Fonteyne Valérie, Van Praet Charles, Ost Piet, Van Bruwaene Siska, Liefhooghe Nick, Berghen Charlien, De Meerleer Gert, Vanneste Ben, Verbaeys Caroline, Verbeke Sofie, Lumen Nicolaas
Department of Radiotherapy-Oncology, Ghent University Hospital, Ghent, Belgium.
Department of Urology, Ghent University Hospital, Ghent, Belgium.
Eur Urol Focus. 2023 Mar;9(2):317-324. doi: 10.1016/j.euf.2022.09.005. Epub 2022 Sep 23.
The optimal treatment for patients with pathological node-positive (pN1) prostate cancer (PCa) is unclear.
To evaluate whether whole-pelvis radiotherapy (WPRT) improves clinical relapse-free survival (cRFS) in comparison to prostate-only radiotherapy (PORT) in pN1 PCa.
DESIGN, SETTING, AND PARTICIPANTS: PROPER was a phase 3 trial randomizing patients to WPRT or PORT. All patients had pN1cM0 PCa with fewer than five lymph nodes involved.
All patients underwent pelvic lymph node dissection followed by radical prostatectomy/primary radiotherapy + 2 yr of androgen deprivation therapy (ADT). Patients were randomized to PORT (arm A) or WPRT (arm B).
The primary outcome was cRFS. The secondary endpoints were overall survival (OS), biochemical relapse-free survival (bRFS), and toxicity. The study was stopped because of poor accrual in June 2021 after the inclusion of 69 patients. We report on OS, bRFS, cRFS, and acute and late toxicity.
The median follow-up was 30 mo in arm A (n = 33) and 36 mo in arm B (n = 31). The 3-yr OS rate was 92% ± 5% in arm A and 93% ± 5% in arm B (p = 0.61). None of the patients died of PCa. The 3-yr bRFS was 79% ± 9% in arm A and 92% ± 5% in arm B (p = 0.08). The 3-yr cRFS rate was 88% ± 6% in arm A and 92% ± 5% in arm B (p = 0.31). No pelvic recurrence was observed in arm B. Acute grade 2 gastrointestinal toxicity was higher with WPRT (15% in arm A vs 45% in arm B; p = 0.03). Limitations are the early closure because of poor accrual and the limited follow-up.
The results of our trial are hypothesis-generating but add evidence supporting the recommendation to offer WPRT to patients with pN1 PCa. However, WPRT is associated with more acute gastrointestinal toxicity.
We looked at the impact of radiotherapy to the whole pelvis (WPRT) for patients with prostate cancer that had spread to the lymph nodes. Although the trial was closed early because of poor enrolment, we found that WPRT improves survival free from relapse, and no recurrences were observed in the pelvis. WPRT is associated with more acute side effects on the gastrointestinal system in comparison to radiotherapy to just the prostate.
病理淋巴结阳性（pN1）前列腺癌（PCa）患者的最佳治疗方案尚不清楚。
评估在pN1前列腺癌中，与仅行前列腺放疗（PORT）相比，全盆腔放疗（WPRT）是否能改善临床无复发生存期（cRFS）。
设计、设置和参与者：PROPER是一项3期试验，将患者随机分为WPRT组或PORT组。所有患者均为pN1cM0前列腺癌，受累淋巴结少于5个。
所有患者均接受盆腔淋巴结清扫，随后行根治性前列腺切除术/初次放疗 + 2年雄激素剥夺治疗（ADT）。患者被随机分为PORT组（A组）或WPRT组（B组）。
主要结局为cRFS。次要终点为总生存期（OS）、生化无复发生存期（bRFS）和毒性。由于入组情况不佳，该研究于2021年6月纳入69例患者后停止。我们报告了OS、bRFS、cRFS以及急性和晚期毒性。
A组（n = 33）的中位随访时间为30个月，B组（n = 31）为36个月。A组3年总生存率为92%±5%，B组为93%±5%（p = 0.61）。没有患者死于前列腺癌。A组3年bRFS为79%±9%，B组为92%±5%（p = 0.08）。A组3年cRFS率为88%±6%，B组为92%±5%（p = 0.31）。B组未观察到盆腔复发。WPRT组急性2级胃肠道毒性更高（A组为15%，B组为45%；p = 0.03）。局限性在于因入组不佳而提前结束以及随访有限。
我们试验的结果具有假设生成性，但增加了支持向pN1前列腺癌患者提供WPRT这一建议的证据。然而，WPRT与更多的急性胃肠道毒性相关。
我们研究了对已扩散至淋巴结的前列腺癌患者进行全盆腔放疗（WPRT）的影响。尽管该试验因入组不佳而提前结束，但我们发现WPRT可改善无复发生存期，且盆腔未观察到复发。与仅对前列腺进行放疗相比，WPRT与更多的急性胃肠道系统副作用相关。
