitor 73%
    Bicalutamide 69%
    Flutamide 10%
Median PSA 7.8 ng/mL (range: 0.1 to 294.8 ng/mL)
Gleason score ≥7 at initial diagnosis 78%

ADT = androgen-deprivation therapy; GnRH = gonadotropin-releasing hormone; PSA = prostate-specific antigen; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509.

References

1. ERLEADA™ [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

2. Data on file. Janssen Biotech, Inc.

3. Smith MR, Saad F, Chowdhury S, et al; for the SPARTAN Investigators. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408-1418.