- 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
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.