Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.
Department of Urology, Providence Cancer Center, Southfield, MI, USA.
Eur Urol. 2017 Oct;72(4):617-624. doi: 10.1016/j.eururo.2017.02.007. Epub 2017 Feb 21.
Erectile dysfunction remains the most common side effect from radical treatment of localized prostate cancer. We hypothesized that the use of vessel-sparing radiotherapy, analogous to the functional anatomy approach of nerve-sparing radical prostatectomy (RP), would improve erectile function preservation while maintaining tumor control for men with localized prostate cancer.
To determine erectile function rates after vessel-sparing radiotherapy.
DESIGN, SETTING, AND PARTICIPANTS: Men with localized prostate cancer were enrolled in a phase 2 single-arm trial (NCT02958787) at a single academic center.
Patients received vessel-sparing radiotherapy utilizing a planning MRI and MRI-angiogram to delineate and avoid the erectile vasculature.
Both physician- and patient-reported inventories were used to capture erectile function at baseline and at 2 and 5 yr after treatment. Validated model-based comparisons were performed to compare vessel-sparing results to nerve-sparing RP and conventional radiotherapy.
From 2001 to 2009, 135 men underwent vessel-sparing radiotherapy. After a planned interim analysis, the trial was stopped after meeting the primary endpoint. The median follow-up was 8.7 yr, with a ≥94% response rate to all inventories at each time point. At 5 yr, 88% of patients were sexually active with or without the use of sexual aids. The 2-yr erectile function rates were significantly improved with vessel-sparing radiotherapy (78%, 95% confidence interval [CI] 71-85%) compared to modeled rates for convention radiotherapy (42%, 95% CI 38-45%; p<0.001) or nerve-sparing prostatectomy (24%, 95% CI 22-27%; p<0.001). At 2 yr after treatment, 87% of baseline-potent men retained erections suitable for intercourse. The 5- and 10-yr rates of biochemical relapse-free survival were 99.3% and 89.9%, and at 5 yr the biochemical failures were limited to the National Comprehensive Cancer Network high-risk group. The single-arm design is a limitation.
Vessel-sparing radiotherapy appears to more effectively preserve erectile function when compared to historical series and model-predicted outcomes following nerve-sparing RP or conventional radiotherapy, with maintenance of tumor control. This approach warrants independent validation.
In this interim analysis we looked at using a novel approach to spare critical erectile structures to preserve erectile function after prostate cancer radiotherapy. We found that almost 90% of patients at 5 yr after treatment remained sexually active, significantly higher than previous studies with surgery or radiotherapy.
勃起功能障碍仍然是局部前列腺癌根治性治疗中最常见的副作用。我们假设，采用类似保留神经的根治性前列腺切除术（RP）的功能解剖方法的血管保留放疗，在保持肿瘤控制的同时，能够改善勃起功能的保留，用于治疗局部前列腺癌患者。
确定血管保留放疗后的勃起功能率。
设计、地点和参与者：在一个学术中心，对局部前列腺癌患者进行了一项 2 期单臂试验（NCT02958787）。
患者接受了血管保留放疗，使用规划 MRI 和 MRI 血管造影来描绘和避开勃起血管。
在治疗后 2 年和 5 年，分别使用医生和患者报告的清单来评估勃起功能。采用基于模型的验证性比较方法，将血管保留结果与保留神经的 RP 和常规放疗进行比较。
2001 年至 2009 年，135 名男性接受了血管保留放疗。在计划进行中期分析后，在达到主要终点后，试验停止。中位随访时间为 8.7 年，所有时间点的所有清单的应答率均≥94%。在 5 年时，88%的患者有性生活，无论是否使用性辅助工具。与常规放疗（42%，95%置信区间[CI] 38-45%；p<0.001）或保留神经的前列腺切除术（24%，95%置信区间[CI] 22-27%；p<0.001）的预测模型相比，血管保留放疗的 2 年勃起功能率显著提高（78%，95%CI 71-85%）。在治疗后 2 年，87%基线勃起功能正常的患者保留了适合性交的勃起。5 年和 10 年的生化无复发生存率分别为 99.3%和 89.9%，5 年时生化失败仅限于国家综合癌症网络高危组。单臂设计是一个局限性。
与保留神经的 RP 或常规放疗后的历史系列和模型预测结果相比，血管保留放疗似乎更有效地保留勃起功能，同时保持肿瘤控制。这种方法需要独立验证。
在这项中期分析中，我们研究了一种新的方法，通过保留关键的勃起结构来保护前列腺癌放疗后的勃起功能。我们发现，在治疗后 5 年，近 90%的患者仍然有性生活，明显高于以前的手术或放疗研究。
