Shore Neal, Hafron Jason, Saltzstein Daniel, Brown Gordon, Belkoff Laurence, Aggarwal Pankaj, Phillips Jennifer, Bhaumik Amitabha, McGowan Tracy
Carolina Urologic Research Center, Myrtle Beach, South Carolina.
Michigan Institute of Urology, West Bloomfield, Michigan.
J Urol. 2024 Nov;212(5):682-691. doi: 10.1097/JU.0000000000004163. Epub 2024 Aug 1.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT04523207.
约25%至50%的高危局限性前列腺癌患者在根治性前列腺切除术后2年内会出现生化复发（BCR）。Apa-RP研究（NCT04523207）调查了在接受根治性前列腺切除术的高危患者中，辅助使用阿帕他胺加雄激素剥夺疗法（ADT）是否能改善无BCR生存期。
Apa-RP是一项在美国社区泌尿外科诊所进行的多中心、开放标签、单臂2期研究。接受根治性前列腺切除术的高危患者接受12个周期的阿帕他胺（每日240毫克；28天为一个周期）加ADT治疗。主要终点是无BCR生存期。次要终点包括睾酮恢复（≥150纳克/分升）和安全性。
共纳入108例患者；中位年龄为66.0岁（范围46.0 - 77.0岁）。术前中位PSA和基线睾酮分别为7.6纳克/毫升（范围2.2 - 62.7纳克/毫升）和340.0纳克/分升（范围43.0 - 939.0纳克/分升）。24个月（计划治疗完成后12个月）时的无BCR率为100%（90%CI 93 - 100）。治疗完成后12个月时血清睾酮恢复率（≥50和≥150纳克/分升）分别为96%（95%CI 88 - 98）和77%（95%CI 66 - 85）。总体而言，107例（99%）患者出现治疗中出现的不良事件，其中24例（22%）出现3至4级事件。
在Apa-RP研究中，无BCR生存期为100%，77%的患者在实际治疗完成后12个月内睾酮恢复（≥150纳克/分升），且安全性可控。这些结果提供了概念验证，即12个周期的阿帕他胺加ADT强化治疗可能成为接受根治性前列腺切除术的高危局限性前列腺癌患者的一种选择。
ClinicalTrials.gov标识符：NCT04523207。
