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In this prespecified exploratory analysis weĪssessed HRQOL using the Functional Assessment of Cancer Therapy-Prostate (FACT-P)Īnd EQ-5D-3L questionnaires, which we collected at baseline, day 1 of cycle 1 (beforeĭose), day 1 of treatment cycles 1-6, day 1 of every two cycles from cycles 7 to 13,Īnd day 1 of every four cycles thereafter. The primary endpoint was metastasis-free survival. Permuted block randomisation was used according to the three baseline stratificationįactors: prostate-specific antigen doubling time (>6 months vs ≤6 months), use of bone-sparing drugs (yes vs no), and presence of local-regional nodal disease (N0 vs N1).
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(2:1) to 240 mg oral apalutamide per day plus androgen deprivation therapy, or matched Participants wereĪged 18 years or older, with non-metastatic castration-resistant prostate cancer,Ī prostate-specific antigen doubling time of 10 months or less, and a prostate-specificĪntigen concentration of 2 ng/mL or more in serum. SPARTAN is a multicentre, international, randomised, phase 3 trial.
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