1. Early biochemical outcomes following PSMA guided approach for bIoCHEmical relapse after prostatectomy-PSICHE trial (NCT05022914): preliminary results.
- Author
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Francolini, Giulio, Francolini, Giulio, Ganovelli, Michele, Di Cataldo, Vanessa, Detti, Beatrice, Caini, Saverio, Loi, Mauro, Simontacchi, Gabriele, Desideri, Isacco, Greto, Daniela, Valzano, Marianna, Serni, Sergio, Vaggelli, Luca, Salvestrini, Viola, Visani, Luca, Becherini, Carlotta, Olmetto, Emanuela, Franzese, Ciro, Baldaccini, Davide, Scorsetti, Marta, Sollini, Martina, Chiti, Arturo, Meattini, Icro, Valicenti, Richard K, Livi, Lorenzo, Francolini, Giulio, Francolini, Giulio, Ganovelli, Michele, Di Cataldo, Vanessa, Detti, Beatrice, Caini, Saverio, Loi, Mauro, Simontacchi, Gabriele, Desideri, Isacco, Greto, Daniela, Valzano, Marianna, Serni, Sergio, Vaggelli, Luca, Salvestrini, Viola, Visani, Luca, Becherini, Carlotta, Olmetto, Emanuela, Franzese, Ciro, Baldaccini, Davide, Scorsetti, Marta, Sollini, Martina, Chiti, Arturo, Meattini, Icro, Valicenti, Richard K, and Livi, Lorenzo
- Abstract
PSICHE (NCT05022914) is a prospective trial to test a [68Ga]Ga- PSMA-11 PET/CT imaging tailored strategy. All evaluable patients had biochemical relapse after surgery and underwent centralized [68Ga]Ga-PSMA-11 PET/CT imaging. The treatment was performed according pre-defined criteria. Observation and re-staging at further PSA progression were proposed to patients with negative PSMA and previous postoperative RT. Prostate bed SRT was proposed to all patients with a negative staging or positive imaging within prostate bed. Stereotactic body radiotherapy (SBRT) to all sites of disease was used for all patients with pelvic nodal recurrence (nodal disease < 2 cm under aortic bifurcation) or oligometastatic disease. At 3 months after treatment, 54.7% of patients had a complete biochemical response Only 2 patients experienced G2 Genitourinary toxicity. No G2 Gastrointestinal toxicity was recorded. A PSMA targeted treatment strategy led to encouraging results and was well tolerated.
- Published
- 2023