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

Author:

Francolini Giulio1,Garlatti Pietro1,Di Cataldo Vanessa1,Detti Beatrice1,Loi Mauro1,Greto Daniela1,Simontacchi Gabriele1,Morelli Ilaria2ORCID,Burchini Luca2,Allegra Andrea Gaetano2,Frosini Giulio2,Ganovelli Michele2,Salvestrini Viola3ORCID,Olmetto Emanuela1,Visani Luca3,Becherini Carlotta1,Valzano Marianna2,Carnevale Maria Grazia2,Roghi Manuele2,Serni Sergio4,Mattioli Chiara2,Desideri Isacco2,Livi Lorenzo2

Affiliation:

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

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

3. CyberKnife Center, Istituto Fiorentino di Cura e Assistenza (IFCA), 50134 Firenze, Italy

4. Department of Urologic Robotic Surgery and Renal Transplantation, Careggi Hospital, University of Florence, 50121 Firenze, Italy

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.

Publisher

MDPI AG

Subject

Cancer Research,Oncology

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