Abstract：
UNASSIGNED: Approximately 25% to 50% of patients with high-risk localized prostate cancer experience biochemical recurrence (BCR) within 2 years of radical prostatectomy. The Apa-RP study (NCT04523207) investigated whether adjuvant apalutamide plus androgen deprivation therapy (ADT) in high-risk patients who have undergone radical prostatectomy improved BCR-free survival.
UNASSIGNED: Apa-RP was a multicenter, open-label, single-arm, phase 2 study conducted in community urology practices in the US. High-risk patients who had radical prostatectomy received 12 cycles of apalutamide (240 mg daily; 28-day cycles) plus ADT. The primary end point was BCR-free survival. Secondary end points included testosterone recovery (≥150 ng/dL) and safety.
UNASSIGNED: One hundred eight patients were enrolled; median age was 66.0 years (range 46.0-77.0 years). Median preoperative PSA and baseline testosterone were 7.6 ng/mL (range 2.2-62.7 ng/mL) and 340.0 ng/dL (range 43.0-939.0 ng/dL), respectively. The BCR-free rate at 24 months (12 months after completion of planned therapy) was 100% (90% CI 93-100). Serum testosterone recovery rate (≥50 and ≥150 ng/dL) 12 months after treatment completion was 96% (95% CI 88-98) and 77% (95% CI 66-85), respectively. Overall, 107 (99%) patients experienced treatment-emergent adverse events, with 24 (22%) experiencing grade 3 to 4 events.
UNASSIGNED: In Apa-RP, BCR-free survival was 100% with 77% of patients having testosterone recovery (≥150 ng/dL) within 12 months of actual treatment completion and a manageable safety profile. These results provide proof of concept that treatment intensification with 12 cycles of apalutamide plus ADT could become an option for patients with high-risk localized prostate cancer who have undergone radical prostatectomy.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04523207.
UNASSIGNED: Apa-RP was a multicenter, open-label, single-arm, phase 2 study conducted in community urology practices in the US. High-risk patients who had radical prostatectomy received 12 cycles of apalutamide (240 mg daily; 28-day cycles) plus ADT. The primary end point was BCR-free survival. Secondary end points included testosterone recovery (≥150 ng/dL) and safety.
UNASSIGNED: One hundred eight patients were enrolled; median age was 66.0 years (range 46.0-77.0 years). Median preoperative PSA and baseline testosterone were 7.6 ng/mL (range 2.2-62.7 ng/mL) and 340.0 ng/dL (range 43.0-939.0 ng/dL), respectively. The BCR-free rate at 24 months (12 months after completion of planned therapy) was 100% (90% CI 93-100). Serum testosterone recovery rate (≥50 and ≥150 ng/dL) 12 months after treatment completion was 96% (95% CI 88-98) and 77% (95% CI 66-85), respectively. Overall, 107 (99%) patients experienced treatment-emergent adverse events, with 24 (22%) experiencing grade 3 to 4 events.
UNASSIGNED: In Apa-RP, BCR-free survival was 100% with 77% of patients having testosterone recovery (≥150 ng/dL) within 12 months of actual treatment completion and a manageable safety profile. These results provide proof of concept that treatment intensification with 12 cycles of apalutamide plus ADT could become an option for patients with high-risk localized prostate cancer who have undergone radical prostatectomy.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04523207.
摘要：
■大约25％至50％的高风险局限性前列腺癌患者在根治性前列腺切除术的2年内经历生化复发。Apa-RP研究（NCT04523207）研究了在接受根治性前列腺切除术的高危患者中，辅助阿帕鲁胺联合雄激素剥夺治疗是否可以改善生化无复发生存率。
■Apa-RP是一个多中心，开放标签，单臂,在美国社区泌尿外科实践中进行的2期研究。接受根治性前列腺切除术的高危患者接受了12个周期的阿帕鲁胺（每天240mg；28天周期）加雄激素剥夺治疗。主要终点是无生化复发生存期。次要终点包括睾酮恢复(≥150ng/dL)和安全性。
■共纳入108名患者；中位年龄为66.0岁（范围46.0-77.0）。术前前列腺特异性抗原中位数和基线睾酮分别为7.6ng/mL（范围2.2-62.7）和340.0ng/dL（范围43.0-939.0），分别。24个月（完成计划治疗后12个月）的生化无复发率为100％（90％CI93-100）。治疗完成后12个月血清睾酮恢复率（≥50和≥150ng/dL）为96%（95%CI88-98）和77%（95%CI66-85），分别。总的来说,107名（99%）患者经历了因治疗引起的不良事件，24（22%）经历3至4级事件。
■在Apa-RP中，无BCR生存率为100％，其中77％的患者在实际治疗完成后12个月内睾酮恢复（≥150ng/dL），安全性可控。这些结果提供了概念的证据，即12个周期的阿帕鲁胺加ADT的治疗强化可以成为接受根治性前列腺切除术的高风险局限性前列腺癌患者的选择。
■Apa-RP是一个多中心，开放标签，单臂,在美国社区泌尿外科实践中进行的2期研究。接受根治性前列腺切除术的高危患者接受了12个周期的阿帕鲁胺（每天240mg；28天周期）加雄激素剥夺治疗。主要终点是无生化复发生存期。次要终点包括睾酮恢复(≥150ng/dL)和安全性。
■共纳入108名患者；中位年龄为66.0岁（范围46.0-77.0）。术前前列腺特异性抗原中位数和基线睾酮分别为7.6ng/mL（范围2.2-62.7）和340.0ng/dL（范围43.0-939.0），分别。24个月（完成计划治疗后12个月）的生化无复发率为100％（90％CI93-100）。治疗完成后12个月血清睾酮恢复率（≥50和≥150ng/dL）为96%（95%CI88-98）和77%（95%CI66-85），分别。总的来说,107名（99%）患者经历了因治疗引起的不良事件，24（22%）经历3至4级事件。
■在Apa-RP中，无BCR生存率为100％，其中77％的患者在实际治疗完成后12个月内睾酮恢复（≥150ng/dL），安全性可控。这些结果提供了概念的证据，即12个周期的阿帕鲁胺加ADT的治疗强化可以成为接受根治性前列腺切除术的高风险局限性前列腺癌患者的选择。
