Abstract：
OBJECTIVE: To assess efficacy and safety of prostatic artery embolization (PAE) in patients with advanced prostate cancer (PCa).
METHODS: In this prospective single-center, single-arm, pilot study, 9 men with advanced PCa underwent PAE. PAE was performed with the use of 250-400 µm Embozene microspheres (Boston Scientific, Natick, Massachusetts, USA). International Prostate Symptoms Score (IPSS), urinary peak flow (Qmax) and post-void residual urine volume (PVR) was assessed at 12 weeks and up to 12 months. Changes in total prostate volume (TPV) and tumor responses by PSA, changes in tumor volume and evaluation of tumor regression by multiparametric magnetic resonance imaging were assessed at 12 weeks after PAE.
RESULTS: IPSS reduction in median 6 points (0-19) and a significant decrease in PVR from median 70 (20-600) mL to 10 (0-280) mL could be achieved within 12 weeks after PAE. Median TPV and tumor volumes (TV) increased slightly from 19.7 (6.4-110.8) mL to 23.4 (2.4-66.3) mL and 6.4 (4.6-18.3) mL to 8.1 (2.4-25.6) mL at a median of 12 weeks after the procedure. Significant tumor necrosis (≥ 50%) was found in one patient. Eight patients showed > 50% of viable tumor on post-PAE MRI according to MRI. Only one Clavien-Dindo Grade 1 adverse event related to PAE occurred.
CONCLUSIONS: PAE with the use of 250-400 µm microspheres is feasible, safe and effective in some patients with advanced PCa regarding functional outcomes. A cytoreductive effect might be achieved in individual patients but must be further assessed.
BACKGROUND: NCT03457805.
METHODS: In this prospective single-center, single-arm, pilot study, 9 men with advanced PCa underwent PAE. PAE was performed with the use of 250-400 µm Embozene microspheres (Boston Scientific, Natick, Massachusetts, USA). International Prostate Symptoms Score (IPSS), urinary peak flow (Qmax) and post-void residual urine volume (PVR) was assessed at 12 weeks and up to 12 months. Changes in total prostate volume (TPV) and tumor responses by PSA, changes in tumor volume and evaluation of tumor regression by multiparametric magnetic resonance imaging were assessed at 12 weeks after PAE.
RESULTS: IPSS reduction in median 6 points (0-19) and a significant decrease in PVR from median 70 (20-600) mL to 10 (0-280) mL could be achieved within 12 weeks after PAE. Median TPV and tumor volumes (TV) increased slightly from 19.7 (6.4-110.8) mL to 23.4 (2.4-66.3) mL and 6.4 (4.6-18.3) mL to 8.1 (2.4-25.6) mL at a median of 12 weeks after the procedure. Significant tumor necrosis (≥ 50%) was found in one patient. Eight patients showed > 50% of viable tumor on post-PAE MRI according to MRI. Only one Clavien-Dindo Grade 1 adverse event related to PAE occurred.
CONCLUSIONS: PAE with the use of 250-400 µm microspheres is feasible, safe and effective in some patients with advanced PCa regarding functional outcomes. A cytoreductive effect might be achieved in individual patients but must be further assessed.
BACKGROUND: NCT03457805.
摘要：
目的：评价前列腺动脉栓塞术（PAE）治疗晚期前列腺癌（PCa）的疗效和安全性。
方法：在这个前瞻性单中心中，单臂,试点研究,9名患有先进PCa的男子接受了PAE。PAE是使用250-400μmEmbozene微球进行的(波士顿科学，纳蒂克,马萨诸塞州,美国）。国际前列腺症状评分（IPSS）在12周至12个月时评估尿峰流量(Qmax)和排尿后残余尿量(PVR).前列腺总体积（TPV）的变化和PSA的肿瘤反应，在PAE后12周评估肿瘤体积的变化和通过多参数磁共振成像评估肿瘤消退.
结果：在PAE后12周内，IPSS中位数降低6分（0-19），PVR中位数从70（20-600）mL显著降低至10（0-280）mL。中位TPV和肿瘤体积（TV）从19.7（6.4-110.8）mL略微增加到23.4（2.4-66.3）mL和6.4（4.6-18.3）mL到8.1（2.4-25.6）mL手术后12周。在一名患者中发现了明显的肿瘤坏死（≥50％）。根据MRI，八名患者在PAE后MRI上显示>50％的存活肿瘤。仅发生一例与PAE相关的Clavien-Dindo1级不良事件。
结论：PAE使用250-400μm微球是可行的，在某些晚期PCa患者的功能结局方面安全有效.在个体患者中可能实现细胞还原效应,但必须进一步评估。
背景：NCT03457805。
方法：在这个前瞻性单中心中，单臂,试点研究,9名患有先进PCa的男子接受了PAE。PAE是使用250-400μmEmbozene微球进行的(波士顿科学，纳蒂克,马萨诸塞州,美国）。国际前列腺症状评分（IPSS）在12周至12个月时评估尿峰流量(Qmax)和排尿后残余尿量(PVR).前列腺总体积（TPV）的变化和PSA的肿瘤反应，在PAE后12周评估肿瘤体积的变化和通过多参数磁共振成像评估肿瘤消退.
结果：在PAE后12周内，IPSS中位数降低6分（0-19），PVR中位数从70（20-600）mL显著降低至10（0-280）mL。中位TPV和肿瘤体积（TV）从19.7（6.4-110.8）mL略微增加到23.4（2.4-66.3）mL和6.4（4.6-18.3）mL到8.1（2.4-25.6）mL手术后12周。在一名患者中发现了明显的肿瘤坏死（≥50％）。根据MRI，八名患者在PAE后MRI上显示>50％的存活肿瘤。仅发生一例与PAE相关的Clavien-Dindo1级不良事件。
结论：PAE使用250-400μm微球是可行的，在某些晚期PCa患者的功能结局方面安全有效.在个体患者中可能实现细胞还原效应,但必须进一步评估。
背景：NCT03457805。
