Purpose/Objectives: Salvage radiotherapy (SRT) after a radical prostatectomy is a curative approach for patients with biochemical recurrence (BR). However, outcomes are often less favorable when imaging reveals macroscopic local recurrence. In such cases, dose escalation through stereotactic salvage radiotherapy (SSRT) may offer improved disease control. The STARR trial (NCT05455736) is a prospective, multicenter study evaluating the efficacy and safety of SSRT in patients with macroscopic prostate bed recurrence. This interim analysis reports early findings from the initial patient cohort. Materials and Methods: Patients with BR (PSA > 0.2 ng/mL) post-prostatectomy and PET-confirmed macroscopic recurrence (PSMA or Choline PET, confirmed by MRI) were eligible. Treatment involved CyberKnife®-based SSRT delivering 35 Gy in five fractions to the visible lesion. Androgen deprivation therapy (ADT) was not permitted. Complete biochemical response (CBR) was defined as PSA < 0.2 ng/mL, and biochemical response (BR) as a ≥50% PSA reduction. Additional outcomes included biochemical, radiological, and ADT-free survival (bPFS, rPFS, aPFS). Results: As of analysis, 51 patients were enrolled, with a median follow-up of 16 months (95% CI: 16–22). CBR and BR were achieved in 45.1% and 80.4% of patients, respectively. Events affecting bPFS, rPFS, and aPFS occurred in 12, 5, and 6 patients, with median values not yet reached. Toxicity was minimal, with two cases each of acute grade 2 GI and GU events, and one late grade 2 GI event. No grade ≥ 3 toxicities were reported. Conclusion: Early data support SSRT as a safe and a promising option for macroscopic local recurrence, with encouraging response rates and minimal toxicity.
目的/目标：根治性前列腺切除术后挽救性放疗（SRT）是治疗生化复发（BR）患者的根治性手段。然而，当影像学检查发现肉眼可见的局部复发时，治疗效果往往不佳。在此类情况下，通过立体定向挽救性放疗（SSRT）进行剂量递增可能提供更好的疾病控制。STARR试验（NCT05455736）是一项前瞻性、多中心研究，旨在评估SSRT治疗肉眼可见前列腺床复发的疗效和安全性。本中期分析报告了初始患者队列的早期结果。 材料与方法：入组标准为前列腺切除术后出现BR（PSA > 0.2 ng/mL）且经PET（PSMA或胆碱PET，并经MRI确认）证实为肉眼可见复发的患者。治疗采用基于射波刀®的SSRT，对可见病灶分5次照射，总剂量35 Gy。不允许使用雄激素剥夺疗法（ADT）。完全生化反应（CBR）定义为PSA < 0.2 ng/mL，生化反应（BR）定义为PSA降低≥50%。其他观察指标包括生化、影像学和无ADT生存期（bPFS、rPFS、aPFS）。 结果：截至分析时，共入组51例患者，中位随访时间为16个月（95% CI：16–22）。分别有45.1%和80.4%的患者达到CBR和BR。发生影响bPFS、rPFS和aPFS的事件分别为12例、5例和6例，中位值尚未达到。毒性反应轻微，急性2级胃肠道（GI）和泌尿生殖道（GU）事件各2例，晚期2级GI事件1例。未报告≥3级毒性反应。 结论：早期数据支持SSRT是治疗肉眼可见局部复发的一种安全且前景良好的选择，其反应率令人鼓舞且毒性反应极小。
肿瘤(癌症)患者之家