一项关于前列腺特异性抗原引导下的挽救性放疗及镓-前列腺特异性膜抗原正电子发射断层扫描用于根治性前列腺切除术后生化复发的前瞻性II期研究——PROPER 1试验。
A prospective phase II study of prostate-specific antigen-guided salvage radiotherapy and Ga-PSMA-PET for biochemical relapse after radical prostatectomy - The PROPER 1 trial.
作者信息
Gunnlaugsson Adalsteinn, Johannesson Vilberg, Wieslander Elinore, Brun Eva, Bitzen Ulrika, Ståhl Olof, Bratt Ola, Ahlgren Göran, Ohlsson Tomas, Kjellén Elisabeth, Nilsson Per
机构信息
Department of Oncology and Radiation Physics, Skåne University Hospital and Lund University, Lund, Sweden.
Department of Clinical Physiology and Nuclear Medicine, Skåne University Hospital and Lund University, Lund, Sweden.
出版信息
Clin Transl Radiat Oncol. 2022 Jul 5;36:77-82. doi: 10.1016/j.ctro.2022.07.001. eCollection 2022 Sep.
BACKGROUND AND PURPOSE
The treatment of biochemical recurrence (BCR) after prostatectomy is challenging as the site of the recurrence is often undetectable. Our aim was to test a personalised treatment concept for BCR based on PSA kinetics during salvage radiotherapy (SRT) combined with prostate-specific membrane antigen positron emission tomography (PSMA-PET).
MATERIALS AND METHODS
This phase II trial included 100 patients with BCR. PSMA-PET was performed at baseline. PSA was measured weekly during SRT. Initially, 70 Gy in 35 fractions was prescribed to the prostate bed. Radiotherapy was adapted after 50 Gy. Non-responders (PSA still ≥ 0.15 ng/mL) received sequential lymph node irradiation with a boost to PSMA-PET positive lesions, while responders (PSA < 0.15 ng/mL) continued SRT as planned. PET-findings were only taken into consideration for treatment planning in case of PSA non-response after 50 Gy.
RESULTS
Data from 97 patients were eligible for analysis. Thirty-four patients were classified as responders and 63 as non-responders. PSMA-PET was positive in 3 patients (9%) in the responder group and in 22 (35%) in the non-responder group (p = 0.007). The three-year failure-free survival was 94% for responders and 68% for non-responders (median follow-up 38 months). There were no significant differences in physician-reported urinary and bowel toxicity. Patient-reported diarrhoea at end of SRT was more common among non-responders.
CONCLUSION
This new personalised treatment concept with intensified SRT based on PSA response demonstrated a high tumour control rate in both responders and non-responders. These results suggest a clinically significant effect with moderate side effects in a patient group with otherwise poor prognosis. PSMA-PET added limited value. The treatment approach is now being evaluated in a phase III trial.Clinical trial registration numbers: NCT02699424&ISRCTN45905321.
背景与目的
前列腺切除术后生化复发（BCR）的治疗具有挑战性，因为复发部位往往难以检测到。我们的目的是基于挽救性放疗（SRT）期间的PSA动力学并结合前列腺特异性膜抗原正电子发射断层扫描（PSMA-PET），测试一种针对BCR的个性化治疗方案。
材料与方法
这项II期试验纳入了100例BCR患者。在基线时进行PSMA-PET检查。在SRT期间每周测量PSA。最初，对前列腺床给予35次分割共70 Gy的照射剂量。在50 Gy后调整放疗方案。无反应者（PSA仍≥0.15 ng/mL）接受序贯淋巴结照射，并对PSMA-PET阳性病变进行加量照射，而有反应者（PSA<0.15 ng/mL）按计划继续进行SRT。仅在50 Gy后PSA无反应的情况下，PET检查结果才用于治疗计划。
结果
97例患者的数据符合分析要求。34例患者被分类为有反应者，63例为无反应者。有反应者组中有3例（9%）PSMA-PET呈阳性，无反应者组中有22例（35%）呈阳性（p = 0.007）。有反应者的三年无失败生存率为94%，无反应者为68%（中位随访38个月）。医生报告的泌尿和肠道毒性无显著差异。在无反应者中，患者报告的SRT结束时腹泻更为常见。
结论
这种基于PSA反应强化SRT的新个性化治疗方案在有反应者和无反应者中均显示出较高的肿瘤控制率。这些结果表明，在预后较差的患者群体中，该方案具有临床显著效果且副作用中等。PSMA-PET增加的价值有限。目前正在一项III期试验中评估这种治疗方法。临床试验注册号：NCT02699424&ISRCTN45905321。
Zotero 插件