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一项关于前列腺切除术后肉眼可见前列腺床复发的立体定向挽救性放射治疗(STARR,NCT05455736)的前瞻性试验的三个月前列腺特异性抗原(PSA)及毒性反应

Three Months' PSA and Toxicity from a Prospective Trial Investigating STereotactic sAlvage Radiotherapy for Macroscopic Prostate Bed Recurrence after Prostatectomy-STARR (NCT05455736).

作者信息

Francolini Giulio, Garlatti Pietro, Di Cataldo Vanessa, Detti Beatrice, Loi Mauro, Greto Daniela, Simontacchi Gabriele, Morelli Ilaria, Burchini Luca, Allegra Andrea Gaetano, Frosini Giulio, Ganovelli Michele, Salvestrini Viola, Olmetto Emanuela, Visani Luca, Becherini Carlotta, Valzano Marianna, Carnevale Maria Grazia, Roghi Manuele, Serni Sergio, Mattioli Chiara, Desideri Isacco, Livi Lorenzo

机构信息

Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, 50134 Firenze, Italy.

Department of Biomedical, Experimental and Clinical Sciences "M. Serio", University of Florence, 50121 Firenze, Italy.

出版信息

Cancers (Basel). 2023 Feb 3;15(3):992. doi: 10.3390/cancers15030992.

Abstract

Biochemical recurrences after radical prostatectomy (RP) can be managed with curative purpose through salvage radiation therapy (SRT). RT dose escalation, such as stereotactic RT (SSRT), may improve relapse-free survival in this setting. STARR trial (NCT05455736) is a prospective multicenter study including patients affected by macroscopic recurrence within the prostate bed after RP treated with SSRT. Recurrence was detected with a Choline or PSMA CT-PET. In the current analysis, the early biochemical response (BR) rate and toxicity profile after three months of follow-up were assessed. Twenty-five patients were enrolled, and data about BR and toxicity at three months after treatment were available for 19 cases. Overall, BR was detected after three months in 58% of cases. Four G1-G2 adverse events were recorded; no G ≥ 3 adverse events were detected. SSRT appears feasible and safe, with more than half of patients experiencing BR and an encouraging toxicity profile. The STARR trial is one of the few prospective studies aimed at implementing this promising treatment strategy in this scenario.

摘要

根治性前列腺切除术后(RP)的生化复发可通过挽救性放射治疗(SRT)进行有治愈目的的处理。放射剂量递增,如立体定向放疗(SSRT),可能会改善这种情况下的无复发生存率。STARR试验(NCT05455736)是一项前瞻性多中心研究,纳入了RP术后前列腺床出现肉眼可见复发且接受SSRT治疗的患者。通过胆碱或PSMA CT-PET检测复发情况。在本次分析中,评估了随访三个月后的早期生化反应(BR)率和毒性特征。共纳入25例患者,其中19例有治疗三个月后BR和毒性的数据。总体而言,三个月后58%的病例检测到BR。记录到4例G1-G2级不良事件;未检测到G≥3级不良事件。SSRT似乎可行且安全,超过半数患者出现BR,毒性特征令人鼓舞。STARR试验是少数旨在在这种情况下实施这种有前景的治疗策略的前瞻性研究之一。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/637c/9913280/80a857ec6ea4/cancers-15-00992-g001.jpg

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