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e17100 Background: Approximately 50% of pts with HR LPC have disease recurrence ≤2 years after RP. Apa-RP (NCT04523207) studied adjuvant Apa + ADT in pts with HR LPC who had undergone RP to determine if the combination improved biochemical recurrence (BCR)-free rate vs historical data from pts who received RP alone. Data are presented for subgroups of Black and non-Black pts. Methods: In this multicenter, open-label, single-arm, phase 2 study conducted at 28 US sites, treatment-naïve pts with HR LPC who had RP received Apa (240 mg; QD) for 12 cycles (28 day cycles) + ADT for 12 months. The study had a diversity goal to enroll ~15% Black pts. The primary endpoint was confirmed BCR-free rate at 24 months, where BCR is defined as two sequential prostate-specific antigen (PSA) levels of >0.2 ng/mL. Secondary endpoints included testosterone recovery (≥150 ng/mL) rate and safety. Modified intention-to-treat analysis set is reported. Results: 108 pts were enrolled (n=15 Black, n=93 non-Black). Black pts were younger than non-Black pts (mean 58.4 vs 66.3 years). Other baseline characteristics were similar, including: median pre-operative PSA 7.6 ng/dL (range 2.2–62.7) and baseline testosterone 340.0 ng/dL (range 43.0–939.0). Confirmed BCR-free rate was 100% (90% CI 93.4, 100.0) (Table); unconfirmed BCR-free rate was 98.4% (90% CI 92.2, 99.7) (Table). Serum testosterone recovery (≥150 ng/dL) event rate at 24 months was 77.4% (95% CI 66.6, 85.1) (Table). Treatment-emergent adverse events were reported in 99.1% (n=107) of pts; 22.2% (n=24) were grade 3–4, 14.8% (n=16) were serious AEs. In total, 13.0% (n=14) and 10.2% (n=11) of pts had treatment dose reductions/interruptions or discontinued due to AEs, respectively. Conclusions: Based on the high BCR-free rate, that persisted for 12 months following treatment, these results suggest that both Black and non-Black pts with HR LPC undergoing RP may benefit from 12 months of treatment intensification with Apa + ADT. Most pts had testosterone recovery. The safety profile of Apa + ADT was consistent with previous reports. Clinical trial information: NCT04523207 . Table: see text
Hafron et al. (Sat,) studied this question.