Nguyen Paul V, Donneaux Bertrand, Louis Céline, Bodgal Zsuzsa, Philippi Sven, Biver Sylvie, Frederick Bérangère, Harzé Ludovic, Lasar Yves, Vogin Guillaume, Nickers Philippe
Department of Radiotherapy, CHU UCL Namur - Site Saint Elisabeth, Namur, Belgium.
Department of Radiotherapy, Centre François Baclesse, Esch-sur-Alzette, Luxembourg.
Front Oncol. 2023 Apr 6;13:1143716. doi: 10.3389/fonc.2023.1143716. eCollection 2023.
Since radical treatments in low risk prostate cancer do not improve overall survival in comparison to active surveillance, preserving quality of life (QOL) remains the key objective. Active surveillance of indolent prostate cancer avoids curative treatment side-effects but necessitates repeated biopsies. Focal stereotactic body radiation therapy (focal SBRT) may be an alternative. This non-randomized Phase-II trial examined the feasibility and safety of focal SBRT for low and favorable intermediate-risk prostate cancer.
Patients were recruited in 2016-2019 if they had: localized CAPRA ≤ 3 prostate adenocarcinoma; an isolated PIRADS≥4 macroscopic tumor on MRI; WHO Performance Status 0-1; and no major urinary symptoms. 36.25 Gy (80% isodose prescription) were delivered in 5 fractions every other day. Primary outcome was delay between focal SBRT and salvage-treatment initiation. Secondary outcomes were: acute/late genitourinary/rectal toxicity; biological, clinical and MRI local control; and change in QOL measures.
Over a median follow-up of 36 months, salvage prostatectomy in the 24 eligible patients was never required. Three-year biochemical progression-free survival was 96%. The single biochemical recurrence was a small (2-mm) Gleason 6 (3 + 3) lesion in the non-irradiated lobe. All 19 patients with ≥1 post-treatment MRI evaluations demonstrated complete radiological response. Acute/late grade ≥3 toxicities did not occur: all acute toxicities were grade-1 genitourinary (38% patients), grade-2 genitourinary (8%), or grade-1 rectal (13%) toxicities. There was one (4%) late grade-1 genitourinary toxicity. QOL was unchanged at last follow-up, as shown by IPSS (2.86 to 3.29, p>0.05), U-QOL (0.71 to 0.67, p>0.05), and IIEF5 (the 14 initially potent patients maintained potency (IIEF5 > 16)).
Focal SBRT is feasible, well-tolerated, and preserves QOL. This innovative robotized approach challenges active surveillance.
由于与主动监测相比，低风险前列腺癌的根治性治疗并不能提高总体生存率，因此保持生活质量（QOL）仍然是关键目标。惰性前列腺癌的主动监测可避免根治性治疗的副作用，但需要重复进行活检。立体定向体部聚焦放射治疗（focal SBRT）可能是一种替代方法。这项非随机II期试验研究了focal SBRT用于低风险和有利的中风险前列腺癌的可行性和安全性。
2016年至2019年招募患者，入选标准为：局限性CAPRA≤3的前列腺腺癌；MRI上孤立的PIRADS≥4的宏观肿瘤；世界卫生组织表现状态0-1；且无严重泌尿系统症状。每隔一天分5次给予36.25 Gy（80%等剂量处方）。主要结局是focal SBRT与挽救性治疗开始之间的延迟。次要结局包括：急性/晚期泌尿生殖系统/直肠毒性；生物学、临床和MRI局部控制；以及生活质量测量指标的变化。
中位随访36个月期间，24例符合条件的患者从未需要进行挽救性前列腺切除术。三年生化无进展生存率为96%。唯一的生化复发是未照射叶中的一个小（2毫米）Gleason 6（3+3）病变。所有19例接受≥1次治疗后MRI评估的患者均显示完全放射学缓解。未发生急性/晚期≥3级毒性：所有急性毒性均为1级泌尿生殖系统毒性（38%的患者）、2级泌尿生殖系统毒性（8%）或1级直肠毒性（13%）。有1例（4%）晚期1级泌尿生殖系统毒性。如国际前列腺症状评分（IPSS）（从2.86至3.29，p>0.05）、泌尿生活质量评分（U-QOL）（从0.71至0.67，p>0.05）和国际勃起功能指数5（IIEF5）（最初14例有性功能的患者保持性功能（IIEF5>16））所示，最后一次随访时生活质量未发生变化。
focal SBRT是可行的，耐受性良好，并能保持生活质量。这种创新的机器人化方法对主动监测提出了挑战。
